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Product
Antiretroviral products (Lamivir HBV )
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Antiretroviral products (Lamivir HBV )
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Lamivir HBV
Lamivudine Tablets
COMPOSITION
Each Tablet Contains
Lamivudine… 100mg
INDICATIONS
LAMIVIR- HBV is indicated for the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.
DOSAGE AND ADMINISTRATION
Adults: The recommended oral dose of LAMIVIR- HBV for treatment of chronic hepatitis B in adults is 100 mg once daily. Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known. |
The formulation and dosage of lamivudine in LAMIVIR- HBV are not appropriate for patients dually infected with HBV and HIV. If lamivudine is administered to such patients, the higher dosage indicated for HIV therapy should be used as part of an appropriate combination regimen, and the prescribing information for LAMIVIR as well as LAMIVIR-HBV should be consulted.
Dose Adjustment: It is recommended that doses of LAMIVIR- HBV be adjusted in accordance with renal function (Table 3) (see PHARMACOLOGY , Special populations).
Table 3. Adjustment of Adult Dosage of LAMIVIR-HBV in Accordance With Creatinine Clearance
| Creatinine Clearance
(mL/min)
|
Recommended Dosage
of LAMIVIR-HBV |
| ≥50 |
100 mg once daily
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| 30-49 |
100 mg first dose, then 50 mg once daily |
| 15-29 |
100 mg first dose, then 25 mg once daily |
| 5-14 |
35 mg first dose, then 15 mg once daily |
| <5 |
35 mg first dose, then 10 mg once daily |
No additional dosing of LAMIVIR- HBV is required after routine (4-hour) hemodialysis or peritoneal dialysis.
CONTRAINDICATIONS
LAMIVIR- HBV Tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the products.
PACKAGING INFORMATION
Lamivir -HBV: Blister pack of 10 tablets
Container of 30 tablets
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