Converide

Converide

irbesartan + hydrochlorothiazide

Manufacturer:

Medochemie

Distributor:

Medochemie
Concise Prescribing Info
Contents
Per 150/12.5 mg FC tab Irbesartan 150 mg, hydrochlorothiazide 12.5 mg. Per 300/12.5 mg FC tab Irbesartan 300 mg, hydrochlorothiazide 12.5 mg
Indications/Uses
Essential HTN. Initial therapy in patients w/ moderate to severe essential HTN for whom the benefit of prompt BP reduction exceeds the risk of initiating combination therapy. Adult patients whose BP that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Dosage/Direction for Use
Initially 150/12.5 mg once daily. May increase dose to max of 300/25 mg once daily after 1-2 wk therapy as needed.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to irbesartan, hydrochlorothiazide or other sulfonamide-derived substances. Pregnancy (2nd & 3rd trimesters) & lactation. Hydrochlorothiazide: Refractory hypokalaemia, hypercalcaemia. Co-administration w/ ACE inhibitors in patients w/ diabetic nephropathy; w/ aliskiren-containing medicines in patients w/ diabetes. Severe renal impairment (CrCl <30 mL/min); co-administration w/ aliskiren-containing medicines in patients w/ moderate to severe renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment, biliary cirrhosis & cholestasis.
Special Precautions
Hypersensitivity reactions may occur in patients w/ or w/o history of allergy or bronchial asthma. Possible increased risk of non-melanoma skin cancer (basal cell carcinoma & squamous cell carcinoma) w/ increasing cumulative dose of hydrochlorothiazide exposure. Regularly check skin for any new lesions & promptly report any suspicious skin lesions; limit exposure to sunlight. Correct vol &/or Na depletion prior to therapy initiation. Increased risk of severe hypotension & renal insufficiency when patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated w/ ACE inhibitors or AIIA. Patients w/ aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Not recommended in patients w/ primary aldosteronism. Thiazide may impair glucose tolerance; may adjust dose of insulin or oral hypoglycemics in diabetic patients. May increase cholesterol & triglyceride levels w/ thiazide. Possible hyperuricaemia or may precipitate frank gout in patients receiving thiazide. Perform periodic determination of serum electrolytes at appropriate intervals. Possible +ve analytic result in anti-doping test due to hydrochlorothiazide. Patients whose vascular tone & renal function predominantly depend on renin-angiotensin-aldosterone sytem activity. Possible SLE exacerbation or activation; photosensitivity reactions w/ thiazide. Possible transient myopia & acute angle-closure glaucoma; consider prompt medical/surgical treatment if intraocular pressure remains uncontrolled. Contains lactose. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended to combine w/ ACE inhibitors or aliskiren; lithium. Dizziness or weariness may occur during treatment & may affect ability to drive vehicles or operate machines. Periodically monitor K, creatinine & serum uric acid levels in patients w/ impaired renal function. Not recommended for patients w/ severe renal dysfunction (CrCl <30 mL/min). Not indicated in patients w/ severe hepatic impairment. Patients w/ impaired hepatic function. Not recommended during the 1st trimester of pregnancy. Not recommended for use in childn & adolescents.
Adverse Reactions
Dizziness; nausea/vomiting; abnormal urination; fatigue; increased BUN, creatinine & creatine kinase. Hydrochlorothiazide: Aplastic & haemolytic anemia, bone marrow depression, leucopenia, neutropenia/agranulocytosis, thrombocytopenia; depression, sleep disturbances; light-headedness, paraesthesia, restlessness, vertigo; transient blurred vision, xanthopsia, acute myopia & secondary acute angle-closure glaucoma; cardiac arrhythmias; postural hypotension; resp distress; pancreatitis, anorexia, constipation, diarrhoea, gastric irritation, appetite loss, sialadenitis; jaundice; anaphylactic reactions, TEN, cutaneous lupus erythematosus-like reactions, necrotising angitis, photosensitivity reactions, rash, cutaneous lupus erythematosus reactivation, urticaria; muscle spasm, weakness; interstitial nephritis, renal dysfunction; fever; electrolyte imbalance, glycosuria, hyperglycemia, hyperuricemia, increased cholesterol & triglycerides.
Drug Interactions
May increase antihypertensive effect w/ other antihypertensives. Increased serum lithium conc by irbesartan. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medication that may increase serum K levels (eg, heparin Na). Attenuated antihypertensive effect w/ NSAIDs. Hydrochlorothiazide: Potentiatied orthostatic hypotension w/ alcohol, barbiturates or narcotics. May adjust dose of antidiabetics. Impaired absorption w/ colestyramine & colestipol resins. May increase electrolyte depletion w/ corticosteroids, ACTH. Possible onset of digitalis-induced cardiac arrhythmias. May reduce diuretic, natriuretic & antihypertensive effects of thiazide w/ NSAIDs. Possible decreased effect of pressor amines. May potentiate effect of nondepolarizing skeletal muscle relaxants (eg, tubocurarine). May increase incidence of hypersensitivity reactions to allopurinol; may increase serum uric acid levels. May increase serum Ca levels. Risk of symptomatic hyponatraemia w/ carbamazepine. May enhance hyperglycaemic effect of β-blockers. May increase bioavailability w/ anticholinergics (eg, atropine, beperiden). May increase risk of adverse effects caused by amantadine. May reduce renal excretion of cytotoxic medications (eg, cyclophosphamide, MTX) & potentiate myelosuppressive effects.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Converide 150/12.5 mg FC tab
Packing/Price
100 × 10's;3 × 10's
Form
Converide 300/12.5 mg FC tab
Packing/Price
100 × 10's;3 × 10's
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