Composition: Eprosartan mesylate equivalent to 300mg, 400mg, 600mg eprosartan free base.
Presentation: Oval, film-coated tablets, 300mg white, 400mg, pink; capsule-shaped, film-coated tablet, 600mg white.
Storage and stability: Do not store above 25C.
Action: Selective angiotensin II receptor (type AT1) antagonist.
Indications: Treatment of essential hypertension.
Contraindications: Known hypersensitivity to components; pregnancy; severe hepatic impairment.
Dosage and administration: Recommended dose 600mg once daily. May be increased to 800mg once daily if further response is required. Achievement of maximal blood pressure reduction in most patients may take two to three weeks. Eprosartan may be used alone or in combination with other antihypertensives (eg, thiazide-type diuretics, calcium channel blockers) if a greater blood pressure lowering effect is required. Eprosartan should be taken with food.
Elderly >75 years, clinical experience is limited. A starting dose of 300mg once daily is recommended.
Mild to moderate hepatic impairment, starting dose of 300mg once daily recommended.
Renal impairment, no dosage adjustment required in patients with a creatinine clearance 60-80ml/min. In patients with a creatinine clearance <60ml/min, 300mg once daily is recommended.
Children, treatment not recommended as safety and efficacy have not been established.
Overdosage: Limited data are available. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, supportive treatment should be instituted.
Precautions: As clinical experience limited, caution is recommended in patients with a creatinine clearance <60ml/min and in those undergoing dialysis. As with other angiotensin II antagonists, pretreatment and periodic monitoring of serum potassium and creatinine levels is recommended in patients with impaired renal function. There is no experience of concomitant administration with potassium sparing diuretics or potassium supplements; regular monitoring of serum potassium levels is recommended when drugs that may increase potassium are given with eprosartan in patients with renal impairment.
Sodium and/or volume depletion should be corrected before commencing therapy, or existing diuretic therapy should be reduced.
During treatment of hypertension, occassional dizziness or weariness may occur so care should be taken when driving or operating machines.
Drug interactions: No clinically significant drug interactions have been observed.
Side effects: In placebo-controlled studies of patients taking 600-800mg once daily, adverse experiences (incidence of 1 per cent or higher) included: dizziness, arthralgia, rhinitis, flatulence, hypertriglyceridemia. Angioedema has been infrequently reported. Elevated serum potassium concentrations and significantly low values of haemoglobin have been noted in 0.9 per cent and 0.1 per cent of patients respectively.
Net price: 28 tablets 300mg £12.50, 600mg £14.75; 56 tablets 400mg £16.96.
Supplier: Solvay Healthcare Ltd, Mansbridge Road, Westend, Southampton, SO18 3JD. Tel 02380 467000, fax 02380 465350.
Legal class: POM.