Lisinopril 10mg tab-vertex 30 pc

Description

Composition
Active substance:
1 tablet contains: lisinopril dihydrate (based on lisinopril) – 5 mg, 10 mg or 20 mg.
Excipients:
Lactose monohydrate, microcrystalline cellulose, sodium kroskarmalloza, magnesium stearate.
Description:
Tablets white or almost white, Valium chamfered (dosages of 5 and 10 mg) or a facet and Valium (20 mg dosage).
Product form:
Tablets of 5 mg, 10 mg or 20 mg. 10, 15 or 30 tablets in blisters of PVC film and aluminum foil.
The dosage of 5 mg 1, 2 or 3 blisters with 10 tablets or 1 or 2 blisters of 30 tablets together with instructions for use in a stack of cardboard.
Dosages of 10 mg and 20 mg of 1, 2 or 3 blisters with 10 tablets or 2 or 4 blisters with 15 tablets with instructions for use in a stack of cardboard.
Contraindications
Hypersensitivity to lizinoprilu or other ACE inhibitors.
Angioedema history in t. H. In a background of ACE inhibitors.
Hereditary angioedema or idiopathic angioedema.
Pregnancy and lactation.
Age 18 years (effectiveness and safety have been established).
Lactase deficiency, lactose intolerance, a syndrome of glucose-galactose malabsorption.
Carefully
Expressed violations kidney function, bilateral renal artery stenosis or stenosis of the artery only kidneys with progressive azotemia, condition after kidney transplantation, azotemia, hyperkalemia, aortic stenosis, hypertrophic obstructive kardimiopatiya, primary aldosteronism, hypotension, cerebrovascular diseases (including cerebrovascular insufficiency ), ischemic heart disease, coronary insufficiency, autoimmune systemic connective tissue diseases (chi le scleroderma, systemic lupus erythematosus); inhibition of bone marrow hematopoiesis; diet restriction salt; hypovolemic states (including due to diarrhea, vomiting..); elderly, hemodialysis vysokoprotochnyh using dialysis membranes with high permeability (AN69®).
Dosage
10 mg
Indications
Arterial hypertension (alone or in combination with other antihypertensive agents).
Chronic heart failure (in a combination therapy for the treatment of patients receiving cardiac glycosides and / or diuretics).
Early treatment of acute myocardial infarction in a combination therapy (in the first 24 hours with stable haemodynamics to maintain these parameters and prevent left ventricular dysfunction and heart failure).
Diabetic nephropathy (albuminuria reduction in patients with type 1 diabetes with normal blood pressure, and patients with type 2 diabetes with hypertension).
Interaction with other drugs
With simultaneous application of the drug to the potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations substitutes salt containing potassium, cyclosporin increased risk of hyperkalemia, especially when impaired kidney function, so they can be jointly used only with regular monitoring of the content of potassium ions in serum and renal function.
Combined use of lisinopril with beta-blockers, blockers “slow” calcium channel (BCCI), diuretics, tricyclic antidepressants / neuroleptics and other antihypertensive agents enhances the severity of the hypotensive action.
Lisinopril slows down lithium preparations. Therefore, the joint application should be regularly monitored in serum lithium concentration.
Antacids and cholestyramine reduce the absorption of lisinopril in the gastrointestinal tract.
When combined with insulin and hypoglycemic agents for oral administration is possible the risk of hypoglycemia.
Nonsteroidal anti-inflammatory drugs (NSAIDs) (in t. H., Selective inhibitors of cyclooxygenase-2 (COX-2)), estrogen agonists reduce the hypotensive effect of lisinopril.
With simultaneous use of ACE inhibitors and drugs intravenously gold (sodium aurothiomalate) describes a symptom, including facial flushing, nausea, vomiting and reduced blood pressure.
When coupled with a selective serotonin reuptake inhibitor may lead to severe hyponatremia.
Joint application with allopurinol, procainamide, cytostatics can lead to leukopenia.
Overdose
Symptoms (occur when receiving a single dose of 50 mg): marked reduction of blood pressure, the dryness of the oral mucosa, drowsiness, urinary retention, constipation, anxiety, irritability.
Treatment: the specific antidote is available. Symptomatic therapy. Gastric lavage, application enterosorbents and laxatives. Results Intravenous administration of 0.9% sodium chloride solution. In the case of bradycardia resistant to treatment, requires the use of an artificial pacemaker. Necessary to monitor blood pressure, indicators of water and electrolyte balance. Hemodialysis is effective.
pharmachologic effect
Pharmacodynamics:
ACE inhibitor reduces the formation of angiotensin II from angiotensin I. Reduction of angiotensin II leads to a direct decrease in aldosterone release. Reduce bradykinin degradation and increases the synthesis of prostaglandins. , Decreases total peripheral vascular resistance, blood pressure (BP), preload, the pressure in the pulmonary capillaries, causes an increase in cardiac output and increase tolerance to myocardial stress in patients with chronic heart failure. It expands the artery to a greater extent than the vein. Some effects are explained by the influence on the tissue renin-angiotensin-aldosterone system. With prolonged use decreases myocardial hypertrophy of the arteries and resistive type. It improves blood flow to the ischemic myocardium.
ACE inhibitors prolong the life expectancy of patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients with myocardial infarction without clinical manifestations of heart failure.
Valid -. 1 h Maximum antihypertensive effect is determined after 6-7 hours, and stored for 24 hours When hypertension effect noted in the first days after initiating treatment, stable action develops in 1-2 months.. With a sharp lifting of the drug were observed marked increase in blood pressure.
In addition to lowering blood pressure lisinopril reduces albuminuria. Lisinopril does not affect the concentration of blood glucose in diabetic patients, and does not lead to increased incidence of hypoglycemia.
Pharmacokinetics:
Suction. After ingestion lisinopril absorbed from the gastrointestinal tract (GIT) by an average of 25%, but the absorption can vary from 6 to 60%. Bioavailability is 25%. Food intake does not affect the absorption of lisinopril.
Distribution. Almost does not bind to plasma proteins. Maximum blood plasma concentration of 90 ng / ml is achieved after 7 hours. The permeability of the blood-brain and the placental barrier is low.
Metabolism. Lisinopril is not biotransformed in the body.
Withdrawal. Excreted by the kidneys unchanged. The half-life is 12 hours.
Pharmacokinetics in specific patient groups. In patients with chronic heart failure of absorption and clearance of lisinopril reduced bioavailability is 16%.
In patients with renal insufficiency lisinopril concentration several times higher than the concentration in the blood plasma of healthy volunteers, the marked increase in the time to reach maximum concentration in the blood plasma and increased half-life.
Pregnancy and breast-feeding
The use of Lisinopril during pregnancy is contraindicated. In establishing pregnancy receiving Lisinopril the drug should be stopped as soon as possible. ACE inhibitors in the II and III trimester of pregnancy has adverse effects on the fetus (expressed may decrease blood pressure, renal failure, hyperkalemia, hypoplasia of bones of the skull, intrauterine death). Information about the negative effects of the drug on the fetus when used during the I trimester there. For newborns and infants who have been exposed to intrauterine ACE inhibitor should be closely monitored for timely detection of significant decrease in blood pressure, oliguria and hyperkalemia.
Lisinopril crosses the placenta. No data on the penetration of Lisinopril passes into breast milk. If the drug Lisinopril is necessary during lactation, the breast-feeding should be abolished.
Conditions of supply of pharmacies
On prescription.
side effects
The incidence of side effects characterized as often (> 1%), rare (
The most common side effects are dizziness, headache, fatigue, diarrhea, dry cough, nausea.
Cardio-vascular system: often – a marked decrease in blood pressure, orthostatic hypotension; rarely – chest pain, tachycardia, bradycardia, exacerbation of symptoms of chronic heart failure, impaired atrioventricular conduction, myocardial infarction.
Central nervous system: often – paresthesia, mood lability, confusion, drowsiness, convulsive twitching of the muscles of the limbs and lips, rare – asthenic syndrome.
From the side of hematopoiesis: rarely – leukopenia, neutropenia, agranulocytosis, thrombocytopenia, prolonged treatment – anemia (decreased hemoglobin, hematocrit, erythropenia).
The respiratory system: rarely – dyspnea, bronchospasm.
From the digestive system: rare – dryness of the oral mucosa, anorexia, dyspepsia, taste changes, abdominal pain, pancreatitis, jaundice (hepatocellular and cholestatic), hepatitis.
For the skin: rarely – urticaria, pruritus, increased sweating, alopecia, photosensitivity.
From the urogenital system: rarely – renal dysfunction, oliguria, anuria, acute renal failure, uremia, proteinuria, reduced potency.
Laboratory parameters: often – hyperkalemia, hyponatremia; rarely – hyperbilirubinemia, increased activity of “liver” enzymes, hypercreatininemia, increasing the concentration of urea and creatinine.
Allergic reactions: rare – angioneurotic edema of face and extremities, lips, tongue, epiglottis and / or throat, skin rashes, itching, fever, false positive results of the test for antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), eosinophilia, leukocytosis. In rare cases – intestinal angioedema.
Other: arthralgia / arthritis, vasculitis, myalgia.
special instructions
symptomatic hypotension
In most pronounced decrease in blood pressure occurs with a decrease in blood volume (CBV), caused by the diuretic therapy, decrease of sodium chloride in the diet, dialysis, vomiting or diarrhea. In patients with chronic heart failure with concurrent renal failure or without her, perhaps marked reduction in blood pressure.
Under the strict supervision of a physician should use Lisinopril patients with ischemic heart disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke. Transient hypotension is not a contraindication to receive the next dose.
In applying the drug Lisinopril, in some patients with chronic heart failure but with normal or decreased blood pressure, there may be a decrease in blood pressure, which is usually not a cause for discontinuation of treatment.
Prior to drug treatment, if possible, should be to normalize the sodium content and / or make up the bcc carefully control action Lisinopril initial dose of the drug on the patient.
In the case of renal artery stenosis (especially when bilateral stenosis or in the presence of artery stenosis single kidney) and circulatory failure due to lack of ions of sodium and / or liquid, use Lisinopril drug can lead to renal failure, acute renal failure, which It is usually irreversible even after discontinuation of the drug.
In acute myocardial infarction
Shows the use of standard therapy (thrombolytics, aspirin, beta-blockers). Lisinopril may be used in conjunction with intravenous or using therapeutic transdermal nitroglycerin systems.
Surgery / general anesthesia
With extensive surgical procedures, as well as the use of other means, causing a decrease in blood pressure, Lisinopril, blocking the formation of angiotensin II, may cause unpredictable marked decrease in blood pressure.
In elderly patients the same dose results in a higher concentration of drug in the blood, so extra care is required in determining the dose.
Since it is impossible to eliminate the potential risk of agranulocytosis, requires periodic monitoring of blood picture. In applying the drug in a dialysis-polyacryl nitrile membranes can occur anaphylactic shock, it is recommended that any other type of membrane dialysis or other designation antihypertensives.
The effect on the ability of control of vehicles and mechanisms
No data on the effect of the drug Lisinopril on the ability to drive vehicles and mechanisms applied in therapeutic doses, however, be aware that at the beginning of treatment may develop hypotension, which may affect the ability to drive vehicles and work with potentially dangerous machinery and also may cause dizziness and drowsiness, so be careful.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside, 1 time per day in the morning, regardless of the meal, preferably in one and the same time.
When hypertension patients not receiving other antihypertensives, prescribed 5 mg 1 time per day. If no effect dose is increased every 2-3 days by 5 mg to average therapeutic doses of 20-40 mg / day (increased doses above 40 mg / day usually will not lead to further reduction in blood pressure). A typical daily maintenance dose – 20 mg.
The maximum daily dose – 40 mg.
The full effect usually develops within 2-4 weeks after the start of treatment, which should be considered when increasing the dose. When insufficient clinical effect of the drug can be combined with other antihypertensives.
If the patient has received prior treatment with diuretics, the use of these drugs should be discontinued for 2-3 days prior to the application of the drug Lisinopril. If this is not possible, the initial dose Lisinopril should not exceed 5 mg per day. In this case, after the first dose recommended medical supervision for several hours (maximum action is reached after about 6 hours), since it may be a marked reduction in blood pressure.
When renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system also is advisable to assign a low initial dose of 5 mg per day, under increased medical supervision (control of blood pressure, renal function, the content of potassium ions in serum). Maintenance dose, continuing strict medical control, should be determined depending on the dynamics of blood pressure.
In renal failure because the lisinopril excreted by the kidneys, the initial dose should be determined according to the creatinine clearance. Further selection of doses to be performed in dependence on the individual reactions at regular monitoring of renal function, potassium, sodium in serum.
Creatinine clearance, ml / min Initial Dose, mg / day 30-70 5-10 10-30 5 (including patients on hemodialysis)
When hypertension resistant shows long-term maintenance of 10-15 mg / day therapy.
In chronic heart failure: initial dose – 2.5 mg per day with gradual increase after 3-5 days to 5-10 mg per day. The maximum daily dose – 20 mg.
Acute myocardial infarction (in combination therapy): in the first 24 hours – 5 mg, and then 5 mg every other day, 10 mg every two days and then 10 mg 1 time per day. The course of treatment – at least 6 weeks.
In case of long pronounced decrease in blood pressure (systolic blood pressure less than 90 mm Hg. V. Over 1 h) drug treatment should be discontinued.
Diabetic nephropathy: in patients with type 2 diabetes drug is applied 10 mg Lisinopril 1 time per day. The dose may, if necessary, be increased to 20 mg 1 time per day in order to achieve values ​​below the diastolic blood pressure of 75 mm Hg. Art. in the “sitting” position. Patients with type 1 diabetes is the same dose, in order to achieve values ​​below the diastolic blood pressure of 90 mm Hg. Art. in the “sitting” position.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist