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RiteMED Losartan

RiteMED Losartan

losartan

Manufacturer:

Sandoz

Distributor:

RiteMED
Concise Prescribing Info
Contents
Losartan K
Indications/Uses
Essential HTN in adults, childn & adolescents 6-18 yr. Renal disease in adults w/ HTN & type 2 DM w/ proteinuria ≥0.5 g daily as part of an antihypertensive treatment. Chronic heart failure in adults when treatment w/ ACE inhibitors is not considered suitable. Reduction in risk of stroke in adult hypertensive patients w/ left ventricular hypertrophy documented by ECG.
Dosage/Direction for Use
HTN Initial & maintenance dose: 50 mg once daily, may be increased to 100 mg once daily for additional benefit in some patients. Hypertensive type II diabetic patient w/ proteinuria ≥ 0.5 g daily Initially 50 mg once daily, may be increased to 100 mg once daily based on BP response from 1 mth onwards after initiation of therapy. Heart failure Initially 12.5 mg once daily, titrated at wkly intervals (ie, 12.5 mg daily, 25 mg daily, 50 mg daily, 100 mg daily, up to a max: 150 mg once daily) as tolerated. Reduction in risk of stroke in hypertensive patient w/ left ventricular hypertrophy documented by ECG Initially 50 mg once daily, increased to 100 mg once daily & added w/ a low dose hydrochlorothiazide. Patient w/ intravascular vol depletion Initially 25 mg once daily. Patient >50 kg 50 mg once daily, can be adjusted to max of 100 mg once daily in exceptional cases, >20 to <50 kg 25 mg once daily, can be increased to max of 50 mg once daily in exceptional cases.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren in patients w/ type 2 diabetes. Severe hepatic impairment. Pregnancy.
Special Precautions
Hypersensitivity. Not recommended in patients w/ primary aldosteronism. Excessive BP decrease in patients w/ ischaemic CV & cerebrovascular disease could result in MI or stroke. 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; heart failure & concomitant severe renal impairment, w/ severe heart failure (NYHA class IV) & w/ heart failure & symptomatic life-threatening cardiac arrhythmias; suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Black patients. Closely monitor patients w/ history of angioedema; patients especially those w/ heart failure & CrCl 30-50 mL/min for plasma conc of K & CrCl values. Correct vol- &/or Na-depletion prior to administration. Regularly monitor renal function particularly in presence of other conditions (eg, fever, dehydration) likely to impair renal function. Not recommended in concomitant use w/ K-sparing diuretics, K supplements & K-containing salt substitutes; ACE inhibitors. Avoid use w/ aliskiren in patients w/ severe renal impairment (GFR <30 mL/min). Concomitant use w/ β-blocker; other agents blocking the RAS eg, ACE inhibitors or aliskiren. Dizziness or drowsiness may occur which may affect ability to drive & use machines. Lactation. Not recommended in childn <6 yr; w/ hepatic impairment; w/ GFR <30 mL/min/1.73 m2.
Adverse Reactions
Dizziness. HTN: Vertigo; hyperkalaemia. Hypertensive patients w/ left ventricular hypertrophy: Vertigo; asthenia, fatigue. Chronic heart failure: Anaemia; orthostatic hypotension (including dose-related orthostatic effects); renal impairment & failure; increased blood urea, serum creatinine & serum K. HTN & type 2 diabetes w/ renal disease: Orthostatic hypotension (including dose-related orthostatic effects); asthenia, fatigue; hypoglycaemia, hyperkalaemia.
Drug Interactions
Increased incidence of hypotension, hyperkalaemia, & changes in renal function in dual blockade of the RAS w/ ACE inhibitors or aliskiren. Hypotensive action may be increased w/ other antihypertensives. May increase risk of hypotension w/ other substances which may induce hypotension eg, TCAs, antipsychotics, baclofene, & amifostene. Decreased exposure to active metabolite w/ fluconazole. Reduced plasma conc of active metabolite w/ rifampicin. May lead to increases in serum K w/ other medicinal products which retain K [eg, K-sparing diuretics (eg, amiloride, triamterene, spironolactone)] or may increase K levels (eg, heparin), K supplements or K-containing salt substitutes. Reversible increases in serum lithium conc & toxicity. Antihypertensive effect may be attenuated & may lead to 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 ie, selective COX-2 inhibitors, ASA at anti-inflammatory doses & non-selective NSAIDs.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
RiteMED Losartan tab 100 mg
Packing/Price
30's (P16.79/tab, P503.8/box)
Form
RiteMED Losartan tab 50 mg
Packing/Price
30's (P385.68/box, P12.86/tab)
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