Losartan Potassium is an orally active, nonpeptide angiotensin II (A II)
receptor antagonist. It is the first of a new class of drugs introduced for
clinical use in hypertension. This novel agent binds competitively and
selectively to the A II subtype I [AT1] receptor, thereby blocking A IIinduced
physiological effects. An active metabolite of Losartan, EXP
3174, contributes substantially to its antihypertensive effect, which
persists throughout 24 hours after once daily administration. Unlike
ACE inhibitors, they do not inhibit the breakdown of bradykinin and
other kinins, and thus do not appear to cause the persistent dry cough,
which commonly complicates ACE inhibitor therapy.

Losartan is effective in 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.

The usual starting dose of Losartan is 50 mg once daily. Some patients
may receive an additional benefit by increasing the dose to 100 mg
once daily. In patients with possible depletion of intravascular volume
(e.g. patients treated with diuretics) and in patients with a history of
hepatic impairment, a lower initial dose of 25 mg is recommended. No
initial dosage adjustment is necessary for elderly patients (upto 75
years) or for patients with renal impairment, including patients on
dialysis. Losartan may be administered with or without food.

Losan is contraindicated in patients who are hypersensitive to any
component of this product.

Sodium and/or volume depleted patients, such as, those receiving
high doses of diuretics, symptomatic hypotension may occur in rare
cases after initiation of therapy. Sodium and/or volume depletion
should be corrected before starting treatment with Losartan for
example, by reducing the diuretic dose. If hypotension occurs, the
patient should be placed in the supine position and, if necessary, given
an IV infusion of normal saline. Treatment can be continued once the
blood pressure has stabilized. A lower dose should be considered for
patients with a history of hepatic impairment.

Losan is contraindicated during pregnancy. It should not be prescribed
during lactation as there is no information in human on the passage of
Losan into breast milk.

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

The side effects with Losartan are mild and rare. In controlled clinical
trial in patients with essential hypertension, dizziness was the only side effect reported that occurred with an incidence greater than
placebo in 1% or more of patients treated with Losartan. Rarely rash
was reported.

Losan 25: Each film-coated tablet contains Losartan Potassium USP 25 mg.
Losan 50: Each film-coated tablet contains Losartan Potassium USP 50 mg.
Losan 25: Box containing 3 x 10 tablets in blister pack.
Losan 50: Box containing 3 x 10 tablets in blister pack.

Store in a cool and dry place, away from light.