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Usp

Sustiva

Sustiva is one of the growing number of drugs used to fight HIV infection. HIV, the human immunodeficiency virus, weakens the immune system until it can no longer fight off infections, leading to the fatal disease known as AIDS (acquired immune deficiency syndrome). Like other drugs for HIV, Sustiva works by impairing the virus's ability to multiply. However, when taken alone it may prompt the virus to become resistant. Sustiva is therefore always taken with at least one other HIV medication, such as Retrovir or Crixivan. Even when used properly, it may remain effective for only a limited time.

Sustiva is used for:

Treating HIV infection in combination with other medicines. If Sustiva is taken alone to treat HIV, it may stop working.

Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by blocking the growth of HIV.

Drug Class and Mechanism

Sustiva is an oral medication that is used for the treatment of infections with the human immunodeficiency virus (HIV). It is similar to nevirapine (Viramune) and delavirdine (Rescriptor). Sustiva is in a class of drugs called reverse transcriptase inhibitors which also includes zalcitabine (Hivid), zidovudine (Retrovir), didanosine (Videx), and lamivudine (Epivir). During infection with HIV, the HIV virus multiplies within the body's cells. The newly-formed viruses then are released from the cells and spread throughout the body where they infect other cells. In this manner, the infection continually spreads to new, uninfected cells that the body is continually producing, and HIV infection is perpetuated. When producing new viruses, the HIV virus must manufacture new DNA for each virus. Reverse transcriptase is the enzyme that the virus uses to form this new DNA. Sustiva directly inhibits the activity of reverse transcriptase and blocks the production of DNA and new viruses. Unlike zidovudine, efavirenz does not need to be converted to an active form. Sustiva does not kill existing HIV virus and it is not a cure for HIV.

SIDE EFFECTS

The most significant adverse events observed in patients treated with SUSTIVA are nervous system symptoms, psychi-atric symptoms, and rash. Unless otherwise specified, the analyses described below included 1008 patients treated with regimens containing SUSTIVA and 635 patients treated with a control regimen in controlled trials.

Precaution

Do NOT use Efavirenz if you are allergic to any ingredient in Efavirenz. 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, breast-feeding, or of childbearing age; 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 liver or kidney problems. Efavirenz may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Efavirenz with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Efavirenz; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Do not take more of Efavirenz than prescribed by your doctor. Taking more medicine than prescribed may not provide additional benefits and may increase the risks of side effects. Efavirenz is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. Efavirenz does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Efavirenz will not prevent you from getting sexually transmitted infections (STIs). Always use a condom during sexual intercourse. If your health changes, check with your doctor. Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Efavirenz. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Efavirenz may interfere with certain lab tests, including cannabinoids false-positive result. Be sure your doctor and lab personnel know you are taking Efavirenz. Hormonal birth control (eg, birth control pills) may not work as well while you are using Efavirenz. To prevent pregnancy, use an extra form of birth control (eg, condoms). Lab tests, including liver function, may be performed while you use Efavirenz. These tests may be used to monitor your condition or check for side effects. Talk to your doctor about whether you should have a pregnancy test before you begin taking Efavirenz. Efavirenz may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Efavirenz while you are pregnant. It is not known if Efavirenz is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Efavirenz to the baby.

Drug Interactions With Sustiva

Sustiva can interact with some medications used to treat various fungal infections, including candidiasis and cryptococcal meningitis. If Sustiva is combined with Vfend (voriconazole), the Vfend dose should be increased to 400mg every 12 hours and the Sustiva dose should be decreased to 300mg once daily (one 200 mg and two 50 mg Sustiva capsules once a day). Sustiva can also decrease levels of Sporanox (itraconazole); it is recommended that a Sporanox alternative be used instead. Nizoral (ketoconazole) levels can decrease as well; no dosing recommendations have been made.

Recommended dosage:

ADULTS: The recommended dose is 600 milligrams once a day, in combination with other HIV medications.

CHILDREN: For children 3 years of age and older, weighing between 22 and 88 pounds, the recommended dose is based upon weight. Children weighing more than 88 pounds receive the 600-milligram adult dose.

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