Aprovel卡壓舒

Aprovel

irbesartan

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Irbesartan
Indications/Uses
Treatment of essential HTN; renal disease in adult patients w/ HTN & type 2 DM as part of an antihypertensive drug regimen.
Dosage/Direction for Use
Usual initial & maintenance dose: 150 mg once daily, can be increased to 300 mg daily. Haemodialysed patients & elderly >75 yr Initiate w/ 75 mg once daily. Hypertensive type 2 diabetic patients Initiate w/ 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-containing drugs in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimester of pregnancy.
Special Precautions
Risk of symptomatic hypotension in patients who are vol- &/or Na-depleted. Correct intravascular vol depletion prior to therapy. Increased risk of renovascular HTN in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Monitor K & creatinine serum levels in patients w/ renal impairment. No experience in administration in patients w/ recent kidney transplantation. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use of ACE inhibitors, AIIAs or aliskiren. Close monitoring of serum K in patients at risk of hyperkalaemia. May induce hypoglycaemia in diabetic patient. Consider blood glucose monitoring in patients treated w/ insulin or antidiabetics. Caution in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy; patients whose vascular tone & renal function depend primarily on RAAS. Not recommended in patients w/ primary aldosteronism. Not recommended in combination w/ lithium. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. No clinical experience in patients w/ severe hepatic impairment. Not recommended during the 1st trimester of pregnancy. Not recommended during breastfeeding. Safety & efficacy in childn 0-18 yr has not been established.
Adverse Reactions
Hyperkalaemia. Dizziness, orthostatic dizziness/hypotension; nausea/vomiting; musculoskeletal pain; fatigue; increased plasma creatine kinase.
Drug Interactions
Increased hypotensive effects w/ other antihypertensive agents. Risk of vol depletion & hypotension w/ high dose diuretics. Higher frequency of adverse events w/ ACE inhibitors, AIIAs or aliskiren. Increased serum K levels w/ K supplements, K-sparing diuretics, salt substitutes containing K, or other medicinal products that may increase serum K levels (eg, heparin). Increased serum conc & toxicity of lithium. Attenuation of antihypertensive effect & increased risk of worsening renal function w/ NSAIDs. Increased repaglinide Cmax & AUC.
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 FC tab 150 mg
Packing/Price
28's
Form
Aprovel FC tab 300 mg
Packing/Price
28's
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