Exforge HCT

Exforge HCT

Manufacturer:

Novartis

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5/160/12.5 mg FC tab Amlodipine besylate 5 mg, valsartan 160 mg, hydrochlorothiazide 12.5 mg. Per 10/160/12.5 mg FC tab Amlodipine besylate 10 mg, valsartan 160 mg, hydrochlorothiazide 12.5 mg. Per 10/160/25 mg FC tab Amlodipine besylate 10 mg, valsartan 160 mg, hydrochlorothiazide 25 mg
Indications/Uses
Essential HTN. As substitution therapy in patients whose BP is adequately controlled on the combination of amlodipine, valsartan & hydrochlorothiazide, taken either as 3 single-component formulations or as a dual-component & a single-component formulation.
Dosage/Direction for Use
Administration
May be taken with or without food: Take at the same time each day & preferably in the morning. Swallow whole w/ water. Do not take w/ grapefruit or grapefruit juice.
Contraindications
Hypersensitivity to amlodipine, valsartan, hydrochlorothiazide & other sulphonamide or dihydropyridine derivatives. Severe renal impairment (GFR <30 mL/min/1.73 m2), anuria & patients undergoing dialysis. Hepatic impairment, biliary cirrhosis or cholestasis. Refractory hypokalaemia, hyponatraemia, hypercalcaemia; symptomatic hyperuricaemia. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hypotension; shock including cardiogenic shock; obstruction of outflow tract of the left ventricle (eg, hypertrophic obstructive cardiomyopathy & high grade aortic stenosis); haemodynamically unstable heart failure after acute MI. Pregnancy (2nd & 3rd trimester).
Special Precautions
Correct vol- &/or salt-depletion, hypokalemia & any coexisting hypomagnesemia, pre-existing hyponatremia prior to therapy. Monitor serum electrolytes (particularly K, Na, Mg). Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K or other drugs that may increase K levels. Periodic monitoring of serum electrolytes, creatinine & uric acid serum levels in patients w/ renal impairment. Renal artery stenosis. Kidney transplantation. Mild to moderate hepatic impairment w/o cholestasis. Discontinue use if angioedema, hypercalcaemia, or photosensitivity occurs. Patients w/ CHF, heart failure & CAD. Aortic & mitral valve stenosis. Primary hyperaldosteronism. SLE. May alter glucose tolerance & raise serum levels of cholesterol, triglycerides & uric acid. Acute transient myopia, acute angle-closure glaucoma. Avoid sunlight or artificial UVA. Prior hypersensitivity to other angiotensin II receptor antagonists. Dual blockade of the renin-angiotensin-aldosterone system. Mild to moderate influence on the ability to drive & use machines. Do not initiate during pregnancy. Lactation. Elderly ≥65 yr. Childn & adolescents <18 yr.
Adverse Reactions
Hypokalaemia, dizziness, headache, hypotension, dyspepsia, pollakiuria, fatigue, oedema.
Drug Interactions
Dual blockade of the renin-angiotensin-aldosterone system w/ ACE inhibitors, angiotensin receptor blockers, or aliskiren. Valsartan & hydrochlorothiazide: Reversible increase in serum conc & toxicity of lithium. Attenuated antihypertensive effect w/ NSAIDS. Valsartan: Increased K levels w/ K-sparing diuretics, K supplements, salt containing K. Increased systemic exposure w/ inhibitors of the uptake transporter (eg, rifampicin, ciclosporin) or efflux transporter (eg, ritonavir). Amlodipine: Increased bioavailability w/ grapefruit or grapefruit juice. Significant increase in exposure w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Lower plasma conc w/ CYP3A4 inducers (eg, anticonvulsant agents, rifampicin, St. John's wort). Increase in exposure of simvastatin. Risk of hyperkalaemia w/ dantrolene infusion. Hydrochlorothiazide: Potentiated orthostatic hypotension w/ alcohol, barbiturates or narcotics. Increased risk of adverse reactions of amantadine. Increased bioavailability of thiazide-type diuretics w/ anticholinergic agents (eg, atropine, biperiden). Thiazides may alter glucose tolerance. Risk of lactic acidosis w/ metformin. Increased risk of hyperglycaemia w/ β-blockers & diazoxide. Increased risk of hyperuricaemia & gout-type complications w/ ciclosporin. Reduced renal excretion & potentiated myelosuppressive effects of cytotoxic agents. Digitalis glycosides. Increased risk of acute renal failure w/ iodine contrasting agents. Decreased absorption of thiazide diuretics w/ cholestyramine or colestipol. Increased hypokalaemic effect w/ medicines affecting serum K level. Intensified hyponatraemic effect w/ medicine affecting serum Na level. Risk of hypokalaemia w/ medicines that could induce Torsades de pointes eg, Class Ia & III antiarrhythmics & some antipsychotics. Raised levels of serum uric acid w/ probenecid, sulfinpyrazone & allopurinol. Risk of haemolytic anaemia w/ methyldopa. Potentiated action of curare derivatives. Potentiated antihypertensive action of other antihypertensive drugs. Reduced response to pressor amines (eg, noradrenaline, adrenaline). Potentiated rise in serum Ca w/ vit D or Ca salts.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists / Diuretics
ATC Classification
C09DX01 - valsartan, amlodipine and hydrochlorothiazide ; Belongs to the class of angiotensin II receptor blockers (ARBs), other combinations. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Exforge HCT 10/160/12.5 mg fim-coated tab
Packing/Price
28's
Form
Exforge HCT 10/160/25 mg film-coated tab
Packing/Price
28's
Form
Exforge HCT 5/160/12.5 mg film-coated tab
Packing/Price
28's
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