Pascual Pharma Corp


Full Prescribing Info
Each tablet contains Irbesartan 150 mg and 300 mg.
Irbesartan is specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor and 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 antihypertensive agents.
Pharmacology: 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 to 80%. Peak plasma concentrations of irbesartan occur 1.5 to 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 P450 isoenzyme CYP2C9, to inactive metabolites. It is excreted as unchanged drug and metabolites in the bile and in urine. The terminal elimination half-life is about 11 to 15 hours.
Irbesartan is used in the management of hypertension including the treatment of renal disease in hypertensive diabetic patients.
Dosage/Direction for Use
In hypertension, irbesartan is given a dose of 150 mg once daily increased, if necessary, to 300 mg once daily.
A lower initial dose of 75 mg once daily may be considered in elderly patients over 75 years, for patients with intravascular volume depletion, and for those receiving hemodialysis.
Children aged 6 to 12 years with hypertension may be given a dose of 75 mg once daily, increased to 150 mg once daily if necessary.
For the treatment of renal disease in hypertensive type II diabetics, irbesartan should be given in an initial dose of 150 mg once daily, increased to 300 mg once daily for maintenance.
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 is not removed by hemodialysis.
Pregnancy and hypersensitivity to irbesartan and any component in its formulation is contraindicated in the use of the drug.
Special Precautions
Use in Pregnant Women: Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, irbesartan should be discontinued as soon as possible.
Use in Lactating Mothers: 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 administering this drug to lactating mothers.
Use in Elderly Patients: No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Use in Children: Pharmacokinetic parameters in pediatric subjects (age 6-16) were comparable to adults. At doses up to 150 mg daily for 4 weeks, irbesartan was well tolerated in hypertensive children and adolescents.
Adverse Reactions
Treatment with angiotensin II receptor antagonists is associated with dizziness and headache. Hypotension, characterized as orthostatic and dose related, was seen in patients with volume depletion such as 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. Hypersensitivity reaction such as 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 CYP 2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine. However, in clinical studies the consequences of concomitant were negligible. Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P450 isozymes 1A1, 1A2, 2A6, 286, 2D6, 2E1, or 3A4.
In separate studies of patients receiving maintenance doses of warfarin, hydrochlorothiazide, or digoxin, irbesartan administration for 7 days had no effect on the pharmacokinetics of digoxin. The pharmacokinetics of irbesartan were not affected by co-administration of nifedipine or hydrochlorothiazide.
Store at temperatures not exceeding 30°C.
Shelf-Life: 24 months.
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.
Irbepro tab 150 mg
28's (P16.7/tab)
Irbepro tab 300 mg
28's (P29/tab)
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