Co-Diovan

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

Essential HTN in adults whose BP is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.

1 tab once daily.

May be taken with or without food.

Hypersensitivity to valsartan, hydrochlorothiazide, or other sulfonamide-derived medicinal products. Severe hepatic impairment, biliary cirrhosis & cholestasis; severe renal impairment (CrCl <30 mL/min), anuria; refractory hypokalaemia, hyponatraemia, hypercalcaemia, & symptomatic hyperuricaemia. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). 2nd & 3rd trimester of pregnancy.

Correct Na &/or vol depletion before starting treatment. Should not be used in patients w/ severe chronic heart failure or other conditions w/ stimulation of the renin-angiotensin-aldosterone system (RAAS); unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; primary hyperaldosteronism. Caution in patients w/ aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy; mild to moderate hepatic impairment w/o cholestasis. Periodically monitor serum K, creatinine & uric acid levels in patients w/ renal impairment. No experience on the safe use of Co-Diovan in patients who have recently undergone kidney transplantation. Occasional dizziness or weariness may occur; caution when driving vehicles or operating machines. Not recommended during breast-feeding. Not recommended in childn <18 yr. Valsartan: Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K, or other agents that may increase K levels (eg, heparin) is not recommended. Reports of angioedema. Caution in patients w/ prior hypersensitivity to AIIA. Dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is not recommended. ACE inhibitors & ARBs should not be used concomitantly in patients w/ diabetic nephropathy. Not recommended during 1st trimester of pregnancy. Hydrochlorothiazide: Perform periodic determination of serum electrolytes at appropriate intervals. Risk of hypokalaemia, hyponatraemia, hypochloraemic alkalosis, hypomagnesaemia, hypercalcaemia; exacerbation or activation of SLE; photosensitivity; non-melanoma skin cancer. May alter glucose tolerance & raise serum levels of cholesterol, triglycerides & uric acid. Hypersensitivity reactions to hydrochlorothiazide are more likely in patients w/ allergy & asthma. Associated w/ an idiosyncratic reaction resulting in choroidal effusion w/ visual field defect, acute transient myopia & acute angle-closure glaucoma. Caution in patients w/ impaired hepatic function or progressive liver disease.

Uncommon: Dehydration; paraesthesia; blurred vision; tinnitus; hypotension; cough; myalgia; fatigue. Valsartan: Uncommon: Vertigo; abdominal pain. Hydrochlorothiazide: Hypokalaemia, increased blood lipids (mainly at higher doses), hyponatraemia, hypomagnesaemia, hyperuricaemia; postural hypotension; loss of appetite, mild nausea & vomiting; urticaria & other forms of rash; impotence.

Reversible increases in serum lithium conc & toxicity. Increased effects of other agents w/ antihypertensive properties (eg, guanethidine, methyldopa, vasodilators, ACE inhibitors, ARBs, β-blockers, Ca channel blockers, direct renin inhibitors). Possible decreased response to pressor amines. Attenuated antihypertensive effect, worsening of renal function & increased serum K w/ NSAIDs. Valsartan: Higher frequency of adverse events w/ combined use of ACE inhibitors, ARBs or aliskiren. Additive effect on K levels w/ K-sparing diuretics, K supplements, salt substitutes containing K & other substances that may increase K levels. Potential increase in systemic exposure w/ OATP1B1/OATP1B3 inhibitor (eg, rifampin, ciclosporin), or MRP2 inhibitor (eg, ritonavir). Hydrochlorothiazide: Increased hypokalaemic effect w/ kaliuretic diuretics, corticosteroids, laxatives, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives. Due to risk of hypokalaemia, caution when used w/ medicinal products that could induce torsades de pointes, in particular class Ia & III antiarrhythmics & some antipsychotics. Potential intensified hyponatraemic effect w/ antidepressants, antipsychotics, antiepileptics. Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects favouring the onset of digitalis-induced cardiac arrhythmias. Potential hypercalcaemia w/ vit D or Ca salts. Dose adjustment of the antidiabetic medicinal product may be necessary. Risk of lactic acidosis w/ metformin. Increased risk of hyperglycaemia w/ β-blockers. May enhance hyperglycaemic effect of diazoxide. Dose adjustment of uricosuric medications, probenecid or sulfinpyrazone may be necessary. May increase incidence of hypersensitivity reactions to allopurinol. May increase risk of adverse effects caused by amantadine. Decreased absorption w/ cholestyramine or colestipol. May reduce renal excretion & potentiate myelosuppressive effects of cytotoxic agents (eg, cyclophosphamide, MTX). Potentiated action of skeletal muscle relaxants eg, curare derivatives. Increased risk of hyperuricaemia & gout-type complications w/ ciclosporin. Potentiated orthostatic hypotension w/ alcohol, barbiturates or narcotics. Isolated reports of haemolytic anaemia w/ methyldopa. Increased risk of acute renal failure in case of diuretic-induced dehydration, especially w/ high doses of iodine product.

Angiotensin II Antagonists / Diuretics

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.

P₁S₁S₃