valsartan + hydrochlorothiazide




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
2nd-line treatment of HTN in patients whose BP is inadequately controlled by monotherapy.
Dosage/Direction for Use
May be taken with or without food.
Hypersensitivity to valsartan, hydrochlorothiazide or sulfonamide derivatives. Refractory hypokalemia; hyponatremia; hypercalcemia; symptomatic hyperuricemia. Concomitant use w/ aliskiren in diabetic type 2 patients. Severe hepatic impairment, biliary cirrhosis & cholestasis. Anuria, severe renal impairment (CrCl <30 mL/min). Pregnancy.
Special Precautions
Discontinue immediately & not to be re-administered if angioedema occurs. Allergy or asthma. Risk of hypotension in Na- &/or vol-depleted patients; unilateral or bilateral renal artery stenosis or stenosis to solitary kidney; SLE; heart failure, severe chronic heart failure or other conditions w/ renin-angiotensin-aldosterone system stimulation; conditions involving enhanced K loss; hypercalcemia. Acute angle-closure glaucoma. Increased risk of non-melanoma skin cancer. Altered glucose tolerance & raised serum levels of cholesterol, triglycerides & uric acid. Correct hypokalemia & any coexisting hypomagnesemia prior to initiation. Periodically check K, Mg & Na serum conc; creatinine & uric acid levels. Regularly check for new skin lesions; avoid excessive sun exposure. Concomitant use w/ K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs increasing K levels (eg, heparin); ACE inhibitors or aliskiren. Not to be used in severe renal or hepatic impairment, biliary cirrhosis or cholestasis. Mild to moderate hepatic impairment w/o cholestasis; moderate renal impairment. Not to be used in women of childbearing potential, during pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Valsartan: Arthralgia, asthenia, back pain, diarrhoea, dizziness, headache, insomnia, decreased libido, nausea, oedema, pharyngitis, rhinitis, sinusitis, upper resp tract & viral infections. Hydrochlorothiazide: Increased blood lipids. Hypomagnesaemia, hyperuricaemia, decreased appetite; urticaria & other forms of rash; mild nausea & vomiting; orthostatic hypotension; erectile dysfunction.
Drug Interactions
Increased lithium conc & toxicity. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ ACE inhibitors, aliskiren. Increased K levels w/ K-sparing diuretics or K supplements, K-containing salt substitutes, 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 action of other antihypertensive drugs eg, guanethidine, methyldopa, β-blockers, vasodilators, Ca-channel blockers, ACE & direct renin inhibitors, ARBs. Potentiated action of skeletal muscle relaxants eg, curare derivatives. Increased hypokalemic effects w/ kaliuretic diuretics, corticosteroids, ACTH, amphotericin, penicillin G, carbenoxolone, salicylic acid derivatives, antiarrhythmics. Intensified hyponatremic effects w/ antidepressants, antipsychotics, antiepileptics. Weakened antihypertensive effects w/ NSAIDs including COX-2 inhibitors. Altered glucose tolerance of insulin, oral antidiabetics. Thiazide-induced hypokalemia or hypomagnesemia w/ digitalis glycosides. Increased hypersensitivity reactions to allopurinol. Increased adverse effects caused by amantadine. Reduced renal excretion & enhanced myelosuppressive effects of antineoplastic agents eg, cyclophosphamide, methotrexate. Increased bioavailability w/ anticholinergic agents. Decreased absorption by cholestyramine or colestipol. Potentiated rise in serum Ca w/ vit D. Increased risk of hyperuricemia w/ cyclosporine. Hypercalcemia w/ Ca salts. Enhanced hyperglycaemic effect of diazoxide. Hemolytic anemia w/ methyldopa. Potentiated orthostatic hypotension w/ alcohol, barbiturates, narcotics. Reduce response to pressor amines.
MIMS Class
Angiotensin II Antagonists / Diuretics
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 FC tab
Co-Diovan 160/25 mg FC tab
Co-Diovan 80/12.5 mg FC tab
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