Generic Information
CANDESARTAN CILEXETIL
Candesartan Cilexetil is indicated for hypertension, heart failure with impaired left ventricular systolic function.
Angiotensin-ll receptor blocker
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).
Hypertention: initially 8 mg (hepatic impairment 2 mg, renal impairment or intravascular volume depletion 4 mg) once daily, increased if necessary at intervals of 4 weeks to max 32 mg once daily; usual maintenance dose 8 mg once daily. Heart failure: initially 4 mg once daily, increased at intervals of at least 2 weeks to target dose of 32 mg once daily or to max tolerated dose.
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.
Hypersensitivity to any component of this product. Pregnancy, breast-feeding, cholestasis.
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high dose diuretics). Hyperkalemia occurs occassionally; angioedema has also been reported with some angiotension II receptor antagonist. Also vertigo, headache; rarely hepatitis, blood disorders, hyponatraemia, back pain, arthralgia, myalgia, rash, urticaria, pruritous.
When pregnancy is detected, Candesartan Cilexetil should be discontinued as soon as possible. It should be used in lactation.
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.
Store in a cool & dry place. Protect from light and moisture