OSARTAN

Losartan potassium

Description:

Osartan (Losartan potassium) is the first orally active angiotensin-II receptor (type-AT₁) antagonist. Angiotensin-II is a potent vasoconstrictor, which is the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone secreting effects of angiotensin-II to the AT₁ receptor. Osartan is now regarded as the first choice therapy for treating high blood pressure.

Composition:

Each film coated tablet contains Losartan potassium INN 50 mg.

Indications:

Osartan is indicated for the treatment of all grades of hypertension, congestive heart failure, and renal arterial stenosis. Combination of other antihypertensive drugs is also recommended.

Dosage & administration:

The usual starting dose is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g. patients treatment with diuretics), and patients with a history of hepatic impairment. The total daily dose is 25-100 mg, may be given once or twice daily.

If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.

If blood pressure is not controlled by Osartan alone, a low dose of a diuretic may be added. No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.

Osartan may be administered in combination with other antihypertensive drugs.

Osartan may be taken with or without food.

Contraindications:

Osartan is contraindicated in pregnancy and lactation. It is also contraindicated to patients who are hypersensitive to Losartan Potassium or any component of this product.

Side-effects:

In general, treatment with Osartan was well tolerated. The overall incidence of adverse effects reported with Losartan potassium was similar to placebo. The most common adverse events occurring with Osartan were respiratory infection, dizziness and leg pain.

Precautions:

Osartan should be used with caution in patients with known hypersensitivity to drugs that act through renin-angiotensin system. A lower dose should be considered when it is administered to the patients with hepatic impairment. Safety and effectiveness of Osartan in paediatric patients have not been established.

Use in Pregnancy and Lactation:

Osartan must be discontinued as soon as possible when pregnancy is detected. It should not be prescribed during lactation as there is no information in human on the passage of Osartan into breast milk.

Drug Interaction:

No drug interactions of clinical significance have been identified. Compounds which have been studied in clinical pharmacokinetic trials include hydrochlorothiazide, digoxin, warfarin, cimetidine, ketoconazole and phenobarbital.

Storage:

The tablets should be stored at between 15º-30º C, in a dry place & away from light.

Packing:

Box containing 3 x 10's tablets in blister pack.