Valsartan HCT Stada

Valsartan HCT Stada

valsartan + hydrochlorothiazide

Manufacturer:

Stada

Distributor:

HK Medical Supplies
/
Health Express
Concise Prescribing Info
Contents
Valsartan 80 mg, hydrochlorothiazide 12.5 mg
Indications/Uses
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to valsartan, hydrochlorothiazide & 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.
Special Precautions
Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended. Correct Na &/or vol depletion before starting treatment. Patients w/ severe chronic heart failure or other conditions w/ stimulation of the RAAS; unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; primary hyperaldosteronism; aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy; recent kidney transplantation; mild to moderate hepatic impairment w/o cholestasis. Monitor serum K, creatinine & uric acid levels in patients w/ renal impairment. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. 1st trimester of pregnancy. Lactation. Childn <18 yr. Valsartan: Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K or other agents that may increase K levels (heparin, etc). Hydrochlorothiazide: Perform periodic determination of serum electrolytes at appropriate intervals. May exacerbate or activate SLE. May alter glucose tolerance & raise serum levels of cholesterol, triglycerides & uric acid. May reduce urinary Ca excretion. Cases of photosensitivity reactions.
Adverse Reactions
Dehydration; paraesthesia; vision blurred; tinnitus; hypotension; cough; myalgia; fatigue. Valsartan: Vertigo; abdominal pain. Hydrochlorothiazide: Postural hypotension; loss of appetite, mild nausea & vomiting; urticaria & other forms of rash; impotence.
Drug Interactions
Higher frequency of adverse events through combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Increased serum lithium conc & toxicity. Increased effects of other antihypertensives (eg, ACE inhibitors, β-blockers, Ca channel blockers). Possible decreased response to pressor amines. Attenuated antihypertensive effect, worsening of renal function & increased serum K w/ NSAIDs. Valsartan: Increased K plasma levels w/ K-sparing diuretics, K supplements, salt substitutes containing K & other substances that may increase K levels. Hydrochlorothiazide: Decreased K levels w/ medicinal products associated w/ K loss & hypokalaemia (eg, kaliuretic diuretics, corticosteroids, laxatives, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid & derivatives). Risk of hypokalemia w/ medicinal products that could induce torsades de pointes. Digitalis-induced cardiac arrhythmias w/ thiazide-induced hypokalaemia or hypomagnesaemia. Increased serum Ca w/ vit D or Ca salts. Dose adjustment of antidiabetics may be necessary. Risk of lactic acidosis w/ metformin. Increased risk of hyperglycaemia w/ β blockers. Enhanced hyperglycaemic effect of diazoxide. Increased dosage of probenecid or sulfinpyrazone may be necessary. Increased hypersensitivity reactions to allopurinol. Increased bioavailability w/ anticholinergic agents. Increased risk of adverse effects of amantadine. Impaired absorption w/ anionic exchange resins. Reduced renal excretion of cytotoxic agents, potentiating their myelosuppressive effects. Potentiated action of curare derivatives. Increased risk of hyperuricaemia & gout-type complications w/ ciclosporin. Potentiated orthostatic hypotension w/ alcohol, anaesth & sedatives. Reports of haemolytic anaemia w/ methyldopa. Possible hyponatremia w/ carbamazepine. Increased risk of acute renal failure w/ high doses of iodine product.
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
Valsartan HCT Stada FC tab 80 mg/12.5 mg
Packing/Price
28's
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