Posology in Hypertension: The recommended initial dose and usual maintenance dose of Candesartan Cilexetil is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response.
Candesartan Cilexetil may also be administered with other antihypertensive agents (see Contraindications, Precautions and Interactions). Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Candesartan Cilexetil.
Elderly: No initial dose adjustment is necessary in elderly patients.
Patients with introvascular volume depletion: An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion (see Precautions).
Renal impairment: The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis. The dose should be titrated according to response. There is limited experience in patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min) (see Precautions).
Hepatic impairment: An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment. The dose may be adjusted according to response. Candesartan Cilexetil is contraindicated in patients with severe hepatic impairment and/or cholestasis (see Contraindications).
Black patients: The antihypertensive effect of candesartan is less pronounced in black patients than in non-black patients. Consequently, up titration of Candesartan Cilexetil and concomitant therapy may be more frequently needed for blood pressure control in black patients than in non-black patients.
Paediatric population: Children and adolescents aged 6 to < 18 years: The recommended starting dose is 4 mg once daily.
For patients weighing < 50 kg: In patients whose blood pressure is not adequately controlled, the dose can be increased to a maximum of 8 mg once daily.
For patients weighing ≥50 kg: In patients whose blood pressure is not adequately controlled, the dose can be increased to 8 mg once daily and then to 16 mg once daily if needed.
Doses above 32 mg have not been studied in paediatric patients.
Most of the antihypertensive effect is attained within 4 weeks.
For children with possible in travascular volume depletion (e.g., patients treated with diuretics, particularly those with impaired renal function), Candesartan Cilexetil treatment should be initiated under close medical supervision and a lower starting dose than the general starting dose above should be considered (see Precautions).
Candesartan has not been studied in children with glomerular filtration rate less than 30 ml/min/1.73 m2 (see Precautions).
Black paediatric patients: The antihypertensive effect of candesartan is less pronounced in black patients than in nonblack patients.
Children aged below 1 year to <6 years: The safety and efficacy in children aged 1 to <6 years of age has not been established.
Candesartan Cilexetil is contraindicated in children aged below 1 year (see Contraindications).
Posology in Heart Failure: The usual recommended initial dose of Candesartan Cilexetil is 4 mg once daily. Up-titration to the target dose of 32 mg once daily (maximum dose) or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks (see Precautions). Evaluation of patients with heart failure should always comprise assessment of renal function including monitoring of serum creatinine and potassium.
Candesartan Cilexetil can be administered with other heart failure treatment, including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products. Candesartan Cilexetil may be co-administered with an ACE-in hibitor in patients with symptomatic heart failure despite optimal standard heart failure therapy when mineralocorticoid receptor antagonists are not tolerated. The combination of an ACE inhibitor, a potassium-sparing diuretic and Candesartan Cilexetil is not recommended and should be considered only after carefuevaluation of the potential benefits and risks (see Precautions and Adverse Reactions).
Special patient populations: No initial dose adjustment is necessary for elderly patients or in patients with intravascular volume depletion, renal impairment or mild to moderate hepatic impairment.
Paediatric Population: The safety and efficacy of Candesartan Cilexetil in children aged between birth and 18 years have not been established in the treatment of heart failure. No data are available.
Method of administration: Oral use.
Candesartan Cilexetil should be taken once daily with or without food.
The bioavailability of candesartan is not affected by food.