DESCRIPTION

 Anin (Losartan Potassium), the first of a new class of antihypertensives , is an angiotensin IIreceptor (type AT ) antagonist. Angiotensin II is a potent vasoconstrictor, th primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of ypertension. 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 AT receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Losartan Potassium is reversible,competitive inhibitor of the AT, receptor. Neither Losartan nor its active metabolite inhibits ACE (kininase II, the  enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

INDICATION

Anin is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. It is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. It is also indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

DOSAGE AND ADMINISTRATION

The usual starting dose of Anin is 50 mg once daily, with25 mg used in patients with possible depletion of intravascular volume (e.g. patients treated with diuretics) and patients with a history of hepatic impairment. Anin 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 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 Losartan Potassium 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. Anin may be administered with or without food.

CONTRAINDICATIONS

Anin is contraindicated in patients who are hypersensitive to the active ingredient or any component of this drug

PRECAUTIONS

Anin 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. Anin should not be used with Potassium-sparing diuretics

SIDE EFFECTS

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

(1.0% vs 0.0%).

USE IN PREGNANCY & LACTATION

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

OVERDOSE

Limited data are available regarding overdose in human. The most likely manifestation of overdose would be hypotension and tachycardia ; bradycardia could occur from parasympathetic (vagal) stimulation. Supportive treatment should include repletion of the intravascular volume. Neither A nin nor the active metabolite can be removed by hemodialysis.

DRUG INTERACTION

No drug interaction of clinical significance has been identified. Compounds, which have been studied in clinical pharmacokinetic trials, include Hydrochlorothiazide, Digoxin, Warfarin , Cimetidine, Ketoconazole and Phenobarbital.

STORAGE

Store in a dry place. at between 15°C to 30°C and away from light.

PACKAGING

Anin 50 tablet: Box contains 3x10's tablets in blister pack. Each film-coated tablet contains Losartan Potassium USP 50 mg.

WARNING

Keep out of the reach of children.

Manufactured by
Delta Pharma Limited, Bangladesh.