CANDESAN

What it is

CANDESAN contains candesartan cilexetil combined with hydrochlorothiazide in three strengths: 16 mg/12.5 mg, 32 mg/12.5 mg, and 32 mg/25 mg. Candesartan cilexetil is a prodrug suitable for oral use that is rapidly converted to the active medicine, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract. Candesartan is an angiotensin II receptor antagonist, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor. Hydrochlorothiazide inhibits the active reabsorption of sodium, mainly in the distal kidney tubules, and promotes the excretion of sodium, chloride and water.

Approved indications

— Treatment of hypertension.

Dosing overview

The recommended dose of CANDESAN is one tablet once daily, taken with or without food. CANDESAN 16 mg/12.5 mg may be administered in patients whose blood pressure is not optimally controlled with hydrochlorothiazide alone or with candesartan 16 mg monotherapy. CANDESAN 32 mg/12.5 mg or 32 mg/25 mg may be administered in patients whose blood pressure is not optimally controlled with hydrochlorothiazide alone or candesartan 32 mg monotherapy, or at a lower dose of CANDESAN. Most of the antihypertensive effect is usually attained within four weeks of initiation of treatment. Treatment should not be initiated with this fixed dose combination.

Key safety warnings

In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system, treatment with medicines that affect this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure. The concomitant use of angiotensin converting enzyme inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function, and dual blockade of the renin-angiotensin-aldosterone system through the combined use of CANDESAN with these agents is therefore not recommended. An increased risk of non-melanoma skin cancer with increasing cumulative dose of hydrochlorothiazide exposure has been observed in epidemiological studies, with photosensitising actions of hydrochlorothiazide acting as a possible mechanism. Patients taking hydrochlorothiazide should be informed of the risk and advised to regularly check their skin for new lesions and promptly report suspicious lesions, and possible preventive measures such as limited exposure to sunlight and UV rays should be advised. Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome have been reported after taking hydrochlorothiazide, with pulmonary oedema typically developing within minutes to hours after intake with symptoms including dyspnoea, fever, pulmonary deterioration, and hypotension. Hydrochlorothiazide should not be administered to patients who previously experienced acute respiratory distress syndrome following hydrochlorothiazide intake. Treatment with a thiazide diuretic may impair glucose tolerance and dosage adjustment of antidiabetic medicines, including insulin, may be required. Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, acute transient myopia and acute angle-closure glaucoma, with symptoms including acute onset of decreased visual acuity or ocular pain typically occurring within hours to weeks of drug initiation, and untreated acute angle-closure glaucoma can lead to permanent vision loss.

Contraindications

Hypersensitivity to any component of CANDESAN or to sulfonamide derived medicines. Pregnancy and lactation. Severe renal impairment (creatinine clearance less than 30 mL/minute/1.73 m² body surface area). Severe hepatic impairment and/or cholestasis. Gout. The use of CANDESAN in combination with aliskiren-containing medicines in patients with diabetes mellitus (type I or II) or with moderate to severe renal impairment (GFR less than 60 ml/min/1.73m²).

PBS listing

Information on PBS listing is not available in the provided source documents.

Regulatory history

CANDESAN received initial ARTG registration on 27 March 2013, with the fixed-dose combinations 16 mg/12.5 mg, 32 mg/12.5 mg, and 32 mg/25 mg registered in licence category RE. The product information was revised on 4 October 2024 to include a new warning regarding acute respiratory distress syndrome.