Irbezil

Irbezil

irbesartan

Manufacturer:

Aurochem Lab

Distributor:

Endure Medical
Full Prescribing Info
Contents
Irbesartan.
Description
Each film coated tablet contains Irbesartan 300 mg.
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. It undergoes some metabolism in the liver. primarily by the cytochrome P450 isoenzvme 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.
Indications/Uses
It is used in the management of hypertension including the treatment of renal disease in hypertensive diabetic patients.
Dosage/Direction for Use
Hypertension: Initially 150 mg once daily, increased necessary to 300 mg once daily.
Renal disease in hypertension type 2 diabetes mellitus: Initially 150 mg once daily increased according to response to 300 mg once daily.
Haemodialysis or in elderly over 75 years: Initial dose of 75 mg once daily may be used.
Contraindications
Irbesartan is contraindicated in pregnancy.
Special Precautions
It should be used with caution in patients with renal artery stenosis.
Irbesartan is excreted in urine and in bile and reduced doses may therefore 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; volume depletion should be corrected before starting therapy, or a low initial dose should be used. 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.
Adverse Reactions
Adverse effects of Irbesartan have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension.
Hypotension may occur particularly in patient with volume depletion (for example those who have received high dose diuretics). Impaired renal function and, rarely, rash, urticaria, pruritus, angioedema, and raised liver enzyme values may occur. Hyperkalaemia, myalgia, and arthralgia 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. Rhabdomyolysis has been reported rarely.
Drug Interactions
The antihypertensive effects of irbesartan may be potentiated by drugs or other agents that lower blood pressure.
An additive hyperkalaemic effect is possible with potassium supplements, potassium-sparing diuretics, or other drugs that can cause hyperkalaemic; Irbesartan and potassium-sparing diuretics should not generally be given together.
Irbesartan and some other angiotensin II receptor antagonists are metabolized by cytochrome P450 isoenzymes and interactions may occur with drugs that affect these enzymes.
Storage
Store at temperatures not exceeding 30°C.
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.
Presentation/Packing
Form
Irbezil FC tab 150 mg
Packing/Price
100's;10's
Form
Irbezil FC tab 300 mg
Packing/Price
100's;10's
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