NIKP-Losartan HCTZ

NIKP-Losartan HCTZ

losartan + hydrochlorothiazide

Manufacturer:

Nichi-Iko

Distributor:

DKSH
Concise Prescribing Info
Contents
Losartan K 50 mg, hydrochlorothiazide 12.5 mg
Indications/Uses
HTN; reduce the risk of stroke in patients w/ HTN & left ventricular hypertrophy.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to losartan, hydrochlorothiazide, to thiazide group drugs or similar compounds. Patients w/ anuria & dialysis patients. Patients w/ severe hepatic function disorder; acute renal failure. Patients in whom Na & K are clearly depleted in body fluids. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy.
Special Precautions
Patients w/ unilateral or bilateral renal artery stenosis; renal impairment; abnormal serum K values; history or current hepatic function disorder; cerebrovascular disorder; severe coronary or cerebral arteriosclerosis; gout or diabetes or w/ family history of those conditions; hyperuricemia; diarrhea or vomiting; hypercalcemia or hyperparathyroidism. Hypovolemic patients. Patients under limitation of salt intake. Patients being administered w/ digitalis agent, adrenal corticosteroid or ACTH. Patients after sympathectomy. Nursing infant patients. Discontinue during lactation. Elderly.
Adverse Reactions
Anaphylaxis; angioedema; acute hepatitis or fulminant hepatitis; acute renal failure; shock, fainting, loss of consciousness; rhabdomyolysis; hypokalemia, hyperkalemia; arrhythmia; pancytopenia, leucopenia & thrombopenia; aplastic anemia, hemolytic anemia; necrotizing vasculitis; interstitial lung disease, pulmonary edema; aggravation of SLE; hypoglycemia; hyponatremia; acute myopia, angle-closure glaucoma.
Drug Interactions
Increased serum K w/ K-sparing diuretic (eg, spirinolactone, triamterene), K supplement (eg, KCl). Increased risk of hypotension, hyperkalaemia & decreased renal function w/ ACE inhibitors, angiotensin II receptor blockers or aliskiren. Increased risk of orthostatic hypotension w/ barbituric acid derivatives, opium alkaloid narcotic or alcohol. Weakened action of pressor amine (eg, noradrenaline, adrenaline). Amplified neuromuscular blocking effects of tubocurarine & substances w/ similar effects (eg, tubocurarine Cl HCl hydrate, pancuronium Br). Amplified antihypertensive effects w/ β-blockers, nitroglycerin, other drugs w/ antihypertensive efects. Amplified effect of digitalis agent (eg, digoxin, digitoxin). Amplified metabolic alkalosis & hypokalaemia w/ Na lactate. Increased conc of lithium leading to lithium toxicity. Increased risk of hypokalemia w/ adrenal corticosteroid. Increased risk of decline of serum K w/ glycyrrhizinate drugs. Severely weakened action of diabetes drugs (eg, SU drugs, insulin). Weakened action of thiazide w/ cholestyramine. Weakened antihypertensive effect w/ NSAIDs (eg, indomethacin). Antagonized uric acid elimination action of sulfinpyrazone.
ATC Classification
C09DA01 - losartan 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
NIKP-Losartan HCTZ FC tab 50/12.5 mg
Packing/Price
10 × 10's
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