Generic Name: lisdexamfetamine dimesylate (Oral route)

lis-dex-am-FET-a-meen dye-MES-i-late

Commonly used brand name(s):

In the U.S.

• Vyvanse

Available Dosage Forms:

• Capsule

Therapeutic Class: CNS Stimulant

Chemical Class: Lisdexamfetamine

Uses For Vyvanse

Lisdexamfetamine dimesylate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 to 12 years of age and in adults .

Lisdexamfetamine dimesylate increases attention and decreases restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment .

This medicine is available only with your doctor’s prescription .

Before Using Vyvanse

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

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of lisdexamfetamine dimesylate in children 6 to 12 years of age. Safety and efficacy have not been established inchildren younger than 6 years of age and in teenagers .

Geriatric

Adequate and well-controlled studies have not been done in the geriatric population .

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
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Toloxatone
• 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.

• Furazolidone

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:

• Agitation, severe or
• Anxiety, severe or
• Blood vessel problems or
• Glaucoma or
• Heart disease or failure or
• High blood pressure, moderate to severe or
• Hyperthyroidism (overactive thyroid) or
• Tension, severe—Should not be used in patients with these conditions .

• Depression, severe or
• Heart rhythm problems (e.g., fast heartbeat) or
• High blood pressure, mild or
• Motor tics (repeated muscle movements) or
• Psychosis (mental illness) or
• Seizures, history of or
• Tourette’s syndrome, or family history of—May make these conditions worse .

• Drug abuse and dependence, history of—Dependence may be more likely to develop .

Proper Use of Vyvanse

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions .

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one .

This medicine may be taken with or without food .

It is best to take this medicine in the morning. Taking this medicine in the afternoon or evening could make it harder for you to fall asleep .

The capsule should be swallowed whole, and not crushed, divided, or chewed. If you or your child are not able to swallow the capsule whole, carefully open the capsule and pour the medicine into a glass of water. Stir this mixture well and swallow it right away. The drug mixture can not be stored for future use .

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 attention deficit hyperactivity disorder (ADHD):
  • For oral dosage form (capsules):
    • Adults and children 6 to 12 years of age—30 milligrams (mg) once a day in the morning. If needed, your doctor may increase the dose once a week by 10 mg or 20 mg a day until symptoms improve or a maximum dose of 70 mg is reached.
    • Children younger than 6 years of age and teenagers—Use and dose must be determined by your doctor .

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.

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 Vyvanse

It is very important that your doctor check your progress at regular visits and make sure that your dose is right and that the medicine is helping you. Your doctor will need to check your blood, heart, and blood pressure for any problems or unwanted effects that may be caused by this medicine .

You should not use this medicine if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days .

Tell your doctor about all the medicines you take or plan to take, including prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems .

This medicine may cause blurred vision or make you drowsy or dizzy. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well .

Lisdexamfetamine dimesylate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, shortness of breath, or fainting while taking this medicine .

Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child’s height and weight to make sure that your child is growing properly .

Vyvanse 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 immediately if any of the following side effects occur:

Less common

• Uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal cramps
• blurred vision
• change in consciousness
• confusion
• dark-colored urine
• diarrhea
• discouragement
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fainting
• fast breathing
• fast, slow, or irregular heartbeat
• feeling sad or empty
• lack of appetite
• loss of consciousness
• loss of interest or pleasure
• mood or mental changes
• muscle cramps or spasms
• muscle pain or stiffness
• nervousness
• overactive reflexes
• physical attempt to injure yourself
• panic states
• pounding in the ears
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness in legs, arms, hands, or feet
• sweating
• trembling or shaking of hands or feet
• trouble concentrating
• unusual tiredness or weakness
• violent actions

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

• Decreased appetite
• headache
• irritability
• nausea
• sleeplessness
• trouble sleeping
• unable to sleep
• upper abdominal pain
• vomiting
• weight decreased

Less common

• Crying
• depersonalization
• depression
• dizziness
• dry mouth
• dysphoria
• euphoria
• fever
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• rash
• sleepiness or unusual drowsiness

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.

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Generic name: Ezetimibe and Simvastatin
Brand names: Vytorin

Why is Vytorin prescribed?

Vytorin is a cholesterol-lowering drug. It is used along with a special diet to lower the amount of fatty material in the blood— triglycerides and LDL (or “bad”) cholesterol—that can build up on artery walls and block blood flow. At the same time, Vytorin raises HDL (or “good”) cholesterol, which helps prevent fats from building up and clogging the arteries.

Your body needs fat to function properly, but when it accumulates as fatty deposits in the arteries, it increases your risk for heart attack, stroke, and blood-vessel disease. Your doctor may prescribe Vytorin if you are at high risk for heart disease and your cholesterol level is above 130, or if you are at low risk for heart disease and your cholesterol level is above 190.

Vytorin is a combination of two drugs, simvastatin and ezetimibe. Each works in a different way to lower levels of fat in the blood. Normally, the liver produces most of the cholesterol needed to maintain a healthy balance. Simvastatin works by interrupting the process of cholesterol production, mainly in the liver. Ezetimibe reduces the amount of cholesterol absorbed in the intestines.

Most important fact about Vytorin

Vytorin is usually prescribed only if diet, exercise, and weight loss fail to bring your cholesterol levels under control. It’s important to remember that Vytorin is a supplement—not a substitute—for those other measures. To get the full benefit of the medication, you need to stick to the diet and exercise program prescribed by your doctor. All these efforts to keep your cholesterol levels normal are important because they may lower your risk of heart disease. Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone.

How should you take Vytorin?

Take Vytorin once a day in the evening with or without food.

If you are also using the cholesterol-lowering drug cholestyramine, take Vytorin at least 2 hours before or 4 hours after taking the other medication.

• If you miss a dose…
  Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once.

• Storage instructions…
  Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Vytorin.

• Side effects may include:
  Allergic reaction including swelling of the face, lips, throat, or tongue, difficulty breathing or swallowing, or rash; flu; gallstones; headache; inflammation of the gallbladder; inflammation of the liver; inflammation of the pancreas; muscle pain, tenderness, or weakness; nausea; numbness or pain in the hands or feet; upper respiratory infection

Why should Vytorin not be prescribed?

Do not take Vytorin if you are allergic to either ezetimibe or simvastatin. You should also not take Vytorin if you have liver disease or if blood tests suggest a liver problem.

If you are pregnant, plan to become pregnant, or have missed a period, do not take Vytorin. In addition, women who are breastfeeding should not use Vytorin.

Special warnings about Vytorin

Vytorin can cause the breakdown of muscle tissue, which can lead to serious kidney damage and, in rare cases, death from kidney failure. It is very important to stop taking Vytorin and call your doctor immediately if you have muscle pain, tenderness, or weakness that comes on while taking Vytorin, especially if you also have a fever and feel sick.

Vytorin can make certain medical conditions worse. If you have diabetes, kidney disease, any kind of muscle disorder, or if you have ever had liver problems, you must be carefully monitored while taking Vytorin.

Because Vytorin can cause liver problems, your doctor will order a blood test to check your liver enzymes before your first dose and again at regular intervals during treatment. You may have to stop taking Vytorin if your liver enzymes become too high.

Because of possible effects on the liver, it is important to limit your alcohol consumption while taking Vytorin.

Simvastatin and similar drugs have caused cataracts and other serious eye problems in animal studies. Be sure to alert your doctor if you have cataracts or any eye condition that gets worse.

Alert the doctor if you’re scheduled to have surgery. You’ll probably need to stop taking Vytorin several days beforehand.

Possible food and drug interactions when taking Vytorin

If Vytorin is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Combining it with the following increases the chance of muscle damage:
Amiodarone
Antifungal medicines such as itraconazole and ketoconazole
Benzafibrate
Clarithromycin
Clofibrate
Cholestyramine
Cyclosporine
Erythromycin
Fenofibrate
Gemfibrozil
Grapefruit juice (large quantities)
HIV medicines called protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir
Nefazodone
Niacin and nicotinic acid
Verapamil

• Other drugs that may interact with Vytorin include:
  Blood-thinning drugs such as warfarin
  Digoxin
  Propranolol

You should also avoid drinking large amounts of alcohol while taking Vytorin.

Special information if you are pregnant or breastfeeding

Cholesterol is needed for a baby to develop properly. Therefore, you should not take Vytorin if you are pregnant or if you plan to become pregnant. If you find out you’re pregnant during Vytorin treatment, stop taking it and call your doctor. In addition, women who are breastfeeding should not take Vytorin.

Recommended dosage for Vytorin

ADULTS

The usual starting dose is one 10/20 tablet containing 10 milligrams of ezetimibe and 20 milligrams of simvastatin taken once a day in the evening. The doctor may prescribe a lower starting dose (10/10) if you require less aggressive treatment and a higher one (10/40) if you need a large reduction (more than 55 percent) in LDL cholesterol. Depending on your body’s response, the doctor may increase your dose at 2-week intervals up to a maximum of 10/80 milligrams a day.

If you’re taking cyclosporine, the dose of Vytorin should not exceed 10/10 milligrams a day. If you’re taking amiodarone or verapamil, the dose should not exceed 10/20 milligrams a day.

If you have severe kidney disease, the doctor may prescribe a lower dose or have you stop taking Vytorin altogether.

CHILDREN 10 YEARS OF AGE OR OLDER

Vytorin has not been studied in children or adolescents. However, one of the ingredients, simvastatin, is approved for use in children 10 years and older. The recommended starting dose is 10 milligrams once a day in the evening. The dosage may be increased every 4 weeks, as determined by the doctor, up to a maximum of 40 milligrams a day. Girls must have been menstruating for at least 1 year before starting therapy with simvastatin. The drug has not been studied in children less than 10 years old or in doses greater than 40 milligrams a day.

There is limited experience with the use of ezetimibe in children. The drug appears to be metabolized the same as in adults. Ezetimibe is not recommended for children less than 10 years old.

Because of the individual recommendations for simvastatin and ezetimibe, Vytorin is also not recommended for children less than 10 years old.

Overdosage

Although there is no specific information about Vytorin overdose, any medication taken in excess can have serious consequences. If you suspect an overdose, seek emergency treatment immediately.

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)
Brand Names: Advance Care Plus, Bright Beginnings, Cenogen Ultra, CitraNatal 90 DHA, CitraNatal Assure, CitraNatal DHA, CitraNatal Rx, Complete Natal, Complete-RF, CompleteNate, Concept DHA, Concept OB, Dualvit OB, Duet, Duet Chewable, Duet DHA, Duet DHA EC, Edge OB, Folbecal, Foltabs, Foltabs 90 plus DHA, Foltabs plus DHA, Gesticare, Gesticare DHA, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Inatal Ultra, Lactocal-F, Marnatal-F Plus, Maternity, Maxinate, Mission Prenatal, Mission Prenatal HP, Multinatal Plus, Nata 29 OB, Nata 29 Prenatal, Natachew, Natafort, Natelle, Natelle C, Natelle Plus with DHA, Natelle Prefer, Natelle-ez, Neevo, Neevo DHA, Nestabs CBF, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Complete with DHA, OB Natal One, Ob-20, OptiNate, Pre-H-Cal, Precare, Precare Conceive, Precare Premier, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs CBF, Prenatabs FA, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal 19, Prenatal AD, Prenatal Elite, Prenatal H, Prenatal Low Iron, Prenatal Multivitamins, Prenatal Plus, Prenatal Plus Iron, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenate Elite Plus Iron, Prenavite FC, Prenavite PC, PreNexa, Previte Rx, PrimaCare, PrimaCare Advantage, PrimaCare One, Pruet DHA, Pruet DHA EC, RE OB 90 Plus DHA, RE OB Plus DHA, Renate, Renate DHA, Renate DHA Extra, RightStep, Se-Care, Se-Care Conceive, Se-Natal 90, Se-Natal One, Select-OB, Select-OB+DHA, Strongstart, Stuart Prenatal with Beta Carotene, Tandem DHA, Tandem OB, Tri Rx, TriAdvance, TriCare, Trinatal Rx, Trinate, UltimateCare Advance, UltimateCare One, Ultra-Natal, Verotin-BY, Verotin-GR, Vinatal 600, Vinatal Forte, Vinate 90, Vinate Advanced (New Formula), Vinate AZ, Vinate AZ Extra, Vinate C, Vinate Calcium, Vinate Care, Vinate Good Start, Vinate GT, Vinate IC, Vinate II (New Formula), Vinate III, Vinate M, Vinate One, Vinate PN Care, Vinate Ultra, Vitafol PN, Vitafol-OB, Vitafol-OB+DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaphil Plus DHA 90, Vitaspire, Viva DHA, Vynatal F.A.

What are Vynatal F.A. (prenatal multivitamins)?

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while-breast-feeding.

How should I take prenatal vitamins?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

It is important to take prenatal vitamins regularly to get the most benefit.

Store this medication at room temperature away from moisture and heat.

Store prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

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 vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• upset stomach;

• headache; or

• unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• diuretics (water pills);

• heart or blood pressure medications;

• tretinoin (Vesanoid);

• isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

• trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

This list is not complete and there may be other medications that can interact with or be affected by prenatal vitamins. 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 prenatal vitamins.

• 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: 09/23/2009 11:57:32 AM.

Generic Name: Hydrocortisone/Iodoquinol (hye-droe-KOR-ti-sone/eye-oh-doe-KWIN-ole)
Brand Name: Examples include Dermazene and Vytone

Vytone is used for:

Treating inflammation and itching due to certain skin conditions when bacterial or fungal infection may be present. It may also be used for other conditions as determined by your doctor.

Vytone is a topical adrenocortical steroid and antibacterial/antifungal. It works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not clearly understood. The antibacterial/antifungal works by killing sensitive bacteria and fungi.

Do NOT use Vytone if:

• you are allergic to any ingredient in Vytone

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

Before using Vytone:

Some medical conditions may interact with Vytone. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin
• if you have had a recent vaccination; have measles, tuberculosis, chicken pox, or shingles; or have had a positive tuberculosis test
• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Vytone. Because little, if any, of Vytone is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Vytone 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 Vytone:

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

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Vytone, unless your hands are part of the treated area.
• Do not bandage or cover the treated skin area unless directed by your doctor.
• If you miss a dose of Vytone, apply 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. Do not apply 2 doses at once.

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

Important safety information:

• Vytone is for external use only. Do not get Vytone in your eyes. If contact is made with the eyes, flush them immediately with tap water.
• Long-term or repeated use of Vytone may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If Vytone is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Vytone may stain skin and clothing or other fabrics.
• Check with your doctor before having vaccinations while using Vytone.
• Do not use Vytone for other skin conditions at a later time.
• Vytone has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Vytone may interfere with certain lab tests, including thyroid function tests and certain phenylketonuria tests. Be sure your doctor and lab personnel know you are using Vytone. You should wait at least 1 month after stopping treatment with Vytone to have a thyroid function test.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Vytone.
• Vytone should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vytone while you are pregnant. It is not known if Vytone is found in breast milk after topical use. If you are or will be breast-feeding while you use Vytone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vytone:

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:

Dryness; itching.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Vytone; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Vytone:

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

General information:

• If you have any questions about Vytone, please talk with your doctor, pharmacist, or other health care provider.
• Vytone 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 Vytone. 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.

Generic name: Miconazole nitrate, Zinc oxide
Brand names: Vusion

Why is Vusion prescribed?

Vusion ointment is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who have a normal immune systems.

Most important fact about Vusion

Vusion ointment contains medicines that will help treat the yeast infection and the diaper rash. Even if you use Vusion ointment, diaper rash will not go away if you do not keep your child’s diaper area clean and dry.

How should you take Vusion?

Gently, clean the skin on your child’s diaper area with warm (not hot) water. You may also use a very mild soap. Pat the area dry with a soft towel. Use your fingertips and gently apply a thin layer of Vusion ointment to your child’s diaper area at each diaper change. Do not rub Vusion ointment into your child’s skin. Rubbing the skin can cause more irritation. Wash your hands after applying Vusion ointment to your child.

• Storage instructions…
  Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Vusion.

• Side effects may include:
  Irritation (uncommon)

Why should Vusion not be prescribed?

Vusion ointment is not for treatment of all cases of diaper rash. Vusion ointment is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not have yeast infections; therefore, they do not need the medicine that is in Vusion to treat a yeast infection.

Do not use Vusion on your child if he/she is allergic to any of its ingredients.

Special warnings about Vusion

Avoid using any scented soaps, shampoos, or lotions on the diaper area. Do not use Vusion ointment on your child’s diaper rash unless your doctor tells you that there is also a yeast infection. Do not use on any other children.

Tell your doctor about all prescription, over-the-counter, and herbal medications your child is taking before beginning treatment with Vusion. Also, talk to your doctor about your child’s complete medical history.

Possible food and drug interactions when taking Vusion

If Vusion ointment is used with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Vusion with the following:

Miconazole intravaginal cream or suppository
Warfarin

Special information if you are pregnant or breastfeeding

If you are pregnant, be cautious while applying Vusion to your child.

Recommended dosage for Vusion

CHILDREN

A thin layer of Vusion ointment should be spread across the rash using your fingertip, for 7 days. Vusion ointment is applied to the skin on your child’s diaper area at each diaper change. Apply for the full 7 days even if the diaper rash starts to go away. Call your child’s doctor if the diaper rash gets worse or does not go away in 7 days.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Generic Name: teniposide (ten IP oh side)
Brand Names: Vumon

What is Vumon (teniposide)?

Teniposide is a cancer (antineoplastic) medication. Teniposide interferes with the growth of cancer cells and slows their growth and spread in the body.

Teniposide is used in the treatment of acute lymphoblastic leukemia (blood cancer) in children.

Teniposide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Vumon (teniposide)?

Teniposide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of teniposide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); and others. Talk to your doctor about the possible side effects from treatment with teniposide.

Who should not use Vumon (teniposide)?

Do not use teniposide without first talking to your doctor if you have

• Down’s Syndrome;

• bone marrow suppression;

• liver disease; or

• low albumin levels.

The use of teniposide may be dangerous if you have any of the conditions listed above.

Teniposide is in the FDA pregnancy category D. This means that teniposide is known to be harmful to an unborn baby. Do not use teniposide without first talking to your doctor if you are pregnant. Discuss with your doctor the appropriate use of birth control during treatment with teniposide if necessary. It is not known whether teniposide passes into breast milk. Do not take teniposide without first talking to your doctor if you are breast feeding a baby. The safety and effectiveness of teniposide in children has not been established.

How should I use Vumon (teniposide)?

Teniposide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with teniposide depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with teniposide to monitor progress and side effects.

Skin accidentally exposed to teniposide should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store teniposide as directed by the manufacturer. If you are storing teniposide at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of teniposide.

What happens if I overdose?

If for any reason an overdose of teniposide is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a teniposide overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Vumon (teniposide)?

Teniposide can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with teniposide. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to teniposide should be rinsed thoroughly with soap and warm water.

Vumon (teniposide) side effects

If you experience any of the following serious side effects from teniposide, seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

• decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection).

Other, less serious side effects may be more likely to occur. Continue taking teniposide and talk to your doctor if you experience:

• nausea or vomiting;

• drowsiness or dizziness; or

• temporary hair loss.

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 Vumon (teniposide)?

Do not receive “live” vaccines during treatment with teniposide. Administration of a live vaccine may be dangerous during treatment with teniposide.

Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with teniposide.

Where can I get more information?

• Your healthcare provider may have additional information about teniposide that you may read.

• 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: 1.06. Revision Date: 4/12/2009 4:39:46 PM.

Generic Name: isoxsuprine (eye SOCK soo prin)
Brand Names: Vasodilan, Voxsuprine

What is Voxsuprine (isoxsuprine)?

Isoxsuprine is in a class of drugs called vasodilators. Isoxsuprine relaxes veins and arteries, which makes them wider and allows blood to pass through them more easily.

These actions may help treat the symptoms of conditions such as cerebral vascular insufficiency (poor blood flow to the brain), arteriosclerosis (hardening of the arteries), Raynaud’s phenomenon, and other conditions involving poor blood flow in the veins and arteries.

Isoxsuprine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Voxsuprine (isoxsuprine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Isoxuprine may cause dizziness. If you experience dizziness, avoid these activities. Also, rise slowly from a sitting or lying position to avoid falling.

Notify your doctor if you experience a rash or bothersome irregular heartbeats.

Isoxsuprine has been withdrawn from the U.S. market.

What should I discuss with my healthcare provider before taking Voxsuprine (isoxsuprine)?

Isoxsuprine should not be used immediately postpartum (after delivering a baby), or if you have a bleeding disorder. Talk to your doctor about any other medical conditions that you have.

Isoxsuprine is in the FDA pregnancy category C. This means that it is not known whether isoxsuprine will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether isoxsuprine passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Voxsuprine (isoxsuprine)?

Take isoxsuprine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Isoxsuprine is usually taken three or four times a day. Follow your doctor’s instructions.

It is important to take isoxsuprine regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with isoxsuprine to monitor progress and side effects.

Store isoxsuprine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an isoxsuprine overdose include weakness, lightheadedness, fainting, nausea, and vomiting.

What should I avoid while taking Voxsuprine (isoxsuprine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Isoxsuprine may cause dizziness. If you experience dizziness, avoid these activities. Also, rise slowly from a sitting or lying position to avoid falling.

Voxsuprine (isoxsuprine) side effects

Stop taking isoxsuprine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Stop taking isoxsuprine and contact your doctor if you develop a rash.

Other, less serious side effects may be more likely to occur. Continue to take isoxsuprine and talk to your doctor if you experience

• chest pain or an irregular heartbeat (call your doctor if this becomes bothersome);

• nausea or vomiting; or

• dizziness or weakness.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Voxsuprine (isoxsuprine)?

Drugs used to treat high blood pressure and other heart conditions may increase the effects of isoxsuprine. Special monitoring may be necessary.

Drugs other than those listed here may also interact with isoxsuprine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has additional information about isoxsuprine written for health professionals that you may read.

• 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: 2.06. Revision Date: 4/12/2009 4:37:55 PM.

Generic Name: velaglucerase alfa (Intravenous route)

vel-a-GLOO-ser-ase AL-fa

Commonly used brand name(s):

In the U.S.

• VPRIV

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Enzyme

Uses For VPRIV

Velaglucerase alfa injection is used to treat type 1 Gaucher’s disease. This disease is caused by the lack of a certain enzyme, glucocerebrosidase, in the body. This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if the enzyme is not present. Velaglucerase alfa replaces the missing enzyme to help the body process fats.

This medicine is available only with your doctor’s prescription.

Before Using VPRIV

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of velaglucerase alfa injection in children 4 to 17 years of age. However, safety and efficacy have not been established in children younger than 4 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of velaglucerase alfa injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of VPRIV

A nurse or other trained health professional will give you or your child this medicine in a hospital or clinic. This medicine is given through a needle placed in one of your veins.

You or your child may also receive medicines to help prevent unwanted effects from the injection.

Precautions While Using VPRIV

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.

This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, headaches, wheezing, trouble with breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, nausea, unusual tiredness or weakness, or lightheadedness or faintness while you are receiving this medicine.

VPRIV 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 or nurse immediately if any of the following side effects occur:

More common

• Body aches or pain
• cough
• difficulty with breathing
• dizziness
• ear congestion
• facial swelling
• fever or chills
• headache
• loss of voice
• nasal congestion
• nausea or vomiting
• runny nose
• shortness of breath
• skin rash
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Blurred vision
• bone pain
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• nervousness
• pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• pounding in the ears
• slow or fast heartbeat
• sweating

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

• Abdominal or stomach pain
• back pain
• joint pain
• lack or loss of strength

Less common

• Feeling of warmth
• hives or welts
• itching
• redness of the skin
• redness of the face, neck, arms, and occasionally, upper chest

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: Albuterol sulfate Brand names: VoSpire Extended-Release Tablets, AccuNeb, Proventil HFA, Ventolin HFA, Volmax Extended-Release Tablets, Proventil Why is VoSpire Extended-Release Tablets prescribed? Drugs containing albuterol are prescribed for the prevention and relief of bronchial spasms that narrow the airway. This especially applies to the treatment of asthma. Some brands of Proventil are also used for the prevention of bronchial spasm due to exercise. Most important fact about VoSpire Extended-Release Tablets Do not take albuterol more frequently than your doctor recommends. Increasing the number of doses can be dangerous and may actually make symptoms of asthma worse. If the dose your doctor recommends does not provide relief of your symptoms, or if your symptoms become worse, consult your doctor immediately. How should you take VoSpire Extended-Release Tablets? If you are taking extended-release tablets, swallow them whole with some liquid–never chew or crush them. Shake the inhalation aerosol canister well before using and make sure it’s firmly seated in the plastic mouthpiece. Before using it for the first time, prime the canister with 4 sprays into the air away from your face. Prime it with 2 sprays whenever it has not been used for at least 4 days. Use only the adapter that comes with the product; do not use this adapter with any other product. Wash the plastic mouthpiece with warm running water at least once a week to prevent medication buildup and blockage. If you are using an inhalation solution, be sure to protect it from contamination. Keep the tip of the dropper away from the lip of the bottle or any other surface. Do not use the solution if it changes color or becomes cloudy. –If you miss a dose… Take the forgotten dose as soon as you remember; then take any remaining doses for that day at equally spaced intervals. Never take a double dose. –Storage instructions… AccuNeb, Proventil syrup, and Proventil solution for inhalation can be kept in the refrigerator or at room temperature. Proventil aerosol can be stored at temperatures as low as 60 degrees Fahrenheit, but should be at room temperature before use. Protect from excessive heat. Ventolin nebules must be used within 2 weeks of being removed from the refrigerator. Store VoSpire tablets at room temperature in a tight, light-resistant container. Volmax tablets should be kept refrigerated. VoSpire Extended-Release Tablets side effects Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking albuterol. Side effects may include: Aggression, agitation, allergic reaction, anxiety, back pain, chest pain or discomfort, chills and fever, coordination problems, cough, decreased appetite, depression, difficulty speaking, diabetes, diarrhea, dizziness, drowsiness, dry mouth and throat, excitement, fluid retention and swelling, flushing, general bodily discomfort, headache, heart palpitations, heartburn, hives, increased appetite, increased blood pressure, increased difficulty breathing, indigestion, irritability, labored breathing, leg cramps, light-headedness, muscle cramps, muscle spasm, nasal inflammation, nausea, nervousness, nightmares, nosebleed, overactivity, rapid heartbeat, rash, respiratory infection or disorder, restlessness, ringing in the ears, shakiness, sleeplessness, slowed movement, stomachache, stuffy nose, sweating, swelling of mouth and throat, taste sensation on inhalation, throat irritation, tooth discoloration, tremors, unusual taste, urinary problems, vomiting, weakness, wheezing Why should VoSpire Extended-Release Tablets not be prescribed? If you are sensitive to or have ever had an allergic reaction to albuterol or other bronchodilators, you should not take VoSpire Extended-Release Tablets. Make sure that your doctor is aware of any drug reactions that you have experienced. Special warnings about VoSpire Extended-Release Tablets When taking albuterol inhalation aerosol, you should not use other inhaled medications before checking with your doctor. Make sure the doctor is aware of it if you have a heart condition, seizure disorder, high blood pressure, abnormal heartbeat, overactive thyroid gland, or diabetes. Call your doctor immediately if you notice any change in heartbeat or pulse while taking Proventil. You may have an immediate, serious allergic reaction to the first dose of albuterol, causing symptoms such as hives, rash, and swelling of the mouth, throat, lips, and tongue. The drug has been known to cause life-threatening bronchial spasms, especially with the first dose from a new canister or vial. There have also been rare reports of skin reddening and peeling in children taking albuterol syrup. Do not exceed your doctor’s recommended dose of albuterol. If you need more than usual, check with your doctor. Your asthma may be getting unstable, and you may need another medication. Do not, however, change your medication without first consulting your doctor or pharmacist. Possible food and drug interactions when taking VoSpire Extended-Release Tablets Use albuterol inhalation aerosol with other aerosol bronchodilators only if your doctor recommends it. If albuterol is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining albuterol with the following: Antidepressants classified as MAO inhibitors, such as Nardil and Parnate, and tricyclic antidepressants such as Elavil, Norpramin, Pamelor, and Tofranil. Beta blockers (heart and blood pressure drugs such as Inderal, Tenormin, and Sectral) Digoxin (Lanoxin) Drugs similar to albuterol, such as Alupent, Brethine, Isuprel, and epinephrine Drugs that lower potassium levels (water pills such as Lasix or HydroDIURIL) Special information if you are pregnant or breastfeeding The effects of albuterol during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known whether albuterol appears in breast milk. If Proventil is essential to your health, your doctor may advise you to stop nursing your baby until your treatment is finished. Recommended dosage for VoSpire Extended-Release Tablets ADULTS Inhalation Aerosol If you are being treated for a sudden or severe bronchial spasm or the prevention of asthma symptoms, the usual dosage of albuterol inhalation aerosol is 2 inhalations repeated every 4 to 6 hours. More frequent use is not recommended. In some individuals, 1 inhalation every 4 hours may be sufficient. To prevent exercise-induced bronchial spasm, the usual dosage is 2 inhalations, 15 minutes prior to exercise. Tablets The usual starting dose for adults and children 12 years of age and older is 2 or 4 milligrams 3 to 4 times a day. Dosage should not exceed 32 milligrams per day. Syrup The usual starting dose for adults and children over 12 years of age is 1 or 2 teaspoonfuls 3 or 4 times a day. Dosage should not exceed 4 teaspoonfuls 4 times a day. Proventil Inhalation Solution The usual dosage for adults and children 12 years of age and older is 2.5 milligrams administered 3 to 4 times daily by nebulization. Do not use more often or in higher doses. To administer 2.5 milligrams, use the entire contents of a unit-dose bottle of the 0.083% solution or dilute 0.5 milliliter of the 0.5 percent solution with 2.5 milliliters of sterile normal saline solution. Proventil Repetabs, Volmax Extended-Release Tablets, and VoSpire Extended-Release Tablets The usual recommended dosage for adults and children 12 years of age and older is 8 milligrams every 12 hours. In some people, 4 milligrams every 12 hours may be sufficient. If the desired effect is not achieved with the standard dosage, your doctor may increase doses to a maximum of 32 milligrams per day, divided into two 16-milligram doses spaced 12 hours apart. Those taking standard tablets or syrup can switch to extended-release tablets. One extended-release tablet every 12 hours is equivalent to one 2-milligram standard tablet every 6 hours. CHILDREN Inhalation Aerosol The usual dose of albuterol inhalation aerosol for children aged 4 and over (12 and over for Proventil) is 2 inhalations every 4 to 6 hours. To prevent exercise-induced bronchial spasm, the dose is 2 inhalations 15 minutes prior to exercise. Tablets The usual starting dose for children 6 to 12 years of age is 2 milligrams 3 or 4 times a day. The dose can be increased with caution but should not exceed 24 milligrams per day. Safety and effectiveness in children under 6 have not been established. Syrup The usual starting dose for children 6 to 12 years of age is 1 teaspoonful 3 to 4 times a day. The dosage should not exceed 3 teaspoonfuls 4 times a day. For children 2 to 6 years of age, the starting dose is 0.1 milligram per 2.2 pounds of body weight, to a maximum of 4 milligrams, 3 times a day. Proventil Repetabs, Volmax Extended-Release Tablets, and VoSpire Extended-Release Tablets The usual starting dosage for children 6 to 12 years of age is 4 milligrams every 12 hours. The dosage can be increased with caution but should not exceed 24 milligrams per day. AccuNeb Inhalation Solution The usual starting dose for children 2 to 12 years of age is 0.63 or 1.25 milligrams 3 or 4 time daily by nebulization. To administer, use the entire contents of the prescribed unit-dose vial. The 1.25 milligram dosage may be more helpful for children 6 to 12 with more severe asthma, and for children 11 to 12. OLDER ADULTS Oral Dosage The usual starting dose of tablets or syrup is 2 milligrams 3 or 4 times a day. If needed, the dosage may be increased gradually to as much as 8 milligrams 3 or 4 times a day. Overdosage Symptoms of albuterol overdose may include: Dizziness, dry mouth, fatigue, general feeling of illness, headache, high or low blood pressure, insomnia, nausea, nervousness, radiating chest pain, rapid or irregular heartbeat, seizures, tremors Heart attack and even death have been associated with abuse of albuterol inhalation. Exaggerated side effects may also be a sign of an overdose. If you suspect an overdose, seek medical attention immediately.

Generic Name: pazopanib (paz OH pa nib)
Brand Names: Votrient

What is pazopanib?

Pazopanib is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Pazopanib is used to treat advanced renal cell carcinoma (kidney cancer).

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

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

Do not use pazopanib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you take pazopanib, tell your doctor if you have liver disease, heart disease, high blood pressure, underactive thyroid, an ulcer or other stomach disorder, or a history of “Long QT syndrome,” blood clot, or bleeding (stomach, intestinal, or brain).

There are many other medicines that can interact with pazopanib. Tell your doctor about all the prescription and over-the-counter medications you use. You will need regular medical tests to be sure this medication is not causing harmful effects. Do not miss any follow-up visits to your doctor. If you need to have any type of surgery, tell the surgeon ahead of time that you are using pazopanib. Stop using pazopanib and call your doctor at once if you have a serious side effect such as bloody or tarry stools, coughing up blood, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), sudden numbness or weakness, problems with speech or balance, chest pain, or vision and hearing problems.

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

You should not use this medication if you are allergic to it.

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

• liver disease;

• heart disease;

• high blood pressure;

• a personal or family history of “Long QT syndrome”;

• a history of blood clot;

• underactive thyroid;

• an ulcer or other stomach disorder;

• a head injury or bleeding in your brain within the past 6 months; or

• stomach or intestinal bleeding within the past 6 months.

FDA pregnancy category D. Do not use pazopanib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether pazopanib 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.

How should I take pazopanib?

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 pazopanib on an empty stomach, at least 1 hour before or 2 hours after a meal.

Pazopanib is usually taken once per day. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Do not crush a pazopanib tablet. Swallow the pill whole. Crushing the pill may cause your body to absorb too much of the drug at one time. To be sure this medication is not causing harmful effects, your blood and urine may need to be tested on a regular basis. Your heart rate may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Do not miss any follow-up visits to your doctor. If you need to have any type of surgery, tell the surgeon ahead of time that you are using pazopanib. You may need to stop using the medicine for a short time. Store pazopanib at room temperature away from moisture and heat.

See also: Votrient dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 12 hours away, 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.

Overdose symptoms may include extreme tiredness or high blood pressure (severe headache, hearing or vision problems, anxiety, chest pain, shortness of breath, uneven heartbeats).

What should I avoid while taking pazopanib?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Pazopanib side effects

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

• slow healing of a wound or surgical incision;

• dizziness, fainting, fast or pounding heartbeat;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

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

• sudden numbness or weakness (especially on one side of the body), sudden headache, confusion, problems with vision, speech, or balance;

• chest pain or heavy feeling, pain spreading to the arm or shoulder; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• mild nausea or vomiting, diarrhea;

• changes in hair color;

• tired feeling; or

• headache.

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 pazopanib?

Many drugs can interact with pazopanib. Below is just a partial list. Tell your doctor if you are using:

• ADHD medications;

• an antibiotic or antifungal medication;

• an antidepressant or medicine to treat a psychiatric disorder;

• anti-malaria medications;

• asthma or allergy medication;

• cholesterol-lowering drugs;

• diabetes medication you take by mouth;

• drugs to treat erectile dysfunction;

• heart or blood pressure medications, heart rhythm medication;

• HIV or AIDS medications;

• medicines used to prevent organ transplant rejection;

• medicine to treat or prevent nausea and vomiting;

• migraine headache medicines, including ergot medicines or “triptans”;

• other cancer medications;

• sedatives or narcotic pain medication;

• seizure medication; or

• a steroid.

This list is not complete and there are many other medicines that can interact with pazopanib. 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. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about pazopanib.

• 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: 1.02. Revision Date: 12/21/2009 10:18:34 AM.