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Antifungals & Antivirals

Entecavir STADA® 0.5 mg

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains entecavir 0.5 mg.

(As entecavir monohydrate 0.532 mg).

 

Shelf-life:  

24 months from the date of manufacturing.

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

 

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

  • Treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated liver enzyme values, and histologically active disease, including those resistant to lamivudine.
     
  • Entecavir STADA® 0.5 mg should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
     
  • For chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age and older:
    0.5 mg once daily.
  • In adults and adolescents (≥ 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations:
    1 mg once daily.
  • Patients with renal impairment:

    * Hemodialysis (administer after hemodialysis) or continuous ambulatory peritoneal dialysis (CAPD).
  • Hepatic impairment:
    No dosage adjustment is necessary for patients with hepatic impairment.


Or as prescribed by physicians.

 

  • Patients with previously demonstrated hypersensitivity to entecavir or to any ingredient of the product.

     

  • The most common adverse effects of entecavir have been headache, fatigue, dizziness, and nausea. Other adverse effects include diarrhoea,  dyspepsia, insomnia, somnolence, and vomiting. Raised liver enzyme concentrations  may occur and exacerbation of hepatitis has been reported  after stopping  treatment with entecavir. Lactic acidosis, usually associated  with severe  hepatomegaly and steatosis, has been associated with treatment with nucleoside analogues alone or with antiretrovirals.


 

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal  cases, have been reported with the use of nucleoside analogues alone or in  combination with antiretrovirals.
  • Severe acute exacerbations of hepatitis B have been reported in patients  who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic  function should be monitored closely with both clinical and laboratory follow- up for at least several months in patients who discontinue anti-hepatitis B  therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
  • Dosage adjustment of entecavir is recommended for patients with a  creatinine clearance < 50 ml/min, including patients on hemodialysis or  CAPD.
  • The safety and efficacy of entecavir in liver transplant recipients are unknown.
  • If entecavir treatment is determined to be necessary for a liver  transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with  entecavir.
  • Pregnancy: There are no adequate and well-controlled studies in pregnant  women. Because animal reproduction studies are not always predictive of  human response, entecavir should be used during pregnancy only if clearly  needed and after careful consideration of the risks and benefits.
  • Labor and delivery: There are no studies in pregnant women and no data on  the effect of entecavir on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal  acquisition of  HBV.
  • Lactation: It is not known whether this drug is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking entecavir.
  • Effect on ability to drive and use machines: Unknown.

     

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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