irbesartan + hydrochlorothiazide




DCH Auriga - Healthcare
Four Star
Concise Prescribing Info
Per 150/12.5 mg tab Irbesartan 150 mg, hydrochlorothiazide 12.5 mg. Per 300/12.5 mg tab Irbesartan 300 mg, hydrochlorothiazide 12.5 mg. Per 300/25 mg tab Irbesartan 300 mg, hydrochlorothiazide 25 mg
Treatment of essential HTN in patients whose BP is not adequately controlled on irbesartan or hydrochlorothiazide alone. Initial therapy in patients who are likely to need multiple drugs to achieve the BP goals.
Dosage/Direction for Use
1 tab once daily. Initial therapy: One 150/12.5 mg tab once daily. May be increased after 1-2 wk. Max dose: One 300/25 mg tab once daily as needed to control BP.
May be taken with or without food.
Hypersensitivity to irbesartan, hydrochlorothiazide, or to other sulfonamide-derived substances. Severe renal or hepatic impairment; refractory hypokalaemia, hypercalcaemia; biliary cirrhosis & cholestasis. Concomitant use w/ aliskiren-containing drugs in patients w/ DM or w/ renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimester of pregnancy.
Special Precautions
Risk of symptomatic hypotension in vol- &/or Na-depleted patients; severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodic monitoring of K, creatinine & uric acid serum levels in patients w/ renal impairment. Recent kidney transplantation. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) w/ combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Not recommended in patients w/ primary aldosteronism. Not recommended in combination w/ lithium. Patients whose vascular tone & renal function depend predominantly on RAAS. Patients w/ ischemic cardiopathy or CV disease. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Mild to moderate renal impairment. Lactation. Childn. Hydrochlorothiazide: May impair glucose tolerance. Hyperuricemia or frank gout may occur. Periodic determinations of serum electrolytes should be performed. Possible positive analytic result in antidoping test. Hypersensitivity & photosensitivity reactions. Discontinue in case of acute myopia & acute angle-closure glaucoma. Increased risk of non-melanoma skin cancer. Hepatic impairment or progressive liver disease.
Adverse Reactions
Dizziness, fatigue, nausea/vomiting, abnormal urination, increase in BUN, creatine kinase & creatinine.
Drug Interactions
Increased hypotensive effects w/ other antihypertensive agents. Risk of vol depletion & hypotension w/ high dose diuretics. Increased serum conc & toxicity of lithium. K serum disturbances may affect digital glycosides & antiarrhythmics. Irbesartan: Higher frequency of adverse reactions w/ ACE inhibitors, angiotensin II blockers or aliskiren. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes, or other medicinal products that may increase serum K levels (eg, heparin Na). Attenuation of antihypertesive effect & increased risk of worsening renal function w/ NSAIDs. Hydrochlorothiazide: Potentiated serum K-depleting effect w/ other medicinal products associated w/ K loss & hypokalaemia (eg, other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G Na). Potentiated orthostatic hypotension w/ alcohol. May require dose adjustment of antidiabetic & antigout agents. Impaired absorption w/ cholestyramine & colestipol resins. Increased electrolyte depletion w/ corticosteroid & ACTH. Thiazide-induced hypokalaemia or hypomagnesaemia favour the onset of digitalis-induced cardiac arrhythmias. Possible reduced diuretic, natriuretic & antihypertensive effects w/ NSAIDs. Decreased effects of pressor amines. Increased effect of non-depolarizing skeletal muscle relaxant (eg, tubocurarine). Increased incidence of hypersensitivity reactions to allopurinol. Increased serum Ca levels w/ Ca supplements or Ca-sparing agents. Risk of symptomatic hyponatraemia w/ carbamazepine. Enhanced hyperglycaemic effect of β-blocker & diazoxide. Increased bioavailability w/ anticholinergics (eg, atropine, biperiden). Increased risk of adverse reactions of amantadine. Reduced renal excretion & enhanced myelosuppressive effects of cytotoxic agents (eg, cyclophosphamide, methotrexate).
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.
CoAprovel 150/12.5 mg tab
CoAprovel 300/12.5 mg tab
CoAprovel 300/25 mg tab
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