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Co-Diovan

Co-Diovan

valsartan + hydrochlorothiazide

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
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
Indications/Uses
2nd-line treatment of HTN in patients whose BP is inadequately controlled by monotherapy.
Dosage/Direction for Use
1 tab daily. Max: 320 mg/25 mg daily. Mild to moderate hepatic impairment w/o cholestasis Not to exceed valsartan 80 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to valsartan, hydrochlorothiazide or other sulfonamide derivatives. Refractory hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia. Concomitant use w/ aliskiren in diabetic type 2 patients. Severe hepatic & renal (CrCl <30 mL/min) impairment, biliary cirrhosis, cholestasis. anuria. Pregnancy.
Special Precautions
Discontinue immediately & not to be re-administered if angioedema occurs. Not to be administered to patients who previously experienced acute resp distress syndrome. Allergy or asthma; history of sulfonamide or penicillin allergy. Risk of symptomatic hypotension in Na- &/or vol-depleted patients; unilateral or bilateral renal artery stenosis or stenosis to solitary kidney; SLE; heart failure, severe CHF 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. Mild to moderate hepatic impairment w/o cholestasis; moderate renal impairment (CrCl >30 mL/min). Not to be used in women of childbearing potential, during pregnancy & lactation. Ped <18 yr.
Adverse Reactions
Valsartan: Arthralgia, asthenia, back pain, diarrhoea, dizziness, headache, insomnia, decreased libido, nausea, oedema, pharyngitis, rhinitis, sinusitis, URTI, viral infections. Hydrochlorothiazide: Increased blood lipids. Hypomagnesaemia, hyperuricaemia, decreased appetite; orthostatic hypotension; mild nausea & vomiting; urticaria & other forms of rash; erectile dysfunction.
Drug Interactions
Reversible 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 selective COX-2 inhibitors. Increased systemic exposure w/ rifampin, ciclosporin, ritonavir. Hydrochlorothiazide: Potentiated antihypertensive action of other antihypertensives 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. Altered glucose tolerance of insulin, oral antidiabetics. Thiazide-induced hypokalemia or hypomagnesemia w/ digitalis glycosides. Weakened antihypertensive effects w/ NSAIDs including selective COX-2 inhibitors. Increased hypersensitivity reactions to allopurinol. Increased adverse effects caused by amantadine. Reduced renal excretion & enhanced myelosuppressive effects of antineoplastics eg, cyclophosphamide, MTX. Increased bioavailability w/ anticholinergics. 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. Reduced 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.
Presentation/Packing
Form
Co-Diovan 160/12.5 mg FC tab
Packing/Price
28's
Form
Co-Diovan 160/25 mg FC tab
Packing/Price
28's
Form
Co-Diovan 80/12.5 mg FC tab
Packing/Price
28's
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