Candesartan cilexetil

Visa No.: VD-34960-21

Product: Candesartan STADA 4 mg

API: Candesartan cilexetil

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 32333e/QLD - ĐK_08/09/20 25

INDICATIONS

• Treatment of essential hypertension in adults.
• Treatment of heart failure and left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 40%) in adults who are intolerant to angiotensin-converting enzyme (ACE) inhibitors. Candesartan may also be used in combination with an ACE inhibitor to enhance therapeutic efficacy in patients with symptomatic heart failure when mineralocorticoid receptor antagonists are not tolerated.
• Treatment of hypertension in children and adolescents aged 6 to < 18 years.
   

DOSAGE AND ADMINISTRATION

Dosage: 
Hypertension
The recommended initial and maintenance dose of candesartan is 8 mg once daily. Most of the antihypertensive effect is achieved within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose may be increased to 16 mg once daily and up to a maximum of 32 mg once daily, with dose adjustment according to the patient’s response.
Candesartan may also be used in combination with other antihypertensive agents. Combination with hydrochlorothiazide has been shown to produce an additional blood pressure–lowering effect at various doses of candesartan.
Elderly: No initial dose adjustment is required in elderly patients.
Patients with intravascular volume depletion: 
An initial dose of 4 mg once daily is recommended in patients at risk of hypotension, such as those with intravascular volume depletion.
Renal impairment: 
The initial dose is 4 mg once daily in patients with renal impairment, including those undergoing hemodialysis. Dose adjustment should be made according to patient response. Experience is limited in patients with very severe renal impairment or end-stage renal disease (creatinine clearance < 15 mL/min).
Hepatic impairment
An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment. Dose adjustment should be based on patient response.
Candesartan is contraindicated in patients with severe hepatic impairment and/or cholestasis.
Black patients
The antihypertensive effect of candesartan is less pronounced in Black patients than in non-Black patients. Therefore, dose up-titration and combination therapy may be required to achieve blood pressure control in this population.
Children and adolescents
Children and adolescents aged 6 to < 18 years: The recommended initial dose is 4 mg once daily.

• Body weight < 50 kg: In patients whose blood pressure is not adequately controlled, the dose may be increased to a maximum of 8 mg once daily..
• Body weight ≥ 50 kg: In patients whose blood pressure is not adequately controlled, the dose may be increased to 8 mg once daily, and then to 16 mg once daily if necessary

Doses above 32 mg have not been studied in children. In most cases, the antihypertensive effect is achieved within 4 weeks.
In children who may have intravascular volume depletion (e.g. patients treated with diuretics, particularly those with renal impairment), treatment with candesartan should be initiated under close medical supervision, and consideration should be given to a lower starting dose than the usual initial dose.
Candesartan has not been studied in children with a glomerular filtration rate below 30 mL/min/1.73 m².
Black children 
The antihypertensive effect of candesartan is less pronounced in Black patients than in other patients.
Children aged < 1 year to < 6 years

• The safety and efficacy of candesartan in children aged 1 to < 6 years have not been studied.
• Candesartan is contraindicated in children under 1 year of age.

Heart failure
The usual initial dose of candesartan is 4 mg once daily. Dose titration up to a maximum dose of 32 mg once daily, or to the highest tolerated dose, is achieved by doubling the dose at intervals of at least 2 weeks. Evaluation of patients with heart failure should always include assessment of renal function, including monitoring of serum creatinine and potassium Candesartan may be used in combination with other heart failure therapies, including ACE inhibitors, beta-blockers, diuretics, and digitalis. Candesartan may also be used in combination with an ACE inhibitor in patients with symptomatic heart failure. The combination of an ACE inhibitor, a potassium-sparing diuretic, and candesartan is not recommended. Such combination therapy should only be considered after careful evaluation of the potential benefits and risks.
Special populations: No adjustment of the initial dose is required in elderly patients or in patients with intravascular volume depletion, renal impairment, or mild to moderate hepatic impairment.
Children: The safety and efficacy of candesartan in children from birth to 18 years of age for the treatment of heart failure have not been established. No data are available.
Method of administration: For oral use.
Candesartan cilexetil should be taken once daily, with or without food. The bioavailability of candesartan is not affected by food.
 

CONTRAINDICATIONS

Hypersensitivity to candesartan or to any of the excipients.
Second and third trimesters of pregnancy.
Severe hepatic impairment and/or cholestasis.
Children under 1 year of age.
Concomitant use of candesartan cilexetil with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²).
 

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children