Lamivudine

LAMIVUDINE- lamivudine tablet, film coated
Lupin Pharmaceuticals, Inc.

WARNING: EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE

Exacerbations of Hepatitis B

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see WARNINGS AND PRECAUTIONS (5.1)].

Important Differences among Lamivudine-Containing Products

Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV® tablets (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 [see WARNINGS AND PRECAUTIONS (5.1)].

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

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 Regimena 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.

3 DOSAGE FORMS AND STRENGTHS

  • Lamivudine Scored Tablets USP
  • 150 mg, are 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).
  • Lamivudine Tablets USP
  • 300 mg, are gray colored capsule shaped, film coated tablets, debossed with “L” on one side and “6″ on the other side.

4 CONTRAINDICATIONS

Lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

5 WARNINGS AND PRECAUTIONS

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