IRBESARTAN-WGR

What it is

IRBESARTAN-WGR contains irbesartan as the active ingredient, available in tablets of 75 mg, 150 mg or 300 mg. Irbesartan is a specific antagonist of angiotensin II receptors (AT1 subtype). Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting effects of angiotensin II by selective antagonism of the angiotensin II (AT1 subtype) receptors localised on vascular smooth muscle cells and in the adrenal cortex.

Approved indications

— Treatment of hypertension. — Delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (≥ 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.

Dosing overview

The usual initial and maintenance dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should have the dose increased to 300 mg once daily. In patients with hypertension and type II diabetic renal disease, 300 mg of irbesartan once daily is the preferred maintenance dose. Irbesartan may be administered with or without food. In patients with intravascular volume depletion, volume and/or sodium-depletion should be corrected before initiating therapy with irbesartan or a lower starting dose (e.g. 75 mg) should be considered. No dosage reduction is generally necessary in the elderly unless accompanied by uncorrected volume depletion. No dosage reduction is generally necessary in patients with impaired renal function (regardless of degree), unless accompanied by uncorrected volume depletion.

Key safety warnings

Irbesartan has been rarely associated with hypotension in hypertensive patients without other co-morbid conditions. Symptomatic hypotension may be expected to occur in sodium/volume-depleted patients such as those treated vigorously with diuretics and/or salt restriction or on haemodialysis. Irbesartan increases the risk of significant hyperkalaemia in hypertensive patients with type II diabetes and moderate to severe renal insufficiency. Serum potassium should be monitored regularly in such patients. Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including IRBESARTAN-WGR. Patients presented with abdominal pain, nausea, vomiting and diarrhoea. If intestinal angioedema is diagnosed, IRBESARTAN-WGR should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. The use of IRBESARTAN-WGR in patients with psoriasis or a history of psoriasis should be carefully weighed as it may exacerbate psoriasis. Irbesartan may induce hypoglycaemia, particularly in patients treated for diabetes. Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required.

Contraindications

Known hypersensitivity to irbesartan or any other ingredient in IRBESARTAN-WGR tablets is a contraindication. Do not co-administer irbesartan with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment. Do not co-administer irbesartan with ACE inhibitors in patients with diabetic nephropathy. Pregnancy is a contraindication.

Regulatory history

IRBESARTAN-WGR was first registered on the Australian Register of Therapeutic Goods on 30 May 2024, with three product registrations: 75 mg, 150 mg and 300 mg film-coated tablets in blister packs. The product information was revised on 14 August 2025, adding safety updates and adverse effects regarding intestinal angioedema.