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Ibetan

Ibetan

irbesartan

Manufacturer:

Sun Pharma Industries

Distributor:

Corbridge
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. Can be increased to 300 mg in patient insufficiently controlled w/ 150 mg once daily, or other antihypertensive agents can be added. Hemodialysed patient & elderly >75 yr Consider initiation w/ 75 mg once daily. Renal disease Hypertensive type 2 diabetic patient Initially 150 mg once daily & titrate up to 300 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimesters of pregnancy. Lactation.
Special Precautions
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) through combination w/ ACE inhibitors or aliskiren is not recommended. Not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Not recommended in patients w/ primary aldosteronism. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Hyperkalemia may occur especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, &/or heart failure. Acute hypotension, azotemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of the RAAS eg, patients w/ severe CHF or underlying renal disease including renal artery stenosis. Excessive BP decrease in patients w/ ischemic cardiopathy or CV disease could result in MI or stroke. Caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Less favorable effects on renal & CV events in both women & non-white subjects w/ advanced renal disease. Less effective in lowering BP in black people. Correct vol- &/or Na-depletion (eg, in patients w/ vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting) prior to administration. Periodic monitoring of K & creatinine serum levels is recommended in patients w/ renal impairment. Combination w/ lithium is not recommended. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Dizziness or weariness may occur & should be taken into account when driving vehicles or operating machines. No experience in patients w/ severe hepatic impairment; recent kidney transplant. Not recommended during 1st trimester of pregnancy & should not be initiated during pregnancy. Safety & efficacy have not been established in childn.
Adverse Reactions
Hyperkalemia. Dizziness, orthostatic dizziness; orthostatic hypotension; nausea/vomiting; musculoskeletal pain; fatigue; significant increases in plasma creatinine kinase.
Drug Interactions
Hypotensive effects may be increased w/ other antihypertensive agents. May result in vol depletion & risk of hypotension w/ prior treatment of high dose diuretics. Higher frequency of adverse events (eg, hypotension, hyperkalemia & decreased renal function including acute renal failure) in association w/ dual blockade of the RAAS through combination w/ ACE inhibitors or aliskiren. May lead to increases in serum K w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other drugs that may increase serum K levels eg, heparin. Reversible increases in serum conc & toxicity of lithium. Antihypertensive effect may be attenuated w/ NSAIDs ie, selective COX-2 inhibitors, ASA (>3 g daily), non-selective NSAIDs. May lead to increased risk of worsening of renal function, including possible acute renal failure, & increase in serum K w/ NSAIDs in patients w/ poor pre-existing renal function.
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
Ibetan tab 150 mg
Packing/Price
28's
Form
Ibetan tab 300 mg
Packing/Price
28's
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