Bell-Kenz Pharma


Full Prescribing Info
150 mg: Each tablet contains Irbesartan 150 mg.
Irbesartan (Virbez) is an angiotensin II receptor (AT1 subtype) antagonist. It blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. Virbez is an orally active agent that does not require biotransformation into an active form. The oral absorption of Virbez is rapid and complete with an average absolute bioavailability of 60-80%. Following oral administration of Virbez, peak plasma concentrations of Virbez are attained at 1.5-2 hours after dosing. Food does not affect the bioavailability of Virbez. The elimination half-life of Virbez averaged 11-15 hours.
300 mg: Each film-coated tablet contains: Irbesartan 300 mg.
Irbesartan is a specific competitive antagonist of AT1 receptors. The parent drug is orally active and does not require biotransformation.
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 type II Diabetes Mellitus patients.
Dosage/Direction for Use
150 mg: 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.
300 mg: Hypertension, initially 150 mg once daily, increased if necessary to 300 mg once daily.
Renal Disease in hypertensive type II Diabetes Mellitus, initially 150 mg once daily or as prescribed 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.
Irbesartan should not be given to patients with renal artery stenosis, abnormally low pressure, serious muscle damage that may lead to kidney failure, giant hives, pregnancy, decreased blood volume, high amount of potassium in blood, muscle pain and tenderness with increase creatine kinase.
Special Precautions
150 mg: 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.
300 mg: Irbesartan is contraindicated in pregnancy and should be used with care, if at all, during breast feeding. It should be used with caution in patients with renal artery stenosis. Reduced doses may be required in patients with renal impairment and should be considered in patients with hepatic impairment. Patients with volume depletion (for example those who have received high-dose diuretic therapy) may experience hypotension, which may be minimized by initiating treatment with a low dose of Irbesartan. Since hyperkalaemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment, and the concomitant use of potassium-sparing diuretics should generally be avoided.
Use In Pregnancy & Lactation
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 Reactions
150 mg: 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.
300 mg: Adverse effects of Irbesartan have been reported to be usually mild and transient, and include dizziness and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion (for example those who have received high-dose diuretics). Impaired renal function and, rarely, rash, angioedema, and raised liver enzyme values may occur. Hyperkalaemia and myalgia have been reported. Irbesartan appears less likely than ACE inhibitors to cause cough. Other adverse effects that have been reported with angiotensin II receptor antagonists include respiratory-tract disorders, back pain, gastrointestinal disturbances, fatigue, and neutropenia.
Drug Interactions
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.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Tab 150 mg x 30's. FC tab 300 mg x 30's.
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