PreconTM (Losartan Potassium) is the first of new class of antihypertensive, and its principal active metabolite block the vasoconstriction and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues. PreconTM is now regarded as the first-line therapy option for treating high blood pressure.
PreconTM 50 Tablet: Each flim-coated tablet contains Losartan Potassium BP 50 mg.
Hypertension, diabetic nephropathy in type 2 diabetes mellitus, usually 50 mg once daily (intravascular volume depletion, initially 25 mg once daily); if necessary increased after several weeks to 100 mg once daily; elderly over 75 years initially 25 mg daily. Chronic heart failure, initially 12.5 mg once daily, increased at weekly intervals to max. 150 mg once daily if tolerated.
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
Losartan potassium is contraindicated in patients who are hypersensitive to the active ingredient or any component of the drug.
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy- dramnios have also been reported.
Information on the use of angiotensin-II receptor antagonists in breast-feeding is limited. They are not recommended in breast-feeding and alternative treatment options, with better established safety information during breast-feeding, are available.
No drug interactions of clinical significance have been identified. Drugs which have been studied in clinical pharmacokinetic trials include - (1) Hydrochlorothiazide, (2) Digoxin, (3) Warfarin, (4) Cimetidine, (5) Ketoconazole and (6) Phenobarbital.
Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m 2 basis. Limited data are available in regard to overdo sage in humans. The most likely manifestation of over dosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis.
Store in a cool & dry place, protect from light & moisture.
Keep out of reach of children.
PreconTM 50 Tablet: Each box contains 5x10 tablets in Alu-Alu blister pack.