Indications

Irbesartan tablet is indicated for the treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.

Composition

Pharmacology

Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.

Dosage & Administration

Adult: The usual recommended initial and maintenance dose is Irbesartan 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with Irbesartan 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with Irbesartan 150 mg once daily, the dose of Irbesartan can be increased to Irbesartan 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan. In hypertensive type 2 diabetic patients, therapy should be initiated at Irbesartan 150 mg once daily and titrated up to Irbesartan 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure. Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.

Contraindications

Concomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.

Side Effects

One of the main advantages of Irbesartan is the low incidence of adverse effects, especially cough, a common effect of ACE inhibitors which work on the same reninangiotensin system. Common side effects: Headache, dizziness or light-headedness, fatigue, nausea, and vomiting. Less common: Anxiety, Nervousness, Belching, Heartburn, Stomach discomfort, Diarrhoea,  Headache, Muscle or bone pain,  Unusual tiredness.

Pregnancy & Lactation

Pregnancy : Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period. Lactation : Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.

Precautions & Warnings

Patients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.

Therapeutic Class

Angiotensin-ll receptor blocker

Storage Conditions

Store in a cool and dry place, protected from light.