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Antifungals & Antivirals

Adefovir STADA® 10 mg

 
Pack size:   
Box of 3 blisters x 10 tablets.

 
Composition:
Each tablet contains adefovir dipivoxil 10 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

Administered orally without regard to food for the treatment of chronic hepatitis B in adults with:

  • Compensated liver disease with evidence of activeviral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis.
  • Decompensated liver disease in combination with a second agent without cross-resistance to adefovir.
     
  • Adults: 
    Chronic hepatitis B patients with adequate renal function: 10 mg, once daily, taken orally.
  • Patients in renal impairment:
    The oral dose of adefovir dipivoxil should be reduced in patients with renal impairment. The dosing interval should be modified according to the creatinine clearance (CC) of the patient:
    CC 50 ml or more per minute: Usual 10 mg once daily dosage.
    CC 30 to 49 ml/minute: 10 mg every 48 hours.
    CC 10 to 29 ml/minute: 10 mg every 72 hours.
    Haemodialysis patients: 10 mg every 7 days after dialysis.
  • Patients with hepatic impairment:
    No dose adjustment is required.

Or as prescribed by physicians.

 

  • Known hypersensitivity to adefovir or any ingredient in the formulation.
     



 

Very common

  • Increases in creatinine.
  • Asthenia.

Common

  • Headache.
  • Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence.
  • Rash, pruritus.
  • Renal failure, abnormal renal function, hypophosphatemia.

Not known

  • Gastrointestinal: Pancreatitis.

     

  • Adefovir should be withdraw if there is a rapid increase in aminotransferase concentrations, progressive hepatomegaly or steatosis, or metabolic or lactic acidosis of unknown aetiology.
  • Adefovir should be given with caution to patients with hepatomegaly or other risk factors for liver disease.
  • Patients whose liver enzyme values increase due to response to treatment must be distinguished from those in whom these indicate toxicity.
  • Exacerbations of hepatitis has been reported in patients who developed resistance to adefovir and in those who stopped adefovir; patients who stop treament should be monitored closely for an appropriate period. In order to minimise the risk of resistance in patients with lamivudine-resistant hepatitis B, adefovir should be used with lamivudine and not as monotherapy.
  • Patients taking adefovir with normal renal function should be monitored every 3 months for signs of deteriorating renal function; patients at risk of renal impairment should be monitored more frequently and particular care should be exercised in patients with a creatinine clearance of less than 50 ml/minute, who may require dosage modification, and in those receiving other drugs that may affect renal function.
  • Use of adefovir to treat chronic hepatitis B infection in patients with undiagnosed or untreated HIV infection may result in the emergence of resistant strains of HIV. All patients be tested for HIV antibodies before starting treatment with adefovir.
  • Children and adolescents: The safety and efficacy of adefovir in patients under the age of 18 years have not been established. Adefovir should not be administered to children or adolescents.
  • Elderly: No data are available to support a dose recommendation for patients over the age of 65 years.
     
  • Pregnancy: There are no studies in pregnant women and no data on the effect of adefovir on transmission of HBV from mother to infant. Therefore, appropriate infant immunizations should be used to prevent neonatal acquisition of hepatitis B virus.
  • Lactation: It is not known whether adefovir is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking adefovir.
     
  • No studies on the effects on the ability to drive and use machines have been performed. This drug can cause headache (common), so caution should be taken in patients who intend to drive.

     

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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