KARVEA

What it is

KARVEA contains irbesartan, available in tablets of 75 mg, 150 mg or 300 mg. Irbesartan is a specific antagonist of angiotensin II receptors (AT1 subtype). It 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 microalbuminuria (≥ 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. For 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.

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. Irbesartan may induce hypoglycaemia, particularly in patients treated for diabetes. Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required. Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including Irbesartan. These patients presented with abdominal pain, nausea, vomiting and diarrhoea. If intestinal angioedema is diagnosed, Irbesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.

Contraindications

Known hypersensitivity to irbesartan or any other ingredient in these tablets. 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 contraindicated.

Regulatory history

KARVEA irbesartan tablets were first listed on the ARTG on 18 May 2005, with registrations for the 150 mg and 300 mg strengths. The most recent revision to the product information was dated 27 August 2025, which included safety updates regarding intestinal angioedema.