Indications/Uses
It is used in the management of hypertension and treatment of renal disease in hypertensive diabetic patients.
Dosage/Direction for Use
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.
Or as directed by the Physician.
Overdosage
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.
Administration
May be taken with or without food.
Contraindications
Irbesartan (Virbez) is contraindicated in patients who are hypersensitive to any component of this product.
Special Precautions
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 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 & 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.
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
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.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
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.
MedsGo Class
Angiotensin II Antagonists
Features
Brand
Virbez
Full Details
Dosage Strength
150mg
Drug Ingredients
- Irbesartan
Drug Packaging
Tablet 1's
Generic Name
Irbesartan
Dosage Form
Tablet
Registration Number
DRP-5686
Drug Classification
Prescription Drug (RX)