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Besartan

Besartan

losartan

Manufacturer:

Paradigm Pharma

Distributor:

Littman
Concise Prescribing Info
Contents
Losartan K
Indications/Uses
Essential HTN in adults & in 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. Reduction in the 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. Some patients may receive additional benefit by increasing to 100 mg once daily (in the morning). Hypertensive type II diabetic patients 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 therapy initiation. Heart failure Initially 12.5 mg once daily, dose generally titrated at wkly intervals (ie, 12.5 mg daily, 25 mg daily, 50 mg daily, 100 mg daily, up to max dose: 150 mg once daily) as tolerated by patient. Reduction in the risk of stroke in hypertensive patients w/ left ventricular hypertrophy documented by ECG Initially 50 mg once daily. Add low dose hydrochlorothiazide &/or increase losartan dose to 100 mg once daily based on BP response. Patient w/ intravascular vol depletion Initially 25 mg once daily. Childn 6-18 yr weighing >50 kg 50 mg once daily, can be adjusted in exceptional cases to max of 100 mg once daily, weighing >20-<50 kg 25 mg once daily, can be increased in exceptional cases to 50 mg once daily. Elderly >75 yr Consider initiating therapy w/ 25 mg.
Administration
May be taken with or without food: Swallow whole w/ a glass of water.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment. Pregnancy (2nd & 3rd trimester).
Special Precautions
Hypersensitivity (angioedema). Not recommended in patients w/ primary aldosteronism. Symptomatic hypotension, especially after 1st dose & after increasing dose, may occur in patients who are vol- &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Excessive BP decrease in patients w/ ischemic CV & cerebrovascular disease could result in MI or stroke. Patients w/ bilateral artery stenosis or stenosis of the 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. Risk of severe arterial hypotension, & (often acute) renal impairment. Closely monitor plasma conc of K & CrCl values, & especially patients w/ heart failure & CrCl 30-50 mL/min. Regularly monitor renal function during treatment, particularly in presence of other conditions likely to impair renal function eg, fever, dehydration. Not recommended in concomitant use w/ K-sparing diuretics, K supplements & K-containing salt substitutes; ACE inhibitors. Concomitant use w/ β-blocker. Consider lower dose in patients w/ history of hepatic impairment. Discontinue use immediately when pregnancy is diagnosed. Not recommended during breastfeeding. Closely observe for hypotension in infants whose mothers have taken losartan. Not recommended in childn <6 yr, w/ GFR <30 mL/min/1.73 m2, & w/ hepatic impairment.
Adverse Reactions
Anemia; dizziness; vertigo; orthostatic hypotension (including dose-related orthostatic effects); renal impairment & failure; asthenia; fatigue; hyperkalemia; increased blood urea, serum creatinine, & serum K; hypoglycemia.
Drug Interactions
Hypotensive action may be increased w/ other antihypertensives. May increase risk of hypotension w/ other substances which may induce hypotension eg, TCAs, antipsychotics, baclofen & amisfostine. Decreased exposure to the active metabolite of losartan w/ fluconazole (CYP2C9 inhibitor). Reduced plasma conc of the 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 w/ NSAIDs ie, selective COX-2 inhibitors, ASA at anti-inflammatory doses, & non-selective NSAIDs. May lead to increased risk of worsening of renal function, including possible acute renal failure, & increased serum K w/ NSAIDs. Higher frequency of adverse events (eg, hypotension, hyperkalemia, & decreased renal function) & decreased renal function (including acute renal failure) associated w/ dual blockade of the renin-angiotensin-aldosterone system through combined use w/ ACE inhibitors or aliskiren.
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
Besartan FC tab 50 mg
Packing/Price
100's (P1,450/box);30's
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