Posology : מינונים

4.2    Posology and method of administration

Posology
Hypertension
Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone.

Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended.

When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled.

The usual maintenance dose of OCSAAR PLUS is one tablet of OCSAAR PLUS once daily. For patients who do not respond adequately to OCSAAR PLUS, the dosage may be increased to two tablets of OCSAAR PLUS once daily. The maximum dose is two tablets of OCSAAR PLUS once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy.

Reduction in the risk of stroke in patients with hypertension and left ventricular hypertrophy The usual starting dose is 50 mg of losartan once daily. If goal blood pressure is not reached with losartan 50 mg, therapy should be titrated using a combination of losartan and a low dose of hydrochlorothiazide (12.5 mg) and, if needed, the dose should then be increased to losartan 100 mg and hydrochlorothiazide 12.5 mg once daily. If necessary, the dose should be increased to losartan 100 mg and hydrochlorothiazide 25 mg once daily. OCSAAR PLUS is a suitable alternative formulation in patients who would otherwise be treated concomitantly with losartan 50 mg plus hydrochlorothiazide 12.5 mg.

Use in patients with renal impairment and haemodialysis patients
No initial dosage adjustment is necessary in patients with moderate renal impairment (i.e., creatinine clearance 30-50 ml/min). Losartan and hydrochlorothiazide tablets are not recommended for haemodialysis patients. OCSAAR PLUS tablets must not be used in patients with severe renal impairment (i.e., creatinine clearance <30 ml/min) (see section 4.3).

Use in patients with intravascular volume depletion
Volume and/or sodium depletion should be corrected prior to administration of OCSAAR PLUS tablets.

Use in patients with hepatic impairment
OCSAAR PLUS is contraindicated in patients with severe hepatic impairment (see section 4.3).

Use in the elderly
Dosage adjustment is not usually necessary for the elderly.
Paediatric population

Use in children and adolescents (< 18 years)
There is no experience in children and adolescents. Therefore, OCSAAR PLUS should not be administered to children and adolescents.

Method of administration
OCSAAR PLUS may be administered with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1).
OCSAAR PLUS tablets should be swallowed whole with a glass of water.
OCSAAR PLUS may be administered with or without food.