Losarite

Losarite

losartan + hydrochlorothiazide

Manufacturer:

RiteMED

Distributor:

United Lab
Concise Prescribing Info
Contents
Per 50 mg/12.5 mg tab Losartan K 50 mg, hydrochlorothiazide 12.5 mg. Per 100 mg/25 mg tab Losartan K 100 mg, hydrochlorothiazide 25 mg
Indications/Uses
HTN for patients in whom combination therapy is appropriate.
Dosage/Direction for Use
Adult Initial & maintenance dose: One 50 mg/12.5 mg tab once daily. Patient who does not respond adequately Adjust to max dose: one 100 mg/25 mg tab daily, or two 50 mg/12.5 mg tab daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to losartan K, hydrochlorothiazide or other sulfonamide derivatives. Therapy resistant hypokalemia or hypercalcemia; refractory hyponatremia; symptomatic hyperuricemia/gout; anuria. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment, cholestasis & biliary obstructive disorders. Severe renal impairment (CrCl <30 mL/min). Pregnancy.
Special Precautions
Exercise caution when driving vehicles or operating machinery. Not to be used during pregnancy. Discontinue use as soon as possible when pregnancy is detected. Lactation. Childn. Losartan: Hypersensitivity. Not recommended in patients w/ primary hyperaldosteronism. Risk of severe arterial hypotension & often acute renal impairment in patients w/ heart failure w/ or w/o renal impairment. Patients w/ bilateral renal artery stenosis or stenosis of artery to a solitary kidney; recent kidney transplantation; ischemic CV & cerebrovascular disease; aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Black patients. Correct intravascular vol depletion prior to therapy. Closely monitor patients w/ history of angioedema. Periodically monitor renal function in susceptible patients eg, those whose renal function is dependent on the renin-angiotensin-aldosterone system (RAAS) (eg, those w/ severe cardiac insufficiency, preexisting renal dysfunction or vol depletion). Not recommended in concomitant use w/ K-sparing diuretics, K supplements & K-containing salt substitutes or other drugs that may increase serum K eg, trimethoprim-containing products. Avoid concomitant use w/ ACE inhibitors in patients w/ diabetic nephropathy. Not to be administered in severe hepatic impairment. History of hepatic impairment. Hydrochlorothiazide: Hypersensitivity reactions may occur in patients w/ or w/o history of allergy or bronchial asthma. History of sulfonamide or penicillin allergy. Discontinue use in case of an idiosyncratic reaction resulting in transient myopia & acute angle-closure glaucoma; prior to taking parathyroid function test. Exacerbation or activation of SLE. May impair glucose tolerance; decrease urinary Ca excretion & cause intermittent & slight elevation of serum Ca; increase cholesterol & triglyceride levels. Increased urinary excretion of Mg which may result in hypomagnesemia. Hyperuricemia may occur or acute gout may be precipitated. Antihypertensive effects may be enhanced in postsympathectomy patients. Increased risk of non-melanoma skin cancer (basal & squamous cell carcinoma). Regularly monitor serum electrolytes. Observe patients for clinical signs of fluid or electrolyte imbalance eg, vol depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia, or hypokalemia. Renal disease resulting in severe renal impairment. Hepatic or progressive liver disease.
Adverse Reactions
Dizziness; upper resp infection; cough; back pain.
Drug Interactions
Losartan: Increased serum lithium conc & toxicity. May lead to increases in serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements, K-containing salt substitutes, or other medicines that may increase serum K (eg, trimethoprim-containing products). Antihypertensive effect may be reduced & may result in increased risk of worsening of renal function (including possible acute renal failure) & an increase in serum K particularly in patients w/ poor preexisting renal function w/ NSAIDs eg, selective COX-2 inhibitors & non-selective NSAIDs. Increased risk of hypotension, hyperkalemia & changes in renal function in dual blockade of the RAAS w/ ACE inhibitors or aliskiren. May increase risk of hypotension w/ TCAs, antipsychotics, baclofen, amifostine. Decreased conc including its active metabolite w/ rifampicin & fluconazole. Hydrochlorothiazide: Potentiated orthostatic hypotension w/ alcohol, barbiturates, or narcotics. Increased risk of adverse effects w/ amantadine. Potentiated aminoglycoside nephrotoxicity w/ diuretic-induced vol depletion. Bioavailability may be increased w/ anticholinergic agents eg, atropine, biperiden. Adjust dose of antidiabetics (eg, insulin, hypoglycemic agents) as thiazides may impair glucose tolerance. May enhance hyperglycemic effect of diazoxide. Adjust dose of antigout medication as hydrochlorothiazide may raise level of serum uric acid & hypersensitivity reaction w/ allopurinol. Increased serum Ca levels due to decreased excretion. Symptomatic hyponatremia may occur w/ carbamazepine. Thiazide-induced hypokalemia or hypomagnesemia may favor onset of digitalis-induced cardiac arrhythmias. Impaired absorption w/ cholestyramine & colestipol resins. Intensified electrolyte depletion/imbalance particularly hypokalemia w/ corticosteroids, ACTH, amphotericin B (parenteral), stimulant laxative, or glycyrrhizin (found in liquorice). Decreased renal excretion & increased myelosuppressive effects w/ cytotoxics eg, cyclophosphamide, MTX. May increase risk of hyperuricemia & gout-type complications w/ ciclosporin. Increased serum lithium conc & risk of lithium toxicity. Possible decreased response to pressor amines eg, epinephrine. Diuretic, natriuretic & antihypertensive effects may be reduced w/ NSAIDs including COX-2 inhibitors. Possible increased responsiveness to non-depolarizing skeletal muscle relaxants eg, tubocurarine. May potentiate hyponatremia w/ SSRIs eg, citalopram, escitalopram, sertraline. Additive hypokalemia w/ & may increase serum conc of topiramate. Increased risk of acute renal failure w/ large doses of iodine contrast media. Additive effect w/ other antihypertensives.
MIMS Class
Angiotensin II Antagonists / Diuretics
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
Losarite tab 100 mg/25
Packing/Price
50's (P16.25/tab, P812.5/box)
Form
Losarite tab 50 mg/12.5 mg
Packing/Price
50's (P13.25/tab, P662.5/box)
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