Each TEVETEN^® tablet contains eprosartan mesylate dihydrate, equivalent to 400 mg or 600 mg eprosartan free base.

 

Treatment of Essential Hypertension.

 

Known hypersensitivity to components of the product.

 

Patients whose renal function is dependent on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe cardiac insufficiency, bilateral renal artery stenosis, or renal artery stenosis of a solitary kidney) have developed oliguria and/or progressive, azotaemia and rarely acute renal failure during therapy with angiotensin converting enzyme (ACE) inhibitors. Since there is currently inadequate therapeutic experience in patients with severe cardiac insufficiency or renal artery stenosis, it cannot be ruled out that renal function may be impaired with Teveten¨ due to inhibition of the renin-angiotensin-aldosterone system.
When eprosartan is used in patients with renal impairment, renal function should be assessed before starting treatment with eprosartan and at intervals during the course of therapy. If worsening of renal function is observed during therapy, treatment with eprosartan should be reassessed. As safety and efficacy in children have not been established, treatment of children is not recommended.

 

There is little experience with the use of Teveten¨ during pregnancy. Drugs that act directly on the renin-angiotensin-aldosterone system can cause foetal and neonatal morbidity and death when administered to pregnant women during the second and third trimester. As with other drugs affecting the renin - angiotensin - aldosterone system, Teveten¨ should not be used in pregnancy, and if pregnancy is detected, Teveten¨ should be discontinued as soon as possible.
Lactation: Breast feeding women should not be treated with TEVETEN^®®

 

In placebo-controlled clinical trials, the overall incidence of adverse experiences reported with Teveten¨ was comparable to placebo. Adverse experiences have usually been mild and transient in nature and have only required discontinuation of therapy in 4.1% of patients treated with Teveten¨ (6.5% for placebo).
Facial swelling and / or angioedema have been very rarely reported.

 

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. No dose adjustment is required in the elderly, or in patients with hepatic impairment or renal insufficiency (creatinine clearance > 5 mL/min).

 

for PDF files, a free viewer is downloadable on the Adobe Systems' World Wide Website