losartan + hydrochlorothiazide


Amherst Lab


Concise Prescribing Info
Per 50/12.5 mg FC tab Losartan K 50 mg, hydrochlorothiazide 12.5 mg. Per 100/25 mg FC tab Losartan K 100 mg, hydrochlorothiazide 25 mg
HTN; for patients in whom combination therapy is appropriate.
Dosage/Direction for Use
Adult 1 tab losartan 50 mg + HCTZ 12.5 mg once daily. For patients who do not respond adequately, adjust to max dose of 1 tab losartan 100 mg + HCTZ 50 mg once daily or 2 tab losartan 50 mg + HCTZ 12.5 mg once daily.
May be taken with or without food.
Hypersensitivity to losartan, sulphonamide-derived substances (as hydrochlorothiazide). Therapy resistant hypokalemia or hypercalcemia. Severe hepatic impairment; cholestasis & biliary obstructive disorders. Refractory hyponatremia. Symptomatic hyperuricemia/gout. Severe renal impairment (ie, CrCl <30 mL/min). Anuria. Concomitant use w/ aliskiren in patients w/ type 2 diabetes. Pregnancy.
Special Precautions
Correct vol &/or Na depletion prior initiation of treatment. Electrolyte/fluid imbalances. Symptomatic hypotension. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Contains lactose. May affect ability to drive & use machines. Women of childbearing potential. Lactation. Not to be administered to childn & adolescent <18 yr. Losartan: History of angioedema; mild to moderate hepatic impairment. Closely monitor K plasma conc & CrCl values especially in patients w/ heart failure & CrCl 30-50 mL/min. Concomitant use w/ K-sparing diuretics, K supplements & K-containing salt substitutes; w/ other agents blocking the renin-angiotensin-system eg, ACE inhibitors or aliskiren. Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Recent kidney transplantation. Primary aldosteronism. CHD & cerebrovascular disease. Risk of severe arterial hypotension, & (often acute) renal impairment in patients w/ heart failure. Patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Black patients. Hydrochlorothiazide: Perform periodic determination of serum electrolytes at appropriate intervals. Dilutional hyponatremia in edematous patients. May impair glucose intolerance; latent DM. Discontinue use before carrying out tests for parathyroid function; if acute myopia & secondary angle-closure glaucoma occur. Increased cholesterol & triglyceride levels. Diuretic-induced hyperuricemia. Intrahepatic cholestasis; hepatic coma. Hypersensitivity reactions; exacerbations or activation of SLE. May cause a positive reaction to 'anti-doping' tests in athletes.
Adverse Reactions
Dizziness. Losartan: Insomnia; headache; cough, upper resp infection, nasal congestion, sinusitis, sinus disorder; abdominal pain, nausea, diarrhea, dyspepsia; muscle cramp, back & leg pain, myalgia; renal impairment & failure; asthenia, fatigue, chest pain; hyperkalemia, mild reduction of hematocrit & Hb, hypoglycemia. Hydrochlorothiazide: Cephalalgia.
Drug Interactions
Losartan: Increased incidence of hypotension, hyperkalemia & changes in renal function w/ other agents acting on the renin-angiotensin-system. Reduced active metabolite levels w/ rifampicin & fluconazole. Increased serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, or salt substitutes containing K. Reduced lithium excretion. Attenuation of antihypertensive effect & may lead to increased risk of worsening of renal function, including possible acute renal failure, & increase in serum K, especially in patients w/ poor pre-existing renal function w/ NSAIDs (ie, selective COX-2 inhibitors, ASA at anti-inflammatory doses) & non-selective NSAIDs. May increase the risk of hypotension w/ TCAs, antipsychotics, baclofen, amifostine. Hydrochlorothiazide: Potentiation of orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Dose adjustment of antidiabetics (oral agents & insulin); uricosuric medicinal products (probenecid, sulfinpyrazone). Risk of lactic acidosis w/ metformin. Additive effect w/ other antihypertensives. Impaired absorption w/ cholestyramine & colestipol resins. Intensified electrolyte depletion/imbalance, particularly hypokalemia w/ corticosteroids, ACTH; amphotericin B (parenteral), stimulant laxatives or glycyrrhizin (found in liquorice). Possible decreased response to pressor amines (eg, adrenaline). Possible increased responsiveness to skeletal muscle relaxants, nondepolarizing (eg, tubocurarine). Reduced renal clearance of lithium & high risk of lithium toxicity. May increase incidence of hypersensitivity reactions to allopurinol. Increased bioavailability by decreasing GI motility & stomach emptying rate w/ anticholinergic agents (eg, atropine, biperiden). May reduce renal excretion of cytotoxic agents (eg, cyclophosphamide, methotrexate) & potentiate their myelosuppressive effects. May enhance toxic effect of salicylates (in high dosages) on the CNS. Isolated reports of hemolytic anemia w/ methyldopa. May increase risk of hyperuricemia & gout-type complications w/ cyclosporine. Thiazide-induced hypokalemia or hypomagnesemia may favor onset of digitalis-induced cardiac arrhythmias w/ digitalis glycosides. May increase serum Ca levels due to decreased excretion. Risk of symptomatic hyponatremia w/ carbamazepine. Increased risk of acute renal failure w/ high doses of iodine contrast media.
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.
Combizar 100/25 mg FC tab
30's (P36.75/film-coated tab, P1,102.56/box)
Combizar 50/12.5 mg FC tab
30's (P777.04/box, P25.9/film-coated tab)
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