Irbesartan Sandoz

Irbesartan Sandoz





Agencia Lei Va Hong
Concise Prescribing Info
Essential HTN in adults. Renal disease in adults w/ HTN & type 2 DM as part of antihypertensive regimen.
Dosage/Direction for Use
150 mg once daily, can be increased to 300 mg. Hypertensive w/ type 2 DM Initially 150 mg titrated to 300 mg once daily. Haemodialysed patients & elderly >75 yr Initially 75 mg.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimester).
Special Precautions
Patients who are vol- &/or Na-depleted. Increased risk of renovascular HTN in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE inhibitors, AIIAs or aliskiren. Closely monitor serum K in patients w/ renal impairment, overt proteinuria due to diabetic renal disease &/or heart failure. Patients w/ aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; primary aldosteronism; patients whose vascular tone & renal function depend predominantly on the activity of RAAS. Patients w/ recent kidney transplantation. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Combination w/ lithium is not recommended. May affect ability to drive or operate machinery. Black patients. Not recommended during the 1st trimester of pregnancy. Lactation. Childn <18 yr.
Adverse Reactions
Hyperkalaemia (especially in diabetic patients). Dizziness, orthostatic dizziness; orthostatic hypotension; nausea/vomiting; musculoskeletal pain; fatigue; significant increase in plasma creatine kinase.
Drug Interactions
Increased hypotensive effects w/ other antihypertensives. Higher frequency of adverse reactions w/ ACE inhibitors, AIIAs or aliskiren. Vol depletion & risk of hypotension w/ high dose diuretics. Increased serum K w/ K-sparing diuretics, K supplements, salt substitutes containing K or products that may increase K level (eg, heparin). Reversible increase in serum lithium conc & toxicity of lithium. Increased risk of worsening of renal function, increase serum K & attenuation of antihypertensive effect w/ NSAIDs (ie, selective COX-2 inhibitors, acetylsalicylic acid >3 g/day & non-selective NSAIDs).
ATC Classification
C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Irbesartan Sandoz 150 mg FC tab
Irbesartan Sandoz 300 mg FC tab
Irbesartan Sandoz FC tab 75 mg
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in