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Indications:

is prescribed for adults infected with human immunodeficiency virus (HIV). HIV causes the immune system to break down so that it can no longer respond effectively to infection, leading to the fatal disease known as acquired immune deficiency syndrome (AIDS). Retrovir slows down the progress of HIV. Combining Retrovir with other drugs such as Epivir and Crixivan can help slow the progression. Retrovir is also prescribed for HIV-infected children over 3 months of age who have symptoms of HIV or who have no symptoms but, through testing, have shown evidence of impaired immunity. Retrovir taken during pregnancy often prevents transmission of HIV from mother to child.

Contraindications:

RETROVIR Tablets, Capsules, and Syrup are contraindicated in patients who have had potentially life-threatening allergic reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations

Adverse reactions:

Body as a Whole: Back pain, chest pain, flu-like syndrome, generalized pain, redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS]. Cardiovascular: Cardiomyopathy, syncope. Endocrine: Gynecomastia. Eye: Macular edema. Gastrointestinal: Dysphagia, flatulence, oral mucosa pigmentation, mouth ulcer. General: Sensitization reactions including anaphylaxis and angioedema, vasculitis. Hemic and Lymphatic: Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia. Hepatobiliary Tract and Pancreas: Hepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis. Musculoskeletal: Increased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV-1 disease), rhabdomyolysis, tremor. Nervous: Anxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo. Respiratory: Dyspnea, rhinitis, sinusitis. Skin: Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria. Special Senses: Amblyopia, hearing loss, photophobia, taste perversion. Urogenital: Urinary frequency, urinary hesitancy.

Interactions:

Antiretroviral Agents Stavudine: Concomitant use of zidovudine with stavudine should be avoided since an antagonistic relationship has been demonstrated in vitro. Nucleoside Analogues Affecting DNA Replication: Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of RETROVIR against HIV-1; concomitant use of such drugs should be avoided. Doxorubicin Concomitant use of zidovudine with doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro. Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration of ganciclovir, interferon alfa, ribavirin, and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of zidovudine.

Warnings:

This drug has been studied for only a limited period of time. Long-term safety and effectiveness are not known, especially for people who are in a less advanced stage of AIDS or AIDS-related complex (the condition that precedes AIDS), and for those using the drug over a prolonged period of time. Retrovir can cause an enlarged liver and the chemical imbalance known as lactic acidosis. This serious and sometimes fatal side effect is more likely in women, people who are overweight, and those who have been taking drugs such as Retrovir for an extended period. Signs of lactic acidosis include fatigue, nausea, abdominal pain, and a feeling of unwellness. Contact your doctor if you experience any of these symptoms. Treatment with Retrovir may have to be discontinued. If you develop a blood disease, you may require a blood transfusion, and your doctor may reduce your dose or take you off the drug altogether. Make sure your doctor monitors your blood count on a regular basis. The use of Retrovir has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination or to nursing infants. Retrovir should be used with extreme caution by people who have a bone marrow disease. Some people taking Retrovir develop a sensitization reaction, often signaled by a rash. If you notice a rash developing, notify your doctor. Contact your doctor immediately if you develop shortness of breath, muscle weakness, abdominal pain, or any unexpected problems while being treated with Retrovir. Because little data are available concerning the use of Zidovudine in people with impaired kidney or liver function, check with your doctor before using Retrovir if you have either problem. Like other HIV drugs, Retrovir sometimes causes a redistribution of body fat, resulting in added weight around the waist, a "buffalo hump" of fat on the upper back, breast enlargement, and wasting of the face, arms, and legs. It’s not known why this occurs, or what long-term effects it might have.

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