Each tablet contains: Irbesartan 150 mg and Hydrochlorothiazide 12.5 mg.
Irbesartan is a specific competitive antagonist of Angiotensin-II receptor (AT1 subtype). The parent drug is orally active and does not require biotransformation.
Hydrochlorothiazide is a moderately potent diuretic for treating hypotension. Its main action is the inhibition of the NaCl reabsorption in the distal convoluted tubules of the kidney.
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 2% as unchanged drug. The terminal elimination half-life is about 11 to 15 hours. Hydrochlorothiazide is fairly rapidly absorbed from the gastrointestinal tract. It is reported to have bioavailability of about 65 to 75%. It has been estimated to have plasma half-life of between about 5 and 15 hours and appears to be preferentially bound to red blood cells. It is excreted mainly unchanged in the urine. Hydrochlorothiazide crosses the placental barrier and distributed into breast milk.
For the treatment of primary or secondary lipid disorders, secondary prevention of coronary artery disease: Primary prevention in patients at high risk for coronary artery disease.
1 tablet once daily; 150 mg/12.5 mg may be administered when BP is not adequately controlled with hydrochlorothiazide or Irbesartan 150 mg alone. If necessary, it may be administered with another antihypertensive drugs. If patient is not sufficiently controlled. Or as prescribed by the physician.
Irbesartan is contraindicated in pregnancy and should be used with care, if at all, during breast feeding. It should be used with caution in patients with renal artery stenosis. Reduced doses may 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, which may be minimized initiating treatment with a low dose of Irbesartan. 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.
Hydrochlorothiazides should not be given to patients with Addison's disease and should be given with caution renal impairment since they can further reduce renal function.
Irbesartan have been reported to be usually mild and transient, and include dizziness and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion (for example those who have received high-dose diuretics). Impaired renal function and, rarely, rash, angioedema, and raised liver enzyme values may occur. Hyperkalaemia and myalgia 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.
Hydrochlorothiazide and other thiazide diuretics may cause a number of metabolic disturbances especially at high doses. They may provoke hyperglycemia and glycosuria in diabetic and other susceptible patients.
Store at temperatures not exceeding 30°C.
C09DA04 - irbesartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.