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Indications/Uses
Management of hypertension including the treatment of renal disease in hypertensive diabetic patients.
Dosage/Direction for Use
Hypertension: 150 mg once daily, increased to 300 mg once daily, if necessary.
Elderly >75 Years, Patients with Intravascular Volume Depletion and Those Receiving Hemodialysis: A lower initial dose of 75 mg once daily may be considered.
Children 6-12 Years: 75 mg once daily, increased to 150 mg once daily, if necessary.
Renal Disease in Hypertensive Type II Diabetes: Initial Dose: 150 mg once daily, increased to 300 mg once daily for maintenance.
Elderly >75 Years, Patients with Intravascular Volume Depletion and Those Receiving Hemodialysis: A lower initial dose of 75 mg once daily may be considered.
Children 6-12 Years: 75 mg once daily, increased to 150 mg once daily, if necessary.
Renal Disease in Hypertensive Type II Diabetes: Initial Dose: 150 mg once daily, increased to 300 mg once daily for maintenance.
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. Irbesartan is not removed by hemodialyis.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to irbesartan and any component of Irvex.
Use in pregnancy. Drugs that act directly on the renin-angiotensin system can cause fatal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, irbesartan should be discounted as soon as possible.
Use in pregnancy. Drugs that act directly on the renin-angiotensin system can cause fatal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, irbesartan should be discounted as soon as possible.
Special Precautions
Use in lactation:The excretion of irbesartan in breast milk has not yet been established. In a study done in animals, irbesartan was found to pass into the milk of lactating rats. Thus, caution should be taken when adminstering Irvex to lactating mothers.
Use in children: Pharmacokinetic parameters in pediatric subjects (6-16 years) were comparable to adults. At doses up to 150 mg daily for 4 weeks, irbesartan was well-tolerated in hypertensive children and adolescents.
Use in the elderly: No overall differences in effectiveness or safety were observed between this subjects and younger subjects but greater sensitivity of some older individuals cannot be ruled out.
Use in children: Pharmacokinetic parameters in pediatric subjects (6-16 years) were comparable to adults. At doses up to 150 mg daily for 4 weeks, irbesartan was well-tolerated in hypertensive children and adolescents.
Use in the elderly: No overall differences in effectiveness or safety were observed between this subjects and younger subjects but greater sensitivity of some older individuals cannot be ruled out.
Use In Pregnancy & Lactation
Use in pregnancy. Drugs that act directly on the renin-angiotensin system can cause fatal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, irbesartan should be discounted as soon as possible.
Use in lactation:The excretion of irbesartan in breast milk has not yet been established. In a study done in animals, irbesartan was found to pass into the milk of lactating rats. Thus, caution should be taken when adminstering Irvex to lactating mothers.
Use in lactation:The excretion of irbesartan in breast milk has not yet been established. In a study done in animals, irbesartan was found to pass into the milk of lactating rats. Thus, caution should be taken when adminstering Irvex to lactating mothers.
Adverse Reactions
Treatment with angiotension II receptor antagonists is associated with dizziness and headache. Hypotension, characterized as orthostatic and dose-related, was seen in patients with volume depletion eg, those receiving high-dose diuretics.
Other adverse effects associated with the use of irbesartan include gastrointestinal disturbance, fatigue, muscle and joint pains, congestion, hyperkalemia, back pain, vertigo, migraine, cough, acute pancreatitis and increase in liver enzymes.
Hypertsensitivity reactions eg, rash, urticaria, pruritus and angioedema have been reported with the use of irbesartan.
Other adverse effects associated with the use of irbesartan include gastrointestinal disturbance, fatigue, muscle and joint pains, congestion, hyperkalemia, back pain, vertigo, migraine, cough, acute pancreatitis and increase in liver enzymes.
Hypertsensitivity reactions eg, rash, urticaria, pruritus and angioedema have been reported with the use of irbesartan.
Drug Interactions
No significant drug-drug pharmacokinetic (or pharmacodynamic) interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin and nifedipine.
In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine. However, in clinical studies, the consequences of concomitant irbesartan on the pharmacodynamics of warfarin were negligible. Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P-450 isozymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1 or 3A4.
In seperate studies of patients recieving maintenance doses of warfarin, hydrochlorothiazide or digoxin, irbesartan administration for 7 days had no effect on the pharmacodynamics of warfarin (prothrombin time) or pharmacokinetics of digoxin. The pharmacokinetics of irbesartan were not affected by co-administration of nifedipine or hydrochlorothiazide.
In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine. However, in clinical studies, the consequences of concomitant irbesartan on the pharmacodynamics of warfarin were negligible. Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P-450 isozymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1 or 3A4.
In seperate studies of patients recieving maintenance doses of warfarin, hydrochlorothiazide or digoxin, irbesartan administration for 7 days had no effect on the pharmacodynamics of warfarin (prothrombin time) or pharmacokinetics of digoxin. The pharmacokinetics of irbesartan were not affected by co-administration of nifedipine or hydrochlorothiazide.
Storage
Store at temperatures not exceeding 30°C.
Action
Irbesartan is a specific competitive antagonist of angiotensin I (AT1) receptors with a much greater affinity (>8500-fold) for the AT1 receptors than for the AT2 receptor with no agonist activity. It is a potent antihypertensive drug which is administered orally, and may be given alone or in combination with diuretics and/or other antihypertinsive agents.
Pharmacokinetics: Irbesartan is an orally active agent that does not require biotransformation into an active form. It is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of 60-80%. Peak plasma concentrations of irbesartan occur 1.5-2 hrs after an oral dose. Irbesartan is about 96% bound to plasma proteins. It undergoes some metabolism in the liver, primarily by the cytochrome P-450 isoenzyme CYP2C9, to inactive metabolites. It is excreted as unchanged drug and metabolites in the bile and in urine. The terminal elimination t½ is about 11-15 hrs.
Pharmacokinetics: Irbesartan is an orally active agent that does not require biotransformation into an active form. It is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of 60-80%. Peak plasma concentrations of irbesartan occur 1.5-2 hrs after an oral dose. Irbesartan is about 96% bound to plasma proteins. It undergoes some metabolism in the liver, primarily by the cytochrome P-450 isoenzyme CYP2C9, to inactive metabolites. It is excreted as unchanged drug and metabolites in the bile and in urine. The terminal elimination t½ is about 11-15 hrs.
MedsGo Class
Angiotensin II Antagonists
Features
Brand
Irvex
Full Details
Dosage Strength
300mg
Drug Ingredients
- Irbesartan
Drug Packaging
Tablet 1's
Generic Name
Irbesartan
Dosage Form
Tablet
Registration Number
DRP-3871
Drug Classification
Prescription Drug (RX)