Concise Prescribing Info
Contents
Irbesartan
Indications/Uses
Essential HTN. Diabetic nephropathy w/ elevated serum creatinine & proteinuria (>300 mg daily) in patients w/ type 2 diabetes & HTN.
Dosage/Direction for Use
Initial & maintenance dose: 150 mg once daily, may be increased to 300 mg or other anti-hypertensive agents can be added. Hypertensive type 2 diabetic patient Initially 150 mg once daily, titrated up to 300 mg once daily. Elderly >75 yr & haemodialysis patient Initially 75 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren-containing drugs in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimesters of pregnancy.
Special Precautions
Not recommended in primary aldosteronism & dual blockade of renin-angiotensin-aldosterone system. Bilateral renal artery stenosis or artery stenosis to single functioning kidney; aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy; hyperkalaemia; ischaemic cardiopathy or CV disease. Correct vol &/or Na depletion prior to administration. Periodic monitoring of serum K & creatinine levels, electrolytes & BP. Black patients. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in combination w/ ACE inhibitors; lithium. May affect ability to drive & use machines. Renal impairment & recent kidney transplantation. Not recommended during 1st trimester of pregnancy & lactation. Not recommended in childn & adolescents.
Adverse Reactions
Hyperkalaemia. Dizziness, orthostatic dizziness & hypotension; nausea/vomiting; musculoskeletal pain; fatigue; significant increased plasma creatine kinase.
Drug Interactions
Increased hypotensive effects w/ diuretics & other anthypertensive agents. Higher frequency of adverse events w/ ACE inhibitors or aliskiren. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other drugs increasing serum K levels eg, heparin. Reversible increased serum lithium conc & toxicity. Attenuated antihypertensive effect w/ NSAIDs eg, selective COX-2 inhibitors, ASA & non-selective NSAIDs.
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
Cruzor FC tab 300 mg
Packing/Price
3 × 10's
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