Abacavir and Lamivudine (Oral Route)

HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir and lamivudine combination will not cure or prevent HIV infection or the symptoms of AIDS . This medicine helps keep HIV from reproducing, and appears to slow down the destruction of the immune system . This may help delay the development of serious health problems usually related to AIDS or HIV infection. Abacavir and lamivudine combination will not keep you from spreading HIV to other people . People who receive this medicine may continue to have other problems usually related to AIDS or HIV infection.

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

This product is available in the following dosage forms:

• Tablet

Before Using

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 abacavir and lamivudine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of this medicine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Interferon Alfa


• Ribavirin


• Zalcitabine

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

• Methadone


• Tipranavir

Other Interactions

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:

• Diabetes or


• Heart disease or


• Hepatitis B, history of or


• Hepatitis C, history of or


• High blood pressure or


• High cholesterola€”Use with caution. May make these conditions worse.

• Genetic condition (e.g., gene variation called HLA-B*5701)a€”This condition may increase the risk for serious and life-threatening side effects.

• Kidney disease, severe or


• Liver diseasea€”Should not be used in patients with these conditions.

Proper Use

Take this medicine exactly as directed by your doctor . Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not start or stop taking this medicine without checking with your doctor first.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When your supply of this medicine runs low, get more from your pharmacy or from your doctor . The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to this medicine and be harder to treat.

This medicine will be given together with other medicines for HIV infection. Take all of the medicines your doctor gives you at the right time of day. These medicines work best when there is a constant amount in the blood . To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicines, check with your doctor .

Abacavir and lamivudine combination contains a fixed amount of each medicine in the tablet .

This medicine can be taken with or without food.

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 oral dosage form (tablets):
  
  
  
  • For HIV infection:
    
    
    
    • Adultsa€”600 milligrams (mg) of abacavir and 300 mg of lamivudine (equal to one tablet) once a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions

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.

This medicine may cause a severe allergic reaction in some patients. This reaction usually occurs within 6 weeks after the medicine is started, but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Stop taking this medicine and check with your doctor 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 which describes symptoms of severe allergic reactions that may be caused by abacavir and lamivudine combination. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

If you must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past .

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver . These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin .

When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.

This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.

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.

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

• Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of the face, feet, or hands; pain in the joints; pain in the muscles; shortness of breath; skin rash; sore throat; swelling of the feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting

Incidence not known

• Blistering, peeling, or loosening of the skin


• Bloating


• Burning, numbness, tingling, or painful sensations


• Chest pain


• Chills


• Constipation


• Convulsions


• Dark urine


• Decreased appetite


• Diarrhea


• Difficulty with swallowing


• Dizziness


• Fast heartbeat


• Fast, shallow breathing


• Feeling of fullness


• General feeling of discomfort


• Hives or welts


• Indigestion


• Itching


• Light-colored stools


• Loss of appetite


• Loss of bladder control


• Muscle cramping


• Muscle spasm or jerking of all extremities


• Pains in the stomach, side, or abdomen, possibly radiating to the back


• Pale skin


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Red, irritated eyes


• Redness of the skin


• Red skin lesions, often with a purple center


• Sleepiness


• Sores, ulcers, or white spots on the lips or in the mouth


• Sudden loss of consciousness


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Tightness in the chest


• Troubled breathing with exertion


• Unsteadiness or awkwardness


• Unusual bleeding or bruising


• Upper right abdominal pain


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


• Wheezing


• Yellow eyes and 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

• Abnormal dreams


• Burning feeling in the chest or stomach


• Fear


• Feeling of constant movement of self or surroundings


• Lightheadedness


• Nervousness


• Sensation of spinning


• Severe and throbbing headache


• Sleeplessness


• Stomach upset


• Tenderness in the stomach area


• Trouble with sleeping


• Unable to sleep

Incidence not known

• Abnormal breathing sounds


• Blurred vision


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Dry mouth


• Fruit-like breath odor


• Flushed, dry skin


• Hair loss


• Increased hunger


• Increased thirst


• Increased urination


• Muscle weakness


• Redistribution or accumulation of body fat


• Sweating


• Swelling or inflammation of the mouth


• Thinning of the hair


• Unexplained weight loss

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.