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Antifungals & Antivirals

Tefostad T300

Pack szie:    

Box of 30 tablets. Bottle of 30 tablets.

 

Composition:

Each film-coated tablet contains tenofovir disoproxil fumarate 300 mg.

 

Shelf-life:

36 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

Use in conjunction with other antiretroviral agents (should not be used alone) in the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.

Post-exposure prophylaxis of HIV infection (occupational exposure or nonoccupational exposure) in individuals associated with a risk for transmission of the virus.

Treatment of chronic hepatitis B in adults.

Adults

  • Treatment of HIV infection: 1 tablet once daily, in conjunction with other antiretrovirals.
  • Post-exposure prophylaxis following occupational exposure to HIV (preferably within hours rather than days and continued for 4 weeks, if tolerated): 1 tablet once daily in conjunction with other antiretrovirals (usually in conjunction with lamivudine or emtricitabine).
  • Post-exposure prophylaxis following nonoccupational exposure to HIV (preferably within 72 hours and continued for 28 days): 1 tablet once daily in conjunction with at least 2 other antiretrovirals.
  • Treatment of chronic hepatitis B: The recommended dosage is 1 tablet once daily past 48 weeks.

Hepatic impairment patients: dosage adjustment is not required.

Renal impairment patients

Doses of tenofovir disoproxil fumarate should be modified by adjustment of the dosing interval in patients with renal impairment according to their creatinine clearance (Clcr):

+ Clcr ≥ 50 mL/min: Usual once-daily dosage.

+ Clcr 30 to 49 mL/minute: Every 48 hours.

+ Clcr 10 to 29 mL/minute: Every 72 to 96 hours.

   + Haemodialysis patients: A dose every 7 days or after a cumulative total of 12 hours of dialysis.

Tefostad T300 is administered orally once daily without regard to meals.

Known hypersensitivity to tenofovir disoproxil fumarate or any ingredient in the formulation.

Mild gastrointestinal effects, particularly diarrhoea, nausea and vomiting, abdominal pain, flatulence, dyspepsia, and anorexia. Serum-amylase concentrations may be raised and pancreatitis has been reported. Hypophosphataemia. Skin rashes. Peripheral neuropathy, headache, dizziness, insomnia, depression, asthenia, sweating, and myalgia. Raised liver enzymes, hypertriglyceridaemia, hyperglycaemia, and neutropenia. Renal impairment, (including Fanconi syndrome). Lactic acidosis, severe hepatomegaly and steatosis.

  • Adipogenic effects and bone effects has been reported with antiretroviral therapy.
  • Discontinue using when hepatomegaly, raised quickly aminotransferase, lactic acidosis. Hepatic function should be closely monitored follow up for at least several months after tenofovir is discontinued.
  • Tenofovir disoproxil fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. The use of tenofovir disoproxil fumarate in women of childbearing potential must be accompanied by the use of effective contraception. It is recommended that mothers being treated with tenofovir disoproxil fumarate do not breast-feed their infants. As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.
  • Patients should be aware of how they react to drug before driving or operating machinery.

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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