Medications

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One tablet contains 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ). INN. Losartanum, hydrochlorothiazide 40 weeks pregnant ingredients: Each tablet contains 41 mg of lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM
4.1 Indications for Sartene plus 50 mg / 12.5 mg is indicated for the treatment of essential hypertension 40 weeks pregnant in patients with losartan or hydrochlorothiazide monotherapy is not adequately controlled. 4.2 Posology and method of administration Sartene plus 50 / 12.5 mg may be administered concomitantly with other antihypertensive agents. Sartene plus 50 / 12.5 mg tablets should be swallowed with a full glass of water. Sartene plus 50 / 12.5 mg may be administered with or without food. Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients with treatment with losartan or hydrochlorothiazide alone did not provide 40 weeks pregnant adequate results. It is recommended that the individual components (losartan and hydrochlorothiazide) titration. When clinically appropriate, consideration may be given a direct change 40 weeks pregnant from monotherapy to the fixed-dose combination 40 weeks pregnant in patients who have not achieved adequate 40 weeks pregnant blood pressure drop. The usual maintenance dose is one Sartene plus 50 / 12.5 mg tablet (50 mg losartan / HCTZ 12.5 mg) once a day. Patients who do not respond adequately to Sartene plus 50 / 12.5 mg, the dose may be increased to one Sartene 40 weeks pregnant plus 100/25 mg tablets 40 weeks pregnant (100 mg losartan / HCTZ 25 mg). The maximum dose is one Sartene plus 100/25 mg tablets per day. The antihypertensive 40 weeks pregnant effect is attained within three to four weeks after initiation of therapy. Use in renal failure and hemodialysis patients with moderate renal impairment (creatinine clearance 30 ... 50 mL / min), no dosage adjustment is necessary. Losartan and hydrochlorothiazide tablets are not recommended for use in hemodialysis patients. Losartan / HCTZ tablets must not be used in severe renal impairment (creatinine clearance <30 mL / min) for the treatment of patients (see section 4.3). Use in patients with intravascular fluid volume decreased intravascular volume and / or sodium depletion should be corrected prior to administration of Losartan / HCTZ tablets. Use in patients with hepatic impairment Losartan / HCTZ is contraindicated in patients with severe hepatic impairment (see section 4.3). Use in elderly No dosage adjustment is normally required. Use in children and adolescents 40 weeks pregnant (<18 years) There is no experience in children and adolescents. Therefore, do not losartan / hydrochlorothiazide in children and adolescents. 4.3 Contraindications - Hypersensitivity to losartan, sulphonamide derivatives (eg, hydrochlorothiazide) or to any of the excipients. - Uncontrolled hypokalemia or hypercalcemia. - Severe hepatic impairment; cholestasis and biliary obstructive disorder. - Refractory hyponatremia. - Symptomatic hyperuricaemia / gout. - Second and third trimesters of pregnancy 40 weeks pregnant (see sections 4.4 and 4.6). - Severe renal impairment (ie creatinine clearance <30 40 weeks pregnant ml / min). - Anuria. 4.4 Special warnings and precautions for use Losartan Angioedema: Angioedema (swelling of the face, lips, throat and / or tongue) should be closely 40 weeks pregnant monitored (see section 4.8). Hypotension and reduced intravascular 40 weeks pregnant fluid volume decreased intravascular fluid volume and / or sodium (eg patients with high doses of diuretic therapy, dietary salt restriction, diarrhea or vomiting) symptomatic hypotension may occur, especially after the first dose. These conditions should be corrected before Sartene plus 50 / 12.5 mg tablets (see sections 40 weeks pregnant 4.2 and 4.3). Electrolyte disturbances in renal impairment in diabetic and non-diabetic patients with electrolyte disturbances are common and must be corrected. 40 weeks pregnant Therefore, should be carefully monitored in serum potassium concentration and creatinine clearance. Particular care should be exercised in patients with heart failure and those with a creatinine clearance between 30 ... 50 mL / min. Losartan / HCTZ concomitant administration of potassium-sparing diuretics, potassium supplements and potassium-containing salt is not recommended (see section 4.5). Hepatic impairment Based on pharmacokinetic data in cirrhotic plasma concentrations of losartan significantly su