Exforge HCT

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

Essential HTN.

Adult 1 tab daily, may be increased after 2 wk. Max: Amlodipine 10 mg, valsartan 320 mg, HCTZ 25 mg Hepatic impairment, elderly Consider starting w/ amlodipine 5 mg.

May be taken with or without food.

Hypersensitivity to amlodipine, valsartan, HCTZ or other sulfonamides. Anuria. Concomitant use w/ ARBs or ACE inhibitors w/ aliskiren in type 2 diabetes patients. Pregnancy.

Risk of hypotension in Na- &/or vol-depleted patients; correction of any preexisting depletion prior initial treatment. Severe renal impairment/CKD. May increase blood urea & serum creatinine in patients w/ unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney. Recent kidney transplantation. Hepatic impairment or biliary obstructive disorders. Discontinue immediately & do not re-administer in patients who developed angioedema or have a history of angioedema w/ other drugs. Patients w/ serious CHF (NYHA functional class III-IV) or post-MI; acute MI, severe obstructive CAD; aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Correction of hypokalemia & any coexisting hypomagnesemia prior to the initiation of therapy. Monitor imbalances in electrolytes, particularly K. May precipitate new onset hyponatremia & hypochloremic alkalosis or exacerbate preexisting hyponatremia. May exacerbate or activate SLE. May alter glucose tolerance & serum levels of cholesterol, triglycerides & uric acid. May cause or exacerbate hyperuricemia & precipitate gout in susceptible patients. Hypercalcemia. Pathological changes in parathyroid gland of patients w/ hypercalcemia and hypophosphatemia on prolonged therapy. Allergy or asthma. Acute angle closure glaucoma w/ risk factors of history of sulfonamide or penicillin allergy. Dual blockade of the renin-angiotensin system. Increased risk of non-melanoma skin cancer (NMSC) [eg, basal cell carcinoma (BCC) & squamous cell carcinoma (SCC)]. Regularly check the skin for any new & suspicious skin lesions. Avoid concomitant use w/ ARBs or ACE inhibitors w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). Concomitant use w/ other agents blocking RAS eg, ACE inhibitors or aliskiren. Concomitant use w/ K supplements, K sparing diuretics, salt substitutes containing K, or other drugs that may increase K levels (eg, heparin). Protect skin & limit from excessive sun exposure. Not to be used in women planning to become pregnant. Pregnancy & lactation. Not recommended in patients <18 yr.

Amlodipine: Headache, somnolence, dizziness; palpitations; flushing; abdominal pain, nausea; edema, fatigue. HCTZ: Hypokalemia, increased blood lipid. Hyponatraemia, hypomagnesaemia, hyperuricaemia, decreased appetite; orthostatic hypotension; mild nausea & vomiting; urticaria & other forms of rash; erectile dysfunction.

Reversible increases in serum lithium conc & toxicity. Amlodipine: Increased exposure to simvastatin. May increase plasma conc w/ CYP34A inhibitors (eg, ketoconazole, itraconazole, ritonavir). Increase exposure w/ grapefruit juice. CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Valsartan: Increased incidence of hypotension, hyperkalemia, & changes in renal function w/ ARBs, ACE inhibitors or aliskiren. K supplements, K-sparing diuretics, salt substitutes containing K, or other drugs that may increase K levels (eg, heparin). Attenuation of antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors. May increase systemic exposure to valsartan w/ inhibitors of the uptake transporter (eg, rifampin, ciclosporin) or efflux transporter (eg, ritonavir). Hydrochlorothiazide: May potentiate antihypertensive action of other antihypertensive drugs (eg, guanethidine, methyldopa, β-blockers, vasodilators, Ca channel blockers, ACE inhibitors, ARBs, Direct Renin Inhibitors. Potentiate the action of skeletal muscle relaxants (eg, curare derivatives). Increased hypokalemic effect w/ kaliuretic diuretics, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, carbenoxolone, salicylic acid derivatives or antiarrhythmics. Increased hyponatremic effect w/ antidepressants, antipsychotics, antiepileptics. May alter glucose tolerance w/ antidiabetic agents. May induce hypokalemia or hypomagnesemia w/ digitalis glycosides. May decrease diuretic & antihypertensive activity w/ NSAIDs & COX-2 selective inhibitors. Co-administration may increase the incidence of hypersensitivity reactions to allopurinol. May increase the risk of adverse effects caused by amantadine. May reduce renal excretion & enhance the myelosuppressive effects of cytotoxic agents. Increased bioavailability w/ anticholinergic agents (eg, atropine, biperiden). Decreased bioavailability w/ prokinetic drugs (eg, cisapride). Decreased absorption w/ cholestyramine or colestipol. May potentiate rise in serum Ca w/ vit D or Ca salts. Increased risk of hyperuricemia & gout-type complications w/ ciclosporin. May enhance the hyperglycemic effect of diazoxide. Methlydopa. Alcohol, barbiturates or narcotics. Pressor amines (eg, noradrenaline).

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.

Rx