ABACAVIR (Systemic)
Some commonly used brand names are:
In the U.S.?
Category
Description
Abacavir (a-BAK-a-veer) is used, in combination with other medicines,in the treatment of the infection caused by the human immunodeficiency virus(HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).
Abacavir will not cure or prevent HIV infection or AIDS; however, it helpskeep HIV from reproducing and appears to slow down the destruction of theimmune system. This may help delay the development of problems usually relatedto AIDS or HIV disease. Abacavir will not keep you from spreading HIV to otherpeople. People who receive this medicine may continue to have other problemsusually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription, in thefollowing dosage forms:
Oral- Oral solution (U.S.)
- Tablets (U.S.)
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For abacavir, the followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to abacavir. This medicine should notbe taken if you have ever had an allergic reaction to it, because it couldcause another severe reaction that may result in death. Also tell yourhealth care professional if you are allergic to any other substances, suchas foods, preservatives, or dyes.
Pregnancy?Abacavir has not been studied in pregnant women.However, it has been found to cause birth defects and other problems in animalsat doses many times the human dose. Before taking this medicine, make sureyour doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding?It is not known whether abacavir passes into breastmilk. However, because of the possibility that this medicine could cause unwantedeffects in nursing babies and the risk of passing HIV on to the infant, breast-feedingis not recommended. Mothers who are taking this medicine and who wish to breast-feedshould discuss this with their doctor.
Children?This medicine has been tested in children 3 monthsof age and older and, in effective doses, has not been shown to cause differentside effects or problems than it does in adults.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof abacavir in the elderly with use in other age groups.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.
Other medical problems?The presence of other medical problemsmay affect the use of abacavir. Make sure you tell your doctor if you haveany other medical problems, especially:
- Allergy to abacavir or any ingredients in the medicine?Youshould tell your doctor immediately if you have signs of an allergic reaction.If you have ever taken abacavir in the past, you should tell your doctor rightaway.
- Liver problems, moderate or severe?Abacavir has not been studiedin patient with liver problems, so it should not be used.
- Risk factors for liver disease such as:
- Being overweight or
- Taking other HIV medicines for long periods of time?Seriousside effects could occur; caution should be used
Proper Use of This Medicine
Take this medicine exactly as directed by your doctor. Do not takeit more often, and do not take it for a longer time than your doctor ordered.
Dosing?The dose of abacavir will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of abacavir. If your dose is different,do not change it unless your doctor tells you to do so.
- For oral dosage form (oral solution ortablets):
- For HIV infection:
- Adults and adolescents 16 years of age and older?300 milligrams(mg) two times a day or 600 mg once a day. This medicine can be taken withor without food.
- Children 3 months to 16 years of age?Dose is based on bodyweight and must be determined by your doctor. The usual dose is 8 mg per kilogram(kg) (3.6 mg per pound) of body weight two times a day.
Missed dose?If you miss a dose of this medicine, take it assoon as you remember. However, if it is almost time for the next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Keep the oral solution from freezing.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Thismedicine may cause a severe allergic reaction in some patients. This reactionusually occurs within 6 weeks after the medicine is started but may occurat any time. If untreated, it can lead to severe low blood pressure and evendeath. Stop taking this medicine and check with yourdoctor immediately if you notice sudden fever, skin rash, diarrhea, nausea,stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough,shortness of breath, or sore throat.
When you begin taking this medicine, you will be given a warning card whichdescribes symptoms of severe allergic reactions that may be caused by abacavir.The warning card also provides information about how to treat these allergicreactions. For your safety, you should carry the warning card with you atall times.
Side Effects of This Medicine
Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.
Stop taking this medicineand get emergency help immediately if any of the following side effectsoccur:
Less common
Abdominal or stomach pain; cough; diarrhea; difficult or labored breathing; fever; headache; joint or muscle pain; nausea; numbness or tingling of hands, feet, or face; redness and soreness of eyes; shortness of breath; skin rash; sore throat; sores in mouth; swellingof feet or lower legs; vomiting; unusual feeling of discomfort or illness; unusualtiredness
Incidence not known?occurred during clinical practice
Blistering, peeling, loosening of skin; chills; dark urine; itching; light-colored stools; red, irritated eyes; red skin lesions, often witha purple center; sores, ulcers or white spots inmouth or on lips; unusual weakness; upper right abdominal pain; yellow eyesand skin
Check with your doctor as soon as possible if any of the followingside effects occur:
Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:
Incidence not known?occurred during clinical practice
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Developed: 06/14/1999
Revised: 11/09/2004
