Hyskon

30/06/10

Generic Name: dextran, high molecular weight (DEX tran)
Brand Names: Dextran 70 6% in 0.9% Sodium Chloride, Dextran 70 6% in 5% Dextrose, Gentran 70, Hyskon

What is high-molecular weight dextran?

High-molecular weight dextran is a plasma volume expander derived from natural sources of sugar (glucose). It works by restoring blood plasma lost through severe bleeding.

Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Dextran is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

Dextran is also used to expand the inside of the uterus, making it easier for a doctor to see with a scope during a diagnostic procedure called hysteroscopy.

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


What is the most important information I should know about high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If possible before you receive dextran, tell your doctor if you have a bleeding or blood clotting disorder, a blood cell disorder, heart disease or congestive heart failure, kidney disease, a stomach or intestinal disorder, pulmonary edema (fluid in the lungs), urination problems, a food or drug allergy, or if you are on a low-salt diet.

In an emergency 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.

Tell your doctor about all other medications you use, especially a blood thinner, steroid medication, digoxin, or a diuretic.

What should I discuss with my health care provider before I receive high-molecular weight dextran?

You should not be given this medication if you are allergic to dextran, or if you have severe kidney or heart disease.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. If possible before you receive dextran, tell your doctor if you have:

  • a bleeding or blood clotting disorder;

  • a blood cell disorder such as thrombocytopenia (lack of platelets);

  • heart disease or congestive heart failure;

  • kidney disease;

  • a stomach or intestinal disorder;

  • pulmonary edema (fluid in the lungs);

  • urination problems not caused by hypovolemia;

  • a food or drug allergy; or

  • if you are on a low-salt diet.

FDA pregnancy category C. It is not known whether dextran is harmful to an unborn baby. If possible before you receive this medication, tell your doctor if you are pregnant. It is not known whether dextran passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency 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.

How is high-molecular weight dextran given?

Dextran is given as an injection through a needle placed into a vein. For a hysteroscopy procedure, dextran is placed into the uterus using a small tube.

You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving this medication.

To be sure dextran is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with dextran.

What happens if I miss a dose?

Since dextran is given as needed by a healthcare professional, it is not likely that you will miss a dose.


What happens if I overdose?

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

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

What should I avoid after receiving high-molecular weight dextran?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after you are treated with dextran.


High-molecular weight dextran 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. Tell your caregivers at once if you have a serious side effect such as:

  • wheezing or tight feeling in your chest;

  • urinating less than usual or not at all;

  • swelling in your hands or feet;

  • unusual bleeding, or any bleeding that will not stop;

  • feeling like you might pass out; or

  • burning, itching, swelling, or pain around the IV needle.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;

  • joint pain;

  • stuffy nose;

  • mild itching; or

  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect high-molecular weight dextran?

Before you receive dextran, tell your doctor if you are also using:

  • a blood thinner such as warfarin (Coumadin);

  • steroids (prednisolone and others);

  • digoxin (digitalis, Lanoxin); or

  • a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

This list is not complete and there may be other drugs that can interact with dextran. 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 doctor or pharmacist can provide more information about dextran.
  • 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: 4/12/2009 4:40:03 PM.

 

Hytakerol

30/06/10

Generic Name: dihydrotachysterol (dy hy dro tak is TER ol)
Brand Names: DHT, DHT Intensol, Hytakerol

What is Hytakerol (dihydrotachysterol)?

Dihydrotachysterol is a form of vitamin D. Vitamin D is needed by the body to keep your bones and teeth healthy. It also helps your body absorb and use calcium more efficiently to help protect bones and teeth.

Dihydrotachysterol is used to treat hypocalcemia (lack of calcium in the blood) and hypoparathyroidism (lack of parathyroid hormone in the body).

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


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

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

Vitamin D is stored up in the body rather than passed in the urine like some other vitamins. Do not take more than the recommended dose, or your body could build up dangerously high levels of vitamin D, leading to vitamin D poisoning. Vitamin D is also taken in when you eat certain foods, which can add to the total amount in your body when you are taking dihydrotachysterol.

Symptoms of a dihydrotachysterol overdose may come on slowly. Early overdose symptoms may include bone pain, bowel problems, dry mouth, ongoing headache, increased thirst and urination, loss of appetite, muscle pain, and unusual weakness. Late signs of overdose include high fever, cloudy urine, mood changes, uneven heartbeats, nausea, vomiting, and severe stomach pain.

Dihydrotachysterol may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

While you are taking dihydrotachysterol, avoid taking antacids that contain magnesium (such as Milk of Magnesia) or calcium (such as Rolaids Soft Chew, Maalox Quick Dissolve, Alka-Mints, Fast Acting Mylanta, and others).


What should I discuss with my health care provider before taking Hytakerol (dihydrotachysterol)?

Before using this medication, tell your doctor if you have:

  • heart disease;

  • circulation problems;

  • kidney disease; or

  • sarcoidosis.

If you have any of these conditions, you may not be able to use dihydrotachysterol , or you may need a dosage adjustment or special tests during treatment.

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. It is not known whether dihydrotachysterol 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 Hytakerol (dihydrotachysterol)?

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

Vitamin D is stored up in the body rather than passed in the urine like some other vitamins. Do not take more than the recommended dose, or your body could build up dangerously high levels of vitamin D, leading to vitamin D poisoning. Vitamin D is also taken in when you eat certain foods, which can add to the total amount in your body when you are taking dihydrotachysterol.

Measure the liquid form of this medication 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 where you can get one.

Dihydrotachysterol may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Store this medication at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

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.

Symptoms of a dihydrotachysterol overdose may come on slowly. Early overdose symptoms may include bone pain, bowel problems, dry mouth, ongoing headache, increased thirst and urination, loss of appetite, muscle pain, and unusual weakness. Late signs of overdose include high fever, cloudy urine, mood changes, uneven heartbeats, nausea, vomiting, and severe stomach pain.

What should I avoid while taking Hytakerol (dihydrotachysterol)?

Avoid taking antacids that contain magnesium (such as Milk of Magnesia) or calcium (such as Rolaids Soft Chew, Maalox Quick Dissolve, Alka-Mints, Fast Acting Mylanta, and others).


Hytakerol (dihydrotachysterol) 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 dihydrotachysterol and call your doctor at once if you have any of these serious side effects:

  • bone pain, hard lumps under your skin;

  • eyes that are more sensitive to light;

  • eye redness or discharge;

  • weight loss;

  • metallic taste in your mouth;

  • urinating more than usual, especially at night;

  • nausea, vomiting;

  • severe stomach pain;

  • high fever; or

  • uneven heartbeats.

Continue using dihydrotachysterol and talk with your doctor if you have any of these less serious side effects:

  • dry skin;

  • changes in your bowel habits;

  • dry mouth; or

  • muscle 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 Hytakerol (dihydrotachysterol)?

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

  • calcium or vitamin D supplements;

  • multivitamins that contain calcium or vitamin D; or

  • a diuretic (water pill) such as Aldactazide, Diuril, Maxzide, Moduretic, HCTZ, and others.

If you are using any of these drugs, you may not be able to use dihydrotachysterol, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect dihydrotachysterol. 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 has more information about dihydrotachysterol written for health professionals that you may read.

What does my medication look like?

Dihydrotachysterol is available with a prescription under the brand names DHT Intensol and Hytakerol. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • 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 June 7, 2006drugs, 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: 7/25/06 10:54:33 AM.

 

HyTan

30/06/10

Generic Name: chlorpheniramine and hydrocodone (KLOR fen IR a meen and HYE droe KOE done)
Brand Names: HyTan, Novasus, S-T Forte 2, TussiCaps, Tussionex PennKinetic

What is HyTan (chlorpheniramine and hydrocodone)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough suppressant.

The combination of chlorpheniramine and hydrocodone is used to treat runny or stuffy nose, sneezing, and cough caused by the common cold or flu.

Chlorpheniramine and hydrocodone may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about HyTan (chlorpheniramine and hydrocodone)?

Do not take this medication more often than prescribed. An overdose of chlorpheniramine and hydrocodone can cause life-threatening side effects. To be sure you get the correct dose, measure this medicine carefully with a marked measuring spoon or syringe, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Before you take chlorpheniramine and hydrocodone, tell your doctor if you have asthma or another breathing disorder, a history of head injury or brain tumor, stomach or intestinal problems, liver or kidney disease, glaucoma, urination problems or an enlarged prostate, Addison’s disease, or underactive thyroid.

Chlorpheniramine and hydrocodone 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 while using chlorpheniramine and hydrocodone. Alcohol may increase drowsiness and dizziness. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not give this medicine to a child younger than 6 years old.

What should I discuss with my healthcare provider before taking HyTan (chlorpheniramine and hydrocodone)?

You should not take this medication if you are allergic to chlorpheniramine or hydrocodone.

Before taking chlorpheniramine and hydrocodone, tell your doctor if you are allergic to any drugs, or if you have:

  • asthma or other breathing disorder;

  • a history of head injury or brain tumor;

  • stomach or intestinal problems;

  • liver or kidney disease;
  • glaucoma;

  • urination problems or an enlarged prostate;

  • Addison’s disease; or

  • underactive thyroid.

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

FDA pregnancy category C. Chlorpheniramine and hydrocodone may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chlorpheniramine and hydrocodone passes into breast milk or if it could harm a nursing baby. Do not take 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. Do not give chlorpheniramine and hydrocodone to a child younger than 6 years old.


How should I take HyTan (chlorpheniramine and hydrocodone)?

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.

Do not take this medication more often than you doctor has prescribed. An overdose of chlorpheniramine and hydrocodone can cause life-threatening side effects. Shake the oral solution (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid carefully with a marked measuring spoon or syringe, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Do not mix this medicine with any other liquid before taking it. Chlorpheniramine and hydrocodone can be taken with food if it upsets your stomach. Store chlorpheniramine and hydrocodone at room temperature away from moisture and heat. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

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 you think you have used too much of this medicine. An overdose of chlorpheniramine and hydrocodone can be fatal, especially to a child.

Overdose symptoms may include dry mouth, cold and clammy skin, flushing, large pupils, nausea, vomiting, severe dizziness or drowsiness, seizure (convulsions), shallow breathing, slow heart rate, blue colored skin, feeling light-headed, or fainting.

What should I avoid while taking HyTan (chlorpheniramine and hydrocodone)?

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 while using chlorpheniramine and hydrocodone. Alcohol may increase drowsiness and dizziness.

HyTan (chlorpheniramine and hydrocodone) 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 any of these serious side effects:

  • weak or shallow breathing;

  • chest tightness;

  • painful urination;

  • urinating less than usual or not at all; or

  • confusion, hallucinations, or unusual behavior.

Less serious side effects may include:

  • dizziness, drowsiness, trouble concentrating;

  • mood changes, anxiety;

  • blurred vision;

  • constipation, nausea, vomiting, loss of appetite;

  • dry mouth or throat;

  • sweating; or

  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect HyTan (chlorpheniramine and hydrocodone)?

Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine and hydrocodone. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medicine.

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

  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  • bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

  • glycopyrrolate (Robinul);

  • mepenzolate (Cantil);

  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine); or

  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with chlorpheniramine and hydrocodone. 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 chlorpheniramine and hydrocodone.
  • 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: 2.04. Revision Date: 4/12/2009 4:40:53 PM.

 

HyperRHO S/D

30/06/10

Generic Name: rho(d) immune globulin (Injection route, Intramuscular route, Intravenous route)

roe (D) im-MYOON GLOB-yoo-lin

Intravenous routePowder for SolutionSolution

  • Intravascular Hemolysis (IVH)
    • Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin.
    • IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).
    • Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported.
    • Closely monitor patients treated with Rho(D) immune globulin for ITP in a health care setting for at least eight hours after administration. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after Rho(D) immune globulin administration, post-treatment laboratory tests should be performed, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect) .

Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin. IVH can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Alert patients and closely monitor for the signs and symptoms of IVH in a health care setting for at least eight hours after administration for ITP. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period. If signs and/or symptoms of IVH are present or suspected, post-treatment laboratory tests should be performed, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect) .

Commonly used brand name(s):

In the U.S.

  • BayRho-D
  • HyperRHO S/D
  • MicRhogam Ultra-Filtered
  • Rhogam
  • RhoGAM Ultra-Filtered Plus
  • Rhophylac
  • WinRho SDF

In Canada

  • Winrho SDF

Available Dosage Forms:

  • Powder for Solution
  • Solution
  • Injectable

Therapeutic Class: Immune Serum

Uses For HyperRHO S/D

Rho(D) immune globulin is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. ITP is a type of blood disorder where the person has a very low number of platelets. Platelets help to clot the blood. Rho(D) immune globulin is also used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive. It belongs to a group of medicines called immunizing agents. Rho(D) immune globulin works to boost the immune system and prevent excessive bleeding.

The Rh factor is one part of the red blood cell. A person has either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will create antibodies that can destroy the red blood cells. When a pregnant woman is Rh-negative and her baby is Rh-positive, the baby’s blood can get into her system and cause her to make antibodies. When the same woman has a second baby with Rh-positive blood, the antibodies will destroy the red blood cells in the baby. Rho(D) immune globulin is given to these women during pregnancy or after delivery to prevent them from making antibodies.

This medicine is to be administered only by or under the supervision of your doctor.


Before Using HyperRHO S/D

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 Rho(D) immune globulin in children. It is not recommended for an infant with Rh-positive blood whose mother is Rh-negative.

Geriatric

Although appropriate studies on the relationship of age to the effects of Rho(D) immune globulin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Rho(D) immune globulin in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, and might have conditions that require an adjustment in the dose for patients receiving Rho(D) immune globulin.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Varicella Virus Vaccine

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:

  • Anemia, severe or
  • Blood clotting problems, history of or
  • Breathing problems, severe or
  • Disseminated intravascular coagulation (blood clotting problem) or
  • Kidney problems or
  • Pulmonary edema (fluid in the lungs), history of—Use with caution. May make these conditions worse.
  • Atherosclerosis (hardening of the arteries), history of or
  • Heart or blood vessel problems or
  • Hyperviscosity (thick blood), history of or
  • Stroke—Use with caution. May cause side effects to become worse.
  • Autoimmune hemolytic anemia (bleeding problem) or
  • Hemolysis, active (red blood cells are being destroyed) or
  • Immunoglobulin A (IgA) deficiency with antibodies against IgA—Should not be used in patients with these conditions.
  • Diabetes—The liquid form of WinRho® contains maltose. Some glucose testing systems will not work properly if maltose is in the blood. Discuss this with your doctor.




Proper Use of rho(d) immune globulin

This section provides information on the proper use of a number of products that contain rho(d) immune globulin. It may not be specific to HyperRHO S/D. Please read with care.

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


Precautions While Using HyperRHO S/D

It is very important that your doctor check the progress of you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you or your child have back pain; shaking chills; a fever; dark urine; a decreased amount of urine; a sudden weight gain; swelling of the hands or feet; or shortness of breath after receiving this medicine. These may be symptoms of a serious blood problem called intravascular hemolysis (IVH).

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have itching, a rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may cause blood clots, especially in patients with a history of blood clotting problems, heart disease, and atherosclerosis (hardening of the arteries) or circulation problems. Patients who stay in bed for a long time because of surgery or illness may also have blood clots. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.

This medicine may cause a rare and serious lung problem a few hours after it is given. Tell your doctor right away if you or your child have any breathing problems with or without a fever after you receive the medicine.

While you are being treated with Rho(D) immune globulin, do not have any immunizations (vaccines) without your doctor’s approval. Live virus vaccines should not be given for 3 months after receiving Rho(D) immune globulin.

HyperRHO S/D 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:

Rare

  • Bloody urine
  • decreased frequency of urination or amount of urine
  • fever
  • increased blood pressure
  • increased thirst
  • loss of appetite
  • lower back pain
  • nausea or vomiting
  • pale skin
  • swelling of the face, fingers, or lower legs
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain

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:

Less common

  • Soreness at the place of injection

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: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

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

  • heart disease or a history of coronary artery disease (hardened arteries);

  • high triglycerides (a type of fat in the blood);

  • a bleeding disorder (such as hemophilia); or

  • immune globulin A (IgA) deficiency.

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although RHo (D) immune globulin is screened, tested, and treated to reduce the risk of it containing infectious agents, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.


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 receiving RHo (D) immune globulin?

Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

RHo (D) immune globulin side effects

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

  • fever, chills, shaking, back pain, dark colored urine;

  • rapid breathing, feeling short of breath.

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

  • pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious side effects may include:

  • joint or muscle pain;

  • headache, dizziness;

  • feeling weak or tired;

  • mild itching or skin rash;

  • nausea, diarrhea, vomiting, stomach pain; or

  • pain or tenderness where the medicine was injected.

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 RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. 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 doctor or pharmacist can provide more information about RHo (D) immune globulin.
  • 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: 3.01. Revision Date: 05/13/2010 11:06:17 AM.

 

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

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

  • heart disease or a history of coronary artery disease (hardened arteries);

  • high triglycerides (a type of fat in the blood);

  • a bleeding disorder (such as hemophilia); or

  • immune globulin A (IgA) deficiency.

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although RHo (D) immune globulin is screened, tested, and treated to reduce the risk of it containing infectious agents, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.


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 receiving RHo (D) immune globulin?

Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

RHo (D) immune globulin side effects

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

  • fever, chills, shaking, back pain, dark colored urine;

  • rapid breathing, feeling short of breath.

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

  • pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious side effects may include:

  • joint or muscle pain;

  • headache, dizziness;

  • feeling weak or tired;

  • mild itching or skin rash;

  • nausea, diarrhea, vomiting, stomach pain; or

  • pain or tenderness where the medicine was injected.

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 RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. 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 doctor or pharmacist can provide more information about RHo (D) immune globulin.
  • 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: 3.01. Revision Date: 05/13/2010 11:06:17 AM.

 

Hyperstat

30/06/10

Generic Name: diazoxide
Dosage Form: Injection

For Intravenous Use in
Hospitalized Patients Only

PRODUCT INFORMATION

Hyperstat Description

Hyperstat I.V. Injection is a non-diuretic benzothiadiazine antihypertensive agent. Each ampule (20 mL) contains 300 mg diazoxide, USP, in a clear, sterile, colorless aqueous solution; the pH is adjusted to approximately 11.6 with sodium hydroxide.

Diazoxide has the following structural formula:

Diazoxide is 7-chloro-3-methyl-2H-1,2,4-benzothiadiazine 1,1-dioxide, with the empirical formula C8H7ClN2O2S, and the molecular weight 230.7. It is a white crystalline powder practically insoluble to sparingly soluble in water.

Hyperstat – Clinical Pharmacology

Hyperstat I.V. Injection produces a prompt reduction of blood pressure in man by relaxing smooth muscle in the peripheral arterioles. Cardiac output is increased as blood pressure is reduced. Studies in animals demonstrate that coronary blood flow is maintained, while renal blood flow is increased after an initial decrease.

Transient hyperglycemia occurs in the majority of patients treated with Hyperstat, but usually requires treatment only in patients with diabetes mellitus. It will respond to the usual management measures, including insulin.

Blood glucose levels should be monitored, especially in patients with diabetes and in those requiring multiple injections of diazoxide. Cataracts have been observed in a few animals receiving repeated daily doses of intravenous diazoxide.

Since diazoxide causes sodium retention, repeated injections may precipitate edema and congestive heart failure. Increased volume of extracellular fluid may be a cause of treatment failure in nonresponsive patients. The increase in fluid volume characteristically responds to diuretic agents if adequate renal function exists. Concurrently administered thiazide diuretics may be expected to potentiate the antihypertensive and hyperuricemic actions of diazoxide. (See Drug Interactions.)

Diazoxide is extensively bound to serum protein (>90%). The plasma half-life is 28 ± 8.3 hours; however, the duration of its antihypertensive effect is variable, generally lasting less than 12 hours.

Indications and Usage for Hyperstat

Hyperstat I.V. Injection is indicated for short-term use in the emergency reduction of blood pressure in severe, nonmalignant and malignant hypertension in hospitalized adults; and in acute severe hypertension in hospitalized children, when prompt and urgent decrease of diastolic pressure is required. Treatment with orally effective antihypertensive agents should not be instituted until blood pressure has stabilized. The use of Hyperstat I.V. Injection for longer than 10 days is not recommended.

Hyperstat I.V. Injection is ineffective against hypertension due to pheochromocytoma.





Contraindications

Hyperstat I.V. Injection should not be used in the treatment of compensatory hypertension, such as that associated with aortic coarctation or arteriovenous shunt, and should not be used in patients hypersensitive to diazoxide, other thiazides, or other sulfonamide-derived drugs.

Warnings

Rapid Decrease of Blood Pressure

Caution must be observed when reducing severely elevated blood pressure. Diazoxide should only be administered utilizing the new 150-mg minibolus dosage. The use of a 300-mg intravenous dose of diazoxide has been associated with angina and with myocardial and cerebral infarction. One instance of optic nerve infarction was reported when a 100-mmHg reduction in diastolic pressure occurred over ten minutes following a single 300-mg bolus. In one prospective trial conducted in patients with severe hypertension and coexistent coronary artery disease, a 50% incidence of ischemic changes in the electrocardiogram was observed following single 300-mg bolus injections of diazoxide. The desired blood pressure lowering should therefore be achieved over as long a period of time as is compatible with the patient’s status. At least several hours and preferably 1 or 2 days is tentatively recommended.

Improved safety with equal efficacy can be achieved by administering Hyperstat I.V. Injection as a minibolus dose (1 to 3 mg/kg every 5 to 15 minutes up to a maximum of 150 mg in a single injection) until a diastolic blood pressure below 100 mmHg is achieved. Hyperstat I.V. Injection should not be administered in a bolus dose of 300 mg since this mode of administration is less predictable and less controllable than the minibolus dosage. If hypotension severe enough to require therapy results from the reduction in blood pressure, it will usually respond to the Trendelenberg maneuver. If necessary, sympathomimetic agents such as dopamine or norepinephrine may be administered.

Special attention is required for patients with diabetes mellitus and those in whom retention of salt and water may present serious problems.

Myocardial Lesions in Animals

Intravenous administration of diazoxide in dogs has induced subendocardial necrosis and necrosis of papillary muscles. These lesions, which are also produced by other vasodilator drugs (ie, hydralazine, minoxidil) and by catecholamines, are presumed to be related to anoxia resulting from a combination of reflex tachycardia and decreased perfusion.

Precautions

General

Hyperstat (diazoxide) I.V. Injection is an effective antihypertensive agent requiring close monitoring of the patient’s blood pressure at frequent intervals. Its administration may occasionally cause hypotension requiring treatment with sympathomimetic drugs. Therefore, Hyperstat I.V. Injection should be used primarily in the hospital or where adequate facilities exist to treat such untoward responses.

Hyperstat I.V. Injection should be administered only into a peripheral vein. Because the alkalinity of the solution is irritating to tissue, avoid extravascular injection or leakage. Subcutaneous administration has produced inflammation and pain without subsequent necrosis. If leakage into subcutaneous tissue occurs, the area should be treated with warm compresses and rest.

Hyperstat I.V. Injection should be used with care in patients who have impaired cerebral or cardiac circulation, that is, patients in whom abrupt reduction in blood pressure might be detrimental or those in whom mild tachycardia or decreased blood perfusion may be deleterious (see WARNINGS). Prolonged hypotension should be avoided so as not to aggravate preexisting renal failure.

Information for Patients

During and immediately following intravenous injection of Hyperstat I.V. Injection, the patient should remain supine.

Laboratory Tests

Diagnostic laboratory tests necessary to establish the patient’s condition and status should be carried out prior to treatment with Hyperstat I.V. Injection. During and following treatment with Hyperstat I.V. Injection, laboratory tests to monitor the effects of treatment with this drug and the patient’s condition should be done. Among the tests (not necessarily inclusive) are: hematologic (hematocrit, hemoglobin, white blood cell and platelet counts); metabolic (glucose, uric acid, total protein, albumin); electrolyte (sodium, potassium) and osmolality; renal function (creatinine, urine-protein); electrocardiogram.

Drug Interactions

Diazoxide is highly bound to serum protein. It can be expected to displace other substances which are also bound to protein, such as bilirubin or coumarin and its derivatives; resulting in higher blood levels of these substances.

An undesirable hypotension may result when diazoxide is administered to patients who have received other antihypertensive medication within 6 hours.

One patient in a clinical study exhibited excessive hypotension after concomitant administration of Hyperstat with hydralazine and methyldopa. An episode of maternal hypotension and fetal bradycardia occurred in a patient in labor who received both reserpine and hydralazine prior to administration of diazoxide. Neonatal hyperglycemia following intrapartum administration of Hyperstat I.V. Injection has also been reported.

Hyperstat I.V. Injection should not be administered within 6 hours of the administration of: hydralazine, reserpine, alphaprodine, methyldopa, beta-blockers, prazosin, minoxidil, the nitrites and other papaverine-like compounds.

Concomitant administration with thiazides or other commonly used diuretics may be expected to potentiate the hyperuricemic and antihypertensive effects of diazoxide.

Drug/Laboratory Test Interactions

The hyperglycemic and hyperuricemic effects of diazoxide preclude proper assessment of these metabolic states. Increased renin secretion, IgG concentrations and decreased cortisol secretion have also been noted. Diazoxide inhibits glucagon-stimulated insulin release and will cause a false-negative insulin response to glucagon. In the rat, dog, and monkey, diazoxide increased serum free fatty acids and decreased plasma insulin levels.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal dosing study has been done to evaluate the carcinogenic potential of diazoxide. No laboratory studies of mutagenic potential or animal studies of effects on fertility have been done.

Pregnancy Category C

Diazoxide has been shown to reduce fetal and/or pup survival; and to reduce fetal growth in rats, rabbits, and dogs at daily doses of 30, 21, or 10 mg/kg, respectively. In rats treated at term, diazoxide, at doses of 10 mg/kg and above, prolonged parturition.

The safety of Hyperstat I.V. Injection in pregnancy has not been established.

Nonteratogenic Effects

Diazoxide crosses the placental barrier and appears in cord blood. When given to the mother prior to delivery, the drug may produce fetal or neonatal hyperbilirubinemia, thrombocytopenia, altered carbohydrate metabolism, and possibly other side effects that have occurred in adults.

Labor and Delivery

Hyperstat I.V. Injection is not indicated for use in pregnancy. Intravenous administration of the drug during labor may cause cessation of uterine contractions, requiring administration of an oxytocic agent.

Nursing Mothers

Information is not available concerning the passage of Hyperstat in breast milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from diazoxide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

See INDICATIONS AND USAGE.

Adverse Reactions

It is reasonable to speculate that the currently recommended minibolus dosing regimen, which has replaced the 300-mg bolus dose in clinical practice, will result in adverse effects which are of similar character but of lesser frequency and severity.

In clinical experience with the rapid bolus administration of 300 mg, the most common adverse reactions reported were: hypotension (7%); nausea and vomiting (4%); dizziness and weakness (2%). Additional adverse reactions reported with bolus administration of 300 mg were as follows:

Cardiovascular: sodium and water retention after repeated injections, especially important in patients with impaired cardiac reserve; hypotension to shock levels; myocardial ischemia, usually transient and manifested by angina, atrial and ventricular arrhythmias, and marked electrocardiographic changes, but occasionally leading to myocardial infarction; optic nerve infarction following too rapid decrease in severely elevated blood pressure; supraventricular tachycardia and palpitation; bradycardia; chest discomfort or nonanginal “tightness in the chest.”

Central Nervous System: cerebral ischemia, usually transient but occasionally leading to infarction and manifested by unconsciousness, convulsions, paralysis, confusion, or focal neurological deficit such as numbness of the hands; vasodilative phenomena, such as orthostatic hypotension, sweating, flushing, and generalized or localized sensations of warmth; various transient neurological findings secondary to alteration in regional blood flow to brain, such as headache (sometimes throbbing), dizziness, lightheadedness, sleepiness (also reported as lethargy, somnolence or drowsiness), euphoria or “funny feeling,” ringing in the ears and momentary hearing loss, and weakness of short duration; apprehension or anxiety.

Gastrointestinal: rarely, acute pancreatitis; nausea, vomiting and/or abdominal discomfort; anorexia; alteration in taste; parotid swelling; salivation; dry mouth; lacrimation; ileus; constipation and diarrhea.

Other: hyperglycemia in diabetic patients, especially after repeated injections; hyperosmolar coma in an infant; transient hyperglycemia in nondiabetic patients; transient retention of nitrogenous wastes; various respiratory finding secondary to the relaxation of smooth muscle, such as dyspnea, cough and choking sensation; warmth or pain along the injected vein; cellulitis without sloughing and/or phlebitis at the injection site of extravasation; back pain and increased nocturia; hypersensitivity reactions, such as rash, leukopenia and fever; papilledema induced by plasma volume expansion secondary to the administration of diazoxide reported in a patient who had received eleven injections (300 mg/dose) over a 22-day period; malaise and blurred vision; transient cataract in an infant; hirsutism, and decreased libido.

Overdosage

Overdosage of Hyperstat I.V. Injection may cause undesirable hypotension. Usually, this can be controlled with the Trendelenberg maneuver. If necessary, sympathomimetic agents, such as dopamine or norepinephrine, may be administered. Failure of blood pressure to rise in response to such agents suggests that the hypotension may have been caused by something other than diazoxide. Excessive hyperglycemia resulting from overdosage will respond to conventional therapy of hyperglycemia.

Hyperstat Dosage and Administration

Hyperstat I.V. Injection was originally recommended for use by bolus administration of 300 mg. Recent studies have shown that minibolus administration of Hyperstat I.V. Injection, ie, doses of 1 to 3 mg/kg repeated at intervals of 5 to 15 minutes is as effective in reducing blood pressure. Minibolus administration usually provides a more gradual reduction in blood pressure and thus may be expected to reduce the circulatory and neurological risks associated with acute hypotension.

Hyperstat I.V. Injection is administered undiluted and rapidly by intravenous injections of 1 to 3 mg/kg up to a maximum of 150 mg in a single injection. This dose may be repeated at intervals of 5 to 15 minutes until a satisfactory reduction in blood pressure (diastolic pressure below 100 mmHg) has been achieved.

With the patient recumbent, the calculated dose of Hyperstat I.V. Injection is administered intravenously in 30 seconds or less.

Hyperstat I.V. Injection should only be given into a peripheral vein. Do not administer it intramuscularly, subcutaneously, or into body cavities. Avoid extravasation of the drug into subcutaneous tissues.

Following the use of Hyperstat I.V. Injection, the blood pressure should be monitored closely until it has stabilized. Thereafter, measurements taken hourly during the balance of the effect should indicate any unusual response. A further decrease in blood pressure 30 minutes or more after injection should be investigated for causes other than the action of Hyperstat I.V. Injection. It is preferable that the patient remain supine for at least 1 hour after injection. In ambulatory patients, the blood pressure should also be measured with the patient standing before surveillance is ended.

Repeated administration of Hyperstat I.V. Injection at intervals of 4 to 24 hours usually will maintain the blood pressure below pretreatment levels until a regimen of oral antihypertensive medication can be instituted. The interval between injections may be adjusted by the duration of the response to each injection. It is usually unnecessary to continue treatment with Hyperstat I.V. Injection for more than 4 to 5 days.

Since repeated administration of Hyperstat I.V. Injection can lead to sodium and water retention, administration of a diuretic may be necessary both for maximal blood pressure reduction and to avoid congestive heart failure. (See CLINICAL PHARMACOLOGY.)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Hyperstat Supplied

Hyperstat I.V. Injection is supplied in a 20-mL ampule, containing 300 mg diazoxide, in a clear, sterile, colorless, aqueous solution; box of one ampule (NDC 0085-0201-05).

Protect from light and freezing. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Copyright © 1972, 1984, 1985, Schering Corporation. All rights reserved.

B-13570817

Hyperstat 
diazoxide  injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-0201
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
diazoxide (diazoxide) Active 300 MILLIGRAM  In 20 MILLILITER
Sodium Hydroxide Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0085-0201-05 1 AMPULE In 1 BOX contains a AMPULE
1 20 mL (MILLILITER) In 1 AMPULE This package is contained within the BOX (0085-0201-05)

Revised: 05/2006Schering Corporation

 

HyperTET S/D

30/06/10

Generic Name: tetanus immune globulin (Intramuscular route)

TET-n-us im-MYOON GLOB-yoo-lin

Commonly used brand name(s):

In the U.S.

  • Baytet
  • HyperTET S/D

Available Dosage Forms:

  • Solution

Therapeutic Class: Immune Serum

Uses For HyperTET S/D

Tetanus immune globulin is used to prevent tetanus infection (also known as lockjaw). Tetanus is a serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

In recent years, two thirds of all tetanus cases have been in persons 50 years of age and older. A tetanus infection in the past does not make you immune to tetanus in the future.

Tetanus immune globulin works by giving your body the antibodies it needs to protect it against tetanus infection. This is called passive protection. This passive protection lasts long enough to protect your body until your body can produce its own antibodies against tetanus.

Tetanus immune globulin is to be administered only by or under the supervision of your doctor or other health care professional.


Before Using HyperTET S/D

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

Although there is no specific information comparing use of tetanus immune globulin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of tetanus immune globulin in the elderly with use in other age groups. However, there is no evidence that the effects of tetanus immune globulin in older adults differ from those in younger persons.

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

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.

Other Medical Problems

The presence of other medical problems may affect the use of tetanus immune globulin. Make sure you tell your doctor if you have any other medical problems.




Proper Use of tetanus immune globulin

This section provides information on the proper use of a number of products that contain tetanus immune globulin. It may not be specific to HyperTET S/D. Please read with care.

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 injection dosage form:
    • For preventing tetanus infection:
      • Adults and children—250 units injected into a muscle.

HyperTET S/D 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:

Rare

  • Difficulty in breathing or swallowing
  • hives
  • itching, especially of soles or palms
  • reddening of skin, especially around ears
  • swelling of eyes, face, or inside of nose
  • unusual tiredness or weakness, sudden and severe

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.

 

Hyphed

30/06/10

Generic Name: chlorpheniramine, hydrocodone, and pseudoephedrine (klor feh NEER ah meen, hye droe KOE doe N, sue do eh FEH drin)
Brand Names: Atuss HD, Atuss HS, Cordron-HC, Cordron-HC NR, Histinex PV, Hydrocof-HC, Hydrotuss HC, Hyphed, Notuss-Forte, P-V-Tussin Syrup, Pediatex HC, Q-V Tussin

What is Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is in a group of drugs called narcotics and is similar to codeine. Hydrocodone is a cough suppressant that affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, hydrocodone, and pseudoephedrine is used to treat cough, sneezing, itching, watery eyes, runny nose, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Chlorpheniramine, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

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 take this medication with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use any other over-the-counter cough, cold, allergy, or sleep 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 an antihistamine, decongestant, or cough suppressant. 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.

What should I discuss with my healthcare provider before taking Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Do not use this medication if you are allergic to hydrocodone or other narcotic pain relievers such as fentanyl (Actiq, Duragesic), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), and oxymorphone (Opana). 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.

Before taking chlorpheniramine, hydrocodone, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney or liver disease;

  • heart disease or high blood pressure;

  • enlarged prostate or urination problems;

  • diabetes;

  • glaucoma;

  • a thyroid disorder;

  • asthma, COPD, sleep apnea, or other breathing disorders;

  • a history of head injury or brain tumor;

  • epilepsy or other seizure disorder;

  • low blood pressure;

  • gallbladder disease;

  • Addison’s disease or other adrenal gland disorders;

  • mental illness; or

  • a history of drug or alcohol addiction.

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

FDA pregnancy category C. Hydrocodone may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.


How should I take Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

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. Cough or cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine 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.

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.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

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. An overdose of hydrocodone can be fatal. Overdose symptoms may include extreme dizziness or drowsiness, confusion, feeling restless or nervous, cold and clammy skin, warmth or tingly feeling, nausea, vomiting, slow or shallow breathing, slow heart rate, pinpoint pupils, fainting, seizure (convulsions), or coma.

What should I avoid while taking Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

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 becoming overheated or dehydrated during exercise and in hot weather.

Do not drink alcohol while you are taking this medication. Alcohol can increase some of the side effects of chlorpheniramine, hydrocodone, and pseudoephedrine. Do not take this medication with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Life-threatening side effects may result.

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

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Chlorpheniramine and pseudoephedrine 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 chlorpheniramine or pseudoephedrine.

Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine) 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:

  • fast, pounding, or uneven heartbeats;

  • shallow breathing, slow heartbeat;

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

  • confusion, hallucinations, unusual thoughts or behavior;

  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  • urinating less than usual or not at all; or

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects may include:

  • blurred vision;

  • dry mouth;

  • nausea, vomiting, stomach pain, constipation, mild loss of appetite;

  • mild dizziness, drowsiness;

  • problems with memory or concentration;

  • ringing in your ears;

  • warmth, tingling, or redness under your skin;

  • restless or excitability (especially in children);

  • sleep problems (insomnia); or

  • skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

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

  • cimetidine (Tagamet);

  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  • zidovudine (Retrovir, AZT);

  • antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  • aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others);

  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;

  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  • a diuretic (water pill), or blood pressure medication;

  • medication to treat irritable bowel syndrome;

  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril); or

  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with chlorpheniramine, hydrocodone, and pseudoephedrine. 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 chlorpheniramine, hydrocodone, and pseudoephedrine.
  • 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: 2.07. Revision Date: 4/12/2009 4:41:03 PM.

 

Hypaque-Cysto

30/06/10

Generic Name: diatrizoate meglumine
Dosage Form: injection

Sterile Aqueous Injection

NOT FOR INTRATHECAL USE

Not For Intravascular Use

For Retrograde Cystourethrography

Rx ONLY

Hypaque-Cysto Description

Hypaque-Cysto, brand of diatrizoate meglumine, is a water-soluble radiopaque diagnostic medium. It is a triiodinated benzoic acid derivative. It is constituted as a radiopaque iodinated anion (diatrizoate) and a radiolucent cation (meglumine). It is a colorless, microcrystalline solid which is readily soluble in water.

Hypaque-Cysto is a sterile aqueous solution containing 30 g (w/v) of the meglumine salt of diatrizoic acid per 100 mL aqueous solution. The sterile solution is clear and colorless to pale yellow. The pH is adjusted between 6.5 and 7.7 with hydrochloric acid, or diatrizoic acid, or meglumine. It does not contain an antibacterial preservative. It is relatively thermostable and may be autoclaved. Edetate calcium disodium 1:10,000 has been added as a sequestering stabilizing agent. Each 1 mL contains approximately 141 mg of organically bound iodine.

It has an osmolality of 633 mosm/kg (determined by VPO) and is hypertonic to blood.

The viscosity of the solution is 1.94 cp at 25°C and 1.42 cp at 37°C.

Hypaque-Cysto is a 30 percent solution of 1-Deoxy-l (methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodobenzoate (C11H9I3N2O4 • C7H17NO5) with a molecular weight of 809.13, and has the following structural formula:

Hypaque-Cysto – Clinical Pharmacology

Retrograde introduction of Hypaque-Cysto solution provides radiopacity of the contents of the urinary bladder. When used during micturation as a function test, it also opacifies the bladder neck and lower urinary tract. Continuous fluoroscopic and monitoring of urinary bladder contractions will demonstrate cystoureteric reflux and its extent, if present.

Hypaque-Cysto is not absorbed from the urinary tract to any extent (< 2°), therefore, systemic effects are rare. However, pyelorenal intravasation (especially in patients with ureteric reflux) can occur. Therefore, the potential for adverse effects, such as occur with intravascular use, are possible.

At physiologic pH, the water-soluble contrast media are completely dissociated into a radiopaque anion and a solubilizing cation.

EXCRETION

Hypaque-Cysto which gains inadvertent intravascular entry is not metabolized but excreted unchanged in the urine, each diatrizoate molecule remaining “obligated” to its cation moiety.

Diatrizoate solutions may be excreted either through the kidneys or the liver. These two excretory pathways are not mutually exclusive, but the main route of excretion seems to be governed by the affinity of the contrast medium for serum albumin. From 0% to 10% of diatrizoate meglumine is bound to serum protein.

Diatrizoate salts are excreted unchanged predominantly through the kidneys by glomerular filtration. The amount excreted during any period of time is determined by the filtered load; ie, the product of plasma contrast media concentration and glomerular filtration rate.

The liver and small intestine provide the major alternate route of excretion for diatrizoate. In patients free of severe renal disease, the fecal recovery is less than 2 percent. In patients with severe renal impairment the excretion of these contrast media through the gallbladder and into the small intestine sharply increases; up to 20 percent in the feces in 48 hours.

Saliva is a minor secretory pathway for injectable radiopaque diagnostic agents. In patients with normal renal function, minimal amounts of contrast media are secreted unchanged.

PREGNANCY AND LACTATION

Diatrizoate meglumine crosses the human placental barrier by simple diffusion and appears to enter fetal tissues passively. No apparent harm to the fetus occurs. Procedures including radiation involve a certain risk related to the exposure of the fetus.

Diatrizoate solutions are excreted unchanged in human milk.





Indications and Usage for Hypaque-Cysto

Hypaque-Cysto is indicated for retrograde cystourethrography in adult and pediatric patients.

Contraindications

Hypaque-Cysto has no absolute contraindication in its recommended use.

Warnings

SEVERE ADVERSE EVENTS—INADVERTENT INTRATHECAL USE

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.

Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media. Nonetheless, it is prudent to avoid prolonged contact of blood with syringes containing ionic contrast media.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringe in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

Serious or fatal reactions have been associated with the vascular entry of radiopaque media. It is important that a course of action be carefully planned in advance for the treatment of possible serious reactions.

Precautions

General

Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for the management of any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. Competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions have occurred (See ADVERSE REACTIONS).

The possibility of a reaction, including serious, life-threatening, fatal, anaphylatic or cardiovascular reactions should always be considered (see ADVERSE REACTIONS). It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate and appropriate personnel be readily available in case of any reaction.

ALLERGIC HISTORY

Before injecting a contrast medium, the patient should be questioned for a history of allergy. A positive history does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is considered essential, but caution should be exercised (see ADVERSE REACTIONS).

The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS). The susceptible population includes patients with a history of a previous reaction to a contrast media, patients with a known sensitivity to iodine per se, and patients with known clinical hypersensitivity (ie, bronchial asthma, hay fever, and food allergies).

Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

TEST DOSE

The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous for the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast media, may be more accurate than pretesting in predicting adverse reactions.

Information for Patients

Patients receiving injectable radiopaque diagnostic agents should be instructed to:

  • Inform the physician if they are pregnant (see CLINICAL PHARMACOLOGY).
  • Inform the physician if they are allergic to any drugs, food, or if they have had any reactions to previous injections of dyes used for x-ray procedures (see PRECAUTIONS).

Drug/Laboratory Test Interactions

Under certain circumstances (pH, temperature, concentrations, time), diatrizoate solutions are incompatible with promethazine hydrochloride, diphenhydramine hydrochloride, brompheniramine maleate, or papaverine hydrochloride solutions.

BENADRYL®, brand of diphenhydramine hydrochloride, may cause precipitation when mixed in the same syringe with Hypaque-Cysto.

Although interference with these laboratory tests have not been reported following cystography absorption (from the bladder or by pyelorenal back flow), they have occurred following direct intravenous injection. Therefore, if any of these studies, which might be affected by contrast media are indicated, it is recommended that they be performed prior to administration of the contrast medium or two or more days afterwards.

Diatrizoate salts interfere with several laboratory urine and blood tests.

Blood Tests

Coagulation: Diatrizoate salts significantly inhibit all stages of coagulation. The fibrinogen concentration, Factors V, VII, and VIII are decreased. Prothrombin time and thromboplastin time are increased.

Platelet aggregation: High levels of plasma and diatrizoate meglumine inhibit platelet aggregation.

Serum calcium: Diatrizoate salts may decrease serum calcium levels. However, this depletion of serum calcium may also be the result of the addition of chelating agents (edetate disodium) in the preparation of certain contrast media.

Red cell counts: Transitory decreases in red cell counts. Technetium-99m-RBC labeling interference.

Leukocyte counts: Decrease.

Urea nitrogen (BUN): Transitory increase (see CLINICAL PHARMACOLOGY).

Serum creatinine: Transitory increase.

Urine Tests

Urine osmolarity and specific gravity. Decreased due to induced diuresis.

Urine cultures. Diatrizoate in urine cultures may inhibit bacterial growth.

Thyroid Function Tests

Protein-bound iodine (PBI) and total serum organic iodine: Transient increase of both tests following cystography and retrograde pyelography have been noticed. The results of PBl and radioactive iodine uptake studies which depend on iodine estimations will not accurately reflect thyroid function for up to 16 days following administration of iodinated media. However, thyroid function tests not depending on iodine estimations, eg, T3 resin uptake or free thyroxine assays are not affected.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed in order to evaluate carcinogenic potential, mutagenesis, or whether Hypaque-Cysto can affect fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with diatrizoate meglumine. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, diatrizoate meglumine should be given to a pregnant woman only if clearly needed.

Labor and Delivery

It is not known whether use of these contrast agents during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Diatrizoate salts are excreted unchanged in human milk. Because of the potential adverse reactions, although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when these contrast media are administered to a nursing woman.

Adverse Reactions

Not For Intravascular Use

Because inadvertent intravascular entry of Hypaque-Cysto is possible during urethrocystography (bladder absorption or pyelorenal back flow), the occurrence of systemic adverse effects is possible. However, the relative incidence and severity of the following reactions refer only to experience with direct intravascular injection.

Approximately 95 percent of adverse reactions accompanying the intravascular use of diatrizoate salts are of mild to moderate severity. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physicochemical properties of the contrast media, the dose, and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, the mode of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

The reported incidence of adverse reactions to contrast media in patients with a history of allergy are twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Most adverse reactions to injectable contrast media appear within one to three minutes after the start of injection, but delayed reactions may occur.

Adverse reactions are grouped by organ system and listed below by decreasing order of occurrence and with an approximate incidence of occurrence. Significantly more severe reactions are listed before the other reactions regardless of frequency.

Greater Than 1 in 100 Patients

Body as a Whole: Reported incidences of death range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later, the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor.

Isolated reports of hypotensive collapse and shock following urography are found in the literature. The incidence of shock is estimated to occur in 1 out of 20,000 (0.005 percent) patients.

Cardiovascular System: The most frequent adverse reaction to diatrizoate salts is vasodilation (feeling of warmth). The estimated incidence is 49 percent.

Digestive System: Nausea 6 percent, vomiting 3 percent.

Nervous System: Paresthesia 6 percent, dizziness 5 percent.

Respiratory System: Rhinitis 1 percent, increased cough 2 percent.

Skin and Appendages: Urticaria 1 percent.

Pain at the injection site is estimated to occur in about 12 percent of the patients undergoing urography. Pain is usually due to extravasation.

Painful hot erythematous swelling above the venipuncture site was estimated to occur in more than 1 percent of the patients undergoing phlebography.

Special Senses: Perversion of taste 11 percent.

Urogenital System: Osmotic nephrosis of the proximal tubular cells is estimated to occur in 23 percent of patients following excretory urography.

Less Than 1 in 100 Patients

Other infrequently reported reactions without accompanying incidence rates are listed below, grouped by organ system.

Body as a Whole: Malaria relapse, uremia, high creatinine and BUN (see PRECAUTIONS-Drug/Laboratory Test Interactions), thrombocytopenia, leukopenia, and anemia.

Cardiovascular System: Cerebral hematomas, hemodynamic disturbances, sinus bradycardia, transient electrocardiographic abnormalities, ventricular fibrillation, petechiae, chest pain, and cardiac arrest.

Digestive System: Severe unilateral or bilateral swelling of the parotid and submaxillary glands.

Nervous System: Convulsions, paralysis, and coma.

Respiratory System: Asthma, dyspnea, laryngeal edema, pulmonary edema, and bronchospasm.

Skin and Appendages: Skin necrosis.

Special Senses: Bilateral ocular irritation, lacrimation, itching, conjunctival chemosis, infection, and conjunctivitis.

Urogenital: Renal failure, pain.

Hypaque-Cysto Dosage and Administration

After the bladder is emptied, Hypaque-Cysto is gently instilled without force, often beyond the first desire to micturate, but not beyond the point of urgency or mild discomfort. The volume required to fill the bladder to slightly less than capacity may vary from patient to patient.

Bladder capacity in normal adults is generally 200 mL to 300 mL, and rarely, up to 600 mL. Capacity at birth is 20 mL to 50 mL, and increases about 400 percent in the first year. In children 3 to 5 years old, bladder capacity is 150 mL to 180 mL. In children older than 8 years, it is in the low adult range.

In disease, bladder capacity in adults may vary from 50 mL in a hypertonic reflex bladder to over 1000 mL in an atonic or sensory paralytic bladder or chronic lower urinary tract obstruction.

Repeat examination may be required to detect reflux, or in function studies.

The concentration varies with technique and equipment used. Hypaque-Cysto may be diluted with sterile water or 5 percent dextrose solution, as indicated in the following table. A 10 percent solution is isotonic.

STANDARD PACKAGE (250 mL of Hypaque-Cysto in 500 mL bottle)
TO MAKE ADD FINAL SOLUTION CONTAINS
Final conc. Final volume Sterile water or 5% dextrose solution Iodine
30% 250 mL _ 141 mg/mL
25% 300 mL 50 mL 118 mg/mL
21.4% 350 mL 100 mL 101 mg/mL
20% 375 mL 125 mL 94 mg/mL
18.8% 400 mL 150 mL 88 mg/mL
16.7% 450 mL 200 mL 78 mg/mL
15% 500 mL 250 mL 71 mg/mL

Note: To achieve the following concentrations some of the contrast agent must be removed prior to dilution.

TO MAKE REMOVE ADD FINAL SOLUTION CONTAINS
Final conc. Final volume Sterile water or 5% dextrose solution Iodine
12% 500 mL 50 mL 300 mL 56 mg/mL
12% 375 mL 100 mL 225 mL 56 mg/mL
10% 450 mL 100 mL 300 mL 47 mg/mL

Dilution and withdrawal of the contrast agent should be accomplished under aseptic conditions with sterile syringes. The solution should be inspected visually for particulate matter and discoloration prior to administration.

How is Hypaque-Cysto Supplied

STANDARD PACKAGE

Calibrated 500 mL dilution bottles containing 250 mL Hypaque-Cysto; rubber stoppered, with hangers, inner removable seal and screw neck. Box of 10 (NDC 0407-0734-10)

Protect from light. Contains no preservatives, therefore, discard any unused portion remaining in the container.

Store at 15°C to 30°C (59°F to 86°F).

Distributed by Amersham Health Inc.
Princeton, NJ 08540

Printed in USA

Revised February 2003
HNC-3D

HYPAQUE – CYSTO 
diatrizoate meglumine  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0407-0734
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
diatrizoate meglumine (diatrizoic acid) Active 30 GRAM  In 100 MILLILITER
Iodine Inactive 141 MILLIGRAM  In 1 MILLILITER
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0407-0734-10 10 BOTTLE In 1 BOX contains a BOTTLE
1 500 mL (MILLILITER) In 1 BOTTLE This package is contained within the BOX (0407-0734-10)

Revised: 08/2007Amersham Health Inc.

 

 

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