Irbesartan Sandoz

Irbesartan Sandoz

irbesartan

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Irbesartan
Indications/Uses
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.
Administration
May be taken with or without food.
Contraindications
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.
Presentation/Packing
Form
Irbesartan Sandoz 150 mg FC tab
Packing/Price
30's
Form
Irbesartan Sandoz 300 mg FC tab
Packing/Price
28's
Form
Irbesartan Sandoz FC tab 75 mg
Packing/Price
28's
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