Name:
Lyzoril. International non-proprietary name lisinopril Pharmaceutical tablet format Composition 1 tablet contains the active substance lisinopril 2.5 mg or 5 mg or 10 mg or 20 mg and excipients: Lysoryl 2.5 mg: corn starch, mannitol, calcium phosphate dihydrate, magnesium stearate; Lysoryl 5 mg: corn starch, mannitol, calcium phosphate dihydrate, magnesium stearate, iron oxide red; Lysoryl 10 mg: corn starch, mannitol, calcium phosphate dihydrate, magnesium stearate, iron oxide red; Lysoryl 20 mg: corn starch, mannitol, calcium phosphate dihydrate, magnesium stearate, iron oxide red.
Description:
of Lyzoril 2.5 mg: White or almost white, round, double-sided convex tablets, debossed with “2.5” on one side and “BL” on the other. Lizoril 5 mg: Light pink to pink, round, double-sided domed tablets debossed with “5” and a score line on one side and “BL” on the other. Lizoril 10 mg: Light pink to pink, round, double-sided domed tablets debossed with “10” on one side and “BL” on the other. Lizoril 20 mg tablets: Light pink to pink, round, double-sided domed tablets debossed with “20” on one side and “BL” on the other. Pharmacotherapeutic group ACE inhibitor. ATX code C09AA03. Pharmacological action Pharmacodynamics Suppresses the formation of angiotensin II from angiotensin I. A decrease in the content of angiotensin II leads to a direct decrease in the release of aldoseron. Reduces the degradation of bradykinin and increases the synthesis of prostaglandin. Reduces total peripheral vascular resistance, blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in cardiac output and an increase in myocardial exercise tolerance in patients with heart failure. Expands arteries more than veins. Some effects are explained by the effect on the tissue renin-angiotensin systems. With prolonged use, hypertrophy of the myocardium and walls of resistive arteries decreases. Improves blood supply to ischemic myocardium. ACE inhibitors prolong life expectancy in patients with heart failure, slow down the progression of left ventricular dysfunction in patients who have had myocardial infarction without clinical manifestations of heart failure. The beginning of action – in 1 hour. The maximum effect is determined after 6-7 hours, duration – 24 hours. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months. Pharmacokinetics Bioavailability of the drug is 25-50%, weakly binds to plasma proteins. The maximum concentration in blood serum is reached in 7 hours. Eating does not affect absorption. Lizoril is not metabolized and is excreted unchanged in the urine. Most of it is released during the initial phase (effective half-life of 12 hours), followed by the terminal long-term phase (half-life of about 30 hours). Permeability through the blood-brain barrier and placental – low. Indications for the use of arterial hypertension (in monotherapy or in combination with other antihypertensive agents); chronic heart failure (as part of combination therapy for the treatment of patients taking digitalis and / or diuretics); Contraindications Hypersensitivity to lisinopril and other ACE inhibitors, severe renal dysfunction, bilateral renal artery stenosis or stenosis of the artery to a single kidney with progressive azotemia, condition after kidney transplantation, azotemia, primary hyperaldosteronism, aortic stenosis (and similar obstructions to blood flow), hereditary angioedema , pregnancy, lactation, age up to 18 years (efficacy and safety have not been established) With caution, arterial hypotension, oppression of bone marrow hematopoiesis, hyponatremia (increased risk of arterial hypotension in patients on a low-salt or salt-free diet), systemic connective tissue diseases, diabetes mellitus , gout, hyperuricemia, coronary heart disease, cerebrovascular insufficiency, severe chronic heart failure, hyperkalemia, old age. Dosage and administration Take orally before, during or after meals. Arterial hypertension The initial dose of Lizoril is 5 mg 1 time per day. The dose changes in accordance with the change in blood pressure. The usual dose is 10 mg per day in a single dose. If there is no adequate response, the dose may be increased to 20 to 40 mg per day. The maximum daily dose is 80 mg. For 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 (CC). With CC more than 30 ml / min. the recommended initial dose of Lizoril is 5-10 mg per day. With QC from 30 to 10 ml / min. the initial dose is 2.5 – 5 mg per day. With 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 appears to be effective in some patients, but is more commonly achieved with doses of 5-20 mg per day. Side effects From the side of the cardiovascular system: decreased blood pressure, chest pain, rarely – orthostatic hypotension, tachycardia, bradycardia, symptoms of heart failure, impaired atrioventricular conduction. From the nervous system: dizziness, headache, fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely – asthenic syndrome, mood lability, confusion. From the gastrointestinal tract: nausea, dyspepsia, anorexia, taste changes, abdominal pain, diarrhea, dry mouth. On the part of the hematopoietic organs: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decreased hemoglobin content, erythrocytopenia). From the respiratory system: dyspnea, bronchospasm, apnea. Allergic reactions: angioedema, skin rashes, itching. Laboratory indicators: hyperkalemia, hyperuricemia, rarely – increased activity of “liver” transaminases, hyperbilirubinemia. Others: dry cough, decreased potency, rarely – acute renal failure, arthralgia, myalgia, fever, edema (of the tongue, lips, limbs), impaired development of the fetal kidneys. Interaction with other drugs No significant interaction of Lisinopril with propranalol, hydrochlorothiazide, digoxin was noted. It is possible to reduce the hypotensive effect of Lisinopril while taking it with non-steroidal anti-inflammatory drugs, estrogens, sympathomimetics. Hydrochlorothiazide may potentiate the antihypertensive effect of Lisinopril. Combined use with beta-blockers, slow calcium channel blockers and diuretics increases the hypotensive effect of Lisinopril. With simultaneous use with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium, salt substitutes containing potassium, the risk of developing hyperkalemia increases, especially in patients with impaired renal function. Lisinopril reduces the loss of potassium caused by diuretics such as thiazide. When co-administered with lithium preparations, Lisinopril may slow down the excretion of lithium from the body. Antacids and cholestyramine reduce the absorption of Lisinopril in the gastrointestinal tract. Special instructionsDuring treatment requires regular medical supervision. For patients with impaired renal function, it is necessary to reduce the dose or reduce the frequency of taking Lizoril. In patients taking Lyzoril, it was reported about the development of angioedema of the face, lips, tongue, glottis and / or larynx. In such cases, you must immediately stop taking Lyzoril. In patients with chronic heart failure and concomitant renal failure, after taking Lizoril, a sharp decrease in blood pressure is observed. Treatment of such patients should be started under close medical supervision with a minimum dose of 2.5 mg Lizoril. Release form Tablets of 2.5 mg, 5 mg, 10 mg and 20 mg. 10 or 14 tablets in strips or blisters. 2, 3, 4, 5 or 10 blisters or strips, together with instructions for use, are placed in a cardboard pack. Storage conditions In a dry, dark place, at temperatures below 25°C. Keep out of the reach of children. Shelf life 3 years. Do not use after the expiry date stated on the package. Terms of dispensing from pharmacies By prescription. ProducerIPKA Laboratories Limited, India 48, Kandivli Industrial Estate, Kandivli (West), Mumbai -400067, India 48, Kandivli Industrial Estate, Kandivli (West), Mumbai, 400067, India 36, bldg. 2, office 233-235 Buy Lizoril tablets 20mg No. 14×2 Price for Lizoril tablets 20mg No. 14×2
INN | LISINOPRIL |
---|---|
The code | 17 554 |
Barcode | 8 901 079 004 208 |
Dosage | 20mg |
Active substance | Lisinopril |
Manufacturer | Ipka Laboratories Ltd., India |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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