Osartil
Film coated tablet

Presentation
Osartil : Each tablet contains Losartan Potassium INN 50 mg.
Osartil 25 : Each tablet contains Losartan Potassium INN 25 mg.

Description
Osartil (Losartan Potassium), the first of a new class of antihypertensives, is an angiotensin II receptor (type AT1) antagonist. Angiotensin II is a potent vasoconstrictor, 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 vasoconstriction and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues. Osartil is now regarded as the first-line therapy option for treating high blood pressure.

Indications
Osartil is indicated for the treatment of all grades of hypertension and congestive heart failure. It may be used alone or in combination with other antihypertensive agents. It is an effective alternative for patients who have to discontinue an ACE inhibitor because of persistent dry cough.

Dosage and Administration
The usual starting dose of Osartil is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g. patients treated with diuretics), and patients with a history of hepatic impairment. Osartil can be administered once or twice daily with total daily doses ranging from 25 to 100 mg. 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 Osartil 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. Osartil may be administered with or without food.

Side effects
Overall incidence of adverse effects of Osartil is comparable to placebo in clinical studies. The most common adverse events occuring with Osartil at a rate of >1% above placebo were upper respiratory infection (7.9% vs 6.9%), dizziness (3.5% vs 2.1%) and leg pain (1.0% vs 0.0%).

Precautions
Osartil should be used with caution in patients with known hypersensitivity to the drugs that act through renin-angiotensin system. Special precaution should be taken when it is administered to the patients with renal and hepatic impairment. Safety and effectivenss of Osartil in pediatric patients have not been established.

Contraindications
Losartan potassium is contraindicated in patients who are hypersensitive to the active ingredient or any component of the drug.

Use in Pregnancy and Lactation
Osartil must be discontinued as soon as possible when pregnancy is detected. It should not be prescribed during lactation as there is no information in humans on the passage of Losartan (Osartil) into breast milk.

Drug interactions
No drug interactions of clinical significance have been identified. Drugs which have been studied in clinical pharmacokinetic trials include - (1) Hydrochlorothiazide,
(2) Digoxin, (3) Warfarin, (4) Cimetidine, (5) Ketoconazole and (6) Phenobarbital.

Storage
Store in a dry place, at between 150 c and 300 c, away from light.

Commercial pack
Osartil : Box containing 5 blister strips of 10 tablets.
Osartil 25 : Box containing 5 blister strips of 10 tablets