Rx Item-Ziagen 300Mg Tab 60 By Viiv Healthcare

Item info. These highlights do not include all the info. needed to use ZIAGEN safely and effectively. See full prescribing info. for ZIAGEN. ZIAGEN (abacavir) tablets, for oral use ZIAGEN (abacavir) oral solution Init ial U.S. Approval: 1998 WARNING: HYPERSENSITIVITY REACTIONS, and LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY See full prescribing info. for complete boxed warning. Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with ZIAGEN (abacavir). Hypersensitivity to ZIAGEN is multi- organ clinical syndrome. Patients who carry the HLA -B*5701 allele are at high er risk of experiencing hypersensitivity reaction to abacavir. ZIAGEN is contraindicated in patients with prior hypersensitivity reaction to abacavir and in HLA -B*5701 -positive patients. Discontinue ZIAGEN as soon as hypersensitivity reaction is suspected. Regardless of HLA -B*5701 status, permanently discontinue ZIAGEN if hypersensitiv ity cannot be ruled out, even when other diagnoses are possible. Following hypersensitivity reaction to ZIAGEN NEVER restart ZIAGEN or any other abacavir -containing product. Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acido sis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. -- RECENT MAJOR CHANGES -- Boxed Warning 09/2015 Indications and USAge 09/2015 Dosage and Administration, Screening for HLA B*5701 Allele rior to Starting ZIAGEN 09/2015 Dosage and Administration, Recommended Dosage for Pediatric Patients (2. ) 03/2015 Contraindications 09/2015 Warnings and Precautions, Hypersensitiv ty Reaction 09/2015 Warnings and Prec autions, Related Products that are Not Recommended 03/2015 -INDICATIONS AND USAGE - ZIAGEN, nucleoside analogue human immunodeficiency virus (HIV -1) reverse transcriptase inhibitor is indicated in combination with other antiretroviral agents for he treatment of HIV -1 infection. DOSAGE AND ADMINISTRATION ? Before initiating ZIAGEN, screen for the HLA -B*5701 allele 1) Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. (2. 2) Pediatric Patients Aged Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 00 mg daily. (2. 3) Patients with Hepatic Impairment: Mild hepatic impairment 200 mg twice daily. (2. 4) DOSAGE FORMS AND STRENGTHS ? Tablets: 300 mg scored Oral Solution: 20 mg per mL CONTRAINDICATIONS ? Presence of HLA -B*5701 allele.

RX ITEM-Ziagen 300Mg Tab 60 By Viiv Heal
NDC 49702-0221-18 UPC/GTIN No.3-49702-22118-5 Mfg.Part No.22118

Ziagen 300Mg Tab 60 By Viiv Healthcare
BRAND: ZIAGEN NDC: 49702-0221-18,49702022118 UPC: 3-49702-22118-5,349702221185

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