Drug Catalog - Product Detail
LAMIVUDINE FCT TB 300MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0603-06 | LUPIN PHARMACEUTICALS | 30 | 300MG | TABLET |
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Description
11 DESCRIPTION Lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-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 229.26 g per mol. It has the following structural formula: Lamivudine is a white to off-white solid that is soluble in water. Lamivudine tablets USP are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients crospovidone, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. image-01
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Lamivudine Scored Tablets USP, 150 mg White to off white scored capsule shaped, film coated tablets, debossed on both tablet faces, such that, when broken in half "L" and "5" code is present on both halves of the tablet ("L" on one side and "5" on the opposite face of the tablet). Bottle of 60 tablets (NDC 68180-602-07) with child-resistant closure. Bottle of 100 tablets (NDC 68180-602-01) with child-resistant closure. Lamivudine Tablets USP, 300 mg Gray coloured capsule shaped, film coated tablets, debossed with "L" on one side and "6" on the other side. Bottle of 30 tablets (NDC 68180-603-06) with child-resistant closure. Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Lamivudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV. ( 1 ) Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1(HIV-1) infection. Limitations of Use The dosage of this product is for HIV-1 and not for HBV.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. ( 2.1 ) Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 300 mg daily. ( 2.2 ) Patients with Renal Impairment: Doses of lamivudine must be adjusted in accordance with renal function. ( 2.3 ) 2.1 Recommended Dosage for Adult Patients The recommended dosage of lamivudine tablets in HIV-1-infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food . 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 ( 5.1 )] . 2.2 Recommended Dosage for Pediatric Patients Lamivudine scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing lamivudine scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to safely and reliably swallow lamivudine tablets, the oral solution formulation may be prescribed [see WARNINGS AND PRECAUTIONS ( 5.6 )] . 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 Scored (150-mg) in Pediatric Patients a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies ( 14.2 )] . b Patients may alternatively take one 300-mg tablet, which is not scored. Weight (kg) Once-Daily Dosing Regimen a Twice-Daily Dosing Regimen Using Scored 150-mg Tablet AM Dose PM Dose Total Daily Dose 14 to <20 1 tablet (150 mg) ½ tablet (75 mg) ½ tablet (75 mg) 150 mg > 20 to <25 1½ tablets (225 mg) ½ tablet (75 mg) 1 tablet (150 mg) 225 mg > 25 2 tablets (300 mg) b 1 tablet (150 mg) 1 tablet (150 mg) 300 mg 2.3 Patients with Renal Impairment Dosing of lamivudine tablets are 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 in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance Creatinine Clearance ( mL / min ) Recommended Dosage of Lamivudine ≥50 150 mg twice daily or 300 mg once daily 30 to 49 150 mg once daily 15 to 29 150 mg first dose, then 100 mg once daily 5 to 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 is required after routine (4-hour) hemodialysis or peritoneal dialysis. Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.