Drug Catalog - Product Detail
LAMIVUDINE/ZIDOVUDINE, USP TB 150/300MG 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64380-0707-03 | STRIDES PHARMA | 60 | 150-300MG | NA |
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Description
11 DESCRIPTION Lamivudine and zidovudine tablets, USP are combination tablets containing lamivudine, USP and zidovudine, USP. Lamivudine (EPIVIR) and zidovudine (RETROVIR, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and zidovudine tablets, USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, USP 300 mg of zidovudine, USP and the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, povidone, and opadry white. Opadry white contains hypromellose, titanium dioxide and polyethylene glycol 400 (macrogol). Lamivudine, USP: The chemical name of lamivudine, USP is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine, USP is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine, USP has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C 8 H 11 N 3 O 3 S and a molecular weight of 229.3 g per mol. It has the following structural formula: Lamivudine, USP is a white to off-white crystalline and is soluble in water. Zidovudine, USP: The chemical name of zidovudine, USP is 3′-azido-3′-deoxythymidine. It has a molecular formula of C 10 H 13 N 5 O 4 and a molecular weight of 267.24 g per mol. It has the following structural formula: Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg per mL in water at 25°C. Lamivudine Structure Zidovudine Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Lamivudine and zidovudine tablets, USP [150/300 mg], containing 150 mg lamivudine and 300 mg zidovudine, are white to off-white colored, oval, film coated tablets with "LZ" engraved on one side and breakline on other side. They are available as follows: 60 Tablets/Bottle (NDC 64380-707-03) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Lamivudine and Zidovudine tablets, USP a combination of 2 nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV - 1 infection. ( 1 ) Lamivudine and zidovudine tablets, USP a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Adults and Adolescents weighing greater than or equal to 30 kg: 1 tablet orally twice daily. (2.1) • Pediatrics weighing greater than or equal to 30 kg: 1 tablet orally twice daily. (2.2) • Because Lamivudine and zidovudine tablets, USP is a fixed-dose tablet and cannot be dose adjusted, lamivudine and zidovudine tablets are not recommended in patients requiring dosage adjustment or with hepatic impairment or experiencing dose-limiting adverse reactions. (2.3, 4) 2.1 Recommended Dosage for Adults and Adolescents The recommended oral dose of lamivudine and zidovudine tablets, USP in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine, USP and 300 mg of zidovudine, USP) taken orally twice daily. 2.2 Recommended Dosage for Pediatric Patients The recommended oral dosage of scored lamivudine and zidovudine tablets, USP for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered orally twice daily. Before prescribing lamivudine and zidovudine tablets, USP, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a lamivudine and zidovudine tablet, USP, the liquid oral formulations should be prescribed: EPIVIR (lamivudine) oral solution and RETROVIR (zidovudine) syrup. 2.3 Not Recommended Due to Lack of Dosage Adjustment Because lamivudine and zidovudine tablets, USP is a fixed-dose tablet and cannot be dose adjusted, lamivudine and zidovudine tablets, USP are not recommended for: • pediatric patients weighing less than 30 kg [see Use in Specific Populations (8.4)]. • patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations (8.6)]. • patients with hepatic impairment [see Use in Specific Populations (8.7)]. • patients experiencing dose-limiting adverse reactions. Liquid and solid oral formulations of the individual components of lamivudine and zidovudine tablets, USP are available for these populations.