The composition 1 tablet:
- active substances: 1 tablet contains lisinopril dihydrate in terms of 100% substance 10 mg or 20 mg and hydrochlorothiazide 12.5 mg
- excipients: mannitol (E 421), magnesium stearate, calcium hydrogen phosphate, corn starch, corn starch.
Dosage form. Tablets.
Main physical and chemical properties: white or almost white tablets of flat cylindrical shape with beveled edges and a notch on one side.
10 tablets in a blister, 1, 2 or 3 blisters in a box.
Indications for use:
ACE inhibitors (ACE inhibitors) and diuretics. Arterial hypertension of mild or moderate severity, has a stable course on the background of therapy with lisinopril and hydrochlorothiazide in the same dosages.
- Hypersensitivity to lisinopril and other ACE inhibitors, to hydrochlorothiazide and sulfonamide derivatives or other components of the drug.
- History of angioneurotic edema associated with the use of ACE inhibitors.
- Hereditary or idiopathic angioneurotic edema.
- Hemodynamically significant stenosis of the aortic or mitral valve or hypertrophic cardiomyopathy.
- Severe renal failure or end-stage disease.
- Severe liver disease.
- Exacerbation of gout.
- Renal artery stenosis (bilateral or unilateral).
- Cardiogenic shock.
- Condition with unstable hemodynamics after acute myocardial infarction.
- Hemodialysis using high-flow membranes (eg AN 69).
- Serum creatinine> 220 μmol/l.
- Concomitant use of aliskiren-containing drugs in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2).
- Pregnancy planning.
- Pregnancy and breastfeeding.
- Children’s age (up to 18 years).
Method of application and dose:
The use of a combined drug with a fixed-dose is not suitable for starting therapy. A fixed-dose combination drug can replace a combination of 10 mg or 20 mg lisinopril and 12.5 mg hydrochlorothiazide for patients whose condition has been stabilized by treatment with individual active substances in the same dosages as those administered as separate drugs. The usual dose is 1 tablet once a day. Like any other medicine that is taken once a day, Lisinoprazide should be taken at about the same time each day.
If the desired therapeutic effect cannot be achieved within 2-4 weeks of treatment, the dose can be increased to 2 tablets once a day.
Previous diuretic therapy.
After taking the first dose of lisinoprazide, symptomatic hypotension may develop. This condition is more likely to occur in patients with dehydration and/or salt deficiency as a result of previous diuretic therapy. Diuretic therapy should be discontinued 2-3 days before the start of lisinoprazide therapy. If this is not possible, treatment with individual components in a low dose (lisinopril 5 mg) should be started.
Patients with renal insufficiency.
Lisinoprazide should not be used as initial therapy in patients with renal insufficiency. Lisinoprazide should be used in patients with mild or moderate renal impairment (creatinine clearance 30 and less than 80 ml/min) only after dose titration of individual components. In this case, the recommended dose of lisinopril, which is prescribed in the form
of a separate drug is 5-10 mg.
It is known that the efficacy and tolerability of lisinopril and hydrochlorothiazide when co-administered were the same in elderly patients and in younger patients with hypertension.
In the dose range of 20 mg to 80 mg, the efficacy of lisinopril was the same in elderly (over 65 years) and younger patients with hypertension. In elderly patients with hypertension, lisinopril monotherapy was as effective in lowering diastolic blood pressure as hydrochlorothiazide or atenolol monotherapy. If renal impairment is observed in an elderly patient, the starting dose of lisinopril should be adjusted.
The drug is used in children because the safety and effectiveness of the drug in children (under 18 years) have not been established.