Co-Diovan

Co-Diovan

valsartan + hydrochlorothiazide

Manufacturer:

Novartis

Distributor:

DCH Auriga

Marketer:

IQVIA
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
HTN in adult (≥18 yr) whose BP is not adequately controlled by monotherapy.
Dosage/Direction for Use
1 tab once daily. Usual starting dose: 160/12.5 mg once daily. May be increased after 1-2 wk to a max dose of 320 mg/25 mg. Max antihypertensive effect is seen w/in 2-4 wk.
Administration
May be taken with or without food: Do not divide into equal doses.
Contraindications
Hypersensitivity to valsartan, hydrochlorothiazide or other sulfonamide derivatives. Patient w/ anuria & biliary obstructive disorders; severe hepatic & renal impairment (GFR <30 mL/min). Pre-existing hypokalemia, hyponatremia, hyperchloremic alkalosis, hypophosphatemia, hyperuricemia. Concomitant use w/ aliskiren in patient w/ type 2 diabetes. Pregnancy & lactation.
Special Precautions
Sensitivity reactions may occur in patient w/ allergy & asthma. Regularly monitor for serum electrolyte changes. Symptomatic hypotension in Na- &/or vol depletion. Unilateral or bilateral renal artery stenosis. Biliary obstructive disorders, heart failure/post-MI; risk of acute angle-closure glaucoma. Immediately discontinue in patients who develop angioedema. May exacerbate or activate SLE; alter glucose tolerance & raise serum cholesterol & triglyceride levels; elevate serum uric acid level & cause or exacerbate hyperuricemia & precipitate gout; decrease urinary Ca excretion. Hypercalcemia. Renal & hepatic impairment. Concomitant use w/ other agents blocking the renin angiotensin system (RAS) eg, ACE inhibitors. Patients w/ severe CHF, oliguria &/or progressive azotemia. Evaluate renal function in patients w/ heart failure or post-MI. Increased risk of non-melanoma skin cancer. Regularly check skin for any new lesions. Limit exposure to sunlight. Childn <18 yr.
Adverse Reactions
Increase blood lipids in higher doses. Hypomagnesemia, hyperuricemia, decreased appetite. Orthostatic hypotension, which may be aggravated by alcohol, anesth or sedatives. Mild nausea & vomiting. Urticaria & other forms of rashes. Erectile dysfunction.
Drug Interactions
Increase serum conc & toxicity of lithium. Valsartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ agents blocking the RAS eg, ACE inhibitors or aliskiren. Concomitant use of K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that may alter K levels (eg, heparin). Attenuation of antihypertensive effect may occur w/ NSAIDs including selective COX-2 inhibitors. Increased systemic exposure w/ inhibitors of hepatic uptake transporter OATP1B1 (eg, rifampin, ciclosporin) & efflux transporter MRP2 (eg, ritonavir). Hydrochlorothiazide: Potentiate the antihypertensive action of other antihypertensives (eg, guanethidine, methyldopa, β- blockers, vasodilators, Ca channel blockers, ACE inhibitors, angiotensin receptor blockers & direct renin inhibitors). Potentiates action of skeletal muscle relaxants (eg, curare derivatives). Increased hypokalemic effect w/ kaliuretic diuretics, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives or antiarrhythmics. Intensified hyponatremic effect w/ antidepressants, antipsychotics, antiepileptics. May alter glucose tolerance (adjust dose of insulin & oral antidiabetics). Risk of thiazide-induced hypokalemia or hypomagnesemia as unwanted effects favoring the onset of digitalis-induced cardiac arrhythmias. Weakened diuretic & antihypertensive activity w/ NSAIDs (eg, salicylic acid derivative, indomethacin). Increased incidence of hypersensitivity reactions w/ allopurinol. Risk of adverse effects caused by amantadine. Reduce renal excretion of cytotoxic agents (eg, cyclophosphamide, MTX) & enhance their myelosuppressive effects. Increased (w/ anticholinergic agents eg, atropine, biperiden) or decreased (w/ prokinetic drugs eg, cisapride) bioavailability. Decreased absorption w/ cholestyramine or colestipol. May potentiate the rise in serum Ca/hypercalcemia w/ vit D or Ca salts. Increased risk of hyperuricemia & gout-type complications w/ ciclosporin. May enhance hyperglycemic effect of diazoxide. Occurrence of hemolytic anemia w/ methyldopa. Potentiated orthostatic hypotension w/ alcohol, barbiturates or narcotics. May reduce the response to pressor amines (eg, noradrenaline).
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 tab
Packing/Price
28's
Form
Co-Diovan 160/25 mg tab
Packing/Price
28's
Form
Co-Diovan 80/12.5 mg tab
Packing/Price
28's
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