Name:
Lisinopril Release form Tablets. Dosage 5 mg. Pack quantity: 60 pcs. ProducerPharmlend SP LLC. INN Lisinopril. FTGApf blocker.
Description:
Tablets, white or almost white, round, biconvex. Composition and pharmacotherapeutic group Each tablet of Lisinopril contains the active substance – lisinopril 5 mg and excipients: corn starch, microcrystalline cellulose, povidone K-30, talc, magnesium stearate, anhydrous colloidal silicon dioxide, calcium hydrogen phosphate, sodium starch glycolate. It belongs to the group of angiotensin-converting enzyme inhibitors (ACE inhibitors). Expands peripheral vessels, which facilitates the work of the heart and lowers blood pressure (BP). Normalization of blood pressure avoids such consequences of arterial hypertension as myocardial infarction and stroke. Indications for use – Arterial hypertension: as monotherapy or in combination with other antihypertensive drugs. – Chronic heart failure: as part of combination therapy with cardiac glycosides and / or diuretics. – Early short-term (6 weeks) treatment of acute myocardial infarction: as part of combination therapy. – Diabetic nephropathy: reduction of albuminuria in patients with type 1 diabetes mellitus with normal blood pressure and patients with type 2 diabetes mellitus with arterial hypertension. Contraindications Do not take the drug in the following cases – hypersensitivity to lisinopril, excipients or other ACE inhibitors; – angioedema in the past (including against the background of ACE inhibitor therapy), hereditary Quincke’s edema or idiopathic edema; – pregnancy, lactation; – age up to 18 years; – renal failure with creatinine clearance ≤ 30 ml/min; – if you are taking blood pressure lowering medicines containing aliskiren and have diabetes or kidney disease. Warnings When prescribing Lisinopril, be sure to consult your doctor if: – you are pregnant, suspect or plan to be pregnant, or are breastfeeding; – are on a salt-restricted diet, dialysis, recent illness with diarrhea or vomiting; – suffer from diabetes mellitus, liver disease, kidney disease (including narrowing of the renal artery) or a kidney transplant; – have recently suffered a heart attack (myocardial infarction), cardiogenic shock; – you are observed about the narrowing of the heart valves (stenosis of the aorta / mitral valve), hypertrophic cardiomyopathy; – suffer from diseases of the blood vessels, joints, including rheumatoid; – you have low blood pressure and dizziness when you change position; – in the past there was angioedema or Quincke’s edema, the signs of which are: itching, red spots on the skin, swelling of the face, shortness of breath; – have been treated for bee or wasp stings; – have undergone an apheresis procedure to lower cholesterol levels; are taking medicines or supplements that contain potassium. Interaction with other dosage forms When prescribing Lisinopril, be sure to inform your doctor when taking any of the following medicines. Perhaps, when they are taken together, a dose adjustment or additional examinations will be necessary. Potassium-sparing diuretics (spironolactone, triamterene, amiloride): ACE inhibitors reduce potassium loss, the level of potassium in the blood increases significantly. Monitoring of potassium levels is recommended. Diuretics (thiazides, furosemide, other drugs that reduce blood pressure (beta-blockers – propanolol, atenolol; calcium channel blockers – amlodipine, nifedipine); nitrates or other vasodilators; anesthetics, tricyclic antidepressants, antipsychotics); risk of developing hypotension. BP control recommended. Medicines containing aliskiren. In diabetes mellitus or renal insufficiency, co-administration is contraindicated. Medicines to dissolve blood clots. Nitrates for the treatment of heart disease. Lithium preparations for the treatment of certain mental illnesses. Non-steroidal anti-inflammatory drugs (indomethacin, ibuprofen, etc.): with their long-term use, the hypotensive effect of ACE inhibitors may decrease. Aspirin (when taken more than 3 grams per day). Ephedrine, norepinephrine, epinephrine: possible decrease in the hypotensive effect of lisinopril Drugs for the treatment of diabetes: their ability to lower sugar levels is enhanced. Regular monitoring of blood glucose levels is recommended. Medicines for the treatment of bronchial asthma. Medicines for the treatment of nasal congestion, sinusitis, incl. over-the-counter. Allopurinol to treat gout, procainamide to treat arrhythmias, medicines to suppress the immune system (cyclosporine). Injectable gold preparations: symptoms such as facial flushing, hot flashes, nausea, dizziness, lowering blood pressure, incl. expressed. Use during pregnancy and lactation Lisinopril is contraindicated in the second, third trimesters of pregnancy (toxic effect on the fetus) and during breastfeeding. The use of lisinopril is not recommended during the first trimester of pregnancy. If pregnancy is planned or confirmed, the drug is canceled, an alternative treatment is prescribed. If necessary, admission during lactation – breastfeeding stops. When taking lisinopril, you must use contraception. Influence on the ability to drive vehicles and control mechanisms As with other antihypertensive drugs, the ability to drive a car and other mechanisms may decrease, especially at the beginning of treatment or when the dosage is changed. This effect depends on the individual sensitivity of the patient. Method of application and recommended doses It is taken orally once, in the morning, regardless of the meal. The duration of admission is determined by the doctor. Arterial hypertension: initial dose – 10 mg per day once, maintenance dose – 20 mg / day, maximum dose – 40 mg / day. When taking diuretics by patients, diuretics are canceled 2-3 days before the start of treatment with Lisinopril. If it is impossible to cancel diuretics, the initial dose of Lisinopril is not more than 5 mg / day. Renal failure: the initial dose depends on creatinine clearance: 30-80 ml / min – the initial daily dose of 5-10 mg; 10-30 ml / min – initial daily dose of 2.5-5 mg; less than 10 ml / min – the initial daily dose of 2.5 mg. Heart failure: (simultaneously with diuretics and / or cardiac glycosides): the dose of the diuretic is reduced before starting treatment with lisinopril. The initial dose of Lisinopril is 2.5 mg / day, with a gradual increase by 2.5 mg after 3-5 days to 5-10 mg / day. The recommended dose increase is no more than 10 mg for 2 weeks. The maximum daily dose is 35 mg. Acute myocardial infarction: Treatment can be started within the first 24 hours after the first signs appear. Treatment should not be started if systolic BP ≤ 100 mmHg. Art. The initial dose is 5 mg every 24 hours, 10 mg every 48 hours and 10 mg daily. If systolic blood pressure ≤ 120 mm Hg. Art., low doses (2.5 mg / day) are taken in the first 3 days after a heart attack, the maintenance dose is 2.5-5 mg. With persistent hypotension (systolic blood pressure ≤ 90 mm Hg for more than 1 hour), treatment with Lisinopril should be suspended. The recommended duration of treatment is 6 weeks. After assessing the patient’s condition, treatment can be continued. In renal insufficiency, the initial dose is selected in accordance with the value of creatinine clearance. Diabetic nephropathy: For patients with type 2 diabetes mellitus complicated by hypertension and the initial stage of nephropathy, the dose is 10 mg / day. The dose may be increased to 20 mg/day to reduce diastolic blood pressure below 90 mm Hg. Art. In renal insufficiency, the initial dose is selected in accordance with the value of creatinine clearance. Elderly age. The dose is determined with caution, depending on the response of the patient and the state of renal function. Children. Not for use in children under 6 years of age. In children over 6 years of age and adolescents in the absence of kidney disease, it is used only as directed by a doctor, the dose is determined individually. If you have taken a dose of Lisinopril more than the doctor recommended If the number of tablets per day that you have taken exceeds the amount recommended by your doctor, or your child has swallowed the tablets, immediately contact a doctor or call an ambulance! An overdose is likely to cause a pronounced decrease in blood pressure, heart rate, stupor, impaired renal function, and a change in blood biochemical parameters. Stop taking the medicine! As a first aid, lay the patient on his back so that the head is lowered and the legs are raised. Control of blood pressure, heart rate. Gastric lavage and antacids are recommended as first aid. If you forget to take your next dose of Lisinopril on time Take the tablet at your next dose. Do not take a double dose in case of a missed dose. Possible side effects Lisinopril, like other ACE inhibitors, can cause side effects with varying frequency: Often (1 in 10-100 cases): dizziness, headache, orthostatic effects, lowering blood pressure, cough, diarrhea, vomiting, allergic rash, renal dysfunction (1 in 100-1,000 cases): mood changes, balance problems, dizziness (vertigo), sleep disturbance, unusual skin sensations (numbness, tingling, crawling), fast or irregular heartbeat, chest pain, cerebral or coronary blood circulation, Raynaud’s syndrome, runny nose, itching, sneezing, nasal congestion, sexual dysfunction, fatigue, weakness, visual or auditory hallucinations. Rare (1 in 1,000-10,000 cases): confusion, olfactory disorders, dry mouth, hair loss, gynecomastia, psoriasis, feeling unwell, irritability. Very rare (less than 1 in 10,000 cases): low blood sugar, nervousness, sweating, abdominal pain with or without nausea/vomiting, decreased urine output, difficulty breathing, shortness of breath, chest tightness, sinus pain, symptoms of sinusitis (high fever, headache, fatigue, cough, loss of taste and smell, bad breath, ear pressure), skin rash, pemphigus. Frequency unknown: depression, fainting. If you experience the following side effects, stop taking the medicine and immediately consult a doctor or call an ambulance: swelling of the hands, face, lips, tongue; difficulty breathing; sudden appearance of rashes, lesions, redness, peeling of the skin; sore throat; severe dizziness or weakness; acute pain in the abdomen; irregular or rapid heartbeat; yellowness of the skin or eyes! Precautions Arterial hypotension. It often develops against a background of fluid or sodium deficiency as a result of taking diuretics, limiting salt intake, in patients on hemodialysis, with diarrhea or vomiting. Systematic monitoring by a doctor is recommended, especially during the period of initiation of treatment and when changing the dose. It is used with caution in patients with coronary artery disease, cerebrovascular disease, in which a sharp decrease in blood pressure can lead to a heart attack or stroke. Aortic/mitral stenosis, hypertrophic cardiomyopathy. Taken with caution. Impaired kidney function. Hypotension when taking lisinopril against the background of bilateral stenosis or stenosis of the artery of the patient’s only kidney can lead to the development of reversible acute renal failure. Applied with caution. Recommended systematic monitoring of kidney function. If renal function worsens during treatment with lisinopril (serum creatinine level > 265 µmol/mol or twice as high as the initial level), stop treatment. It is not used in patients after kidney transplantation. Liver failure. Patients who develop jaundice or develop marked elevations in liver enzymes during treatment with lisinopril should be discontinued and continue treatment with alternative drugs as prescribed by their physician. Diabetes. During the period of taking lisinopril, patients with diabetes need careful monitoring of blood sugar levels. Anaphylactoid reactions. Rare cases of angioedema of the face, extremities, lips, tongue, glottis and/or larynx have been described. Anaphylactoid reactions may develop during low-density lipoprotein apheresis using dextran sulfate in patients taking ACE inhibitors. Temporary withdrawal of lisinopril during apheresis is recommended. In rare cases, life-threatening anaphylactic reactions have been observed in patients who underwent desensitization, including those caused by insect venom, while taking lisinopril. Recommended temporary cancellation of lisinopril during the period of desensitization. Neutropenia/agranulocytosis, thrombocytopenia and anemia. Abnormalities have been observed in rare cases in hypertensive patients with normal renal function and in the absence of other complications. Disappeared after cessation of treatment. It is used with caution in patients with impaired renal function in diseases affecting the vascular system of the kidneys or connective tissue (systemic lupus erythematosus, scleroderma), as well as with concomitant immunosuppressive therapy (corticosteroids, cytotoxic agents, antimetabolites). It is necessary to inform the doctor about the occurrence of any infection. The control of the general analysis of blood is recommended. Hyperkalemia. Lisinopril may increase the level of potassium in the blood, especially in renal and / or heart failure, taking potassium-sparing diuretics. It is recommended to control the level of potassium in the blood. Surgical interventions. During anesthesia, severe hypotension may develop. Inform your doctor about taking lisinopril. Hemodialysis. In a patient on hemodialysis using high-capacity membranes (eg, AN69) and concomitantly treated with an ACE inhibitor, a different type of dialysis membrane or a different class of antihypertensive drug may be recommended. Cough. There are reports of coughing during treatment with ACE inhibitors. Usually the cough is unproductive, persistent and stops after the drug is discontinued. Laboratory research. Taking lisinopril may affect the results of laboratory tests: the number of blood cells or other indicators of a complete blood count, the level of potassium, sodium, creatinine, urea, liver enzymes. Inform your doctor about taking lisinopril. Patients of Afro-Caribbean origin may have a lower efficacy of lisinopril and a more frequent development of allergic reactions. Storage conditions Store in a place protected from moisture and light at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life 2 years. Do not use the medicinal product after the expiration date. Conditions of leave By doctor’s prescription. Packing: 10, 15 tablets in a blister pack made of aluminum foil and PVC film or 30 tablets in a polymer jar with a pull-on lid with first opening control, sealing agent – medical cotton wool. One jar, 3 or 6 blister packs of 10 tablets. 2 or 4 blister packs of 15 tablets together with a leaflet in a secondary package. Buy Lisinopril Farmland tablets 5mg No. 15×4
INN | LISINOPRIL |
---|---|
The code | 134 860 |
Barcode | 4 810 368 013 118 |
Dosage | 5mg |
Active substance | Lisinopril |
Manufacturer | Pharmland SP LLC, Belarus |
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