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Aprovel

Aprovel

irbesartan

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Concise Prescribing Info
Contents
Irbesartan
Indications/Uses
HTN, alone or in combination w/ other antihypertensives eg, thiazide diuretics, β-adrenergic blocking agents, long-acting Ca-channel blocking agents. Renal disease in patients w/ HTN & type 2 diabetes.
Dosage/Direction for Use
Initially 150 mg once daily. May be increased to 300 mg once daily. HTN & type 2 diabetic renal disease Maintenance: 300 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ aliskiren-containing medicines in patients w/ diabetes or w/ moderate to severe renal impairment (GFR <60 mL/min/1.73 m2); ACE inhibitors in patients w/ diabetic nephropathy.
Special Precautions
Symptomatic hypotension may occur, especially after the 1st dose, in patients who are vol- &/or Na-depleted patients by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Renal impairment & kidney transplantation. Hypertensive patients w/ type 2 diabetes & renal disease. Dual blockade of RAAS through combined use w/ ACE inhibitors or aliskiren is not recommended. Not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Hyperkalaemia may occur especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, &/or heart failure. May induce hypoglycaemia in diabetic patients. Patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; whose vascular tone & renal function depend predominantly on activity of the RAAS. Not recommended in patients w/ primary aldosteronism. Periodic monitoring of K & creatinine serum levels is recommended in patients w/ impaired renal function. Combination w/ lithium is not recommended. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Discontinue during pregnancy. Lactation. Paed population. Black people.
Adverse Reactions
Hyperkalaemia. Dizziness, orthostatic dizziness; orthostatic hypotension; nausea/vomiting; musculoskeletal pain; fatigue; increased plasma creatine kinase.
Drug Interactions
May increase serum K w/ K-sparing diuretics, K supplements, salt substitutes containing K or other medicinal products that may increase kalaemia. May attenuate antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors; may deteriorate renal function including possible acute renal failure in elderly, vol-depleted (including those in diuretic therapy), or w/ compromised renal function. Increased serum lithium conc & toxicity. Increased Cmax & AUC of repaglinide. Combination w/ aliskiren-containing medicinal products & ACE inhibitors.
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
Aprovel tab 150 mg
Packing/Price
28's (P25.75/tab, P721/pack)
Form
Aprovel tab 300 mg
Packing/Price
28's (P46.75/tab, P1,309/pack)
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