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Lamivudin 100 ICA (Lamivudine 100 mg)

Each film-coated tablet contains lamivudine 100 mg and excipients q.s. (microcrystalline cellulose, pregelatinized starch, L-HPC, magnesium stearate, film coating excipient).

Dosage form
Film-coated tablets.

Box of 2 blisters x 20 tablets

Lamivudin 100 ICA is indicated for patients from 16 years of age with chronic viral hepatitis B associated with evidence of hepatitis B viral replication (HBV) and active liver inflammation, with one or more of the following conditions:
- elevated serum alanine aminotransferase (ALT) more than or equal to 2 times of normal level.
- liver cirrhosis.
- decompensated liver disease.
- biopsy-proven necro-inflammatory liver disease.
- immunocompromised state.
- liver transplant.

Hypersensitivity to lamivudine.
severely renal impairment.

Dosage and Administration
- Patients from 16 years of age:
Recommended dose: 100 mg once daily.
- Renal impairment patients with creatinine clearance less than 50 mL/ min: reduction of the dosage is recommended.
Lamivudine can be taken with or without food.
Optimal duration of lamivudine therapy has not been established, so this drug should be use under doctor’s instruction.

Treatment discontinuance may be considered in the following situation:
- immunocompetent patients when HBeAg and/or HBsAg seroconversion confirmed.
- female patients become pregnant during therapy.
- patients show signs of intolerance to lamivudine on treatment.
- treatment failed with lamivudine (based on doctor’s examination) e.g. when persistent return of serum ALT to pre-treatment value occurs or when the patient experiences deterioration in liver histology.
Patient compliance should be monitored during lamivudine therapy.
If lamivudine is discontinued, patients should be periodically monitored for evidence of relapsed hepatitis.

Dose adjustment:
- Renal impairment: it is recommended that doses of lamivudine be adjusted in accordance with renal function as followed:

Creatinine clearance(mL/min)  Recommended dosage
More than or equal to 50
39 to 40
15 to 29
5 to 14
Under 5
100 mg once daily
100 mg initial dose, then 50 mg once daily
100 mg initial dose, then 25 mg once daily
35 mg initial dose, then 15 mg once daily
35 mg initial dose, then 10 mg once daily

- Hepatic impairment: Pharmacokinetic parameters of lamivudine are not significantly affected in case of hepatic dysfunction. Therefore, dose adjustment is not necessary unless accompanied by renal impairment.

Patients should be monitored regularly during treatment by a physician experienced in treatment of chronic hepatitis B.

After the treatment of lamivudine is discontinued, some patients may experience clinical or laboratory evidence of relapsed hepatitis, which may have more severe consequences in patients with decompensated liver disease. Patients should be periodically monitored both clinically and by assessment of serum liver function test (for ALT and bilirubin levels) for at least 4 months for evidence of relapsed hepatitis. The doses of 150 mg of lamivudine, twice daily should be maintained for the treatment of patients who are co-infected with HIV and are currently receiving or plan to receive treatment with lamivudine alone or lamivudine and zidovudine concomitantly.

Data on maternal-foetal transmission of hepatitis B virus in pregnant women receiving treatment with lamivudine has not been established. The standard recommended procedures for hepatitis B virus immunization in infants should be followed.

Patients should be advised that therapy with lamivudine has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore, appropriate precautions should still be taken.

Safety and efficacy of lamivudine have not been established in pediatric patients under 2 years of age, patients dually infected with HBV and HCV, HIV or delta hepatitis.

Special warnings
Lactic acidosis/ severe hepatomegaly with steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. A majority of these cases occurred in women. Obesity and prolonged nucleoside exposure may be risk factors. Most of these reports have described patients receiving nucleoside analogues for HIV infection, but some others reported lactic acidosis occurred in patients receiving lamivudine for treatment of hepatitis B.

Particular caution should be exercised when lamivudine is administered to any patients with known risk factors of liver disease; however, care should also be taken to patients without risk factors. Discontinuance of treatment with lamivudine should be required in patients who develop clinical or laboratory finding suggestive of lactic acidosis or pronounced hepatotoxicity (which may induce hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Important differences between lamivudine-containing products, HIV testing, and risk of emergence of resistant HIV: The formulation and dosage of lamivudine in Lanivudin 100 ICA film-coated tablet are not appropriate for patients dually infected with HBV and HIV. If lamivudine is indicated to these patients, a higher dose for HIV treatment should be administered as a part of an appropriate combination regimen, in addition, patients should also be informed about the drug information. Counseling and HIV testing should be offered to all patients before beginning and during lamivudine treatment. It is because the risk of rapid emergence of resistant HIV and the limitation of treatment options when lamivudine is prescribed to treat chronic hepatitis B in patient who has unrecognized or untreated HIV infection or acquired HIV infection during treatment.

- Post-treatment exacerbations of hepatitis: Clinical and laboratory evidences of exacerbations of hepatitis have occurred after discontinuance of lamivudine (these have been primarily detected by serum ALT elevations, in addition to the re-emergence of HBV DNA commonly observed after stopping treatment). Although most events appear to have been self-limited, fatalities have been reported in some cases. The causal relationship between the discontinuance of lamivudine and the post-treatment exacerbations of hepatitis is unknown. Patients should be strictly monitored with both clinical and laboratory follow-up for several months after the treatment ended. There is insufficient evidence to determine whether re-initiation of therapy alters the course of post-treatment exacerbations of hepatitis.

- Pancreatitis
 Pancreatitis has been reported in patients receiving lamivudine, particularly in HIV-infected pediatric patients previously exposed with nucleoside.

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