Home » Drug Information » FDA-Approved Drugs » 1999
Medical Areas: Immunology/Infectious Diseases
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: GlaxoSmithKline
Approval Status: Approved April 1999
Treatment Area: Immunology/Infectious Diseases
AGENERASE is a medication used to treat HIV infection. HIV is
the virus that causes AIDS (acquired immune deficiency syndrome).
AGENERASE is taken by mouth as a soft gel capsule or oral solution.
It belongs to a class of anti-HIV medicines called protease
inhibitors.
The usual dosage for adults and adolescents (at least 13 years
of age) is eight 150-mg soft gel capsules twice a day (morning and
night), in combination with other anti-HIV medicines. AGENERASE can
be taken with or without food, but should not be taken with a
high-fat meal because this could reduce the effectiveness.
Common side effects of AGENERASE are nausea, vomiting, diarrhea,
rash, and a tingling sensation around the mouth. Severe or
life-threatening rash has been reported.
Contact your doctor if you have nausea, vomiting, diarrhea, or
rash. Your doctor may be able to help you manage these
symptoms.
AGENERASE should not be administered concurrently with
astemizole, bepridil, cisapride, dihydroergotamine, ergotamine,
midazolam, and triazolam. Although these drugs have not been
specifically studied, coadministration may result in competitive
inhibition of metabolism of these products and may cause serious or
life-threatening adverse events.
AGENERASE is used only in combination with other anti-HIV
medicines. When used in combination therapy, AGENERASE may help
lower the amount of HIV found in your blood, raise CD4 (T) cell
count, and keep your immune system as healthy as possible so that
it can help fight infection. However, AGENERASE does not have these
effects in all patients.
Amprenavir is an inhibitor of HIV-1 protease. Amprenavir binds
to the active site of HIV-1 protease and thereby prevents the
processing of viral gag and gag-pol polyprotein precursors,
resulting in the formation of immature non-infectious viral
particles.
Children from 4 to 12 years of age can also take AGENERASE. Your
doctor will tell you if the oral solution or capsule is best for
your child. Your child’s doctor will decide the right dose based on
your child’s weight and age. AGENERASE has not been studied in
children under 4 years of age.