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Uses
Lamivudine and Zidovudine tablets USP, a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.
History
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Other Information
Lamivudine and Zidovudine: Lamivudine and Zidovudine tablets USP are combination tablets containing lamivudine and zidovudine. 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, 300 mg of zidovudine, and the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-l-(2-hydroxymethyl-l,3-oxathiolan-5-yl)-(lH)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula:
Lamivudine USP is a white to off-white solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine: The chemical name of zidovudine is 3’-azido-3’-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24. It has the following structural formula:
Zidovudine USP is a white to light yellowish powder with a solubility of 20.1 mg/mL in water at 25°C.
Meets USP Dissolution Test 2.
Sources
Smart Sense Adults Tussin Cf Multi Symptom Cold Manufacturers
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Kmart Corporation
Smart Sense Adults Tussin Cf Multi Symptom Cold | American Health Packaging
2.1 Adults and Adolescents Weighing ≥30 kgThe recommended oral dose of lamivudine and zidovudine tablets in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily.
2.2 Pediatric PatientsThe recommended oral dosage of scored lamivudine and zidovudine tablets 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 twice daily.
2.3 Patients Requiring Dosage Adjustment
Before prescribing lamivudine and zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a lamivudine and zidovudine tablet, the liquid oral formulations should be prescribed: EPIVIR® (lamivudine) oral solution and RETROVIR® (zidovudine) syrup.Because lamivudine and zidovudine is a fixed-dose combination tablet, it should not be prescribed for pediatric patients weighing less than 30 kg or patients requiring dosage adjustment, such as those with reduced renal function (creatinine clearance less than 50 mL/min), patients with hepatic impairment, or patients experiencing dose-limiting adverse reactions. Liquid and solid oral formulations of the individual components of lamivudine and zidovudine are available for these populations.
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