EZChar

30/06/10

Generic Name: charcoal (CHAR coal)
Brand Names: Actidose-Aqua, Activated Charcoal, Charcoal Plus DS, EZChar, Insta-Char, Liqui-Char, Optimum Charcoal

What is EZChar (charcoal)?

Charcoal is used to treat stomach pain caused by excess gas, diarrhea, or indigestion.

Charcoal also is used to relieve itching related to kidney dialysis treatment and to treat poisoning or drug overdose.

Charcoal may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about EZChar (charcoal)?

You should not use this medication if you have ever had an allergic reaction to charcoal.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease, or any type of serious illness.

In a poisoning or overdose situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

If you are taking charcoal at home to treat diarrhea, stop taking it and call your doctor if your diarrhea lasts longer than 2 days or you also have a fever. Do not take charcoal with any other medicine. Take your dose of charcoal at least 2 hours before or 1 hour after a dose of any other medicine. Charcoal binds to other drugs and can make them less effective, which could become dangerous.

What should I discuss with my healthcare provider before taking EZChar (charcoal)?

You should not use this medication if you have ever had an allergic reaction to charcoal.

If possible, before you receive charcoal, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;

  • kidney disease; or

  • any type of serious illness.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

It is not known whether charcoal is harmful to an unborn baby. Before you take charcoal, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether charcoal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

In a poisoning or overdose situation, it may not be possible to tell your caregivers that you are pregnant or breast-feeding before you are treated with charcoal. However, make sure any doctor caring for your pregnancy or your baby knows that you have received the medication.

Do not give this medication to a child younger than 1 year old without the advice of a doctor.


How should I take EZChar (charcoal)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass (8 ounces) of water. Do not crush, break, or chew a charcoal tablet or capsule. Swallow the pill whole.

Charcoal is usually taken after meals or at the first sign of stomach discomfort.

Stop taking charcoal and call your doctor if your diarrhea lasts longer than 2 days or you also have a fever.

Store charcoal at room temperature away from moisture and heat.

What happens if I miss a dose?

Since charcoal is often taken only when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of charcoal is not likely to cause life-threatening symptoms.

What should I avoid while taking EZChar (charcoal)?

Do not take charcoal with any other medicine. Take your dose of charcoal at least 2 hours before or 1 hour after a dose of any other medicine. Charcoal binds to other drugs and can make them less effective, which could become dangerous.

EZChar (charcoal) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect EZChar (charcoal)?

There may be other drugs that can interact with charcoal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about charcoal.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.02. Revision Date: 4/12/2009 4:39:00 PM.

 

ezetimibe

30/06/10

Generic Name: ezetimibe (ez ET i mibe)
Brand Names: Zetia

What is ezetimibe?

Ezetimibe reduces the amount of cholesterol absorbed by the body.

Ezetimibe is used to treat high cholesterol. Ezetimibe is sometimes given with other cholesterol-lowering medications.

Ezetimibe may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about ezetimibe?

Ezetimibe is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Some cholesterol medications should not be taken at the same time. Do not take ezetimibe with cholestyramine (Prevalite, Questran), colestipol (Colestid), or colesevelam (Welchol). Wait at least 4 hours after taking any of these medicines before you take ezetimibe. You may also take ezetimibe 2 hours before taking any of these other medicines.

Ezetimibe may be taken at the same time with fenofibrate (Antara, Lipofen, Lofibra, TriCor, Triglide), or with any of the “statin” drugs such as lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), fluvastatin (Lescol), atorvastatin (Lipitor), or cerivastatin (Baycol).

In rare cases, cholesterol-lowering medication can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

What should I discuss with my healthcare provider before taking ezetimibe?

You should not use this medication if you are allergic to ezetimibe, or if you have liver disease.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • kidney disease;

  • a thyroid disorder; or

  • if you use steroid medicine or hormones (including birth control pills).

In rare cases, cholesterol-lowering medication can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine. FDA pregnancy category C. It is not known whether ezetimibe is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ezetimibe passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medicine.



How should I take ezetimibe?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ezetimibe is usually taken once a day, with or without food. Try to take ezetimibe at the same time each day.

Some cholesterol medications should not be taken at the same time. Do not take ezetimibe with cholestyramine (Prevalite, Questran), colestipol (Colestid), or colesevelam (Welchol). Wait at least 4 hours after taking any of these medicines before you take ezetimibe. You may also take ezetimibe 2 hours before taking any of these other medicines.

Ezetimibe may be taken at the same time with fenofibrate (Antara, Lipofen, Lofibra, TriCor, Triglide), or with any of the “statin” drugs such as lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), fluvastatin (Lescol), or atorvastatin (Lipitor).

It may take up to 2 weeks of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed. Your cholesterol will need to be measured using blood tests at regular intervals. Do not miss any scheduled visits to your doctor.

Ezetimibe is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store ezetimibe at room temperature away from moisture and heat.

See also: Ezetimibe dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of ezetimibe is not expected to produce life-threatening symptoms.

What should I avoid while taking ezetimibe?

Avoid eating foods that are high in fat or cholesterol. Ezetimibe will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.


Ezetimibe side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • unusual muscle weakness, tenderness, or pain;

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • chest pain;

  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate); or

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • numbness or tingly feeling;

  • mild stomach pain, diarrhea;

  • tired feeling;

  • headache;

  • dizziness;

  • depressed mood;

  • runny or stuffy nose, cold symptoms;

  • joint pain, back pain; or

  • cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ezetimibe Dosing Information

Usual Adult Dose for Hyperlipidemia:

10 mg once a day with or without food.

Usual Adult Dose for Sitosterolemia:

10 mg once a day with or without food.

What other drugs will affect ezetimibe?

Before taking ezetimibe, tell your doctor if you are using any of the following drugs:

  • cholestyramine (Prevalite, Questran);

  • colestipol (Colestid);

  • colesevelam (Welchol);

  • gemfibrozil (Lopid);

  • cyclosporine (Neoral, Sandimmune, Gengraf); or

  • a blood thinner such as warfarin (Coumadin).

This list is not complete and there may be other drugs that can interact with ezetimibe. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about ezetimibe.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 09/13/2009 1:05:52 PM.

 

ez-ET-i-mide

Commonly used brand name(s):

In the U.S.

  • Zetia

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Cholesterol Absorption Inhibitor

Uses For ezetimibe

Ezetimibe is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using ezetimibe may help prevent medical problems caused by such substances clogging the blood vessels.

ezetimibe is available only with your doctor’s prescription.


Before Using ezetimibe

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ezetimibe, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ezetimibe or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

ezetimibe has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. ezetimibe should only be used in children 10 years of age or older.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ezetimibe in the elderly with use in other age groups, ezetimibe has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using ezetimibe with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clofibrate
  • Gemfibrozil
  • Niacin

Using ezetimibe with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cholestyramine
  • Colestipol
  • Cyclosporine
  • Fenofibrate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of ezetimibe. Make sure you tell your doctor if you have any other medical problems, especially:

  • Liver disease (or history of) or
  • Liver enzymes, persistently high levels—Use of ezetimibe may make liver problems worse




Proper Use of ezetimibe

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor’s orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, ezetimibe is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

Dosing

The dose of ezetimibe will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of ezetimibe. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

  • For tablet dosage form:
    • For high cholesterol:
      • Adults: 10 milligrams (mg) once daily. May take with or without food.
      • Children up to 10 years of age—Use is not recommended.
      • Children 10 years of age and older—10 milligrams (mg) once daily. May take with or without food.

Missed Dose

If you miss a dose of ezetimibe, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using ezetimibe

It is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol. Your doctor can then decide if you should continue to take it.

Check with your doctor immediately if you think that you may be pregnant. Certain cholesterol medications may cause birth defects or other problems in the baby if taken during pregnancy.

Tell your doctor if you experience any unexplained muscle pain, tenderness, or weakness.

Do not take other medicines unless they have been discussed with your doctor. It is very important that you take all of your medicine. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

ezetimibe Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Frequency not determined

  • Abdominal fullness
  • black tarry stools
  • bleeding gums
  • bloating
  • blood in urine or stools
  • chills
  • constipation
  • darkened urine
  • fast heartbeat
  • fever
  • gaseous abdominal pain
  • general tiredness or weakness
  • indigestion
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • loss of appetite
  • light-colored stools
  • muscle cramps or spasms
  • muscular tenderness, wasting or weakness
  • nausea
  • pains in stomach, side or abdomen, possibly radiating to the back
  • pinpoint red spots on skin
  • recurrent fever
  • severe nausea
  • skin rash
  • unusual bleeding or bruising
  • upper right abdominal pain
  • vomiting
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Fever
  • headache
  • muscle pain
  • runny nose
  • sore throat

Less common

  • Back pain
  • body aches or pain
  • chest pain
  • chills
  • cold or flu-like symptoms
  • congestion
  • coughing
  • diarrhea
  • difficulty in moving
  • dizziness
  • dryness or soreness of throat
  • hoarseness
  • muscle pain or stiffness
  • pain in joints
  • pain or tenderness around eyes and cheekbones
  • shortness of breath or troubled breathing
  • stomach pain
  • stuffy nose
  • tender, swollen glands in neck
  • tightness of chest or wheezing
  • trouble in swallowing
  • unusual tiredness or weakness
  • voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Generic Name: ezetimibe and simvastatin (ez ET i mibe and SIM va stat in)
Brand Names: Vytorin

What is ezetimibe and simvastatin?

Ezetimibe reduces the amount of cholesterol absorbed by the body.

Ezetimibe and simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or “statins.” Ezetimibe and simvastatin reduces levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of “good” cholesterol (high-density lipoprotein, or HDL).

The combination of ezetimibe and simvastatin is used to treat high cholesterol in adults and children who are at least 10 years old.

Ezetimibe and simvastatin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about ezetimibe and simvastatin?

You should not take ezetimibe and simvastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease. Stop taking this medication and tell your doctor right away if you become pregnant.

Before taking ezetimibe and simvastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

There are many other drugs that can increase your risk of serious medical problems if you take them together with ezetimibe and simvastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.


What should I discuss with my healthcare provider before taking ezetimibe and simvastatin?

You should not take ezetimibe and simvastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease.

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • history of liver disease;
  • history of kidney disease;
  • diabetes;

  • a thyroid disorder; or

  • if you drink more than 2 alcoholic beverages daily.

In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid). You may also be more likely to develop this condition if you are of Chinese descent and you take high-dose ezetimibe and simvastatin while also taking medication that contains niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

  • amiodarone (Cordarone, Pacerone);

  • danazol (Danocrine);

  • nefazodone (an antidepressant);

  • gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);

  • antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

  • antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem) or verapamil (Calan, Covera, Isoptin, Verelan);

  • HIV medications such as atazanavir (Reyataz), ritonavir (Norvir), lopinavir/ritonavir (Kaletra), saquinavir (Invirase), and others;

  • medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); or

  • drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take ezetimibe and simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking ezetimibe and simvastatin. Ezetimibe and simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking ezetimibe and simvastatin.


How should I take ezetimibe and simvastatin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Ezetimibe and simvastatin is usually taken once daily in the evening, with or without food. Your doctor may occasionally change your dose to make sure you get the best results.

You may need to stop using ezetimibe and simvastatin for a short time if you have surgery or a medical emergency.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may need to take ezetimibe and simvastatin on a long-term basis for the treatment of high cholesterol. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Ezetimibe and simvastatin dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ezetimibe and simvastatin?

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 2 hours after or 4 hours before you take ezetimibe and simvastatin.

Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with ezetimibe and simvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.


Ezetimibe and simvastatin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking ezetimibe and simvastatin and call your doctor at once if you have any of these serious side effects:

  • unexplained muscle pain, tenderness, or weakness;

  • fever, unusual tiredness, and dark colored urine;

  • swelling, weight gain, urinating less than usual or not at all; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache, memory problems;

  • mild muscle pain;

  • joint pain;

  • numbness or tingly feeling;

  • diarrhea;

  • dizziness, depressed mood;

  • sleep problems (insomnia); or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ezetimibe and simvastatin Dosing Information

Usual Adult Dose for Hyperlipidemia:

Initial dose: 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening.

The dosage range is 10 mg-10 mg to 10 mg-80 mg per day. Initiation of therapy with 10 mg-10 mg per day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10 mg-40 mg per day.

Patients should be placed on a standard cholesterol-lowering diet before receiving ezetimibe-simvastatin and should continue on this diet during treatment with ezetimibe-simvastatin. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’s response.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Initial dose: 10 mg ezetimibe-40 mg simvastatin orally once a day in the evening.

This dose may be titrated to 10 mg-80 mg orally once a day in the evening.

What other drugs will affect ezetimibe and simvastatin?

Tell your doctor about all other medications you use, especially:

  • digoxin (Lanoxin);

  • a blood thinner such as warfarin (Coumadin); or

  • any other “statin” medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor).

This list is not complete and other drugs may interact with ezetimibe and simvastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about ezetimibe and simvastatin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.01. Revision Date: 04/13/2010 3:24:48 PM.

 

Extraneal

30/06/10

Generic Name: icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Dosage Form: peritoneal dialysis solution

Extraneal
(icodextrin) Peritoneal Dialysis Solution

DANGEROUS DRUG-DEVICE INTERACTION

Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using Extraneal (icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods must not be used. Use of GDH-PQQ or GDO-based glucose monitors and test strips has resulted in falsely elevated glucose readings (due to the presence of maltose, see PRECAUTIONS/Drug/Laboratory Test Interactions) and has led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of Extraneal (icodextrin) and its metabolites return to baseline within approximately 14 days following cessation of Extraneal (icodextrin) administration. Therefore falsely elevated glucose levels may be measured up to two weeks following cessation of Extraneal (icodextrin) therapy when GDH-PQQ or GDO-based blood glucose monitors and test strips are used.

Because GDH-PQQ and GDO-based blood glucose monitors may be used in hospital settings, it is important that the health care providers of peritoneal dialysis patients using Extraneal (icodextrin) carefully review the product information of the blood glucose testing system, including that of test strips, to determine if the system is appropriate for use with Extraneal (icodextrin).

To avoid improper insulin administration, educate patients to alert health care providers of this interaction whenever they are admitted to the hospital.

Information regarding glucose monitor and test strip methodology can be obtained from their manufacturers. For a list of toll free numbers for glucose monitor and test strip manufacturers, please contact the Baxter Renal Clinical Help Line 1-888-RENAL-HELP or visit www.glucosesafety.com.

Extraneal Description

Extraneal (icodextrin) Peritoneal Dialysis Solution is a peritoneal dialysis solution containing the colloid osmotic agent icodextrin. Icodextrin is a starch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is:

Each 100 mL of Extraneal contains:

Icodextrin 7.5 g
Sodium Chloride, USP 535 mg
Sodium Lactate 448 mg
Calcium Chloride, USP 25.7 mg
Magnesium Chloride, USP 5.08 mg

Electrolyte content per liter:

Sodium 132 mEq/L
Calcium 3.5 mEq/L
Magnesium 0.5 mEq/L
Chloride 96 mEq/L
Lactate 40 mEq/L

Water for Injection, USP qs

HCl/NaOH may have been used to adjust pH.

Extraneal contains no bacteriostatic or antimicrobial agents.

Calculated osmolarity: 282–286 mOsm/L; pH=5.0-6.0

Extraneal is available for intraperitoneal administration only as a sterile, nonpyrogenic, clear solution in AMBU-FLEX II, AMBU-FLEX III and ULTRABAG containers. The container systems are composed of polyvinyl chloride.

Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Extraneal – Clinical Pharmacology

Mechanism of Action

Extraneal is an isosmotic peritoneal dialysis solution containing glucose polymers (icodextrin) as the primary osmotic agent. Icodextrin functions as a colloid osmotic agent to achieve ultrafiltration during long peritoneal dialysis dwells. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. Like other peritoneal dialysis solutions, Extraneal also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status.

Pharmacokinetics of Icodextrin

Absorption

Absorption of icodextrin from the peritoneal cavity follows zero-order kinetics consistent with convective transport via peritoneal lymphatic pathways. In a single-dose pharmacokinetic study using Extraneal (icodextrin), a median of 40% (60 g) of the instilled icodextrin was absorbed from the peritoneal solution during a 12-hour dwell. Plasma levels of icodextrin rose during the dwell and declined after the dwell was drained. Peak plasma levels of icodextrin plus its metabolites (median Cpeak 2.2g/L) were observed at the end of the long dwell exchange (median Tmax = 13 hours).

At steady-state, the mean plasma level of icodextrin plus its metabolites was about 5 g/L. In multidose studies, steady-state levels of icodextrin were achieved within one week. Plasma levels of icodextrin and metabolites return to baseline values within approximately two weeks following cessation of icodextrin administration.

Metabolism

Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization (DP), including maltose (DP2), maltotriose (DP3), maltotetraose (DP4), and higher molecular weight species. In a single dose study, DP2, DP3 and DP4 showed a progressive rise in plasma concentrations with a profile similar to that for total icodextrin, with peak values reached by the end of the dwell and declining thereafter. Only very small increases in blood levels of larger polymers were observed. Steady-state plasma levels of icodextrin metabolites were achieved within one week and stable plasma levels were observed during long-term administration.

Some degree of metabolism of icodextrin occurs intraperitoneally with a progressive rise in the concentration of the smaller polymers in the dialysate during the 12-hour dwell.

Elimination

Icodextrin undergoes renal elimination in direct proportion to the level of residual renal function. Diffusion of the smaller icodextrin metabolites from plasma into the peritoneal cavity is also possible after systemic absorption and metabolism of icodextrin.

Special Populations

Geriatrics

The influence of age on the pharmacokinetics of icodextrin and its metabolites was not assessed.

Gender and Race

The influence of gender and race on the pharmacokinetics of icodextrin and its metabolites was not assessed.

Clinical Studies

Extraneal has demonstrated efficacy as a peritoneal dialysis solution in clinical trials of approximately 480 patients studied with end-stage renal disease (ESRD).

Ultrafiltration, Urea and Creatinine Clearance

In the active-controlled trials of one to six months in duration, described below, Extraneal used once-daily for the long dwell in either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) therapy resulted in higher net ultrafiltration than 1.5% and 2.5% dextrose solutions, and higher creatinine and urea nitrogen clearances than 2.5% dextrose. Net ultrafiltration was similar to 4.25% dextrose across all patients in these studies. Effects were generally similar in CAPD and APD.

In an additional randomized, multicenter, active-controlled two-week study in high average/high transporter APD patients, Extraneal used once daily for the long dwell produced higher net ultrafiltration compared to 4.25% dextrose. Mean creatinine and urea nitrogen clearances were also greater with Extraneal and ultrafiltration efficiency was improved.

In 175 CAPD patients randomized to Extraneal (N=90) or 2.5% dextrose solution (N=85) for the 8-15 hour overnight dwell for one month, mean net ultrafiltration for the overnight dwell was significantly greater in the Extraneal group at weeks 2 and 4 (Figure 1). Mean creatinine and urea nitrogen clearances were also greater with Extraneal (Figure 2).

Figure 1 – Mean Net Ultrafiltration for the Overnight Dwell

Figure 2 – Mean Creatinine and Urea Nitrogen Clearance for the Overnight Dwell

In another study of 39 APD patients randomized to Extraneal or 2.5% dextrose solution for the long, daytime dwell (10-17 hours) for three months, the net ultrafiltration reported during the treatment period was (mean ± SD) 278 ± 192 mL for the Extraneal group and –138 ± 352 mL for the dextrose group (p<0.001). Mean creatinine and urea nitrogen clearances were significantly greater for Extraneal than 2.5% dextrose at weeks 6 and 12 (p<0.001).

In a six-month study in CAPD patients comparing Extraneal (n=28) with 4.25% dextrose (n=31), net ultrafiltration achieved during an 8-hour dwell averaged 510 mL for Extraneal and 556 mL for 4.25% dextrose. For 12-hour dwells, net ultrafiltration averaged 575 mL for Extraneal (n=29) and 476 mL for 4.25% dextrose (n=31). There was no significant difference between the two groups with respect to ultrafiltration.

In a two week study in high average/high transporter APD patients (4-hour D/P creatinine ratio >0.70 and a 4-hour D/D0 ratio <0.34, as defined by the peritoneal equilibration test (PET)), comparing Extraneal (n=47) to 4.25% dextrose (n=45), after adjusting for baseline, the mean net ultrafiltration achieved during a 14 ± 2 hour dwell was significantly greater in the Extraneal group than the 4.25% dextrose group at weeks 1 and 2 (p<0.001, see Figure 3). Consistent with increases in net ultrafiltration, there were also significantly greater creatinine and urea nitrogen clearances and ultrafiltration efficiency in the Extraneal group (p<0.001, see Figure 3).

Figure 3 – Mean Net Ultrafiltration, Creatinine and Urea Nitrogen Clearances and Ultrafiltration Efficiency for the Long Dwell in High Average/High Transporter Patients

Peritoneal Membrane Transport Characteristics:

After one year of treatment with Extraneal during the long dwell exchange, there were no differences in membrane transport characteristics for urea and creatinine. The mass transfer area coefficients (MTAC) for urea, creatinine, and glucose at one year were not different in patients receiving treatment with Extraneal or 2.5% dextrose solution for the long dwell.





Indications and Usage for Extraneal

Extraneal is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. Extraneal is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET). (See CLINICAL PHARMACOLOGY, Clinical Studies)

Contraindications

Extraneal (icodextrin) is contraindicated in patients with a known allergy to cornstarch or icodextrin, in patients with maltose or isomaltose intolerance, in patients with glycogen storage disease, and in patients with pre-existing severe lactic acidosis.

Warnings

Dangerous Drug-Device Interaction (see BOXED WARNING)

Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using Extraneal (icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods must not be used. Use of GDH-PQQ or GDO-based glucose monitors and test strips has resulted in falsely elevated glucose readings (due to the presence of maltose, see PRECAUTIONS/Drug/Laboratory Test Interactions) and has led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of Extraneal (icodextrin) and its metabolites return to baseline within approximately 14 days following cessation of Extraneal (icodextrin) administration. Therefore falsely elevated glucose levels may be measured up to two weeks following cessation of Extraneal (icodextrin) therapy when GDH-PQQ or GDO-based blood glucose monitors and test strips are used.

Because GDH-PQQ and GDO-based blood glucose monitors may be used in hospital settings, it is important that the health care providers of peritoneal dialysis patients using Extraneal (icodextrin) carefully review the product information of the blood glucose testing system, including that of test strips, to determine if the system is appropriate for use with Extraneal (icodextrin).

To avoid improper insulin administration, educate patients to alert health care providers of this interaction whenever they are admitted to the hospital.

Information regarding glucose monitor and test strip methodology can be obtained from their manufacturers. For a list of toll free numbers for glucose monitor and test strip manufacturers, please contact the Baxter Renal Clinical Help Line 1-888-RENAL-HELP or visit www.glucosesafety.com.

Not for intravenous injection.

Encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including Extraneal (icodextrin). Infrequent but fatal outcomes have been reported.

If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to the identification of the involved organism(s), broad-spectrum antibiotics may be indicated.

Patients with severe lactic acidosis should not be treated with lactate-based peritoneal dialysis solutions (See CONTRAINDICATIONS). It is recommended that patients with conditions known to increase the risk of lactic acidosis [e.g., acute renal failure, inborn errors of metabolism, treatment with drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] must be monitored for occurrence of lactic acidosis before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions.

When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. Serum potassium levels should be monitored carefully in patients treated with cardiac glycosides. For example, rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs; digitalis toxicity may be masked by hyperkalemia, hypermagnesemia, or hypocalcemia. Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis excess. Conversely, toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium high.

Precautions

General

Peritoneal Dialysis-Related

The following conditions may predispose to adverse reactions to peritoneal dialysis procedures: abdominal conditions, including disruption of the peritoneal membrane and diaphragm by surgery, congenital anomalies or trauma prior to complete healing, abdominal tumors, abdominal wall infections, hernias, fecal fistulae, colostomies, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity. Conditions that preclude normal nutrition, impaired respiratory function, recent aortic graft replacement, and potassium deficiency may also predispose to complications of peritoneal dialysis.

Aseptic technique should be employed throughout the peritoneal dialysis procedure to reduce the possibility of infection.

Following use, the drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.

Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Treatment of overinfusion is to drain the peritoneal dialysis solution from the peritoneal cavity.

Need for Trained Physician

Treatment should be initiated and monitored under the supervision of a physician knowledgeable in the management of patients with renal failure.

A patient’s volume status should be carefully monitored to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion and hypovolemic shock. An accurate fluid balance record must be kept and the patient’s body weight monitored.

Significant losses of protein, amino acids, water-soluble vitamins and other medicines may occur during peritoneal dialysis. The patient’s nutritional status should be monitored and replacement therapy should be provided as necessary.

In patients with hypercalcemia, particularly in those on low-calcium peritoneal dialysis solutions, consideration should be given to the fact that Extraneal is not provided in a low-calcium electrolyte solution.

Solutions that are cloudy, contain particulate matter, or show evidence of leakage should not be used.

Insulin-dependent diabetes mellitus

Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation of treatment with Extraneal. Appropriate monitoring of blood glucose should be performed and insulin dosage adjusted if needed (See WARNINGS; PRECAUTIONS, Drug/Laboratory Test Interactions).

Information for Patients

Patients should be instructed not to use solutions if they are cloudy, discolored, contain visible particulate matter, or if they show evidence of leaking containers.

Aseptic technique should be employed throughout the procedure.

To reduce possible discomfort during administration, patients should be instructed that solutions may be warmed to 37°C (98°F) prior to use. Only dry heat should be used. It is best to warm solutions within the overwrap using a heating pad. To avoid contamination, solutions should not be immersed in water for warming. Do not use a microwave oven to warm Extraneal. Heating the solution above 40°C (104°F) may be detrimental to the solution. (See DOSAGE AND ADMINISTRATION, Directions for Use).

Because the use of Extraneal interferes with glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) and glucose-dye-oxidoreductase based blood glucose measurements, patients should be instructed to use only glucose-specific glucose monitors and test strips. (See WARNINGS; PRECAUTIONS, Drug/Laboratory Test Interactions).

A Patient Medication Guide is provided in each carton of Extraneal.

Laboratory Tests

Serum Electrolytes

Decreases in serum sodium and chloride have been observed in patients using Extraneal. The mean change in serum sodium from baseline to the last study visit was –2.8 mmol/L for patients on Extraneal and –0.3 mmol/L for patients on control solution. Four Extraneal patients and two control patients developed serum sodium < 125 mmol/L. The mean change in serum chloride from baseline to last study visit was –2.0 mmol/L for Extraneal patients and + 0.6 mmol/L for control patients. Similar changes in serum chemistries were observed in an additional clinical study in a subpopulation of high average/high transporter patients. The declines in serum sodium and chloride may be related to dilution resulting from the presence of icodextrin metabolites in plasma. Although these decreases have been small and clinically unimportant, monitoring of the patients’ serum electrolyte levels as part of routine blood chemistry testing is recommended.

Extraneal does not contain potassium. Evaluate serum potassium prior to administering potassium chloride to the patient. In situations where there is a normal serum potassium level or hypokalemia, addition of potassium chloride (up to a concentration of 4 mEq/L) to the solution may be necessary to prevent severe hypokalemia. This should be made under careful evaluation of serum and total body potassium, and only under the direction of a physician.

Fluid, hematology, blood chemistry, electrolyte concentrations, and bicarbonate should be monitored periodically. If serum magnesium levels are low, magnesium supplements may be used.

Alkaline Phosphatase

An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESRD patients receiving Extraneal. No associated increases in liver function tests were observed. Serum alkaline phosphatase levels did not show evidence of progressive increase over a 12-month study period. Levels returned to normal approximately two weeks after discontinuation of Extraneal.

There were individual cases where increased alkaline phosphatase was associated with elevated AST (SGOT), but neither elevation was considered causally related to treatment.

Drug Interactions

General

No clinical drug interaction studies were performed. No evaluation of Extraneal’s effects on the cytochrome P450 system was conducted. As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary. In patients using cardiac glycosides (digoxin and others), plasma levels of calcium, potassium and magnesium must be carefully monitored.

Insulin

A clinical study in 6 insulin-dependent diabetic patients demonstrated no effect of Extraneal on insulin absorption from the peritoneal cavity or on insulin’s ability to control blood glucose when insulin was administered intraperitoneally with Extraneal. However, appropriate monitoring (See PRECAUTIONS, Drug/Laboratory Test Interactions) of blood glucose should be performed when initiating Extraneal in diabetic patients and insulin dosage should be adjusted if needed (See PRECAUTIONS).

Heparin

No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with Extraneal.

Antibiotics

No human drug interaction studies with antibiotics were conducted. In vitro studies evaluating the minimum inhibitory concentration (MIC) of vancomycin, cefazolin, ampicillin, ampicillin/flucoxacillin, ceftazidime, gentamicin, and amphotericin demonstrated no evidence of incompatibility of these antibiotics with Extraneal. (See DOSAGE AND ADMINISTRATION)

Drug/Laboratory Test Interactions

Blood Glucose

Blood glucose measurement must be done with a glucose-specific method to prevent maltose interference with test results. Since falsely elevated glucose levels have been observed with blood glucose monitoring devices and test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) or glucose-dye-oxidoreductase based methods, GDH PQQ or glucose-dye-oxidoreductase based methods should not be used to measure glucose levels in patients administered Extraneal. (See WARNINGS).

Serum Amylase

An apparent decrease in serum amylase activity has been observed in patients administered Extraneal. Preliminary investigations indicate that icodextrin and its metabolites interfere with enzymatic-based amylase assays, resulting in inaccurately low values. This should be taken into account when evaluating serum amylase levels for diagnosis or monitoring of pancreatitis in patients using Extraneal.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Icodextrin did not demonstrate evidence of genotoxicity potential in in vitro bacterial cell reverse mutation assay (Ames test); in vitro mammalian cell chromosomal aberration assay (CHO cell assay); and in the in vivo micronucleus assay in rats. Long-term animal studies to evaluate the carcinogenic potential of Extraneal or icodextrin have not been conducted. Icodextrin is derived from maltodextrin, a common food ingredient.

A fertility study in rats where males and females were treated for four and two weeks, respectively, prior to mating and until day 17 of gestation at up to 1.5 g/kg/day (1/3 the human exposure on a mg/m2 basis) revealed slightly low epididymal weights in parental males in the high dose group as compared to Control. Toxicological significance of this finding was not evident as no other reproductive organs were affected and all males were of proven fertility. The study demonstrated no effects of treatment with icodextrin on mating performance, fertility, litter response, embryo-fetal survival, or fetal growth and development.

Pregnancy

Pregnancy Category C

Complete animal reproduction studies including in utero embryofetal development at appreciable multiples of human exposure have not been conducted with Extraneal or icodextrin. Thus it is not known whether icodextrin or Extraneal solution can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Extraneal should only be utilized in pregnant women when the need outweighs the potential risks.

Nursing Mothers

It is not known whether icodextrin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Extraneal is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No formal studies were specifically carried out in the geriatric population. However, 140 of the patients in clinical studies of Extraneal were age 65 or older, with 28 of the patients age 75 or older. No overall differences in safety or effectiveness were observed between these patients and patients under age 65. Although clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Extraneal was originally studied in controlled clinical trials of 493 patients with end-stage renal disease who received a single daily exchange of Extraneal for the long dwell (8-to 16- hours). There were 215 patients exposed for at least 6 months and 155 patients exposed for at least one year. The population was 18-83 years of age, 56% male and 44% female, 73% Caucasian, 18% Black, 4% Asian, 3% Hispanic, and it included patients with the following comorbid conditions: 27% diabetes, 49% hypertension and 23% hypertensive nephropathy.

Rash was the most frequently occurring Extraneal-related adverse event (5.5%, Extraneal; 1.7% Control). Seven patients on Extraneal discontinued treatment due to rash, and one patient on Extraneal discontinued due to exfoliative dermatitis. The rash typically appeared within the first three weeks of treatment and resolved with treatment discontinuation or, in some patients, with continued treatment.

Female patients reported a higher incidence of skin events, including rash, in both Extraneal and dextrose control treatment groups.

Table 1 shows the adverse events reported in these clinical studies, regardless of causality, occurring in ≥ 5% of patients and more common on Extraneal than control.

Table 1 – Adverse Experiences in ≥5% of Patients and More
Common on Extraneal
Extraneal Control
N=493 N=347
Peritonitis 26% 25%
Upper respiratory infection 15% 13%
Hypertension 13% 8%
Rash 10% 5%
Headache 9% 7%
Abdominal pain 8% 6%
Flu Syndrome 7% 6%
Nausea 7% 5%
Cough increase 7% 4%
Edema 6% 5%
Accidental injury 6% 4%
Chest pain 5% 4%
Dyspepsia 5% 4%
Hyperglycemia 5% 4%

Adverse reactions reported with an incidence of > 5% and at least as common on dextrose control included pain, asthenia, exit site infection, infection, back pain, hypotension, diarrhea, vomiting, nausea/vomiting, anemia, peripheral edema, hypokalemia, hyperphosphatemia, hypoproteinemia, hypervolemia, arthralgia, dizziness, dyspnea, skin disorder, pruritis.

Additional adverse events occurring at an incidence of < 5% and that may or may not have been related to Extraneal include: pain on infusion, abdominal enlargement, cloudy effluent, ultrafiltration decrease, postural hypotension, heart failure, hyponatremia, hypochloremia, hypercalcemia, hypoglycemia, alkaline phosphatase increase, SGPT increase, SGOT increase, cramping, confusion, lung edema, facial edema, exfoliative dermatitis, eczema, vesicobullous rash, maculopapular rash, erythema multiforme. All reported events are included in the list except those already listed in Table 1 or the following two paragraphs, those not plausibly associated with Extraneal, and those that were associated with the condition being treated or related to the dialysis procedure.

Extraneal was additionally studied in a subpopulation of 92 high average/high transporter APD patients in a two-week controlled clinical trial where patients received a single daily exchange of Extraneal (n=47) or dextrose control (n=45) for the long dwell (14 ± 2 hours). Consistent with the data reported in the original trials of Extraneal, rash was the most frequently occurring event.

Peritoneal Dialysis-Related

Adverse events common to the peritoneal dialysis, including peritonitis, infection around the catheter, fluid and electrolyte imbalance, and pain, were observed at a similar frequency with Extraneal and Controls (See PRECAUTIONS).

Changes in Alkaline Phosphatase and Serum Electrolytes

An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESRD patients receiving Extraneal. No associated increases in other liver chemistry tests were observed. Serum alkaline phosphatase levels did not show progressive increase over a 12-month study period. Levels returned to normal approximately two weeks after discontinuation of Extraneal.

Decreases in serum sodium and chloride have been observed in patients using Extraneal. The declines in serum sodium and chloride may be related to dilution resulting from the presence of icodextrin metabolites in plasma. Although these decreases have been small and clinically unimportant, monitoring of patients’ serum electrolyte levels as part of routine blood chemistry testing is recommended.

Post-Marketing

The following adverse reactions have been identified during post-approval use of Extraneal. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse reactions are listed by MedDRA System Order Class (SOC), followed by Preferred Term in order of severity.

INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter site infection, Catheter related infection

BLOOD AND LYMPHATIC SYSTEM DISORDERS: Thrombocytopenia, Leukopenia

IMMUNE SYSTEM DISORDERS: Serum sickness, Hypersensitivity

METABOLISM AND NUTRITION DISORDERS: Shock hypoglycemia, Fluid overload, Fluid imbalance

NERVOUS SYSTEM DISORDERS: Hypoglycemic coma, Burning sensation

EYE DISORDERS: Vision blurred

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Bronchospasm, Stridor

GASTROINTESTINAL DISORDERS: Sclerosing encapsulating peritonitis, Aseptic peritonitis, Peritoneal cloudy effluent, Ileus, Ascites, Inguinal hernia, Abdominal discomfort

SKIN AND SUBCUTANEOUS DISORDERS: Toxic epidermal necrolysis, Erythema multiforme, Angioedema, Urticaria generalized, Toxic skin eruption, Swelling face, Periorbital edema, Exfoliative rash, Skin exfoliation, Prurigo, Rash (including macular, papular, erythematous, exfoliative), Dermatitis (including allergic and contact), Drug eruption, Erythema, Onychomadesis, Skin chapped, Blister

MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Arthralgia, Back pain, Musculoskeletal pain

REPRODUCTIVE SYSTEM AND BREAST DISORDERS: Penile edema, Scrotal edema

GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS: Discomfort, Pyrexia, Chills, Malaise, Drug effect decreased, Drug ineffective, Catheter site erythema, Catheter site inflammation, Infusion related reaction (including Infusion site pain, Instillation site pain)

Drug Abuse and Dependence

There has been no observed potential of drug abuse or dependence with Extraneal.

Overdosage

No data are available on experiences of overdosage with Extraneal. Overdosage of Extraneal would be expected to result in higher levels of serum icodextrin and metabolites, but it is not known what signs or symptoms might be caused by exposure in excess of the exposures used in clinical trials. In the event of overdosage with Extraneal, continued peritoneal dialysis with glucose-based solutions should be provided.

Extraneal Dosage and Administration

Extraneal is intended for intraperitoneal administration only. It should be administered only as a single daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritoneal dialysis. The recommended dwell time is 8- to 16- hours.

Not for intravenous injection.

Patients should be carefully monitored to avoid under- or over-hydration. An accurate fluid balance record must be kept and the patient’s body weight monitored to avoid potentially severe consequences including congestive heart failure, volume depletion, and hypovolemic shock.

Aseptic technique should be used throughout the peritoneal dialysis procedure.

To reduce possible discomfort during administration, solutions may be warmed prior to use. (See DOSAGE AND ADMINISTRATION, Directions for Use).

Extraneal should be administered over a period of 10-20 minutes at a rate that is comfortable for the patient.

Do not use Extraneal if it is cloudy or discolored, if it contains particulate matter, or if the container is leaky.

Following use, the drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.

For single use only. Discard unused portion.

Addition of Potassium

Potassium is omitted from Extraneal solutions because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. The decision to add potassium chloride should be made by the physician after careful evaluation of serum potassium.

Addition of Insulin

Addition of insulin to Extraneal was evaluated in 6 insulin-dependent diabetic patients undergoing CAPD for end stage renal disease. No interference of Extraneal with insulin absorption from the peritoneal cavity or with insulin’s ability to control blood glucose was observed. (See PRECAUTIONS, Drug/Laboratory Test Interactions). Appropriate monitoring of blood glucose should be performed when initiating Extraneal in diabetic patients and insulin dosage adjusted if needed (See PRECAUTIONS).

Addition of Heparin

No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with Extraneal.

Addition of Antibiotics

No formal clinical drug interaction studies have been performed. In vitro compatibility studies with Extraneal (icodextrin) and the following antibiotics have demonstrated no effects with regard to minimum inhibitory concentration (MIC): vancomycin, cefazolin, ampicillin, ampicillin/flucoxacillin, ceftazidime, gentamicin, and amphotericin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

Patients undergoing peritoneal dialysis should be under careful supervision of a physician experienced in the treatment of end-stage renal disease with peritoneal dialysis. It is recommended that patients being placed on peritoneal dialysis should be appropriately trained in a program that is under supervision of a physician.

Directions for Use

For complete CAPD and APD system preparation, see directions accompanying ancillary equipment.

Aseptic technique should be used.

Warming

For patient comfort, Extraneal can be warmed to 37°C (98°F). Only dry heat should be used. It is best to warm solutions within the overwrap using a heating pad. Do not immerse Extraneal in water for warming. Do not use a microwave oven to warm Extraneal. Heating above 40°C (104°F) may be detrimental to the solution.

To Open

To open, tear the overwrap down at the slit and remove the solution container. Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap.

Inspect for Container Integrity

Inspect the container for signs of leakage and check for minute leaks by squeezing the container firmly.

Adding Medications

Some drug additives may be incompatible with Extraneal. See DOSAGE AND ADMINISTRATION section for additional information. If the re-sealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added.

  1. Put on mask. Clean and/or disinfect hands.
  2. Prepare medication port site using aseptic technique.
  3. Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive.
  4. Reposition container with container ports up and evacuate medication port by squeezing and tapping it.
  5. Mix solution and additive thoroughly.

Preparation for Administration

  1. Put on mask. Clean and/or disinfect hands.
  2. Place Extraneal on work surface.
  3. Remove pull ring from connector of solution container. If continuous fluid flow from connector is observed, discard solution container.
  4. Remove tip protector from tubing set and immediately attach to connector of solution container.
  5. Continue with therapy set-up as instructed in user manual or directions accompanying tubing sets.
  6. Upon completion of therapy, discard any unused portion.

How is Extraneal Supplied

Extraneal (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:

Container Fill Volume NDC
ULTRABAG 1.5 L NDC 0941-0679-51
ULTRABAG 2.0 L NDC 0941-0679-52
ULTRABAG 2.5 L NDC 0941-0679-53
AMBU- FLEX III 1.5 L NDC 0941-0679-45
AMBU- FLEX III 2.0 L NDC 0941-0679-47
AMBU- FLEX III 2.5 L NDC 0941-0679-48
AMBU- FLEX II 2.0 L NDC 0941-0679-06
AMBU- FLEX II 2.5 L NDC 0941-0679-05

Each 100 mL of Extraneal contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate.

Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Store in moisture barrier overwrap in carton until ready to use. Protect from freezing.

Rx Only

BAXTER, Extraneal, ULTRABAG, and AMBU-FLEX are trademarks of Baxter International Inc.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

Container Label

L5B4974
NDC 0941-0679-06

2000 mL
(APPROX 80 mL EXCESS)

Baxter

Extraneal (icodextrin)
Peritoneal Dialysis Solution

PD-2 7.5% icodextrin

EACH 100 mL CONTAINS 7.5 g ICODEXTRN 535 mg
SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP WATER FOR INJECTION USP

mEq/L SODIUM 132 CALCIUM 3.5 MAGNESIUM 0.5
CHLORIDE 96 LACTATE 40

pH 5.0 – 6.0 pH MAY HAVE BEEN ADJUSTED WITH
HYDROCHLORIC ACID OR SODIUM HYDROXIDE

Extraneal SOLUTION CONTAINS NO BACTERIOSTATIC OR
ANTIMICROBIAL AGENTS

OSMOLARITY (CALC) 282 – 286 mOsmol/L

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY A PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG
THAT MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE IN MOISTURE BARRIER OVERPOUCH IN CARTON
UNTIL READY TO USE

STORE AT 20-25°C (68-77°F) EXCURSIONS PERMITTED
TO 15-30°C (59-86°F) [SEE USP CONTROLLED ROOM
TEMPERATURE] PROTECT FROM FREEZING

Ambu-Flex II CONTAINER

PL 146 PLASTIC

BAXTER Extraneal AMBU-FLEX II AND PL 146 ARE
TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4761237 4886789 6077836 6248726 B1

Carton Label

L5B4974

6-2000 ML
AMBU-FLEX II CONTAINER

7.5%

Extraneal (ICODEXTRIN)
PERITONEAL DIALYSIS SOLUTION

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50309410679062

Extraneal 
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0941-0679
Route of Administration INTRAPERITONEAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ICODEXTRIN (ICODEXTRIN) ICODEXTRIN 7.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 535 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION) SODIUM LACTATE 448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 5.08 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0941-0679-51 1500 mL In 1 BAG None
2 0941-0679-52 2000 mL In 1 BAG None
3 0941-0679-53 2500 mL In 1 BAG None
4 0941-0679-45 1500 mL In 1 BAG None
5 0941-0679-47 2000 mL In 1 BAG None
6 0941-0679-48 2500 mL In 1 BAG None
7 0941-0679-06 2000 mL In 1 BAG None
8 0941-0679-05 2500 mL In 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021321 12/20/2002

Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE LIMITED 211243165 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE CORPORATION 059140764 MANUFACTURE

Revised: 12/2009Baxter Healthcare Corporation

 

Extuss LA

30/06/10

Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)
Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children’s Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E

What is Extuss LA (dextromethorphan and guaifenesin)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Extuss LA (dextromethorphan and guaifenesin)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Extuss LA (dextromethorphan and guaifenesin)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.

FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.



How should I take Extuss LA (dextromethorphan and guaifenesin)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Extuss LA (dextromethorphan and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

Extuss LA (dextromethorphan and guaifenesin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness, anxiety, restless feeling, or nervousness;

  • confusion, hallucinations; or

  • slow, shallow breathing.

Less serious side effects may include:

  • dizziness;

  • headache;

  • skin rash or itching; or

  • nausea, vomiting, or stomach upset.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Extuss LA (dextromethorphan and guaifenesin)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • celecoxib (Celebrex);

  • cinacalcet (Sensipar);

  • darifenacin (Enablex);

  • imatinib (Gleevec);

  • quinidine (Quinaglute, Quinidex);

  • ranolazine (Ranexa);

  • ritonavir (Norvir);

  • sibutramine (Meridia);

  • terbinafine (Lamisil);

  • medicines to treat high blood pressure; or

  • an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about dextromethorphan and guaifenesin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.05. Revision Date: 11/19/2009 2:20:29 PM.

 

EXUBERA

30/06/10

Generic Name: insulin inhalation (IN soo lin in hel AY shun)
Brand Names: EXUBERA

What is insulin inhalation?

Insulin inhalation is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

Insulin inhalation is used to treat type 1 (insulin dependent) or type 2 (non-insulin dependent) diabetes in adults.

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Insulin inhalation may also be used for purposes other than those listed here.


What is the most important information I should know about insulin inhalation?

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Do not use insulin inhalation if you smoke, or if you have recently quit smoking (within the past 6 months). If you start smoking while using insulin inhalation, you will have to stop using this medication and switch to another form of insulin to control your blood sugar.

Before using this medicine, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not insulin inhalation if you have a lung disease that is not well controlled with medication or other treatments.

There are many other drugs that can potentially interfere with the glucose-lowering effects of insulin inhalation. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

If you use insulin inhalation as a meal-time insulin, use it no more than 10 minutes before eating the meal.

This medication is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.


What should I discuss with my health care provider before taking insulin inhalation?

Before using this medicine, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not use insulin inhalation if you have a lung disease that is not well controlled with medication or other treatments.

If you have type 1 diabetes, you should use this medication in addition to another long-acting type of insulin.

If you have type 2 diabetes, this may be the only medication you use to control your blood sugar, or your doctor may prescribe another long-acting insulin or diabetes medicine you take by mouth.

This medication is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Insulin inhalation can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.


How should I take insulin inhalation?

Use insulin inhalation exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If you use insulin inhalation as a meal-time insulin, use it no more than 10 minutes before eating the meal.

To be sure this medication is not causing certain side effects, your lung function will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Continue using insulin inhalation if you have a cold or flu virus that causes upper respiratory symptoms (cough, sore throat, nasal congestion). Check your blood sugar carefully during a time of stress or illness, since this can also affect your glucose levels.

Insulin inhalation is a powder that is supplied in “dose blisters” on cards that are packaged in a clear plastic tray. This tray is sealed inside a foil pouch that also contains a moisture-absorbing preservative packet. The 1-milligram (mg) dose blisters are supplied on a card printed with green ink. The 3-mg dose blisters are supplied on a card printed with blue ink.

Each 1-milligram dose blister of insulin inhalation powder is equal to 3 units of injectable insulin and each 3-milligram dose blister is equal to 8 units of injectable insulin. Using three of the 1-mg dose blisters will not give you the same amount of medicine as one 3-mg dose blister. You may receive too much insulin when using three 1-mg dose blisters together, which could result in hypoglycemia.

If you are combining 1-mg and 3-mg dose blisters to get your correct dose of insulin, always use the least number of blisters possible. For example, if your dose is 4 mg, use a 1-mg blister and a 3-mg blister (a total of two blisters). Do not use four 1-mg blisters or you may receive too much of this medication

The inhaler unit supplied with this medication includes a base, a chamber, and a release unit. Each release unit may be used for up to 2 weeks before replacing. You may use the inhaler for up to 1 year before replacing it.

Store the medication at room temperature, away from moisture and heat. Do not refrigerate or freeze. Protect the medicine from moisture and humidity at all times. Do not store the medicine in a bathroom where you shower.

Once you have opened the foil pouch, keep the unused dose blisters in the pouch and use them within 3 months after opening the pouch. Keep the moisture-absorbing preservative packet contained in the foil pouch and do not open the packet or use its contents.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

If you use this medication as meal-time insulin and you forget to use your dose before a meal, use the insulin when you remember and wait 10 minutes before eating.


What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an insulin inhalation overdose may be the same as signs of low blood sugar: confusion, drowsiness, weakness, fast heartbeat, sweating, tremor, and nausea.

What should I avoid while taking insulin inhalation?

Do not smoke while using insulin inhalation. You should not use this medication if you have smoked within the past 6 months. If you start smoking while using insulin inhalation, you will have to stop using the medication and switch to another form of insulin to control your blood sugar.

Avoid letting your blood sugar get too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.


Insulin inhalation side effects

Hypoglycemia (low blood sugar) is the most common side effect of insulin inhalation. Watch for signs of low blood sugar, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Get emergency medical help if you have any of these signs of an allergic reaction: rash, hives, or itching; wheezing, gasping for breath; fast heartbeat; sweating; feeling light-headed or fainting.

Other less serious side effects are more likely to occur, such as:

  • cough, sore throat;

  • runny or stuffy nose;

  • dry mouth; or

  • ear pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect insulin inhalation?

There are many other drugs that can potentially interfere with the glucose-lowering effects of insulin inhalation. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If you use other inhaled medications, use them before using insulin inhalation.

Where can I get more information?

  • Your pharmacist can provide more information about insulin inhalation.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 01/03/2008 1:07:11 PM.

 

Exubera Powder

30/06/10

Generic Name: Insulin (IN-su-lin)
Brand Name: Exubera

Exubera Powder is used for:

Treating diabetes mellitus. Certain patients (type 1 and some type 2 diabetic patients) may need to use Exubera Powder with a longer-acting form of insulin or with other oral antidiabetic medicines.

Exubera Powder is a fast-acting form of hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Exubera Powder if:

  • you are allergic to any ingredient in Exubera Powder
  • you are having an episode of low blood sugar
  • you have uncontrolled or poorly controlled lung or breathing problems
  • you smoke or you stopped smoking less than 6 months ago

Contact your doctor or health care provider right away if any of these apply to you.

Before using Exubera Powder:

Some medical conditions may interact with Exubera Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you drink alcoholic beverages, smoke, or are regularly exposed to secondhand smoke
  • if you have adrenal, pituitary, or thyroid problems; diabetic ketoacidosis; kidney or liver problems; lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], asthma, bronchitis); nerve problems; respiratory infection; or runny or stuffy nose
  • if you use 3 or more insulin injections per day
  • if you are fasting, have high blood sodium levels, or are on a low-salt diet

Some MEDICINES MAY INTERACT with Exubera Powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar if it occurs
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, pentoxifylline, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
  • Atypical antipsychotics (eg, clozapine, olanzapine), corticosteroids (eg, prednisone), danazol, diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, glucagon, HIV protease inhibitors (eg, ritonavir), hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Exubera Powder’s effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Exubera Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.



How to use Exubera Powder:

Use Exubera Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Exubera Powder comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Exubera Powder refilled.
  • If you are using Exubera Powder with meals, use your dose within 10 minutes before the meal begins unless your doctor tells you otherwise.
  • A health care provider will teach you how to use Exubera Powder. Be sure you understand how to use Exubera Powder. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Be sure that you have blisters that contain the correct amount of medicine that you need. Do NOT use three 1 mg blisters in place of one 3 mg blister. If you need a 3 mg blister and do not have one, use two 1 mg blisters unless your doctor tells you otherwise.
  • Do NOT open the medicine blister or swallow Exubera Powder. Exubera Powder is a powder for inhalation into the lungs. Use it only with the inhaler device provided. Do not use it with any other type of inhaler device.
  • To prepare the inhaler device – Hold it so that the words ” Exubera Inhaler” face you. Pull the black ring at the bottom of the base to pull the base out of the chamber. You should hear a click when the inhaler device is fully extended. The bottom of the chamber must be above the gray button.
  • To load the inhaler device – Hold a medicine blister with the printed side up and the notch pointed toward the inhaler. Insert it into the slot on the inhaler device. Push it in as far as it will go. Make sure the mouthpiece is closed. Pull the blue handle out from the bottom as far as it will go, and then squeeze the blue handle until it snaps shut.
  • To use Exubera Powder – Stand or sit up straight. Hold the inhaler upright, with the blue button facing toward you. Push the blue button until it clicks and watch for the insulin cloud to fill the chamber.
  • After the cloud appears, breathe out normally and turn the mouthpiece so that it is facing toward you. Place the mouthpiece fully in your mouth and form a seal around the mouthpiece with your lips. Do NOT blow into the mouthpiece. Do not block the opening with your tongue or teeth. Breathe in slowly and deeply through your mouth to inhale the insulin cloud and then take the inhaler device out of your mouth. Close your mouth and hold your breath for 5 seconds, and then breathe out normally.
  • Turn the mouthpiece to the closed position. Press the gray button, pull out the used medicine blister, and throw it away. Do not reuse a medicine blister. If you need to inhale another blister to complete your dose, repeat the steps above. Inhale only one blister at a time.
  • To store the inhaler device – Squeeze the 2 chamber release buttons on the side of the base at the same time. Push the base back into the chamber.
  • Carefully follow the instructions for cleaning and caring for the inhaler device. Replace the Exubera release unit every 2 weeks to ensure that the inhaler device will work properly.
  • Exubera Powder begins to lower blood sugar about 10 to 20 minutes after you use a dose. The peak effect occurs about 2 hours after you use a dose. The effect of Exubera Powder lasts for up to 6 hours.
  • If you also use bronchodilators or other inhaled products, they may increase the risk of high or low blood sugar. It is important to time your doses consistently with regard to Exubera Powder. Ask your doctor how to use bronchodilators or other inhaled products with Exubera Powder.
  • It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Exubera Powder.

Important safety information:

  • Exubera Powder may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Exubera Powder with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.
  • Do not smoke while you use Exubera Powder. Smoking may increase your risk of developing low blood sugar. If you start smoking while you are using Exubera Powder, contact your doctor right away.
  • Do not use more than the recommended dose of Exubera Powder, use it more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.
  • Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.
  • Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick-day plan to use in case of illness. When you are sick, test your blood/urine often and call your doctor as instructed.
  • Tell your doctor or dentist that you take Exubera Powder before you receive any medical or dental care, emergency care, or surgery.
  • If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
  • Carry an ID card at all times that says you have diabetes.
  • An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Exubera Powder.
  • Some people using Exubera Powder have developed lung cancer. The people who have developed lung cancer used to smoke cigarettes. It is not known if the lung cancer was related to Exubera Powder. Check with your doctor if you have any questions or concerns.
  • Lab tests, including fasting blood glucose levels, hemoglobin A1c levels, and lung function, may be performed while you use Exubera Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Exubera Powder with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.
  • Exubera Powder should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Exubera Powder can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Exubera Powder while you are pregnant. It is not known if Exubera Powder is found in breast milk. If you are or will be breast-feeding while you use Exubera Powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Exubera Powder:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; dry mouth; increased sputum production; runny or stuffy nose; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chest pain or discomfort; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; shortness of breath; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org) or emergency room immediately. Symptoms may include chills; coma; dizziness; drowsiness; fainting; headache; increased heartbeat; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Exubera Powder:

Store Exubera Powder at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do NOT refrigerate or freeze. Throw away any frozen blisters. Store away from heat, moisture, and light. Do not store in the bathroom. Store inside the wrap to protect the blisters from moisture. Blisters must be used within 3 months after opening the foil wrap. The inhaler may be used for up to 1 year from the date of first use. Keep Exubera Powder out of the reach of children and away from pets.

General information:

  • If you have any questions about Exubera Powder, please talk with your doctor, pharmacist, or other health care provider.
  • Exubera Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Exubera Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Eye Cool

30/06/10

Generic Name: phenylephrine (Ophthalmic route)

fen-il-EF-rin

Commonly used brand name(s):

In the U.S.

  • AK-Dilate
  • Altafrin
  • Eye Cool
  • Mydfrin
  • Neofrin
  • Neo-Synephrine
  • Ocu-Phrin
  • Prefrin Liquifilm

Available Dosage Forms:

  • Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

Uses For Eye Cool

Ophthalmic phenylephrine in strengths of 2.5 and 10% is used to dilate (enlarge) the pupil. It is used before eye examinations, before and after eye surgery, and to treat certain eye conditions. In the U.S., these preparations are available only with your doctor’s prescription.


Before Using Eye Cool

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children may be especially sensitive to the effects of phenylephrine. This may increase the chance of side effects during treatment. In addition, the 10% strength is not recommended for use in infants. Also, the 2.5 and 10% strengths are not recommended for use in low birth weight infants.

Geriatric

Repeated use of 2.5 or 10% phenylephrine may increase the chance of problems during treatment with this medicine. In addition, heart and blood vessel problems have occurred more often in elderly patients than in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Clorgyline
  • Iproniazid
  • Isocarboxazid
  • Nialamide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amitriptyline
  • Amoxapine
  • Clomipramine
  • Desipramine
  • Dothiepin
  • Doxepin
  • Furazolidone
  • Imipramine
  • Lofepramine
  • Midodrine
  • Nortriptyline
  • Opipramol
  • Pargyline
  • Protriptyline
  • Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Guanethidine
  • Propranolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Type 2 diabetes mellitus or
  • Heart or blood vessel disease or
  • High blood pressure—The 2.5 and 10% strengths of phenylephrine may make the condition worse
  • Idiopathic orthostatic hypotension (a certain kind of low blood pressure)—Use of this medicine may cause a large increase in blood pressure to occur




Proper Use of phenylephrine

This section provides information on the proper use of a number of products that contain phenylephrine. It may not be specific to Eye Cool. Please read with care.

Do not use if the solution turns brown or becomes cloudy.

To use:

  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.
  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:

  • It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For ophthalmic solution (eye drops) dosage form:
    • For eye redness:
      • Adults and children—Use one drop of 0.12% solution every three or four hours as needed.
    • For eye exams:
      • Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.
    • For use before eye surgery:
      • Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.
      • Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.
    • For certain eye conditions:
      • Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.
      • Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For non-prescription strength eye drops, follow the package directions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Eye Cool

If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.

For patients using the 2.5 or 10% eye drops:

  • After you apply this medicine to your eyes, your pupils will become unusually large. This will cause your eyes to become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor. Also, if this effect continues for longer than 12 hours after you have stopped using this medicine, check with your doctor.

Eye Cool Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the bodyLess common with 10% solution; rare with 2.5% or weaker solution

  • Dizziness
  • fast, irregular, or pounding heartbeat
  • increased sweating
  • increase in blood pressure
  • paleness
  • trembling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common with 2.5 or 10% solution

  • Burning or stinging of eyes
  • headache or browache
  • sensitivity of eyes to light
  • watering of eyes

Less common

  • Eye irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

 

Generic Name: Tetrahydrozoline (te-tra-hye-DROZ-oh-leen)
Brand Name: Examples include Eye Moisturizing Relief and Murine Tears

Eye Moisturizing Relief Drops are used for:

Temporarily relieving redness, burning, and irritation caused by dry eyes. It may also be used for other conditions as determined by your doctor.

Eye Moisturizing Relief Drops are an eye decongestant and lubricant. It works by constricting the blood vessels in the eye and coating the eye, which relieves redness and dryness.

Do NOT use Eye Moisturizing Relief Drops if:

  • you are allergic to any ingredient in Eye Moisturizing Relief Drops
  • you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Eye Moisturizing Relief Drops:

Some medical conditions may interact with Eye Moisturizing Relief Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have glaucoma, high blood pressure, diabetes, heart problems, or thyroid problems, or you are taking medicine for high blood pressure

Some MEDICINES MAY INTERACT with Eye Moisturizing Relief Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Tricyclic antidepressants (eg, amitriptyline) because they may decrease Eye Moisturizing Relief Drops’s effectiveness
  • Cocaine, furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Eye Moisturizing Relief Drops’s side effects, such as headache, fever, and high blood pressure
  • Bromocriptine or cocaine because their actions and side effects may be increased by Eye Moisturizing Relief Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Eye Moisturizing Relief Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.



How to use Eye Moisturizing Relief Drops:

Use Eye Moisturizing Relief Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Eye Moisturizing Relief Drops are for use in the eye only. Avoid contact with the nose, mouth, or other mucous membranes.
  • To use Eye Moisturizing Relief Drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
  • If you miss a dose of Eye Moisturizing Relief Drops and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Eye Moisturizing Relief Drops.

Important safety information:

  • Remove contact lenses before using Eye Moisturizing Relief Drops.
  • Do not use Eye Moisturizing Relief Drops if it becomes cloudy or changes color.
  • Contact your doctor if you experience changes in your vision, eye pain, irritation, soreness, or continued redness, or if your condition does not improve after 3 days.
  • Use Eye Moisturizing Relief Drops with caution in CHILDREN because they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Eye Moisturizing Relief Drops, discuss with your doctor the benefits and risks of using Eye Moisturizing Relief Drops during pregnancy. It is unknown if Eye Moisturizing Relief Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Eye Moisturizing Relief Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Eye Moisturizing Relief Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; minor stinging when the medicine is dropped into the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain; worsening or persistent eye irritation or redness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Eye Moisturizing Relief Drops may be harmful if swallowed, especially in children.

Proper storage of Eye Moisturizing Relief Drops:

Store Eye Moisturizing Relief Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Eye Moisturizing Relief Drops out of the reach of children and away from pets.

General information:

  • If you have any questions about Eye Moisturizing Relief Drops, please talk with your doctor, pharmacist, or other health care provider.
  • Eye Moisturizing Relief Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Eye Moisturizing Relief Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

 

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