Exforge HCT

Exforge HCT

Manufacturer:

Novartis Healthcare

Distributor:

Novartis Healthcare
Concise Prescribing Info
Contents
Per 5/160/12.5 mg Amlodipine besilate 5 mg, valsartan 160 mg, hydrochlorothiazide (HCTZ) 12.5 mg. Per 5/160/25 mg Amlodipine besilate 5 mg, valsartan 160 mg, HCTZ 25 mg. Per 10/160/12.5 mg Amlodipine besilate 10 mg, valsartan 160 mg, HCTZ 12.5 mg. Per 10/160/25 mg Amlodipine besilate 10 mg, valsartan 160 mg, HCTZ 25 mg. Per 10/320/25 mg Amlodipine besilate 10 mg, valsartan 320 mg, HCTZ 25 mg
Indications/Uses
HTN. Patients whose BP is not adequately controlled on dual therapy or as replacement therapy in patients already receiving amlodipine, valsartan & hydrochlorothiazide at the same dose levels.
Dosage/Direction for Use
Adult 1 tab daily. Hepatic impairment, elderly Consider starting w/ amlodipine 5 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to amlodipine, valsartan, HCTZ or other sulfonamides. Anuria. Concomitant use w/ aliskiren in type 2 diabetes patients. Pregnancy.
Special Precautions
Risk of hypotension in Na- &/or vol-depleted patients. Renal impairment or SLE. Patients w/ hypokalemia, hyponatremia, hypercalcemia or symptomatic hyperuricemia. Unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Disturbance of serum electrolyte balance, glucose tolerance & serum levels of cholesterol, triglycerides & uric acid. Hepatic/renal impairment or biliary obstructive disorders. Discontinue immediately & do not re-administer in patients experiencing angioedema or having history of angioedema w/ other drugs. Heart failure, severe chronic heart failure or other conditions w/ stimulation of renin angiotensin-aldosterone-system. Acute MI. Aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. Acute angle-closure glaucoma. Allergy or asthma. Avoid concomitant use w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). Concomitant use w/ other agents blocking RAS eg, ACE inhibitors or aliskiren. Increased risk of non-melanoma skin cancer (NMSC) [eg, basal cell carcinoma (BCC) & squamous cell carcinoma (SCC)]. Protect skin from excessive sun exposure. Not to be used in women planning to become pregnant. Pregnancy & lactation. Not recommended in patients <18 yr.
Adverse Reactions
Amlodipine: Headache, somnolence, dizziness, palpitations, flushing, abdominal pain, nausea, edema, fatigue, insomnia, mood changes including anxiety, tremor, hypoaesthesia, dysgeusia, paresthesia, syncope, visual impairment, diplopia, tinnitus, hypotension, dyspnea, rhinitis, vomiting, dyspepsia, dry mouth, constipation, diarrhea, alopecia, hyperhidrosis, pruritus, rash, purpura, skin discoloration, photosensitivity, back pain, muscle spasm, myalgia, arthralgia, micturition disorders, nocturia, pollakiuria, gynecomastia, erectile dysfunction, asthenia, pain, malaise, chest pain, wt decreased & increased. HCTZ: Hypokalemia, increased blood lipid, hypomagnesemia, hyperuricemia, hyponatremia, urticaria, other forms of rash, decreased appetite, mild nausea & vomiting, orthostatic hypotension, erectile dysfunction.
Drug Interactions
May increase incidence of hypotension, hyperkalemia & changes in renal function w/ other agents blocking the RAS eg, ACE inhibitors or aliskiren may increase incidence of hypotension, hyperkalemia & changes in renal function. Lithium. May increase K levels w/ K sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, salt substitutes containing K or other drugs that may increase K levels (eg, heparin). Skeletal muscle relaxants (eg, curare derivatives). Other antihypertensives. Hypokalemia w/ corticosteroids, ACTH, amphotericin, penicillin G, carbenoxolone, antiarrhythmics. Hyponatremia w/ antidepressants, antipsychotics, antiepileptics. May decrease antihypertensive effects w/ NSAIDs including Cox-2. May increase systemic exposure to valsartan w/ inhibitors of the uptake transporter (eg, rifampin, ciclosporin) or efflux transporter (eg, ritonavir). Electrolyte imbalance w/ digitalis glycosides. Insulin & oral antidiabetic agents. Anionic exchange resins, allopurinol, amantadine, diazoxide, cytotoxic drugs, anticholinergic agents, vit D, Ca salts, ciclosporin, methyldopa, pressor amines (eg, noradrenaline), barbiturates, narcotics & alcohol. Amlodipine: Simvastatin. May increase plasma conc w/ CYP34A inhibitors (eg, ketoconazole, itraconazole, ritonavir). CYP3A4 inducers (eg, rifampicin, Hypericum perforatum).
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 10/320/25 mg FC tab
Packing/Price
7's
Form
Exforge HCT 5/160/25 mg FC tab
Packing/Price
7's
Form
Exforge HCT 5/160/12.5 mg FC tab
Packing/Price
7's
Form
Exforge HCT 10/160/25 mg FC tab
Packing/Price
7's
Form
Exforge HCT 10/160/12.5 mg FC tab
Packing/Price
7's
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