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GIRAN

Candesartan Cilexetil

Description:

Candesartan Cilexetil is an ester prodrug that is hydrolysed in the body to the active form Candesartan during absorption from the gastro-intestinal tract. Candesartan is angiotensin II receptor (type AT1) antagonist. Candesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues (eg, vascular smooth muscle, adrenal gland).

Composition:

Giran-8 Tablet: Each tablet contains Candesartan Cilexetil INN 8 mg.

Giran-16 Tablet: Each tablet contains Candesartan Cilexetil INN 16 mg.

Indications:

Treatment of hypertension alone or in combination with other antihypertensive agents.

Dosage & Administration:

Initially 4 mg (2 mg in hepatic and renal impairment) once daily adjusted according to response; usual maintenance dose 8 mg once daily; max. 16 mg once daily.

Contraindications:

Hypersensitivity to any component of this product. Pregnancy, breast-feeding, cholestasis.

Drug Interactions:

No significant drug interactions have been reported in studies of Candesartan Cilexetil given with other drugs such as glyburide, nifedipine, digoxin, warfarin, hydrochlorothiazide and oral contraceptives in healthy volunteers. Because candesartan is not metabolised by the cytochrome P-450 system and has no effects on P-450 enzymes, interactions with drugs that inhibit, or are metabolised by, those enzymes could not be expected.

Side-effects:

Side-effects are usually mild. Symptomatic hypotension may occur, particularly in patients with intravascular volume depletion (e.g. those taking high dose diuretics). Also upper respiratory tract and influenza like symptoms including rhinitis and pharyngitis; abdominal pain, back pain, arthralgia, myalgia, nausea, headache, dizziness, peripheral oedema, rash also reported; rarely urticaria, pruritus, blood disorders reported.

Precautions:

Candesartan should be used with caution in renal artery stenosis, aortic or mitral valve stenosis and in obstructive hypertropic cardiomyopathy. Monitoring of plasma-potassium concentration is advised, particularly in the elderly and in patients with renal impairment; lower initial doses may be appropriate in these patients.

Use in Pregnancy and Lactation:

When pregnancy is detected, Candesartan Cilexetil should be discontinued as soon as possible. It should be used in lactation.

Paediatric use:

Safety and effectiveness in paediatric patients have not been established. 

Packing:

Giran-8 Tablet: Each box contains 3×10’s tablets in blister pack.

Giran-16 Tablet: Each box contains 3×10’s tablets in blister pack. 

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