LAMIVUDINE
LAMIVUDINE- lamivudine tablet
Cipla USA Inc.
WARNING: EXACERBATIONS OF HEPATITIS B and DIFFERENT FORMULATIONS OF LAMIVUDINE
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 is 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 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.
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 is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology (12.3)].
Creatinine Clearance (mL/min) | Recommended Dosage of Lamivudine |
≥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 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.
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