Description

Lamivudine/Nevirapine/Zidovudine (150/200/300)mg

Indications and Usage

Lamivudine, Nevirapine, and Zidovudine Tablets is indicated alone as a complete regimen or in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg.

Additional important use regarding the use of nevirapine, a component of Lamivudine, Nevirapine, and Zidovudine Tablets, for the treatment of HIV-1 infection:

• Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Lamivudine, Nevirapine, and Zidovudine Tablets is not recommended to be initiated, unless the benefit outweighs the risk in:
• • adult females with CD4 + cell counts greater than 250 cells per mm 3 or
  • adult males with CD4 + cell counts greater than 400 cells per mm 3

Dosage Administration

Lead-in Period (First 14 days of dosing)

One lamivudine, nevirapine, and zidovudine fixed-dose tablet (containing 150 mg of lamivudine, 200 mg of nevirapine, and 300 mg of zidovudine) taken orally once daily followed by a daily oral dose of lamivudine 150 mg and zidovudine 300 mg 12 hours later.

Maintenance (After 14 days of dosing)

If the initial 14 days of dosing is tolerated without any incidence of rash, the recommended maintenance dose is one lamivudine, nevirapine, and zidovudine fixed-dose tablet (containing 150 mg of lamivudine, 200 mg of nevirapine, and 300 mg of zidovudine) taken orally twice daily.

Lamivudine, Nevirapine, and Zidovudine Tablets can be taken with or without food.

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