ivermectin

eye-ver-MEK-tin

Commonly used brand name(s)

In the U.S.

• Stromectol

Available Dosage Forms:

• Tablet

Therapeutic Class: Anthelmintic

Chemical Class: Avermectin

Uses For ivermectin

Ivermectin is used in the treatment of certain worm infections. It is used to treat river blindness (onchocerciasis) and a certain type of diarrhea (strongyloidiasis). It may also be used for some other kinds of worm infections.

Ivermectin appears to work by paralyzing and then killing the offspring of adult worms. It may also slow down the rate at which adult worms reproduce. This results in fewer worms in the skin, blood, and eyes.

Ivermectin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, ivermectin is used in certain patients with the following medical condition:

• Bancroft's filariasis


• Scabies

Before Using ivermectin

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 ivermectin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ivermectin 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

Studies on ivermectin have been done only in adults and in children weighing 15 kilograms (kg) (33 pounds) and over, and there is no specific information comparing use of ivermectin in children weighing less than 15 kg with use in other age groups.

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 ivermectin in the elderly with use in other age groups.

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. When you are taking ivermectin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ivermectin 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.

• Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Bronchial asthma—Ivermectin may make this problem worse.

Proper Use of ivermectin

Ivermectin is best taken as a single dose with a full glass (8 ounces) of water on an empty stomach (1 hour before breakfast), unless otherwise directed by your doctor.

To help clear up your infection, take ivermectin exactly as directed. Your doctor may want you to take another dose every 3 to 12 months.

Your doctor may also prescribe a corticosteroid (a cortisone-like medicine) for certain patients with river blindness, especially those with severe symptoms. This is to help reduce the inflammation caused by the death of the worms. If your doctor prescribes these two medicines together, it is important to take the corticosteroid along with ivermectin. Take them exactly as directed by your doctor. Do not miss any doses.

Dosing

The dose of ivermectin 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 ivermectin. 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 oral dosage form (tablets):
  
  • For river blindness:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 150 micrograms (mcg) per kilogram (kg) (68 mcg per pound) of body weight as a single dose. The treatment may be repeated every three to twelve months.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. For children weighing 15 kg (33 pounds) or more, the usual dose is 150 mcg per kg (68 mcg per pound) of body weight as a single dose. If necessary, the treatment may be repeated every three to twelve months. For children weighing less than 15 kg, use and dose must be determined by your doctor.
    
    
  
  
  • For strongyloidiasis:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 200 micrograms (mcg) per kilogram (kg) (91 mcg per pound) of body weight as a single dose. Additional doses usually are not needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. For children weighing 15 kg (33 pounds) or more, the usual dose is 200 mcg per kg (91 mcg per pound) of body weight as a single dose. For children weighing less than 15 kg, use and dose must be determined by your doctor.
    
    
  
  

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ivermectin

It is important that your doctor check your progress at regular visits. This is to help make sure that the infection is cleared up completely. In addition, if you have river blindness (onchocerciasis), your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor). If you have a certain type of diarrhea (strongyloidiasis), your doctor may want to examine three stool samples. This should be done over the 3-month period following treatment.

If your symptoms become worse, check with your doctor.

ivermectin may cause some people to become lightheaded. Make sure you know how you react to ivermectin before you drive, use machines, or do anything else that could be dangerous if you are lightheaded. If these reactions occur, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking ivermectin. The results of some tests (blood or liver tests) may be affected by ivermectin.

ivermectin Side Effects

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

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

Less common—for the treatment of river blindness (onchocerciasis) only

• Eye or eyelid irritation, pain, redness, or swelling

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

More common—for the treatment of river blindness (onchocerciasis) only

• Fever, itching or skin rash


• joint or muscle pain


• painful and tender glands in neck, armpits, or groin


• rapid heartbeat

Less common—for the treatment of river blindness (onchocerciasis) only

• Headache


• swelling of the face, hands, arms, feet, or legs

Less common—for the treatment of strongyloidiasis only

• Diarrhea


• dizziness


• skin rash or itching

Rare—for the treatment of river blindness (onchocerciasis) only

• Lightheadedness when getting up from a lying or sitting position

Rare—for the treatment of strongyloidiasis only

• Loss of appetite


• shaking or trembling


• sleepiness

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.

More ivermectin resources

• Ivermectin Dosage
• Ivermectin Use in Pregnancy & Breastfeeding
• Ivermectin Drug Interactions
• Ivermectin Support Group
• 3 Reviews for Ivermectin - Add your own review/rating

• ivermectin Concise Consumer Information (Cerner Multum)


• Ivermectin Prescribing Information (FDA)


• Ivermectin MedFacts Consumer Leaflet (Wolters Kluwer)


• Ivermectin Monograph (AHFS DI)


• Stromectol Prescribing Information (FDA)

Compare ivermectin with other medications

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• Filariasis, Elephantiasis
• Head Lice
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• Scabies
• Strongyloidiasis

isoniazid Oral, Intramuscular

eye-soe-NYE-a-zid

Intramuscular route(Solution)

Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively) should be measured prior to starting isoniazid therapy and periodically throughout treatment. An increased risk of fatal hepatitis associated with isoniazid has been reported in women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring .

Oral route(Tablet;Syrup)

Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively) should be measured prior to starting isoniazid therapy and periodically throughout treatment. An increased risk of fatal hepatitis associated with isoniazid has been reported in women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring .

Commonly used brand name(s)

In the U.S.

• Nydrazid

In Canada

• Pms-Isoniazid

Available Dosage Forms:

• Syrup


• Tablet


• Solution

Therapeutic Class: Antitubercular

Chemical Class: Isonicotinic Acid

Uses For isoniazid

Isoniazid is used to treat tuberculosis (TB) or prevent its return (reactivation). It may be given alone, or in combination with other medicines, to treat TB or to prevent its return (reactivation). isoniazid may also be used for other problems as determined by your doctor.

isoniazid may cause some serious side effects, including damage to the liver. Liver damage is more likely to occur in patients over 50 years of age. You and your doctor should talk about the good isoniazid will do, as well as the risks of taking it.

If you are being treated for active tuberculosis (TB): To help clear up your TB infection completely, you must keep taking isoniazid for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.

Isoniazid is available only with your doctor's prescription.

Before Using isoniazid

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 isoniazid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to isoniazid 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

Isoniazid can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that isoniazid may do as well as the risks of using it.

Geriatric

Hepatitis may be especially likely to occur in patients over 50 years of age, who are usually more sensitive than younger adults to the effects of isoniazid.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are taking isoniazid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Itraconazole


• Levodopa


• Rifampin

Using isoniazid 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.

• Acetaminophen


• Aminosalicylic Acid


• Carbamazepine


• Diazepam


• Disulfiram


• Enflurane


• Ethionamide


• Fosphenytoin


• Ketoconazole


• Meperidine


• Phenytoin


• Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using isoniazid with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use isoniazid, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using isoniazid with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use isoniazid, or give you special instructions about the use of food, alcohol, or tobacco.

• food


• Tyramine Containing Food

Other Medical Problems

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

• Alcohol abuse (or history of) or


• Liver disease—There may be an increased chance of hepatitis with daily drinking of alcohol or in patients with liver disease

• Kidney disease (severe)—There may be an increased chance of side effects in patients with severe kidney disease

• Seizure disorders such as epilepsy—There may be an increased chance of seizures (convulsions) in some patients

Proper Use of isoniazid

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than just the active ingredient, and many liquid medicines contain alcohol.

If you are taking isoniazid by mouth and it upsets your stomach, take it with food. Antacids may also help. However, do not take aluminum-containing antacids within 1 hour of taking isoniazid. They may keep isoniazid from working properly.

For patients taking the oral liquid form of isoniazid:

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your tuberculosis (TB) completely, it is very important that you keep taking isoniazid for the full time of treatment, even if you begin to feel better after a few weeks. You may have to take it every day for as long as 6 months to 2 years. It is important that you do not miss any doses.

Your doctor may also want you to take pyridoxine (e.g., Hexa-Betalin, vitamin B 6) every day to help prevent or lessen some of the side effects of isoniazid. This is not usually needed in children, who receive enough pyridoxine in their diet. If it is needed, it is very important to take pyridoxine every day along with isoniazid. Do not miss any doses.

Dosing

The dose of isoniazid 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 isoniazid. 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 oral dosage forms (tablets, syrup):
  
  • For preventing the return (reactivation) of tuberculosis:
    
    • Adults and teenagers—300 milligrams (mg) once a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 10 mg per kilogram (kg) (4.5 mg per pound) of body weight, up to 300 mg, once a day.
    
    
  
  
  • For treatment of tuberculosis:
    
    • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
    
    
    • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
    
    
  
  


• For injection dosage form:
  
  • For preventing the return (reactivation) of tuberculosis:
    
    • Adults and teenagers—300 mg once a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight, up to 300 mg, once a day.
    
    
  
  
  • For treatment of tuberculosis:
    
    • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
    
    
    • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using isoniazid

It is very important that your doctor check your progress at regular visits. Also, check with your doctor immediately if blurred vision or loss of vision, with or without eye pain, occurs during treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.

Certain foods such as cheese (Swiss or Cheshire) or fish (tuna, skipjack, or Sardinella) may rarely cause reactions in some patients taking isoniazid. Check with your doctor if redness or itching of the skin, hot feeling, fast or pounding heartbeat, sweating, chills or clammy feeling, headache, or lightheadedness occurs while you are taking isoniazid.

Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are taking isoniazid. Also, the regular use of alcohol may keep isoniazid from working properly. Therefore, you should strictly limit the amount of alcoholic beverages you drink while you are taking isoniazid.

If isoniazid causes you to feel very tired or very weak; or causes clumsiness; unsteadiness; a loss of appetite; nausea; numbness, tingling, burning, or pain in the hands and feet; or vomiting, check with your doctor immediately. These may be early warning signs of more serious liver or nerve problems that could develop later.

• For diabetic patients:


• isoniazid may cause false test results with some urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

isoniazid 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:

More common

• Clumsiness or unsteadiness


• dark urine


• loss of appetite


• nausea or vomiting


• numbness, tingling, burning, or pain in hands and feet


• unusual tiredness or weakness


• yellow eyes or skin

Rare

• Blurred vision or loss of vision, with or without eye pain


• convulsions (seizures)


• fever and sore throat


• joint pain


• mental depression


• mood or other mental changes


• skin rash


• unusual bleeding or bruising

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

More common

• Diarrhea


• stomach pain

For injection form

• Irritation at the place of injection

Dark urine and yellowing of the eyes or skin (signs of liver problems) are more likely to occur in patients over 50 years of age.

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.

See also: isoniazid Oral, Intramuscular side effects (in more detail)

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.

More isoniazid Oral, Intramuscular resources

• Isoniazid Oral, Intramuscular Side Effects (in more detail)
• Isoniazid Oral, Intramuscular Use in Pregnancy & Breastfeeding
• Drug Images
• Isoniazid Oral, Intramuscular Drug Interactions
• Isoniazid Oral, Intramuscular Support Group
• 2 Reviews for Isoniazid Oral, Intramuscular - Add your own review/rating

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Infuvite Pediatric

Dosage Form: injection, solution
Infuvite Pediatric -multiple vitamins for infusion

For intravenous infusion after dilution only.

Infuvite Pediatric Description

Infuvite Pediatric is a sterile product consisting of two vials: a 4 mL single-dose vial labeled Vial 1 and a 1 mL single-dose vial labeled Vial 2.

Each 4 mL of Vial 1 contains:

Ascorbic acid (Vitamin C) ......................................... 80 mg

Vitamin A1 (as palmitate)...................................... 2,300 IU

Vitamin D31 (cholecalciferol) ................................... 400 IU

Thiamine (Vitamin B1)

(as the hydrochloride)............................................ 1.2 mg

Riboflavin (Vitamin B2)

(as riboflavin 5-phosphate sodium) ....................... 1.4 mg

Pyridoxine HCl (Vitamin B6) ....................................... 1 mg

Niacinamide .............................................................. 17 mg

Dexpanthenol

(as d-pantothenyl alcohol) ........................................ 5 mg

Vitamin E1 (dl-α-tocopheryl acetate)........................... 7 IU

Vitamin K11.............................................................. 0.2 mg

Inactive ingredients: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injection.

1Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.

Each 1 mL of Vial 2 contains:

Folic acid............................................................... 140 mcg

Biotin....................................................................... 20 mcg

Vitamin B12 (cyanocobalamin).................................. 1 mcg

Inactive ingredients: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection.

Vitamin A 2,300 IU equals 0.7 mg

Vitamin D 400 IU equals 10 mcg

Vitamin E 7 IU equals 7 mg

Multiple vitamin preparation for intravenous infusion: Infuvite Pediatric (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.

Contains no more than 30 mcg/L of aluminum (combined vials 1 and 2).

Indications and Usage for Infuvite Pediatric

Infuvite Pediatric is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition.

Infuvite Pediatric is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Infuvite Pediatric (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body's normal resistance and repair processes.

Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical status. Blood vitamin concentrations should be periodically monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as their sole source of vitamins for long periods of time.

Contraindications

Infuvite Pediatric is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product.

Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.

Warnings

Infuvite Pediatric is administered in intravenous solutions, which may contain aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

Caution should be exercised when administering Infuvite Pediatric to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. In such patients, periodic monitoring of prothrombin time/INR response is essential in determining the appropriate dosage of anticoagulant therapy.

Adequate blood levels of vitamin E are achieved when Infuvite Pediatric is given to infants at the recommended dosage. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result.

Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with Infuvite Pediatric. Additional vitamin A supplementation may be required, especially in low-birth-weight infants. Long-standing specific vitamin deficiencies may require additional therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided by Infuvite Pediatric.

In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing.

Polysorbates have been associated with the E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomagaly, cholestasis, ascites, hypotension and metabolic acidosis) in low-birth-weight infants. However, no such adverse reports have been associated with the use of pediatric multiple vitamins for infusion such as Infuvite Pediatric.

Infuvite Pediatric should be aseptically transferred to the infusion fluid.

Drug-Drug Interactions

Physical incompatibilities

Infuvite Pediatric (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, and chlorothiazide sodium, aminopylline or sodium bicarbonate. Infuvite Pediatric is not physically compatible with ampicillin and it may not be physically compatible with tetracycline HCl. It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.

Some of the vitamins in Infuvite Pediatric may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for Vitamin A, thiamine, and ascorbic acid deficiencies.

Clinical Interactions

A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions.

Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency.Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient's response to methotrexate therapy.

Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.

In patients with pernicious anemia, the hematological response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.

Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.

Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see PRECAUTIONS).

Consult appropriate references for additional specific vitamin-drug interactions.

Drug-Laboratory Test Interactions

Ascorbic acid in the urine may cause false negative urine glucose determinations.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies have not been performed.

Adverse Reactions

There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported after large intravenous doses of thiamine. The risk, however, is negligible if thiamine is coadministered with other vitamins of the B group. There have been no reports of fatal anaphylactoid reactions associated with multivitamin preparations for infusion.

There have been rare reports of the following types of reactions:

Dermatologic – rash, erythema, pruritis

CNS – headache, dizziness, agitation, anxiety

Ophthalmic – diplopia

Allergic – urticaria, shortness of breath, wheezing and angioedema.

Overdosage

The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution.

Infuvite Pediatric Dosage and Administration

Infuvite Pediatric is ready for immediate use in infants and children up to 11 years of age when added to intravenous infusion fluids.

Infuvite Pediatric should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation.

A daily dose of Infuvite Pediatric (4 mL of Vial 1 plus 1 mL of Vial 2) should be added directly to not less than 100 mL of intravenous dextrose, saline or similar infusion solutions.

For administration to infants weighing < 1 kg:

The daily dose is 30% of the contents of Vial 1 (1.2 mL) and of Vial 2 (0.3 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants.

For administration to infants weighing ≥1 kg and < 3 kg: The daily dose is 65% of the contents of Vial 1 (2.6 mL) and of Vial 2 (0.65 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants.

For administration to infants and children weighing ≥3 kg up to 11 years of age: The daily dose is the entire contents of Vial 1 (4 mL) and of Vial 2 (1 mL), unless there is clinical or laboratory evidence for increasing or decreasing the dosage.

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

After Infuvite Pediatric is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A, D, and riboflavin, are light sensitive, therefore, exposure to light should be minimized. DISCARD ANY UNUSED PORTION

How is Infuvite Pediatric Supplied

Infuvite Pediatric – NDC 54643-5646-0, is available in boxes containing 2 vials – Vial 1 (4 mL) and Vial 2 (1 mL), both vials to be used for a single dose.

Infuvite Pediatric – NDC 54643-5646-1, is available in boxes containing 10 vials – 5 each of Vial 1 (4 mL) and 5 each of Vial 2 (1 mL), one Vial 1 plus one Vial 2 to be used for a single dose.

Store under refrigeration 2-8°C (36-46°F).

Rx only

Manufactured by

Sandoz Canada Inc.

145 Jules-Leger Street Boucherville, QC, Canada J4B 7K8

Distributed by

Baxter Healthcare Corporation

Clintec Nutrition Division Deerfield, IL 60015 USA

Printed in Canada

D1006224 Rev. September 2007

® INFUVITE is a registered trademark of Sandoz Canada Inc.

Infuvite Pediatric Carton

2A9008 NDC 54643-5646-1

Baxter

Infuvite Pediatric Multiple Vitamins for Infusion

For intravenous infusion after dilution only.

Sterile Rx only

Contains 5 each of Vial 1 (4 mL) and Vial 2 (1 mL).

One vial of each to be used for a single dose.

Store under refrigeration, 2-8°C (36-46°F).

PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION  asorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54643-5646 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 80 mg  in 5 mL VITAMIN A PALMITATE (VITAMIN A) VITAMIN A 2300 [iU]  in 5 mL CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 5 mL THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE 1.2 mg  in 5 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 1.4 mg  in 5 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1 mg  in 5 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 17 mg  in 5 mL DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 5 mg  in 5 mL ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 7 [iU]  in 5 mL PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 0.2 mg  in 5 mL FOLIC ACID (FOLIC ACID) FOLIC ACID 140 ug  in 5 mL BIOTIN (BIOTIN) BIOTIN 20 ug  in 5 mL CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1 ug  in 5 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 80   ANHYDROUS CITRIC ACID   SODIUM CITRATE   SODIUM HYDROXIDE   HYDROCHLORIC ACID   MANNITOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54643-5646-0 2 VIAL In 1 CARTON contains a VIAL 1 5 mL In 1 VIAL This package is contained within the CARTON (54643-5646-0) 2 54643-5646-1 10 VIAL In 1 CARTON contains a VIAL 2 5 mL In 1 VIAL This package is contained within the CARTON (54643-5646-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021265	02/21/2001

Labeler - Sandoz Canada Inc (244062071)

Revised: 01/2012Sandoz Canada Inc

Imitrex

Generic Name: sumatriptan (Nasal route)

soo-ma-TRIP-tan

Commonly used brand name(s)

In the U.S.

• Imitrex

Available Dosage Forms:

• Spray

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For Imitrex

Sumatriptan nasal spray is used to treat acute migraine attacks in adults. It does not prevent migraine attacks nor treat certain types of migraine headaches (e.g., hemiplegic or basilar type).

Many people find that their headaches go away completely after they take sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the good that it can do.

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

Before Using Imitrex

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 have not been performed on the relationship of age to the effects of sumatriptan nasal spray in the pediatric population. Safety and efficacy have not been established.

Geriatric

Use of sumatriptan nasal spray is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.

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

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Almotriptan


• Dihydroergotamine


• Eletriptan


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Frovatriptan


• Isocarboxazid


• Linezolid


• Methylergonovine


• Methysergide


• Naratriptan


• Phenelzine


• Procarbazine


• Rizatriptan


• Tranylcypromine


• Zolmitriptan

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

• Citalopram


• Desvenlafaxine


• Dexfenfluramine


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Milnacipran


• Paroxetine


• Reboxetine


• Sertraline


• Sibutramine


• St John's Wort


• Tapentadol


• Venlafaxine


• Vilazodone

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:

• Bleeding problems or


• Blurred vision or


• CNS disorders or


• Kidney disease or


• Liver disease or


• Seizures or epilepsy, history of or


• Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

• Cerebrovascular disease (e.g., stroke, transient ischemic attack), or history of or


• Heart attack, history of or


• Heart disease (e.g., angina) or


• Hemiplegic or basilar types of migraine or


• Hypertension (high blood pressure), uncontrolled or


• Ischemic bowel disease or


• Liver disease, severe—Should not be used in patients with these conditions.

• Coronary artery disease, history of or


• Diabetes or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertension (high blood pressure), controlled or


• Obesity or


• Raynaud's syndrome—Use with caution. The chance of side effects may be increased. Heart or blood vessel disease sometimes do not cause any symptoms, some people do not know that they have these problems. Before deciding whether you should use this medicine, your doctor may need to do some tests to make sure that you do not have any of these conditions.

Proper Use of sumatriptan

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

Do not use this medicine for a headache that is different from your usual migraines. Instead, check with your doctor.

To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

If you are not much better in 1 or 2 hours after using this medicine, do not use any more of this medicine for the same migraine. A migraine that is not relieved by the first dose of sumatriptan probably will not be relieved by a second dose, either. Ask your doctor ahead of time about other medicine to be taken if sumatriptan does not work. After taking the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by sumatriptan are sometimes caused by conditions that need other treatment. However, even if sumatriptan does not relieve one migraine, it may still relieve the next one.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, you may use more sumatriptan. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of sumatriptan or pain relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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 nasal dosage form (nasal solution):
  
  • For migraine headaches:
    
    • Adults—5 milligrams (mg) (1 spray into one nostril) or 10 mg (2 sprays in one nostril or 1 spray in each nostril) or 20 mg (1 spray into one nostril). If pain is not relieved, another spray (5 mg, 10 mg, or 20 mg) should not be used for the same migraine attack. Another spray (5 mg, 10 mg, or 20 mg) may be used for a migraine that occurs at a later time as long as it has been at least 2 hours since the last spray. Do not use more than 40 mg in a 24-hour period (one day).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Imitrex

Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraine headaches are worse, or if they are occurring more often, than before you started using this medicine.

Make sure your doctor knows if you are pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, if you smoke, if you are over 40, or if you have gone through menopause. People who use this medicine for a long time might also have a higher risk.

You should not take this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxacid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past two weeks. Do not use this medicine if you have taken other migraine medicines (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (e.g., methysergide, D.H.E. 45®, or Migranal®) within the past 24 hours.

Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor first before taking any other medicines.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using this medicine. Tell your doctor if you have burning, numbness, pain, soreness, or irritation of the nose or throat after using the nasal spray.

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Imitrex Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

Less common

• Chest pain (mild)


• difficulty with swallowing


• heaviness, tightness, or pressure in the chest or neck


• pounding heartbeat


• skin rash, hives, itching, or bumps on the skin

Rare

• Chest pain (severe)


• changes in skin color on the face


• convulsions (seizures)


• fast or irregular breathing


• puffiness or swelling of the eyelids, area around the eyes, face, or lips


• shortness of breath, troubled breathing, or wheezing

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

More common

• Burning, discharge, pain, or soreness in the nose


• change in taste


• discomfort in the jaw, mouth, tongue, throat, nose, or sinuses


• dizziness


• drowsiness


• feeling of burning, warmth, heat, numbness, tightness, or tingling


• feeling cold, “strange,” or weak


• flushing


• lightheadedness


• muscle aches, cramps, or stiffness


• nausea or vomiting


• unusual or unpleasant (after) taste

Less common

• Feeling of constant movement of self or surroundings


• sensation of spinning

Less common or rare

• Anxiety


• burning sensation


• discomfort of the nasal cavity and throat


• general feeling of illness or tiredness


• vision changes

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

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

See also: Imitrex side effects (in more detail)

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More Imitrex resources

• Imitrex Side Effects (in more detail)
• Imitrex Use in Pregnancy & Breastfeeding
• Drug Images
• Imitrex Drug Interactions
• Imitrex Support Group
• 61 Reviews for Imitrex - Add your own review/rating

• Imitrex Prescribing Information (FDA)


• Imitrex MedFacts Consumer Leaflet (Wolters Kluwer)


• Imitrex Monograph (AHFS DI)


• Imitrex Consumer Overview


• Alsuma Consumer Overview


• Alsuma Prescribing Information (FDA)


• Sumatriptan Prescribing Information (FDA)


• Sumatriptan Professional Patient Advice (Wolters Kluwer)


• Sumavel DosePro Consumer Overview


• Sumavel DosePro MedFacts Consumer Leaflet (Wolters Kluwer)


• Sumavel Dosepro Prescribing Information (FDA)

Compare Imitrex with other medications

• Cluster Headaches
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• Migraine
• New Daily Persistent Headache

Isoniazid/Pyrazinamide/Rifampin

Pronunciation: EYE-soe-NYE-a-zid/PIR-a-ZIN-a-mide/rif-AM-pin
Generic Name: Isoniazid/Pyrazinamide/Rifampin
Brand Name: Rifater

Isoniazid/Pyrazinamide/Rifampin may cause severe and sometimes fatal liver problems (eg, hepatitis). The risk of liver problems is greater in patients over 35 years old. It may also be increased by daily use of alcohol, long-term liver problems, or unsanitary injectable drug use. Women, especially those who are black or Hispanic, or who have just had a baby, may also be at increased risk. Hepatitis can develop at any time during treatment, but usually occurs during the first 3 months. Your doctor will monitor your liver function and discuss your progress every month.

Contact your doctor right away if you develop unusual fatigue, weakness or fever that lasts longer than 3 days, general feeling of discomfort, loss of appetite, nausea, vomiting, numbness or tingling of the hands or feet, dark urine, yellowing of the skin or eyes, or stomach pain or tenderness.

Patients with active liver problems should not use Isoniazid/Pyrazinamide/Rifampin.

Isoniazid/Pyrazinamide/Rifampin is used for:

Treating tuberculosis (TB) of the lungs.

Isoniazid/Pyrazinamide/Rifampin is a combination of 3 antibacterial agents. It works by killing sensitive TB bacteria.

Do NOT use Isoniazid/Pyrazinamide/Rifampin if:

• you are allergic to any ingredient in Isoniazid/Pyrazinamide/Rifampin or to any rifamycin (eg, rifabutin)


• you have had severe side effects from isoniazid, such as drug fever, chills, or arthritis


• you have severe liver damage, active liver disease, or liver damage from previous use of Isoniazid/Pyrazinamide/Rifampin


• you have active gout or a history of hepatitis caused by any medicine


• you are taking atazanavir, cabazitaxel, darunavir, delavirdine, dronedarone, etravirine, fosamprenavir, lurasidone, nifedipine, praziquantel, ranolazine, saquinavir, tipranavir, a tyrosine kinase receptor inhibitor (eg, lapatinib), or voriconazole

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

Before using Isoniazid/Pyrazinamide/Rifampin:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diabetes, the blood disease porphyria, kidney problems, nerve problems (eg, neuropathy) or risk of nerve problems, HIV, severe diarrhea due to antibiotic use (pseudomembranous colitis), or a history of liver problems or gout


• if you have a history of alcohol or other substance abuse, have unsanitary injectable drug habits, or drink alcohol daily


• if you are over 35 years old, you have recently given birth, or you have previously taken Isoniazid/Pyrazinamide/Rifampin


• if you wear contact lenses

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

• Atazanavir, cabazitaxel, darunavir, delavirdine, dronedarone, etravirine, fosamprenavir, lurasidone , nifedipine, praziquantel, ranolazine, saquinavir, tipranavir, tyrosine kinase receptor inhibitors (eg, lapatinib), or voriconazole because their effectiveness may be decreased by Isoniazid/Pyrazinamide/Rifampin


• Many prescription and nonprescription medicines (eg, used for alcoholism, allergic reactions, anxiety, arthritis, asthma, birth control, blood thinning, cancer, depression, diabetes, Hansen disease, heart problems, high blood pressure, high cholesterol, high iron blood levels, HIV, hormone replacement, immune system suppression, infections, inflammation, irregular heartbeat, low sodium levels, low vitamin D levels, mental or mood problems, nausea and vomiting, pain, Parkinson disease, seizures, sleep, thyroid) may interact with Isoniazid/Pyrazinamide/Rifampin, increasing the risk of side effects or decreasing effectiveness

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

How to use Isoniazid/Pyrazinamide/Rifampin:

Use Isoniazid/Pyrazinamide/Rifampin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Isoniazid/Pyrazinamide/Rifampin by mouth on an empty stomach at least 1 hour before or 2 hours after eating.


• Take Isoniazid/Pyrazinamide/Rifampin with a full glass of water (8 oz/240 mL).


• If you also take an antacid, take Isoniazid/Pyrazinamide/Rifampin at least 1 hour before you take the antacid.


• If you also take aminosalicylic acid granules, do not take it within 8 to 12 hours of Isoniazid/Pyrazinamide/Rifampin. Check with your doctor if you have questions.


• Continue to take Isoniazid/Pyrazinamide/Rifampin even if you feel well. Do not miss any doses.


• Do not stop taking Isoniazid/Pyrazinamide/Rifampin without checking with your doctor. Rarely, kidney problems have occurred when patients started taking Isoniazid/Pyrazinamide/Rifampin again after therapy was interrupted.


• If you miss a dose of Isoniazid/Pyrazinamide/Rifampin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Isoniazid/Pyrazinamide/Rifampin.

Important safety information:

• Isoniazid/Pyrazinamide/Rifampin may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Isoniazid/Pyrazinamide/Rifampin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before drinking alcohol while taking Isoniazid/Pyrazinamide/Rifampin. Alcohol may increase the risk of liver problems. If you have a history of alcohol abuse, you may also be at increased risk of developing nerve problems from Isoniazid/Pyrazinamide/Rifampin. Notify your doctor if you notice any unusual tingling or numbness in your hands or feet.


• If you have a history of diabetes, alcohol abuse, or poor nutrition, your doctor may recommend that you also take vitamin B₆ while you are taking Isoniazid/Pyrazinamide/Rifampin. This may help to decrease your risk of nerve problems. Discuss any questions with your doctor.


• Isoniazid/Pyrazinamide/Rifampin may cause a reddish orange color of urine, stools, saliva, tears, sweat, sputum, and skin. This is normal and not a cause for concern.


• Isoniazid/Pyrazinamide/Rifampin may cause a permanent reddish orange color of soft contact lenses.


• Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you take Isoniazid/Pyrazinamide/Rifampin may cause severe high blood pressure. Do not eat foods high in tyramine while you take Isoniazid/Pyrazinamide/Rifampin. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.


• Do not eat foods high in histamine while you take Isoniazid/Pyrazinamide/Rifampin. Eating foods high in histamine (eg, skipjack, tuna, tropical fish) while you use Isoniazid/Pyrazinamide/Rifampin may cause low blood pressure, irregular heartbeat, headache, sweating, or flushing. Contact your doctor at once if any of these symptoms occur.


• Ask your health care provider for a complete list of all foods you should avoid while you are taking Isoniazid/Pyrazinamide/Rifampin.


• Hormonal birth control (eg, birth control pills, implants, patches) may not work as well while you are using Isoniazid/Pyrazinamide/Rifampin. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Isoniazid/Pyrazinamide/Rifampin only works against TB bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to take Isoniazid/Pyrazinamide/Rifampin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you take the antibiotic or within several months after you stop taking it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occurs. Do not treat diarrhea without first checking with your doctor.


• Tell your doctor or dentist that you take Isoniazid/Pyrazinamide/Rifampin before you receive any medical or dental care, emergency care, or surgery.


• Isoniazid/Pyrazinamide/Rifampin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Isoniazid/Pyrazinamide/Rifampin.


• Diabetes patients - Isoniazid/Pyrazinamide/Rifampin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. You may also be at increased risk of developing nerve problems from Isoniazid/Pyrazinamide/Rifampin. Contact your doctor if you notice any unusual tingling in your hands or feet.


• Lab tests, including complete blood cell counts, platelet counts, uric acid levels, kidney and liver function, and eye exams, may be performed while you take Isoniazid/Pyrazinamide/Rifampin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Isoniazid/Pyrazinamide/Rifampin with caution in BLACK and HISPANIC WOMEN; they may have a greater risk of severe liver problems from Isoniazid/Pyrazinamide/Rifampin.


• Use Isoniazid/Pyrazinamide/Rifampin with caution in patients over 35 years old; they may have a greater risk of severe liver problems from Isoniazid/Pyrazinamide/Rifampin.


• Isoniazid/Pyrazinamide/Rifampin should be used with extreme caution in CHILDREN younger than 15 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Isoniazid/Pyrazinamide/Rifampin while you are pregnant. Isoniazid/Pyrazinamide/Rifampin is found in breast milk. Do not breast-feed while taking Isoniazid/Pyrazinamide/Rifampin.

Possible side effects of Isoniazid/Pyrazinamide/Rifampin:

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

Diarrhea; dizziness; drowsiness; gas; headache; heartburn; mild joint or muscle aches; mild stomach upset or cramps; nausea; trouble sleeping.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or dark urine, change in the amount of urine produced; changes in vision; chest pain; coughing up blood; dark, tarry, or bloody stools; fever, chills, or sore throat; general feeling of discomfort; increased thirst or urination; irregular heartbeat; joint pain or swelling; loss of appetite; memory problems; menstrual changes; mental or mood changes; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe diarrhea, nausea, or stomach cramps; severe or persistent muscle pain or weakness; severe pain or tenderness in the big toe; shortness of breath; stomach pain or tenderness; swelling of the hands or legs; swollen lymph nodes; symptoms of low B₆ levels (eg, confusion, cracks in the corners of the mouth, irritability, mouth redness or soreness, scaly rash); tingling or numbness in the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Isoniazid/Pyrazinamide/Rifampin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; hallucinations; loss of consciousness; seizures; severe dizziness or nausea; sluggishness; slurred speech; stomach pain or tenderness; symptoms of high blood sugar (eg, confusion, increased thirst or urination, rapid breathing, unusual drowsiness); very slow breathing; vomiting; yellowing of the skin or eyes.

Proper storage of Isoniazid/Pyrazinamide/Rifampin:

Store Isoniazid/Pyrazinamide/Rifampin between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isoniazid/Pyrazinamide/Rifampin out of the reach of children and away from pets.

General information:

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


• Isoniazid/Pyrazinamide/Rifampin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Isoniazid/Pyrazinamide/Rifampin resources

• Isoniazid/Pyrazinamide/Rifampin Side Effects (in more detail)
• Isoniazid/Pyrazinamide/Rifampin Use in Pregnancy & Breastfeeding
• Isoniazid/Pyrazinamide/Rifampin Drug Interactions
• Isoniazid/Pyrazinamide/Rifampin Support Group
• 0 Reviews for Isoniazid/Pyrazinamide/Rifampin - Add your own review/rating

• isoniazid/pyrazinamide/rifampin Concise Consumer Information (Cerner Multum)


• Rifater Prescribing Information (FDA)


• Rifater Concise Consumer Information (Cerner Multum)


• Rifater Advanced Consumer (Micromedex) - Includes Dosage Information

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• Tuberculosis, Active

Ixempra

Generic Name: ixabepilone (Intravenous route)

ix-ab-EP-i-lone

Intravenous route(Powder for Solution)

Contraindicated with capecitabine in patients with AST or ALT greater than 2.5 times the upper limit of normal (ULN) or bilirubin greater than one times ULN due to increased risk of toxicity and neutropenia-related death .

Commonly used brand name(s)

In the U.S.

• Ixempra

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Chemical Class: Epothilone

Uses For Ixempra

Ixabepilone injection belongs to the group of medicines called antineoplastics (cancer medicines). It is used to treat advanced or metastatic breast cancer (breast cancer that has already spread) after other treatments have failed. Ixabepilone is given alone or with another cancer medicine called capecitabine.

Ixabepilone interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells will also be affected by this medicine, other side effects may occur. Some of these may be serious and must be reported to your doctor right away.

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

Before Using Ixempra

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 have not been performed on the relationship of age to the effects of ixabepilone injection in the pediatric population. Efficacy has not yet been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Amprenavir


• Atazanavir


• Carbamazepine


• Clarithromycin


• Delavirdine


• Dexamethasone


• Fosamprenavir


• Indinavir


• Itraconazole


• Ketoconazole


• Nefazodone


• Nelfinavir


• Phenobarbital


• Phenytoin


• Rifabutin


• Rifampin


• Ritonavir


• Saquinavir


• St John's Wort


• Telithromycin


• Voriconazole

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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:

• Allergy to a medicine (e.g., Taxol®) that contains Cremophor® EL or polyoxyethylated castor oil or


• Liver disease, severe or


• Neutropenia (low white blood cell count) or


• Thrombocytopenia (low platelet count)—Should not be used in patients with these conditions.

• Diabetes—Use with caution. This medicine may increase your chance of having nerve problems.

• Heart disease, or history of or


• Nerve problems (e.g., peripheral neuropathy)—Use with caution. May make these conditions worse.

• Liver disease, mild—Use with caution. This medicine should not be given with capecitabine to patients with this condition.

Proper Use of Ixempra

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.

This medicine is usually given once every 3 weeks. Each treatment usually takes about 3 hours. You may also receive medicines to help prevent possible allergic reactions to the injection.

This medicine often causes diarrhea, nausea, and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Your doctor may give you a medicine to help prevent these side effects.

Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body. Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using Ixempra

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Ixabepilone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood counts are low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as safety razors and fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

Check with your doctor right away if you have chest pain, difficulty with breathing, a fast or pounding heartbeat, or unusual weight gain. These could be symptoms of a serious heart problem.

Ixabepilone contains alcohol, which may cause some people to become dizzy or drowsy. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Ixempra Side Effects

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

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• body aches or pain


• burning, numbness, tingling, or painful sensations


• burning pain on urination


• chest pain


• chills


• cough


• difficult or labored breathing


• ear congestion


• fever


• headache


• loss of voice


• lower back or side pain


• nasal congestion


• painful or difficult urination


• pale skin


• red, swelling, or painful skin


• runny nose


• scaling of the skin on the hands and feet


• shortness of breath


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• swelling of the hands, ankles, feet, or lower legs


• swollen glands


• tightness in the chest


• tingling of the hands and feet


• troubled breathing with exertion


• ulceration of the skin


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain


• weakness in the arms, hands, legs, or feet


• wheezing

Less common

• Bleeding gums


• blood in the urine or stools


• confusion


• decreased urination


• dizziness


• dry mouth


• fainting


• fast heartbeat


• hives


• hoarseness


• increase in heart rate


• irritation


• itching


• joint pain, stiffness, or swelling


• lightheadedness


• pinpoint red spots on the skin


• rapid breathing


• rash


• sunken eyes


• swelling of the eyelids, face, or lips


• thirst


• trouble with swallowing


• wrinkled skin

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

More common

• Bad, unusual, or unpleasant (after) taste


• bone pain


• change in taste


• cracked lips


• diarrhea


• difficulty having a bowel movement (stool)


• discoloration of the fingernails or toenails


• feeling of warmth


• hair loss or thinning of the hair


• heartburn


• lack or loss of strength


• loss of appetite


• nausea


• redness of the face, neck, arms, and occasionally, upper chest


• stomach pain


• sudden sweating


• swelling or inflammation of the mouth


• vomiting


• weight loss

Less common

• Darkening of the skin


• flaking and falling off of the skin


• sleeplessness


• trouble with sleeping


• unable to sleep


• watering of the eyes

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.

See also: Ixempra side effects (in more detail)

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.

More Ixempra resources

• Ixempra Side Effects (in more detail)
• Ixempra Use in Pregnancy & Breastfeeding
• Ixempra Drug Interactions
• Ixempra Support Group
• 0 Reviews for Ixempra - Add your own review/rating

• Ixempra Prescribing Information (FDA)


• Ixempra Consumer Overview


• Ixempra Monograph (AHFS DI)


• Ixempra MedFacts Consumer Leaflet (Wolters Kluwer)


• Ixabepilone Professional Patient Advice (Wolters Kluwer)

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