Candesartan STELLA 16 mg

Rx

Indications

• Treatment of essential hypertension in adults and children aged 6 to < 18 years.
• Treatment of heart failure (NYHA class II-III) in patients with left ventricular systolic dysfunction (ejection fraction ≤ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations. Combination therapy with an ACE inhibitor compared with therapy with either type of agent alone, but not supported, or when patients were intolerant of ACE inhibitors.

Dosage

Hypertension

Adults:

• 8 mg once daily. Most of the 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.
• Patients with intravascular volume depletion: An initial dose of 4 mg may be considered in patients at risk for hypotension.
• In patients with hepatic impairment: An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment. Candesartan is contraindicated in patients with severe hepatic impairment or cholestasis.
• In patients with renal impairment: An initial dose of 4 mg once daily, including for patients on haemodialysis. There is limited experience in patients with very severe or end-stage renal impairment (Clcr < 15 ml/min).

Child 6–18 years:

• < 50 kg: Initially 4 mg once daily (lower dose in intravascular volume depletion), adjusted according to response; maximum 8 mg once daily.
• ≥ 50 kg: Initially 4 mg once daily (lower dose in intravascular volume depletion), adjusted according to response; maximum 16 mg once daily.

Heart failure

• The usual initial dose of candesartan is 4 mg once daily. The dose should be doubled at intervals of not less than 2 weeks up to 32 mg once daily (maximum dose) if tolerated.

Usage

• Candesartan STELLA 16 mg is only administered orally.

• Patients who are hypersensitive to any component of this product.
• Second and third trimesters of pregnancy.
• Severe hepatic impairment and/or cholestasis.
• The concomitant use of candesartan cilexetil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).
• Children aged below 1 year.
• Heart failure with potassium concentration > 5 mmol/liter, blood creatinine > 265 micromol/liter (> 30 mg/liter) or creatinine clearance < 30 ml/min (using the Cockcroft formula).

Common

• Respiratory infection;
• Dizziness/vertigo, headache (treatment of hypertension);
• Hyperkalaemia (treatment of heart failure);
• Hypotension;
• Renal impairment, including renal failure in susceptible patients (treatment of heart failure).

• Changes in renal function may be anticipated in susceptible patients treated with candesartan.
• Patients with heart failure given candesartan commonly have some reduction in blood pressure. In patients with symptomatic hypotension this may require temporarily reducing the dose of candesartan, or diuretic, or both, and volume repletion.
• Sensitivity reactions, including various anaphylactoid reactions and/or angioedema, have been reported.
• Hyperkalemia may occur in patients with congestive heart failure receiving candesartan, especially in those receiving concomitant therapy with an ACE inhibitor and/or a potassium-sparing diuretic (e.g., spironolactone).
• Hypotension may occur during anaesthesia and surgery in patients treated with angiotensin II antagonists due to blockade of the renin-angiotensin system.
• The use of candesartan is not recommended in patients with primary hyperaldosteronism.
• Renal function may deteriorate markedly (e.g., oliguria, progressive azotemia, renal failure, death) in patients during therapy with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor antagonist (e.g., candesartan cilexetil).
• Candesartan STELLA 16 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Angiotensin II receptor antagonists (AIIRAs) should not be initiated during pregnancy. When pregnancy is detected, drugs should be discontinued as soon as possible. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
• Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
• ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
• Candesartan has not been studied in children with a glomerular filtration rate less than 30 ml/min/1.73 m². For children with possible intravascular volume depletion (e.g. patients treated with diuretics, particularly those with impaired renal function), candesartan treatment should be initiated under close medical supervision and a lower starting dose should be considered.
• It should be taken into account that occasionally dizziness or weariness may occur during treatment with candesartan.