Artal-H

Artal-H

losartan + hydrochlorothiazide

Manufacturer:

Hiral Labs

Distributor:

AGlobal Care
Concise Prescribing Info
Contents
Losartan K 50 mg, hydrochlorothiazide 12.5 mg
Indications/Uses
Essential HTN in patients whose BP is not adequately controlled on losartan or hydrochlorothiazide alone.
Dosage/Direction for Use
Usual maintenance dose: 50 mg/12.5 mg once daily, may be increased to 100 mg/25 mg once daily in patients who do not respond adequately to 50 mg/12.5 mg. Max: 100 mg/25 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to losartan or sulphonamide-derived substances (as hydrochlorothiazide). Therapy resistant hypokalaemia or hypercalcaemia. Severe hepatic impairment, cholestasis & biliary obstructive disorders. Refractory hyponatraemia. Symptomatic hyperuricaemia/gout. Severe renal impairment (CrCl <30 mL/min). Anuria. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimester).
Special Precautions
May affect ability to drive & use machines. Not recommended during pregnancy (1st trimester) & lactation. Losartan: Angioedema. Electrolyte imbalances. Dual blockade of the renin-angiotensin-aldosterone system. Liver & renal function impairment. Patients w/ recent kidney transplantation. Primary hyperaldosteronism. CHD & cerebrovascular disease. Heart failure w/ or w/o renal impairment. Less effective in lowering BP in Blacks. Hydrochlorothiazide: Hypotension & electrolyte/fluid imbalance. Metabolic & endocrine effects. Hepatic impairment. Hypersensitivity reactions may occur w/ or w/o history of allergy or bronchial asthma. Exacerbation or activation of SLE. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Adverse Reactions
Losartan: Insomnia; headache, dizziness; cough, upper resp infection, nasal congestion, sinusitis, sinus disorder; abdominal pain, nausea, diarrhoea, dyspepsia; muscle cramp, back pain, leg pain, myalgia; asthenia, fatigue, chest pain; hyperkalaemia, mild reduction of haematocrit & Hb. Hydrochlorothiazide: Cephalagia.
Drug Interactions
Losartan: Reduced levels of active metabolites w/ rifampicin & fluconazole. Increased serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements or salt substitutes containing K. Reduced excretion of lithium. Attenuation of antihypertensive effects w/ NSAIDs (ie, selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses & non selective NSAIDs). Higher frequency of adverse events eg, hypotension, hyperkalaemia & decreased renal function (including acute renal failure) w/ ACE inhibitors. May increase risk of hypotension w/ TCAs, antipsychotics, baclofene, amifostine. Hydrochlorothiazide: Potentiation of orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Risk of lactic acidosis w/ metformin. Additive effect w/ other antihypertensives. Impaired absorption w/ cholestyramine & colestipol resins. Intensified electrolyte depletion, particularly hypokalemia w/ corticosteroids, ACTH; amphotericin B (parenteral), stimulant laxatives or glycyrrhizin (from liquorice). Possible decreased response to pressor amines (eg, adrenaline). Possible increased responsiveness to non-depolarizing skeletal muscle relaxants (eg, tubocurarine). Reduced renal clearance of lithium & increased risk of toxicity. May raise serum level of uric acid w/ uricosurics; may increase the incidence of hypersensitivity reactions to allopurinol. Increase bioavailability w/ anticholinergics (eg, atropine, biperiden). May reduced renal excretion of cytotoxics (eg, cyclophosphamide, methotrexate). May enhance toxic effects of salicylates. Isolated reports of haemolytic anaemia w/ methyldopa. May increase risk of hyperuricaemia & gout-type complications w/ cyclosporin. Serum K disturbances w/ digitalis glycosides & antiarrhythmics. Class Ia (eg, quinidine, hydroquinidine, disopyramide) & class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrythmics; some antipsychotics (eg, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol); bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV. May increase serum Ca levels w/ Ca salts & supplements. May interfere w/ tests for parathyroid function. Risk of symptomatic hyponatremia w/ carbamazepine. Increased risk of acute renal failure w/ 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.
Presentation/Packing
Form
Artal-H FC tab
Packing/Price
100's;30's
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