APROVEL

SPECIFICATION

150mg & 300mg

Generics

Irbesartan

About

Irbesartan : Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.

Indication

Treatment of essential hypertension.

Side Effects

 Cardiac disorders: Common: increases in blood urea nitrogen (BUN), creatinine and creatine kinase Uncommon: decreases in serum potassium and sodium .Uncommon: syncope, hypotension, tachycardia, oedema.Nervous system disorders: Common: dizziness Uncommon: orthostatic dizziness Not known: headache . Ear and labyrinth disorders: Not known: tinnitus. Respiratory, thoracic and mediastinal disorders: Not known: cough. Gastrointestinal disorders: Common: nausea/vomiting , Uncommon: diarrhoea , Not known: dyspepsia, dysgeusia .

Drug Interactions

penicillin G sodium, salicylic acid and derivatives) , ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporine or other medicinal p roducts such as heparin sodium) , quinidine, hydroquinidine, disopyramide).

When not to Use

Do not take if: - You are in the second or third trimester of pregnancy, - You are breast-feeding or - If you are allergic to any of the ingredients.

Precaution

There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists. While this is not documented with Irbesartan/Hydrochlorothiazide , a similar effect should be anticipated.