APO-INDAPAMIDE

What it is

APO-INDAPAMIDE SR is a sustained release tablet containing 1.5 mg of indapamide hemihydrate. The tablet contains lactose monohydrate as an excipient with known effect.

Approved indications

— Treatment of hypertension.

Dosing overview

The recommended dose for adults is one APO-INDAPAMIDE SR tablet daily, taken orally in the morning. The tablet should be swallowed whole and must not be chewed or crushed. The action is progressive, with optimum reduction in blood pressure usually seen after four weeks, and a further small reduction observed over the following four to six weeks. A larger dose than one tablet daily is not recommended as there is little additional antihypertensive effect, whilst the diuretic effect becomes more pronounced.

Key safety warnings

Hypokalaemia may occur at all doses, with symptoms including weakness, cramps, and cardiac dysrhythmias. Hypokalaemia is a particular hazard in patients treated with digoxin as dangerous or fatal arrhythmias may be precipitated. Patients receiving indapamide should be monitored for signs and symptoms of fluid or electrolyte imbalance, including hyponatraemia, hypochloraemia and hypokalaemia; blood urea, nitrogen and uric acid should also be assessed during treatment, with signs of electrolyte imbalance including dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscle fatigue, hypotension, oliguria, gastrointestinal disturbances, tachycardia and ECG changes. Hyperuricaemia may occur during treatment with indapamide, and gout has been reported rarely; tendency to gout attacks may be increased in patients with hyperuricaemia. Cases of photosensitivity reactions have been reported with thiazides and thiazide-related diuretics, and it is recommended to stop treatment if a photosensitivity reaction occurs. Sulfonamide derivative drugs can cause choroidal effusion with visual field defect, 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; untreated acute angle-closure glaucoma can lead to permanent vision loss.

Contraindications

APO-INDAPAMIDE SR is contraindicated in severe renal failure, anuria, progressive and severe oliguria; hepatic coma, hepatic encephalopathy or severe impairment of liver function; known hypersensitivity to indapamide, other sulphonamide derivatives, or any of the excipients; and hypokalaemia.

PBS listing

APO-INDAPAMIDE SR 1.5 mg sustained release tablet is listed on the PBS with two items, under restricted listing, at an ex-manufacturer price of A$5.07.

Regulatory history

APO-INDAPAMIDE SR indapamide hemihydrate 1.5 mg modified release tablet was first registered on the ARTG on 7 May 2014 under licence category RE.