Irbezyd 150/Irbezyd 300

Irbezyd 150/Irbezyd 300 Special Precautions

irbesartan

Manufacturer:

Cadila Healthcare

Distributor:

Metro Drug

Marketer:

Zydus Healthcare Phils
Full Prescribing Info
Special Precautions
General: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
As observed for angiotensin converting enzyme inhibitors, Irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in nonblacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
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 (Irbezyd) tablets.
Renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with drugs that affect the renin angiotensin-aldosterone system. While this is not documented with Irbesartan (Irbezyd) tablets, a similar effect should be anticipated with angiotensin II receptor antagonists.
Renal impairment and kidney transplantation: When Irbesartan (Irbezyd) tablets is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Irbezyd (Irbesartan Tablets) in patients with a recent kidney transplantation.
Hypertensive patients with type 2 diabetes and renal disease: The effects of Irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.
Hyperkalaemia: As with other drugs that affect the renin angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan (Irbezyd) tablets, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Primary aldosteronism: Patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan (Irbezyd) tablets is not recommended.
Use in Pregnancy: The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Because of the possibility that irbesartan may have a similar effect on the fetus, it should not be used during pregnancy.
Use in Lactation: Irbesartan should be avoided in nursing mothers.
Use in Children: Irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available.
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