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Description of Ziagen
ZIAGEN is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is ( 1 S,cis)- 4-[2-amino-6-(cyclopropylamino)-9 H -purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S , 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C 14 H 18 N 6 O) 2 •H 2 SO 4 and a molecular weight of 670.76 g per mol. It has the following ...
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Uses of Ziagen
ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. ZIAGEN, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Available dosage forms and strengths
ZIAGEN tablets contain 300 mg of abacavir as abacavir sulfate. The tablets are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with “GX 623” on both sides. ZIAGEN oral solution contains 20 mg per mL of abacavir as abacavir sulfate. The solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid, which may turn brown over time. • Tablets: 300 mg scored • Oral Solution: 20 mg per mL
How should you take Ziagen
• Before initiating ZIAGEN, screen for the HLA-B*5701 allele. • Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 600 mg daily. • Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily. 2.1 Screening for HLA-B*5701 Allele prior to Starting ZIAGEN Screen for the HLA‑B*5701 allele prior to i...
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Precautions and contraindications for Ziagen
ZIAGEN is contraindicated in patients: • who have the HLA‑B*5701 allele . • with prior hypersensitivity reaction to abacavir . • with moderate or severe hepatic impairment . • Presence of HLA-B*5701 allele. • Prior hypersensitivity reaction to abacavir. • Moderate or severe hepatic impairment.
In case of overdosage
There is no known specific treatment for overdose with ZIAGEN. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.
Warnings and Cautions
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. 5.1 Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with ZIAGEN (abacavir). These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 week...
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Drug interactions
• Methadone: An increased methadone dose may be required in a small number of patients. • Riociguat: The riociguat dose may need to be reduced. 7.1 Methadone In a trial of 11 HIV‑1–infected subjects receiving methadone‑maintenance therapy with 600 mg of ZIAGEN twice daily (twice the currently recommended dose), oral methadone clearance increased . This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a ...
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Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZIAGEN during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Def...
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Notice: This medical information is provided to help you better understand this medical condition or process and may contain information about medication often used as part of a treatment plan prescribed by a doctor. It is not intended to be used as either a diagnosis or recommendation for treatment of your medical situation. If you are unwell, concerned about your physical or mental state, or are experiencing symptoms, you should speak with your doctor or primary health care provider. If you are in medical distress, please contact emergency services (such as 911).
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