Each tablet contains Irbesartan 150 mg.
Irbesartan is a potent, orally active, selective angiotensin II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The selective antagonism of the angiotensin II (AT1) receptors results in increase in plasma renin levels and angiotensin II levels and a decrease in plasma aldosterone concentration. Serum potassium levels are not significantly affected by Irbesartan alone at the recommended doses. Irbesartan does not inhibit ACE (kininase II), an enzyme which generates angiotensin II and also degrades bradykinin into inactive metabolites. Irbesartan does not require metabolic activation for this activity.
Pharmacology: Pharmacokinetics: Irbesartan is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of 60% to 80%. Peak plasma concentrations of irbesartan occur 1.5 to 2 hours after an oral dose. Irbesartan is about 96% bound to plasma proteins. It undergoes some metabolism in the liver, primarily by the cytochrome P450 isoenzyme CYP2C9, to inactive metabolites. It is excreted as unchanged drug and metabolites in the bile and in urine; about 20% of an oral or intravenous dose is excreted in the urine, with less than 2% as unchanged drug. The terminal elimination half-life is about 11 to 15 hours.
It is used in the management of hypertension and treatment of renal disease in hypertensive diabetic patients.
The usual dose is 150 mg once daily, increased if necessary to 300 mg once daily (in hemodialysis or in elderly over 75 years, initial dose of 75 mg once daily may be used). No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Or as directed by the Physician.
No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Irbesartan (Virbez) is contraindicated in patients who are hypersensitive to any component of this product.
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting-enzyme inhibitors has been associated with oliguria and progressive azotemia and (rarely) with acute renal failure and death. Irbesartan would be expected to behave similarly.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: No overall differences in effectiveness or safety were observed between geriatric patients and younger patients.
Use in Pregnancy: Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women.
For Nursing Mothers: It is not known whether Irbesartan is excreted in human milk, but Irbesartan or some metabolic of Irbesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Adverse effects have been reported to be usually mild and transient in nature. The most common drug-related side effects were dizziness, asthenia/fatigue and vertigo. The overall incidence of side effects reported with Irbesartan was comparable to placebo.
No significant drug-drug pharmacokinetics (or pharmacodynamics) interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin and nifedipine.
Store at temperatures not exceeding 30°C. Protect from light.
C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Virbez tab 150 mg
30's (P540/box, P18/tab)
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