Lizoril - instructions for use, doses, side effects, contraindications

Excipients: corn starch 26.25 mg, mannitol 18.00 mg, calcium hydrophosphate dihydrate 54.00 mg, magnesium stearate 1.05 mg, ferric oxide red oxide 0.105 mg.

Each 10 mg tablet contains:

Active substance: lisinopril dihydrate 10.89 mg is equivalent to anhydrous lisinopril 10.00 mg

Excipients: corn starch 52,50 mg, mannitol 36,00 mg, calcium hydrophosphate dihydrate 108.00 mg, magnesium stearate 2.10 mg, ferric oxide red oxide 0.210 mg.

Each 20 mg tablet contains:

Active substance: lisinopril dihydrate 21.78 mg is equivalent to anhydrous lisinopril 20.00 mg

Excipients: corn starch 52,50 mg, mannitol 36,00 mg, calcium hydrophosphate dihydrate 108.00 mg, magnesium stearate 2.10 mg, ferric oxide red 1.15 mg.

Description:

Tablets 5 mg: From light pink to pink, round, biconvex tablets with engraving "5" and dividing the risk on one side and "BL" on the other.

Tablets 10 mg: From light pink to pink, round, biconvex tablets with engraving "10" on one side and "BL" on the other.

Tablets of 20 mg: From light pink to pink, round, biconvex tablets with engraving "20" on one side and "BL" on the other.

Pharmacotherapeutic group:ACE inhibitor

ATX: & nbsp

C.09.A.A.03 Lisinopril

C.09.A.A ACE Inhibitors

Pharmacodynamics:Suppresses the formation of angiotensin II from angiotensin I.Reduces the content of angiotensin II leads to a direct reduction in aldoseron release. Reduces the degradation of bradykinin and increases the synthesis of prostaglandin. Reduces the overall peripheral vascular resistance, arterial pressure (BP), preload, pressure pulmonary capillaries, causes an increase in cardiac output and increased tolerance of the myocardium to loads in patients with heart failure. Expands arteries more than veins. Some effects are explained by the effect on tissue retin-angiotensin systems. With prolonged use, myocardial hypertrophy and the walls of arteries of resistive type decrease. Improves the blood supply of the ischemic myocardium. ACE inhibitors prolong life expectancy in patients with heart failure, slow the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure. The action takes about 1 hour. The maximum effect is determined after 6-7 hours, duration - 24 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, stable action develops after 1-2 months.

Pharmacokinetics:Bioavailability of the drug is 25 -50%, weakly binds to blood plasma proteins. The maximum concentration in the serum is reached after 7 hours. Eating does not affect absorption. Lisinopril It is not metabolized and is excreted unchanged in urine. The major part of it is released during the initial phase (the effective half-life is 12 hours), followed by a terminal distant phase (half-life of about 30 hours). Permeability through the blood-brain barrier and placental - low.

Indications:

- Arterial hypertension (in the form of monotherapy or in combination with other antihypertensive drugs);

- chronic heart failure (as part of combination therapy to treat patients taking digitalis and / or diuretics).

Contraindications:

- Hypersensitivity to lisinopril and other ACE inhibitors,

- severe renal dysfunction,

- bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney with progressive azotemia, a condition after kidney transplantation, azotemia,

- primary hyperaldosteronism,

- aortic stenosis (and similar obstructions to the blood flow),

- hereditary edema of Quincke,

- Pregnancy,

- the period of lactation,

- age under 18 years (efficiency and safety not established).

Carefully:

- Arterial hypotension,

- oppression of bone marrow hematopoiesis,

- hyponatremia (increased risk of arterial hypotension in patients on a low-salt or salt-free diet);

- systemic diseases of connective tissue,

- diabetes,

- gout,

- hyperuricemia,

- cardiac ischemia,

- cerebrovascular insufficiency,

- severe chronic heart failure,

- hyperkalemia,

- elderly age.

Dosing and Administration:

Take in before, during or after a meal.

Arterial hypertension

The initial dose of Lizoril® is 5 mg once a day. The dose changes in accordance with the change in blood pressure. The usual dose is 10 mg per day with a single dose. If there is no adequate reaction, the dose can be increased to 20-40 mg per day. The maximum daily dose is 80 mg.

Patients taking diuretics, the dose is selected individually.

In case of impaired renal function: the dose is set depending on the values of creatinine clearance (CK). With QC more than 30 ml / min, the recommended initial dose of Lizolil® is 5-10 mg per day.With QC from 30 to 10 ml / min the initial dose is 2.5-5 mg per day. At CC less than 10 ml / min - 2.5 mg.

Chronic heart failure

An initial dose of 2.5 mg per day is recommended. This dose is effective for some patients, but is more often achieved with doses of 5-20 mg per day.

Side effects:

From the cardiovascular system: decreased blood pressure in the chest, rarely-orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, violation of atrioventricular conduction.

From the nervous system: dizziness, headache, fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely - asthenic syndrome, lability of mood, confusion.

From the gastrointestinal tract: nausea, dyspepsia, anorexia, changes in taste, abdominal pain, diarrhea, dry mouth.

From the hematopoiesis: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, erythrocytopenia).

From the respiratory system: dyspnea, bronchospasm, apnea.

Allergic reactions: angio-neurotic edema, skin rashes, itching.

Laboratory indicators: hyperkalemia, hyperuricemia, rarely - increased activity of "liver" transaminases, hyperbilibinemia.

Other: dry cough, decreased potency, rarely - acute renal failure, arthralgia, myalgia, fever, edema (tongue, lips, limbs), impaired fetal kidney development.

Interaction:There was no significant interaction of lisinopril with propranolol, hydrochlorothiazide, digoxin. It is possible to reduce the hypotensive effect of lisinopril with simultaneous administration with non-steroidal anti-inflammatory drugs, estrogens, sympathomimetics. Hydrochlorothiazide can potentiate the antihypertensive effect of lysonopril. Combined use with beta-blockers, blockers of "slow" calcium channels and diuretics increases the hypotensive effect of lisinopril. When used simultaneously with potassium-sparing diuretics (spironolactone, tri-terene, amiloride), potassium, salt substitutes, potassium, the risk of hyperkalemia is especially high, especially in patients with impaired renal function. Liznopril reduces the loss of potassium caused by diuretics such as thiazide. When co-administered with lithium preparations Lisinopril can slow the excretion of lithium from the body. Antacids and colestramine reduce the absorption of lisinopril in the gastrointestinal tract.

Special instructions:

During treatment, regular medical supervision is necessary. For patients with impaired renal function, it is necessary to reduce the dose or reduce the frequency of taking Lizolil®.

Patients taking Lizoril ® were reported to develop angioedema, facial edema, lips, tongue, glottis and / or larynx. In such cases, immediately stop taking Lizolil®. In patients with chronic heart failure and concomitant renal failure, a sharp drop in blood pressure is observed after taking Lizolil®. Treatment of such patients should be started under close supervision of the doctor with a minimum dose of 2.5 mg of Lizolil®.

Form release / dosage:Tablets 5, 10, 20 mg.

Packaging:

For 10 or 14 tablets in a blister of aluminum foil and PVC film.

2 blisters containing 14 tablets or 3 blisters containing 10 tablets in a pack of cardboard, complete with instructions for use.

Storage conditions:

Store in a dry, dark place at a temperature below 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014842 / 01-2003

Date of registration:30.05.2008 / 17.05.2012

Expiration Date:Unlimited

The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India

Information update date: & nbsp24.02.2018

Illustrated instructions

Instructions

Lysoryl (Lisoril)