Exforge HCT

Exforge HCT

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 5/160/12.5 mg Amlodipine 5 mg, valsartan 160 mg, hydrochlorothiazide 12.5 mg. Per 10/160/12.5 mg Amlodipine 10 mg, valsartan 160 mg, hydrochlorothiazide 12.5 mg. Per 10/160/25 mg Amlodipine 10 mg, valsartan 160 mg, hydrochlorothiazide 25 mg
Dosage/Direction for Use
Adult 1 tab daily. Max: 10/320/25 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to amlodipine, valsartan, hydrochlorothiazide or sulfonamides. Anuria; refractory hypokalaemia; hyponatremia; hypercalcemia; symptomatic hyperuricemia. Patients undergoing dialysis. Concomitant use w/ aliskiren in diabetic type 2 patients. Severe hepatic & renal impairment (CrCl <30 mL/min), biliary cirrhosis, cholestasis. Pregnancy.
Special Precautions
Discontinue immediately & not to be re-administered if angioedema occurs. Not indicated as initial therapy. Allergy or asthma. Risk of hypotension in Na- &/or vol-depleted patients; unilateral or bilateral renal artery stenosis, stenosis to solitary kidney or after recent kidney transplantation; heart failure, severe chronic heart failure or other conditions w/ renin-angiotensin-aldosterone system stimulation; acute MI; severe obstructive CAD; aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy; conditions involving enhanced K loss; SLE; hypercalcemia; acute angle-closure glaucoma. Increased risk of non-melanoma skin cancer, basal & squamous cell carcinoma. Altered glucose tolerance & raised serum levels of cholesterol, triglycerides & uric acid. Avoid excessive sun exposure. Correct hypokalemia & any coexisting hypomagnesemia prior to initiation. Periodically check K, Mg & Na serum conc; creatinine & uric acid levels. Concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs increasing K levels (eg, heparin); ACE inhibitors. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment. Not recommended in hepatic impairment & biliary obstructive disorders. Not to be used in women of childbearing potential, during pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Amlodipine: Headache, somnolence, dizziness; palpitations; flushing; abdominal pain, nausea; oedema, fatigue. Valsartan: Insomnia, decreased libido, pharyngitis, rhinitis, sinusitis, upper resp tract & viral infections. Hydrochlorothiazide: Hypokalemia, increased blood lipids. Hypomagnesemia, hyperuricemia, hyponatremia, decreased appetite; orthostatic hypotension; mild nausea & vomiting; urticaria & other forms of rash; erectile dysfunction.
Drug Interactions
Increased serum lithium conc & toxicity. Amlodipine: Increased exposure to simvastatin. Increased plasma conc w/ ketoconazole, itraconazole, ritonavir. Increased exposure w/ grapefruit juice. CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ ACE inhibitors, aliskiren. Increased K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes or drugs increasing K levels eg, heparin. Attenuated antihypertensive effects w/ NSAIDs including COX-2 inhibitors. Increased systemic exposure w/ rifampin, ciclosporin, ritonavir. Hydrochlorothiazide: Potentiated antihypertensive effects of other antihypertensive drugs eg, guanethidine, methyldopa, β-blockers, vasodilators, Ca-channel blockers, ACE inhibitors, ARBs, direct renin inhibitors. Potentiated action of skeletal muscle relaxants. Increased hypokalemic effect w/ kaliuretic diuretics, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives or antiarrhythmics. Intensified hyponatremic effect w/ antidepressants, antipsychotics, antiepileptics. Altered glucose tolerance of insulin, oral antidiabetics. Thiazide-induced hypokalemia or hypomagnesemia w/ digitalis glycosides. Increased hypersensitivity to allopurinol. Increased risk of ARs by amantadine. Enhanced myelosuppressive effects of antineoplastics. Increased bioavailability w/ anticholinergics. Decreased bioavailability w/ prokinetic drugs. Decreased absorption w/ cholestyramine or colestipol. Potentiated rise in serum Ca w/ vit D or Ca salts. Increased risk of hyperuricemia & gout-type complications w/ ciclosporin. Enhanced hyperglycemic effect of diazoxide. Hemolytic anemia w/ methyldopa. Potentiated orthostatic hypotension w/ alcohol, barbiturates, narcotics. Reduced response to pressor amines.
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 FC tab
Packing/Price
28's
Form
Exforge HCT 10/160/25 mg FC tab
Packing/Price
28's
Form
Exforge HCT 5/160/12.5 mg FC tab
Packing/Price
28's
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