DAPA-TABS

What it is

DAPA-TABS is a tablet containing 2.5 mg of indapamide hemihydrate. Each tablet is white and film-coated.

Approved indications

— Treatment of hypertension.

Dosing overview

One DAPA-TABS tablet is taken daily by oral route in the morning. The tablet should be swallowed whole and must not be chewed or crushed. The action of DAPA-TABS is progressive and whilst the optimum reduction in blood pressure is usually seen after four weeks, a further small but useful reduction in blood pressure may be observed over the following four to six weeks.

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. When liver function is impaired, thiazide-related diuretics may cause, particularly in case of electrolyte imbalance, hepatic encephalopathy which can progress to hepatic coma. Administration of the diuretic must be stopped immediately if this occurs. Diuretics should not be given with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Cases of photosensitivity reactions have been reported with thiazides and thiazide-related diuretics. It is recommended to stop treatment if a photosensitivity reaction occurs during treatment. Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss.

Contraindications

DAPA-TABS 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

DAPA-TABS tablets containing indapamide hemihydrate 2.5 mg are listed on the PBS with an ex-manufacturer price of A$4.00.

Regulatory history

DAPA-TABS indapamide hemihydrate 2.5 mg tablet was first registered on the ARTG on 21 November 1997.