RiteMED Irbesartan

RiteMED Irbesartan

irbesartan

Manufacturer:

XL Lab

Distributor:

RiteMED
Concise Prescribing Info
Contents
Irbesartan
Indications/Uses
HTN as monotherapy or in combination w/ other antihypertensive agents. Diabetic nephropathy w/ increased serum creatinine & proteinuria (>300 mg daily) in patients w/ type 2 DM & HTN.
Dosage/Direction for Use
HTN Initially 150 mg once daily. Titrate dose to 300 mg once daily if further reduction in BP is required. Nephropathy in Type 2 diabetic patient Initially 150 mg once daily. Maintenance dose: 300 mg once daily. Dosage in vol- & salt-depleted patient (eg, treated vigorously w/ diuretics or on hemodialysis) Initially 75 mg once daily. Elderly (>75 yr) Initially 75 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; w/ ACE inhibitors in patients w/ diabetic nephropathy. Pregnancy.
Special Precautions
Acute hypotension, azotemia, oliguria or, rarely, acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of renin-angiotensin-aldosterone system. Not recommended in patients w/ primary aldosteronism. Hypotension in vol- or salt-depleted patient. Aortic & mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Hyperkalemia. May affect ability to drive & operate machinery. Renal & severe hepatic impairment. Kidney transplantation. Lactation. Childn <6 yr. Elderly.
Adverse Reactions
Diarrhea, dyspepsia/heartburn, fatigue. Hyperkalemia, dizziness, orthostatic dizziness, orthostatic hypotension. Neutropenia, thrombocytopenia; hypersensitivity reactions eg, rash, urticaria, angioedema; headache, vertigo; tinnitus; tachycardia; edema; cough; dysgeusia, GI disturbances, nausea, vomiting; abnormal liver function, hepatitis, jaundice; leukocytoclastic vasculitis, pruritus; arthralgia, back pain, muscle cramps, musculoskeletal pain, myalgia (in some cases associated w/ increased plasma creatine kinase level), rhabdomyolysis; impaired renal function including cases of renal failure; sexual dysfunction; asthenia, chest pain; decrease in Hb; increase in LFTs, BUN, serum creatinine, plasma creatine kinase.
Drug Interactions
Increased serum K w/ K-sparing diuretics, K supplements/salt substitutes. Increase serum lithium conc & toxicity. Reduced antihypertensive effect w/ NSAIDs, ie, selective COX-2 inhibitors, aspirin >3 g daily. Dual blockade of RAAS w/ ARBs, ACE inhibitors or aliskiren is associated w/ increased risk of hypotension, hyperkalemia & changes in renal function (including acute renal failure). Do not coadminister w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Avoid concomitant use of ACE inhibitors & ARBs in patients w/ diabetic nephropathy. Prior treatment w/ high dose diuretics may result in vol depletion & risk of hypotension when initiating treatment w/ irbesartan.
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
RiteMED Irbesartan tab 150 mg
Packing/Price
20's (P17.2/tab, P344/box)
Form
RiteMED Irbesartan tab 300 mg
Packing/Price
20's (P564/box, P28.2/tab)
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