Composition
LOSAZIDE 50/12.5 mg F.C. Tablets:
Each film coated tablet contains:
Losartan potassium ........................................................... 50 mg
Hydrochlorothiazide ....................................................... 12.5 mg
LOSAZIDE 100/25 mg F.C. Tablets:
Each film coated tablet contains:
Losartan potassium .......................................................... 100 mg
Hydrochlorothiazide ........................................................... 25 mg
Inactive ingredients: Microcrystalline cellulose, pregelatinized starch, magnesium stearate, sodium starch glycolate, hydroxypropyl cellulose, colloidal silicon dioxide.

Therapeutic Indications
Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide monotherapy.

Dosage and Administration
LOSAZIDE may be administered with other antihypertensive agents.
LOSAZIDE tablets should be swallowed with a glass of water.
LOSAZIDE may be administered with or without food.
Hypertension:
LOSAZIDE tablets are 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 is one tablet of LOSAZIDE 50 mg/12.5 mg once daily.
For patients who do not respond adequately to LOSAZIDE 50 mg/12.5 mg, the dosage may be increased to one tablet of LOSAZIDE 100 mg/25 mg once daily. The maximum dose is one tablet of LOSAZIDE 100 mg/25 mg once daily.
In general, the antihypertensive effect is attained within 3-4 weeks after initiation of therapy.
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). LOSAZIDE tablets must not be used in patients with severe renal impairment (i.e. creatinine clearance < 30 ml/min).
LOSAZIDE tablets are not recommended for haemodialysis patients.
Use in patients with intravascular volume depletion:
Volume and/or sodium depletion should be corrected prior to administration of LOSAZIDE tablets.
Use in patients with hepatic impairment:
LOSAZIDE is contraindicated in patients with severe hepatic impairment.
Use in the elderly:
Dosage adjustment is not usually necessary for the elderly.
Use in children and Adolescents (< 18 years):
There is no experience in children and adolescents. Therefore, LOSAZIDE tablets should not be administered to children and adolescents.