Prozart

Each tablet contains: Losartan potassium USP 50 mg.

Pharmacology: Pharmacokinetics: Losartan is readily absorbed from the gastrointestinal tract, but undergoes substantial first-pass metabolized resulting in a systemic bioavailability of about 33%. It is metabolized to an active carboxylic acid metabolized which has greater pharmacological activity then losartan; some inactive metabolites are also formed, Metabolism is primarily by cytochrome P450 isoenzymes CYP2C9 and CYP3A4. Peak plasma concentrations of losartan and E-3174 occur about 1 hour and 3 to 4 hours, respectively, after an oral dose. Both losartan and E-3174 are more than 98% bound to plasma proteins. Losartan is excreted in the urine and in the faeces via bile, as unchanged drug and metabolites. Following oral dosing about 4% of the dose is excreted in urine as the active metabolite. The terminal elimination half-lives of losartan and E-3174 are about 1.5 to 2.5 hours and 3 to 9 hours, respectively.

It is indicated for the treatment of hypertension.
It may be used alone or in combination with other antihypertensive agents.

Route: ORAL.
Adults: Initially 25mg or 50mg once daily (25mg in elderly or those with history of hepatic impairment.) May be increased after several weeks to 100mg once daily.

Significant lethality was observed in mice and rats after oral administration of 1000mg/kg and 2000mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on an mg/m² basis. Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Neither Losartan nor its active metabolite can be removed by hemodialysis.

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

Patients who are intravascularly volume depleted, renal artery stenosis. Monitor serum potassium concentrations especially in elderly patients or those with renal impairment.
Avoid concomitant use of potassium sparing diuretics and potassium supplements.
It should be discontinued when pregnancy is diagnosed.

Headaches, dizziness, asthenia or fatigue. Rarely angioedema, first dose hypotension, transient elevation of liver transaminases and hyperkalaemia, impaired renal function, urticaria and pruritus.

Store at temperature not exceeding 30°C.

Angiotensin II Antagonists

C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.

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