안국약품(주)

1) Compositon
Losartan K (Losartan 45.8mg)---------- 50mg/Tab
2) Dosage & Administration
-. Adult Hypertensive Patients
Losastar may be administered with other antihypertensive agents, and with or without food.
Dosing must be individualized. The usual starting dose of Losastar is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment. Losastar can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.
If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3-6 weeks.
If blood pressure is not controlled by Losastar alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect.
1) No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.
2) Impaired Hepatic Function
Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with impaired liver function.
3) Impaired Renal Function
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function have been reported in susceptible individuals treated with losartan; in some patients, these changes in renal function were reversible upon discontinuation of therapy.
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressiveazotemia and (rarely) with acute renal failure and/or death. Similar outcomes have been reported with losartan.
In studies of ACE inhibitors in patients with unilateral or bilateral renal arterystenosis, increases in serumcreatinine or blood urea nitrogen (BUN) have been reported. Similar effects have been reported with losartan in some patients, these effects were reversible upon discontinuation of therapy. Electrolyte Imbalance
Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients with proteinuria, the incidence of hyperkalemia was higher in the group treated with losartan as compared to the placebo group however, few patients discontinued therapy due to hyperkalemia.
4) Pediatric Hypertensive Patients ≥6 years of age
The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients. Losastar is not recommended in pediatric patients <6 years of age or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2.
5) Hypertensive Patients with Left Ventricular Hypertrophy
The usual starting dose is 50 mg of Losastar once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of Losastar should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response.
-. Nephropathy in Type 2 Diabetic Patients
The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response. Losastar may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).
3) Storage
at tightened container and at 25°C; excursions permitted to 15-30°C
4) Package
30, 300 Tabs
5) Expiry date
36 months from manufactured date