Exforge HCT

Per 5/160/12.5 mg FC tab Amlodipine 5 mg, valsartan 160 mg, hydrochlorothiazide 12.5 mg. Per 10/160/12.5 mg FC tab Amlodipine 10 mg, valsartan 160 mg, hydrochlorothiazide 12.5 mg

Essential HTN.

1 tab/day. Dosage may be increased after 2 wk. Max dose: 10/320/25 mg.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ aliskiren in patients w/ type 2 diabetes. Severe renal impairment (GFR <30 mL/min). Patients w/ anuria. Pregnancy.

Symptomatic hypotension may occur in Na- &/or vol-depleted patients; unilateral/bilateral renal artery stenosis, recent kidney transplantation, hepatic impairment or biliary obstructive disorders; heart failure/post-MI, obstructive hypertrophic, cardiomyopathy; allergy & asthma; risk of acute angle-exposure glaucoma. Discontinue use if angioedema occurs. Acute MI, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Monitor for serum electrolyte changes. Hypokalemia or exacerbate pre-existing hypokalemia; hyponatremia, hypochloremic alkalosis or exacerbate pre-existing hyponatremia. May exacerbate or activate SLE; alter glucose tolerance & raise serum cholesterol & triglyceride levels; elevate serum uric acid level & cause or exacerbate hyperuricemia & precipitate gout; decrease urinary Ca excretion & cause mild elevation of serum Ca. Other agents blocking the renin angiotensin system (RAS) eg, ACE inhibitors. Childn <18 yr.

Amlodipine: Headache, somnolence, dizziness; palpitations; flushing; abdominal pain, nausea; edema, fatigue. Hydrochlorothiazide: Higher doses: Hypokalemia, increased blood lipid level. Hyponatremia, hypomagnesemia, hyperuricemia, decreased appetite; orthostatic hypotension which may be aggravated by alcohol, anesth or sedatives; mild nausea & vomiting; urticaria & other forms of rash; erectile dysfunction.

Increase serum conc & toxicity of lithium. Amlodipine: Simvastatin. CYP3A4 inducers & inhibitors; grapefruit juice. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ agents acting on the RAS eg, ARBs/ACE inhibitors or aliskiren. K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that may increase K levels (eg, heparin). Attenuation of antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors. Increased systemic exposure w/ inhibitors of hepatic uptake transporter OATP1B1 (eg, rifampin, ciclosporin) & efflux transporter MRP2 (eg, ritonavir). Hydrochlorothiazide: Potentiates the action of skeletal muscle relaxants (eg, curare derivatives) & the antihypertensive action of guanethidine, methyldopa, β-blockers, vasodilators, Ca channel blockers, ACE inhibitors, angiotensin receptor blocker & direct renin inhibitors. Increased hypokalaemic effect w/ kaliuretic diuretics, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives or antiarrhythmics. Intensified hyponatremic effect w/antidepressants, antipsychotics, antiepileptics including carbamazepine. Occurrence of thiazide-induced hypokalaemia or hypomagnesemia as unwanted effects favouring the onset of digitalis-induced cardiac arrhythmias. May alter glucose tolerance (adjust the dosage of insulin & oral antidiabetic agents); may reduce renal excretion & enhance myelosuppressive effects of cytotoxic agents (eg, cyclophosphamide, MTX); increase serum uric acid level (it may be necessary to increase dose of probenecid or sulfinpyrazone) & incidence of hypersensitivity reactions to allopurinol. Increased (w/ anticholinergic agents eg, atropine, biperiden) or decreased (w/ prokinetic drugs eg cisapride) bioavailability. Potential haemolytic anaemia w/ methyldopa. May increase the risk of adverse effects caused by amantadine. Decreased absorption w/ cholestyramine or colestipol. May potentiate the rise in serum Ca/hypercalcemia w/vit D or Ca salts; enhance the hyperglycemic effect of diazoxide; potentiate orthostatic hypotension w/ alcohol, barbiturates or narcotics; reduce the response to pressor amines eg, noradrenaline. Increased risk of hyperuricemia & gout-type complication w/ ciclosporin. Hydrochlorothiazide + ACE inhibitor: Attenuation of antihypertensive effect & risk of worsening renal function & increase in serum K w/ NSAIDs.

Angiotensin II Antagonists / Calcium Antagonists / Diuretics

C09DX01 - valsartan, amlodipine and hydrochlorothiazide ; Belongs to the class of angiotensin II receptor blockers (ARBs), other combinations. Used in the treatment of cardiovascular disease.

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