Lamivudine And Zidovudine Recall
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
There is currently no legal information available for this drug.
FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
There is currently no drug history available for this drug.
Lamivudine and zidovudine tablets, USP: Lamivudine and zidovudine tablets, USP are combination tablets containing lamivudine, USP and zidovudine, USP. Lamivudine, USP (3TC) and zidovudine, USP (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 C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula:
Lamivudine, USP is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C.
Zidovudine, USP: The chemical name of zidovudine, USP 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 is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25°C.
The drug product meets the USP Dissolution Test 1.
Lamivudine And Zidovudine Manufacturers
Strides Arcolab Limited
Exelan Pharmaceuticals Inc.
Pd-rx Pharmaceuticals, Inc.
Rebel Distributors Corp
Aurobindo Pharma Limited
H.j. Harkins Company, Inc.
St Marys Medical Park Pharmacy
Teva Pharmaceuticals Usa Inc
Camber Pharmaceuticals, Inc.
American Health Packaging
Unit Dose Services
Bryant Ranch Prepack
Lupin Pharmaceuticals, Inc.
Mylan Pharmaceuticals Inc.
Camber Pharmaceuticals, Inc.
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