Olmetec Tablet 40mg

INDICATIONS AND USAGE

Olmesartan medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

CONTRAINDICATIONS

Olmesartan medoxomil is contraindicated in patients who are hypersensitive to any component of the tablet.

Patients who become pregnant should discontinue the use of olmesartan medoxomil as soon as possible. See Section PRECAUTIONS, Pregnancy and Lactation below – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The concomitant use of olmesartan medoxomil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2) (see Section PRECAUTIONS, Drug Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DOSAGE AND ADMINISTRATION

Dosage must be individualized. The usual recommended starting dose of olmesartan medoxomil is 20 mg once daily when used as monotherapy in patients who are not volume-contracted.

For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of olmesartan medoxomil may be increased to 40 mg.

Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 mL/min) or with moderate to marked hepatic dysfunction (see Section CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), olmesartan medoxomil should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see Section WARNINGS, Volume- or Salt-depleted Patients with Activated Renin-Angiotensin System – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Olmesartan medoxomil may be administered with or without food.

If blood pressure is not controlled by olmesartan medoxomil alone, a diuretic may be added. Olmesartan medoxomil may be administered with other antihypertensive agents.