PREXUM

What it is

Prexum Combi contains perindopril arginine and indapamide hemihydrate as active components. The Prexum Combi LD 2.5/0.625 tablet contains 2.5 mg of perindopril arginine and 0.625 mg of indapamide hemihydrate. The Prexum Combi 5/1.25 tablet contains 5 mg of perindopril arginine and 1.25 mg of indapamide hemihydrate.

Approved indications

— Treatment of hypertension.

Dosing overview

Treatment should be started at the normal dose of one Prexum Combi LD 2.5/0.625 tablet per day as a single dose, preferably to be taken in the morning before a meal. In cases where target blood pressure is not achieved, the dose should be titrated to one tablet of Prexum Combi 5/1.25 daily. Treatment should not be initiated with the combination 5/1.25. The initial dose in the elderly should always be one tablet of Prexum Combi LD 2.5/0.625 daily, and patients should be monitored closely during the initial stages of treatment. In patients with moderate renal insufficiency (creatinine clearance 30–60 mL/min), the maximum dose should be one tablet of Prexum Combi LD 2.5/0.625 daily.

Key safety warnings

Patients should be monitored for signs and symptoms of fluid or electrolyte imbalance; namely hyponatraemia, hypochloraemia, hyperuricaemia, hyperkalaemia and hypokalaemia. Plasma, urea and uric acid levels should also be monitored during treatment. The combination of perindopril and indapamide does not prevent the onset of hypokalaemia particularly in patients with diabetes or in patients with renal failure. As with any antihypertensive agent in combination with a diuretic, regular monitoring of plasma potassium levels should be carried out. Life-threatening angioedema has been reported with most ACE inhibitors. The overall incidence is approximately 0.1%–0.2%. Angioedema of the face, extremities, lips, tongue, mucous membranes, glottis and/or larynx has been reported in patients with ACE inhibitors and has been reported uncommonly with perindopril. A persistent dry irritating cough has been reported with most of the ACE inhibitors. The frequency of reports has been increasing since cough was first recognised as a class-effect of ACE inhibitor treatment with the incidence of cough varying depending upon the ACE inhibitor, dosage and duration of use. The incidence of cough reported following administration of a dose of perindopril and indapamide equivalent to Prexum Combi LD 2.5/0.625 was 4.4%.

Contraindications

Prexum Combi 5/1.25 and Prexum Combi LD 2.5/0.625 are contraindicated in patients with a history of previous hypersensitivity to either of the active ingredients, perindopril or indapamide, or excipient ingredients present in Prexum Combi. They are contraindicated during pregnancy and for lactating women. In cases of severe renal insufficiency (creatinine clearance below 30 mL/min), the treatment is contraindicated. In severe hepatic impairment, treatment is contraindicated. Prexum Combi is contraindicated in patients with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous ACE inhibitor treatment. Prexum Combi is contraindicated in patients with hypokalaemia. Combined use with sacubitril/valsartan fixed dose combinations is contraindicated—Prexum Combi must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan.

PBS listing

No source document contains Australian Pharmaceutical Benefits Scheme listing information for Prexum.

Regulatory history

Prexum Combi 5/1.25 (perindopril arginine / indapamide hemihydrate) was first listed on the ARTG on 13 August 2012. Prexum Combi LD 2.5/0.625 (perindopril arginine 2.5 mg / indapamide hemihydrate 0.625 mg) was first listed on the ARTG on 12 October 2016.