COMPOSITION:
Each tablet contains 300 mg Irbesartan Each tablet contains 150 mg Irbesartan Each tablet contains 75 mg Irbesartan
PROPERTIES:
Irbesartan is an angiotensin II receptor antagonist, it is a specific competitive antagonist of ATI receptors with a much greater affinity for the ATI receptor than for the AT2 receptor and no agonist activity.
Irbesartan blocks the vasoconstrictor and aldosterone - secreting effects of angiotensin II by selectively binding to the ATI angiotensin II receptor. Irbesartan doesn't inhibit ACE, it doesn't affect the response to bradykinin.
PHARMACOKINETICS:
Irbesartan is an orally active agent that doesn't require biotransfonnation into active form - the oral absorption of Irbesartan is rapid and complete with an average absolute bioavailability of 60 - 80 % following oral administration of Irbesartan, peak plasma concentrations of Irbesartan are attained at 1.5-2 hours after dosing, food does not affect the bioavailability of Irbesartan.
The terminal elimination half-life of Irbesartan averaged 11-15 hours steady state
concentrations are achieved within 3 days.
Irbesartan is metabolized via glucuronide conjugation and oxidation.
Irbesartan and its metabolites are excreted by both biliary and renal routes.
Biliary is 90 % bound to serum proteins.
SPECIAL POPULATIONS:
Geriatric: no dosage adjustment is necessary in the elderly.
Renal insufficiency: no dosage adjustment is necessary in patients with mild to
severe renal impairment unless a patient with renal impairment is also volume depleted.
Hepatic insufficiency: no dosage adjustment is necessary in patients with hepatic insufficiency.
INDICATIONS:
Irbesartan is indicated for the treatment of hypertension, it may be used alone or in combination with other antihypertensive agents.
CONTRAINDICATIONS:
- Patients who are hypersensitive to any one of the component
- Pregnant women
SIDE EFFECTS:
The following adverse events occurred at an incidence of 1% or greater abdominal pain, anxiety, nervousness, chest pain, dizziness, edema, headache, nausea, vomiting, rash, rhinitis, tachycardia, muscle cramp, sleep disturbance, numbness, dyspnea, wheezing, and ear pain.
PRECAUTIONS:
When patient becomes pregnant, physicians should have the patient discontinue the use of Irbesartan as soon as possible.
Volume depletion should be corrected prior to administration of Irbesartan or a low starting dose should be used. 
If hypotension occurs, the patient should be placed in the supine position and if necessary, given an intravenous infusion of normal saline. Because of the potential for adverse effects on the nursing or discontinue the drug taking into account the importance of the drug to the mother.
DRUG INTERACTIONS:
The maintenance doses of warfarin, hydrochlorothiazide, or digoxin, Irbesartan administration for 7 days had no effect on the pharmacodynamics of warfarin or pharmacokinetics of digoxin.
The pharmacokinetics of Irbesartan was not affected by co-administration of nifedipine or hydrochlorothiazide.
DOSAGE AND ADMINISTRATION:
The recommended initial dose of Irbesartan is 150 mg once daily, patients
requiring further reduction in blood pressure should be titrated to 300 mg once daily.
The first dose of 75mg should preferably be used in patients with volume or sodium depletion, for example, those patints receiving treatment with high doses of diuretics or dialysis.
Irbesartan may be administrated with or without food.
PRESENTATION:
Boxes of 30 tablets75mg
Boxes of 30 tablets 150mg
Boxes of 30 tablets 300 mg