ADVANT (Candesartan cilexetil), a prodrug, is hydrolyzed to candesartanduring absorption from the gastrointestinal tract.
Candesartan is a selective AT1 subtype angiotensin II receptor antagonist.
ADVANT Tablets 16mg: Each tablet contains Candesartan cilexetil 16mg.
THERAPEUTIC INDICATIONS: Hypertension- ADVANT (Candesartan cilexetil) is indicated for the treatment of hypertension in adults and children 1 to < 17 years of age. It may be used alone or in combination with other antihypertensive agents. Heart Failure: -ADVANT (Candesartan cilexetil) is indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction(<40%) to reduce cardiovascular death and to reduce heart failurehospitalizations. ADVANT (Candesartan cilexetil) also has an added effect on these outcomes when used with an ACE inhibitor. MECHANISM OF ACTION: Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kinase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal re-absorption of sodium. 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, such as vascular smooth muscle and the adrenal gland. Its action is, therefore, independent of the pathways for angiotensin II synthesis. Candesartan cilexetil is rapidly converted to the active drug, candesartan,by ester hydrolysis during absorption from the gastrointestinal tract. Candesartan is an angiotensin II receptor antagonist, selective for AT1receptors, with tight binding to and slow dissociation from the receptor. It has no agonist activity. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because candesartan does not inhibit ACE (kinase II), it does not affect the response to bradykinin. Candesartan does not bind to or block other hormone receptors or ion channels known to be important in cardio vascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatoryfeedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of candesartan on blood pressure.
HOW TO USE
DOSAGE AND ADMINISTRATION: Hypertension- Adults Dosage must be individualized.
Response is dose related over the range of 2 to 32 mg.
The usual recommended starting dose of ADVANT(Candesartan cilexetil) is 16 mg once daily when it is used as mono-therapy in patients who are not volume depleted.
ADVANT (Candesartan cilexetil) can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg.
Most of the antihypertensive effect is present within 2 weeks and maximal blood pressure reduction is generally obtained within 4 to 6weeks of treatment with ADVANT( Candesartan cilexetil ).
ADVANT (Candesartan cilexetil) may be administered with or without food.
Pediatrics: ADVANT (Candesartan cilexetil) may be administered once daily or divided into two equal doses.
Adjust the dosage according to blood pressure response.
For patients with possible depletion of intravascular volume (e.g.,patients treated with diuretics, particularly those with impaired renal function) ,initiate ADVANT (Candesartan cilexetil) under close medical supervision and consider administration of a lower dose.
Children 1 to <6 years of age: The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg. Children 6 to <17 years of age: For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg. For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg. An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with ADVANT (Candesartan cilexetil). Children < 1 year of age must not receive ADVANT (Candesartan cilexetil) for hypertension. Heart Failure: The recommended initial dose for treating heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling thedose at approximately 2-week intervals, as tolerated by the patient.
CONTRAINDICATIONS: Candesartan cilexetil is contraindicated in patients who are hypersensitive to this drug or any component of this product.
WARNINGS / PRECAUTIONS: General -As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.