Drug Catalog - Product Detail
LAMIVUDINE FCT TB 300MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65862-0553-30 | AUROBINDO PHARMA | 30 | 300MG | TABLET |
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Description
Description Section Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-l-(2-hydroxymethyl-l,3-oxathiolan-5-yl)-(1H)-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 C 8 H 11 N 3 O 3 S and a molecular weight of 229.3. It has the following structural formula: Lamivudine is a white to off-white solid with a solubility of approximately 70 mg/mL in water at 20°C. Lamivudine tablets are for oral administration. Each scored 150 mg film-coated tablet and 300 mg film-coated tablet contains 150 mg and 300 mg of lamivudine and the following inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. MM1
How Supplied
How Supplied Section Lamivudine Scored Tablets, 150 mg are white to off-white, film-coated, oval shaped tablets, debossed with ‘66’ and ‘Y’ on either side of the score line on one side and plain with a score line on the other side. Bottle of 60 Tablets NDC 65862-552-60 Carton of 60 (6 x 10) Unit-dose Tablets NDC 65862-552-10 Lamivudine Tablets, 300 mg are white to off-white, film-coated, oval shaped tablets, debossed with ‘67 Y’ on one side and plain on the other side. Bottle of 30 Tablets NDC 65862-553-30 Carton of 30 (3 x 10) Unit-dose Tablets NDC 65862-553-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Indications & Usage
Indications & Usage Section Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.
Dosage and Administration
Dosage & Administration Section Adults and adolescents >16 years of age: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. (2.1) Pediatric patients 3 months up to 16 years of age: Dosage should be based on body weight. (2.2) Patients With Renal Impairment: Doses of lamivudine tablets must be adjusted in accordance with renal function. (2.3) The recommended oral dose of lamivudine tablets in HIV-1-infected adults and adolescents >16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2) ]. Lamivudine tablets are available as scored tablets for HIV-1-infected pediatric patients who weigh ≥14 kg for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1. Table 1. Dosing Recommendations for Lamivudine Tablets in Pediatric Patients Weight (kg) Dosage Regimen Using Scored 150 mg Tablet Total Daily Dose AM Dose PM Dose 14 to 21 ½ tablet (75 mg) ½ tablet (75 mg) 150 mg > 21 to <30 ½ tablet (75 mg) 1 tablet (150 mg) 225 mg ≥30 1 tablet (150 mg) 1 tablet (150 mg) 300 mg Dosing of lamivudine tablets is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3) ] . Table 2. Adjustment of Dosage of Lamivudine Tablets in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine Tablets ≥50 150 mg twice daily or 300 mg once daily 30-49 150 mg once daily 15-29 150 mg first dose, then 100 mg once daily 5-14 150 mg first dose, then 50 mg once daily <5 50 mg first dose, then 25 mg once daily No additional dosing of lamivudine tablets is required after routine (4-hour) hemodialysis or peritoneal dialysis. Although there are insufficient data to recommend a specific dose adjustment of lamivudine tablets in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.