Concise Prescribing Info
Contents
Per 150 mg/12.5 mg FC tab Irbesartan 150 mg, hydrochlorothiazide 12.5 mg. Per 300 mg/12.5 mg FC tab Irbesartan 300 mg, hydrochlorothiazide 12.5 mg. Per 300 mg/25 mg FC tab Irbesartan 300 mg, hydrochlorothiazide 25 mg
Indications/Uses
Essential HTN in adult patients whose BP is inadequately controlled on irbesartan or hydrochlorothiazide alone.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to irbesartan, hydrochlorothiazide or other sulfonamides. Refractory hypokalaemia, hypercalcaemia. Co-administration w/ aliskiren-containing medicines in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic & renal impairment (CrCl <30 mL/min), biliary cirrhosis & cholestasis. 2nd & 3rd trimesters of pregnancy.
Special Precautions
History of allergy or bronchial asthma; sulfonamide or penicillin allergy. Not recommended in dual blockade renin-angiotensin-aldosterone system; primary aldosteronism. Symptomatic hypotension in vol- &/or Na-depleted patients eg, diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Bilateral renal artery stenosis or artery stenosis to single functioning kidney; aortic & mitral valve stenosis or obstructive hypertrophic cardiomyopathy; severe CHF; ischaemic cardiopathy or CV disease; hypertensive patients w/ type 2 DM or renal disease. Non-melanoma skin cancer; choroidal effusion, acute myopia & secondary acute angle-closure glaucoma. May impair glucose tolerance; increased cholesterol & triglycerides; precipitated hyperuricaemia or frank gout; fluid or electrolyte imbalance eg, hypokalaemia, hyponatraemia, hypochloremic alkalosis; decreased urinary Ca excretion; increased urinary Mg excretion; SLE exacerbation or activation; photosensitivity reactions. Discontinue use prior to parathyroid function tests; +ve anti-doping test. Avoid exposure to sun or artificial UVA. Not to be used concomitantly w/ ARBs in patients w/ diabetic nephropathy. Not recommended in combination w/ ACE inhibitors, AIIA or aliskiren; lithium. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes; corticosteroids or ACTH. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Black patients. May affect ability to drive & use machines. Hepatic & mild to moderate renal impairment; progressive liver disease. Not recommended during 1st trimester of pregnancy & lactation. Not recommended in childn & adolescents.
Adverse Reactions
Increased BUN, creatinine & creatine kinase; dizziness; nausea/vomiting; abnormal urination; fatigue.
Drug Interactions
Increased antihypertensive effect w/ other antihypertensive agents. Hypotension, hyperkalaemia & decreased renal function w/ aliskiren-containing products or ACE inhibitors. Reversible increased serum conc & toxicity of lithium. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes, heparin Na. Attenuated antihypertensive effect w/ NSAIDs ie, selective COX-2 inhibitors, ASA >3 g daily & non-selective NSAIDs. Increased Cmax & AUC of repaglinide. Medicinal products affected by serum K disturbances eg, digitalis glycosides, antiarrhythmics. Hydrochlorothiazide: Potentiated orthostatic hypotension w/ alcohol. Dose adjustment of antidiabetic medicinal products. Impaired absorption w/ colestyramine & colestipol resins. Increased electrolyte depletion eg, hypokalaemia w/ corticosteroids, ACTH. Thiazide-induced hypokalaemia or hypomagnaesemia w/ digitalis glycosides. Reduced diuretic, natriuretic & antihypertensive effects w/ NSAIDs. Decreased effect of pressor amines eg, noradrenaline. Potentiated effect of nondepolarizing skeletal muscle relaxants eg, tubocurarine. Raised uric acid levels w/ antigout medicinal products. Increased incidence of hypersensitivity reactions to allopurinol. Increased serum Ca levels w/ Ca salts. Risk of symptomatic hyponatraemia w/ carbamazepine. Enhanced hyperglycaemic effect of β-blockers, diazoxide. Increased bioavailability by anticholinergic agents eg, atropine, beperiden. Increased risk of adverse effects by amantadine. Reduced renal excretion & potentiated myelosuppressive effects of cytotoxic medicinal products eg, cyclophosphamide, MTX.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA04 - irbesartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Irbejub H 150 mg/12.5 mg FC tab
Packing/Price
4 × 7's
Form
Irbejub H 300 mg/12.5 mg FC tab
Packing/Price
4 × 7's
Form
Irbejub H 300 mg/25 mg FC tab
Packing/Price
4 × 7's
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