Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Posology and method of administration** The recommended dose is 600 mg once daily, to be taken in the morning. The dose may be increased to a maximum of 800 mg daily, depending on the blood pressure response, until satisfactory response is achieved. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment. Doses up to 1200 mg per day, for 8 weeks, have been shown in clinical trials to be effective with no apparent dose relationship in the incidence of adverse experiences reported. Teveten™ may be used alone or in combination with other antihypertensives, e.g. thiazide-type diuretics or calcium channel blockers, if a greater blood pressure lowering effect is required. Teveten™ may be taken with or without food. Elderly (> 75 years): As clinical experience is limited in patients over 75 years, a starting dose of 300 mg once daily is recommended. Dosage in hepatically impaired patients: There is limited experience in patients with hepatic impairment (see section Contra-indications and section Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients with mild to moderate hepatic impairment, a starting dose of 300 mg once daily is recommended. Dosage in renally impaired patients: No dose adjustment is required in patients with creatinine clearance 60–80 ml/min. As clinical experience is limited in patients with creatinine clearance <60ml/min, a starting dose of 300mg once daily is recommended (see Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
ORAL
Medical Information
**Indication** Treatment of essential hypertension.
**Contra-indications** Known hypersensitivity to components of the product. Pregnancy and lactation. Severe hepatic impairment. The concomitant use of Teveten™ with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) (see Interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
C09CA02
eprosartan
Manufacturer Information
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
SOLVAY PHARMACEUTICALS B V
SOLVAY PHARMACEUTICALS GMBH
Active Ingredients
Documents
Package Inserts
Teveten Tablet 600mg PI.pdf
Approved: May 21, 2015