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Indications: Agilosart-H 100/25 is a combination of losartan potassium and hydrochlorothiazide used to treat idiopathic hypertension in adults, especially whose blood pressure has not been adequately controlled by losartan or hydrochlorothiazide alone. Hypertensive patients receiving losartan experienced a reduction from baseline proteinuria of -41.5% (95% CI -29.9;-51.1) versus +2.4% (95% CI -22.2; 14.1) in the amlodipine group. 12.5 mg daily, 25 mg daily, 50 mg daily, 100 mg daily, up to a maximum dose of 150 mg once daily) as tolerated by the patient.The usual starting dose is 50 mg of losartan once daily. These conditions should be corrected prior to administration of losartan, or a lower starting dose should be used (see section 4.2). Blood in urine w/taking Losartan Potassium and Hydrochlorothiazide 100mg/12.5 mg? The systemic bioavailability of losartan tablets is approximately 33%. • in controlled clinical trials in >3,000 adult patients 18 years of age and older for essential hypertension The combination of losartan with a beta-blocker should be used with caution (see section 5.1).As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.This medicinal product contains lactose.
During once daily dosing with 100 mg, neither losartan nor its active metabolite accumulates significantly in plasma.Both biliary and urinary excretions contribute to the elimination of losartan and its metabolites. Stabilisation of the cardiovascular system should be given priority. This was mainly attributable to a reduction of the incidence of hospitalisation for heart failure. Excipient with known effect: Each Losartan potassium 100 mg tablet contains 80 mg lactose monohydrate. Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential. Amlodipine was given at doses of 0.05 mg/kg to 0.2 mg/kg (up to a maximum dose of 5 mg per day).Overall, after 12 weeks of treatment, patients receiving losartan experienced a statistically significant reduction from baseline in proteinuria of 36% versus 1% increase in placebo/amlodipine group (p≤0.001). In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with losartan as compared to the placebo group (see section 4.8).

Like other substances that directly affect the renin-angiotensin system, losartan has been shown to induce adverse effects on the late foetal development, resulting in foetal death and malformations. Renal impairment, hypotension, and hyperkalaemia were more common in the 150 mg group than in the 50 mg group, but these adverse events did not lead to significantly more treatment discontinuations in the 150 mg group.In the ELITE Study carried out over 48 weeks in 722 patients with heart failure (NYHA Class II-IV), no difference was observed between the patients treated with losartan and those treated with captopril with regard to the primary endpoint of a long term change in renal function. Furthermore losartan does not inhibit ACE (kininase II), the enzyme that degrades bradykinin. The mean duration of therapy was 264 days.In summary, the mean blood pressure decrease from baseline was similar across all treatment groups (change from baseline to Week 3 in SBP was -7.3, -7.6, and -6.7 mmHg for the low-, medium-, and high dose groups, respectively; the reduction from baseline to Week 3 in DBP was -8.2, -5.1, and 6.7 mmHg for the low-, medium-, and high-dose groups. Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in paediatric patients.Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 mLosartan is also not recommended in children with hepatic impairment (see also section 4.4).Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly. In normotensive children a small decrease in blood pressure was observed in the losartan group (-3.7/-3.4 mm Hg) compared to placebo. Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).The safety and efficacy of children aged 6 months to less than 6 years has not been established. In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily. Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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