Novell Pharma


Averroes Pharma
Concise Prescribing Info
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 as preferred maintenance dose for renal disease treatment. Elderly >75 yr & haemodialysis patient Initially 75 mg.
May be taken with or without food.
Hypersensitivity. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Not recommended in patients w/ primary aldosteronism. Patients w/ aortic & mitral valve stenosis or obstructive hypertrophic cardiomyopathy; ischaemic cardiopathy or ischaemic CV disease. Hyperkalaemia. Bilateral renal artery stenosis or stenosis of artery to single functioning kidney. Monitor serum K & creatinine levels, electrolytes & BP. Correct vol &/or Na depletion prior to therapy. Not recommended in combination w/ ACE inhibitors, ARBs or aliskiren; lithium. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Black patients. 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, increased plasma creatine kinase; tachycardia; orthostatic hypotension, flushing; headache, dizziness; cough, upper resp infection; nausea, vomiting, diarrhoea, dyspepsia/heartburn, dysgeusia; fatigue; renal impairment; urticaria, leukocytoclastic vasculitis; arthralgia, myalgia, rhabdomyolysis, muscle cramps; hypersensitivity reactions; hepatitis, abnormal hepatic function, cholestasis, jaundice; thrombocytopenia; sexual dysfunction; tinnitus.
Drug Interactions
Increased hypotensive effects w/ diuretics & other antihypertensive agents. Increased risk of hypotension, hyperkalaemia & decreased renal function w/ ACE inhibitors, ARBs or aliskiren. Increased serum K levels w/ K-sparing diuretics, K supplements & K-containing salt substitutes; NSAIDs. Increased serum lithium conc & toxicity.
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.
Irbevell FC tab 300 mg
10 × 10's;2 × 10's;3 × 10's
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