valsartan + hydrochlorothiazide




Zuellig Pharma
Concise Prescribing Info
Per 80/12.5 mg tab Valsartan 80 mg, hydrochlorothiazide 12.5 mg. Per 160/12.5 mg tab Valsartan 160 mg, hydrochlorothiazide 12.5 mg. Per 160/25 mg tab Valsartan 160 mg, hydrochlorothiazide 25 mg
HTN (may be used as initial therapy) in adults (≥18 yr).
Dosage/Direction for Use
1 tab daily. Initially 160/12.5 mg once daily. May be increased after 1 to 2 wk to a max of 320 mg/25 mg once daily.
May be taken with or without food.
Hypersensitivity to valsartan, hydrochlorothiazide, other sulphonamide derived drugs. Anuria. Concomitant use w/ aliskiren in patients w/ type 2 diabetes. Pregnancy.
Special Precautions
Concomitant use w/ K supplements, K-sparing diuretics, salt subsititutes containing K, or other drugs that may increase K levels (heparin); ACE inhibitors or aliskiren. Patients w/ conditions involving enhanced K loss eg, salt-losing nephropathies & pre-renal (cardiogenic) impairment of kidney function. Discontinue if hypokalemia is accompanied by clinical signs (eg, muscular weakness, paresis, or ECG alterations), angioedema occurs. Correct preexisting Na &/or vol depletion, hypokalemia & any coexisting hypomagnesemia prior to initiation of therapy. Periodically check K & Mg serum conc. Monitor for electrolyte imbalances eg, K & Na conc. Patients w/ unilateral or bilateral renal artery stenosis, biliary obstructive disorders. Severe renal (GFR <30 mL/min) & hepatic impairment. May precipitate azotemia in patients w/ chronic kidney disease. May exacerbate or activate SLE, hyperuricemia & gout. May alter glucose tolerance & raise serum levels of cholesterol & triglycerides. Hypercalcemia. Acute angle-closure glaucoma. Evaluate patients w/ heart failure/post MI should always include renal function assessment. Increased risk of non-melanoma skin cancer. Regularly check skin for any new lesions. Limit exposure to sunlight. Women of childbearing potential. Lactation.
Adverse Reactions
Dehydration; paresthesia; blurred vision; tinnitus; hypotension; cough; myalgia; fatigue. Dizziness; diarrhoea; arthralgia. Neutropenia; hypokalemia, hyponatremia; syncope; non-cardiogenic pulmonary oedema; renal impairment; increased blood uric acid, blood bilirubin, blood creatinine, blood urea.
Drug Interactions
Increased risk of toxicity of lithium. Concomitant use w/ drugs acting on RAS or ACE inhibitors w/ aliskiren. K-supplements, K-sparing diuretics, salt substitutes containing K or drugs that may alter K levels (eg, heparin). May increase risk of worsening of renal function w/ NSAIDs. Increased valsartan systemic exposure w/ uptake transporter inhibitors (eg, rifampin, ciclosporin) or efflux transporter. May potentiate skeletal muscle relaxant eg, curare derivatives action. Hypokalemic effect may be increased w/ kaliuretic diuretics, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives or antiarrhythmics. Hyponatremic effect may be intensified by antidepressants, antipsychotics, antiepileptics. Glucose tolerance may be altered w/ insulin & oral antidiabetics. Hypokalemia or hypomagnesemia may occur w/ digitalis glycosides. Diuretic & antihypertensive activity may weaken w/ NSAIDs (eg, salicylic acid derivative, indomethacin). Hypersensitivity reactions may increase w/ allopurinol. May increase risk of adverse effects caused by amantadine. Renal excretion may be reduced & enhance myelosuppresive effects of antineoplastic agents (eg, cyclophosphamide, methotrexate). Bioavailability may be increased by anticholinergics (eg, atropine, biperiden); may be decreased by prokinetics eg, cisapride. Absorption may be decreased by cholestyramine or colestipol. Rise in serum Ca may be potentiated w/ vit D or w/ Ca salts. Risk of hyperurecemia & gout complications may increase w/ ciclosporin. Hypercalcemia may occur w/ Ca salts. May enhance hyperglycaemic effect of diazoxide. Hemolytic anemia may occur w/ methyldopa. Orthostatic hypotension may be potentiated w/ alcohol, barbiturates or narcotics.
ATC Classification
C09DA03 - valsartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Co-Diovan 160/12.5 mg tab
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