NATRILIX

What it is

NATRILIX SR is a sustained release tablet containing 1.5 mg of indapamide hemihydrate.

Approved indications

— Treatment of hypertension.

Dosing overview

One NATRILIX SR 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 NATRILIX SR 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. A larger dose than one tablet of NATRILIX SR 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, namely hyponatraemia, hypochloraemia and hypokalaemia, and blood urea, nitrogen and uric acid should also be assessed during treatment. Hyperuricaemia may occur during treatment with indapamide, and gout has been reported rarely, with 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 during treatment. Sulfonamide derivatives have been reported to exacerbate or activate systemic lupus erythematosus, and serious allergic skin reactions such as Stevens-Johnson syndrome have also occasionally been reported with sulfonamides, which should be considered when using indapamide. 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, with symptoms including acute onset of decreased visual acuity or ocular pain and typically occurring within hours to weeks of drug initiation, and untreated acute angle-closure glaucoma can lead to permanent vision loss.

Contraindications

NATRILIX 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.

Regulatory history

NATRILIX indapamide hemihydrate 2.5 mg tablet was first listed on the ARTG on 13 July 1993. NATRILIX SR indapamide hemihydrate 1.5 mg tablet was first listed on the ARTG on 7 December 1998.