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Antifungals & Antivirals

Lamivudin STADA® 100 mg


Pack size:

Box of 3 blisters x 10 film-coated tablets

 

Composition:

Each film-coated tablet contains lamivudine 100 mg.

 

Shelf-life:  

36 months from the date of the manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

For the treatment of chronic hepatitis B with:

  • Compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis.
  • Decompensated liver disease.

Orally taken without regard to meals.

  • For chronic hepatitis B:
    The adult dose is 100 mg once daily by mouth. A dose for children aged over 2 years is 3 mg/kg once daily to a maximum daily dose of 100 mg.
  • Patients with concomitant HIV and hepatitis B infection:
    The dosage regimen appropriate for HIV should be used.
  • Administration in renal impairment:
    Dosage of lamivudine should be reduced in patients with moderate to severe renal impairment (creatinine clearance (CC) below 50 ml/minute).
    Adults with chronic hepatitis B infection:
    CC 30 to 49 ml/minute: 100 mg for the first dose then 50 mg once daily.
    CC 15 to 29 ml/minute: 100 mg for the first dose then 25 mg once daily.
    CC 5 to 14 ml/minute: 35 mg for the first dose then 15 mg once daily.
    CC less than 5 ml/minute: 35 mg for the first dose then 10 mg once daily.
    Haemodialysis patients:
    No further dose adjustment other than in accordance with creatinine clearance is required.
    Peritoneal dialysis patients:
    Not recommended.
    Children:
    Doses should be reduced according to creatinine clearance by the same proportions as in adults.


Or as prescribed by physicians.

 

  • Hypersensitivity to any ingredient of the drug.

 

  • Adverse effects commonly associated with lamivudine include abdominal pain, nausea, vomiting, diarrhoea, headache, fever, rash, alopecia, malaise, insomnia, cough, nasal symptoms, arthralgia, and musculoskeletal pain. Patients taking lamivudine for the treatment of chronic hepatitis B commonly also have increased serum levels of creatinine phosphokinase and alanine aminotransferase.
  • There have been rare instances of rhabdomyolysis. Pancreatitis has been reported rarely. Neutropenia and anaemia (usually when given with zidovudine), thrombocytopenia, and increases in liver enzymes and rare cases of hepatitis have occurred. Lactic acidosis, usually associated with severe hepatomegaly and steatosis, has been reported during treatment with nucleoside reverse transcriptase inhibitors.

     

  • Lamivudine therapy should be stopped in patients who develop abdominal pain, nausea, or vomiting or with abnormal biochemical test results until pancreatitis has been excluded.
  • Treatment with lamivudine may be associated with lactic acidosis and should be discontinued if there is a rapid increase in aminotransferase concentrations, progressive hepatomegaly, or metabolic or lactic acidosis of unknown aetiology. Lamivudine should be used with caution in patients with hepatomegaly or other risk factors for hepatic disease. In patients with chronic hepatitis B, there is a risk of rebound hepatitis when lamivudine is discontinued, and liver function should be monitored in such patients. The possibility of HIV infection should be excluded before beginning lamivudine therapy for hepatitis B, since the lower doses used to treat the latter may permit the development of lamivudine resistant strains of HIV.
  • Dosage reduction may be necessary in patients with impaired renal function.
  • Pregnancy: There are no adequate and controlled studies to date using lamivudine in pregnant women, and the drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.
  • Lactation: Lamivudine is distributed into milk in humans. Because of the potential for serious adverse effects of lamivudine in nursing infants, lactating women receiving lamivudine for the treatment of chronic HBV infection should not breastfeed infants.
  • Effect on ability to drive and use machines: None known.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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