Berlipril 5 tab 5mg 30 pc

Description

Composition
Active substance:
1 tablet contains: Enalapril maleate 5/10/20 mg.
Excipients:
5 mg 1 tablet contains: gelatin, lactose monohydrate, magnesium stearate, basic magnesium carbonate, silicon dioxide colloidal, sodium carboxymethylstarch. 1 tablet of 10 mg and 20 mg contains: lactose monohydrate, magnesium carbonate light, gelatin, sodium carboxymethyl starch, magnesium stearate, brown iron oxide (E 172).
Product form:
Tablets 5 mg, 10 mg or 20 mg.
10 tablets in a blister of aluminum foil.
3 blisters together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to enalapril and other inhibitors of angiotensin-converting enzyme, a history of angioneurotic edema associated with treatment with ACE inhibitors, porphyria, pregnancy, lactation, at the age of 18 years (effectiveness and safety have been established).
Be wary of Berlipril® with primary hyperaldosteronism, bilateral renal artery stenosis, stenosis of the artery to a solitary kidney, hyperkalemia, condition after kidney transplantation; aortic stenosis, mitral stenosis (with impaired hemodynamics), idiopathic hypertrophic subaortic stenosis, connective tissue diseases, coronary heart disease, cerebrovascular diseases, diabetes, renal disease (proteinuria greater than 1 g / day), liver failure, patients on a diet with salt restriction, or on hemodialysis, while admission to immunosuppressants and saluretikami in the elderly (over 65 years).
Dosage
5 mg
Indications
Hypertension (including renovascular hypertension), chronic heart failure (in a combination therapy), asymptomatic left ventricular dysfunction (as part of combination therapy).
Interaction with other drugs
When concomitant administration of enalapril with nonsteroidal antiinflammatory drugs (NSAIDs) may reduce the hypotensive effect of enalapril; potassium-sparing diuretics (spironolactone, triamterene, amiloride) may cause hyperkalemia; with the salts of lithium – lithium down hatching (shown control the concentration of lithium in the blood plasma).
Enalapril reduces the effect of formulations containing theophylline.
Hypotensive effect of enalapril increase diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers digidroperidinovye, hydralazine, prazosin.
Immunosuppressants, allopurinol, cytostatics reinforce haematotoxicity. Drugs that cause bone marrow suppression, increase the risk of neutropenia and / or agranulocytosis.
Simultaneous treatment with antipyretic and analgesic drugs may decrease the effectiveness of the drug.
Overdose
Symptoms: marked reduction of blood pressure until the development of collapse, myocardial infarction, acute stroke or thromboembolic complications, convulsions, stupor.
Treatment: the patient is transferred to a horizontal position with a low headboard. In mild cases shown gastric lavage and intake of brine, in more severe cases – actions to stabilize blood pressure: intravenous administration of saline, plasma expanders, optionally – administering angiotensin II, hemodialysis (elimination rate enalaprilat – 62 ml / min).
pharmachologic effect
Pharmacological group:
ACE inhibitor.
Pharmacodynamics:
Enalapril – antihypertensive from the group of ACE inhibitors. Enalapril is a “prodrug”: as a result of hydrolysis enalaprilat is formed, which inhibits ACE. Its mechanism of action is associated with a decrease in the formation of angiotensin I angiotensin II, reduction of which leads to a direct decrease in aldosterone release. In this decreases total peripheral vascular resistance, systolic and diastolic blood pressure (BP), and post-preload on the myocardium.
Artery expands to a greater extent than the vein, the reflex increase of heart rate frequency is not observed.
The hypotensive effect is more pronounced at high plasma renin level than at normal or reduced its level. Reduction of blood pressure in the therapeutic range has no effect on cerebral blood flow, cerebral blood flow in vessels is maintained at a sufficient level and the background of decrease in blood pressure. Strengthens the coronary and renal blood flow.
With prolonged use of reduced left ventricular hypertrophy and myocyte walls resistive arteries prevents progress of heart failure and slows the development of left ventricular dilation. It improves blood flow to the ischemic myocardium. Reduces platelet aggregation.
It has some diuretic effect.
onset of antihypertensive effect during ingestion – 1 h, reaching a maximum after 4-6 hours and lasts up to 24 hours in some patients to achieve optimal blood pressure level needed therapy for a few weeks.. In heart failure, a significant clinical effect observed in long-term treatment – 6 months or more.
Pharmacokinetics:
After ingestion absorbed 60% of the formulation. Eating does not affect the absorption of enalapril.
Enalapril and 50% bound to plasma proteins. Enalapril is rapidly metabolized in the liver to form the active metabolite enalaprilat, which is a more potent inhibitor of ACE than enalapril. Bioavailability of 40%.
The maximum concentration of enalapril in plasma achieved after 1 hour, enalaprilat -. 4.3 h enalaprilat easily passes through the blood-tissue barriers, excluding the blood-brain, a small amount of cross the placenta and into breast milk.
. Enalaprilat half-life of about 11 hours is derived mainly kidneys enalapril – 60% (20% – as enalapril and 40% – in the form enalaprilat). through the intestine – 33% (6% – as enalapril and 27% – in the form enalaprilat).
Removed during hemodialysis (rate 62 ml / min) and the peritoneal dialysis.
Pregnancy and breast-feeding
Contraindicated.
Conditions of supply of pharmacies
On prescription.
side effects
Berlipril® generally well tolerated and in most cases does not cause side reactions requiring discontinuation of the drug.
Cardio-vascular system: excessive fall in blood pressure, orthostatic collapse, rarely – chest pain, angina pectoris, myocardial infarction (usually associated with a marked reduction of blood pressure), arrhythmia (atrial or bradi- tachycardia, atrial fibrillation), palpitations, thromboembolism branches pulmonary embolism, heart pain, syncope.
From the nervous system: dizziness, headache, fatigue, insomnia, anxiety, confusion, fatigue, sleepiness (2-3%), rarely with high doses – nervousness, depression, paresthesia.
From the senses: vestibular disorders, hearing and visual impairment, tinnitus.
On the part of the gastrointestinal tract: dry mouth, anorexia, disipticheskie disorders (nausea, diarrhea or constipation, vomiting, abdominal pain), ileus, pancreatitis, liver dysfunction and biliary excretion, hepatitis, jaundice.
The respiratory system: nonproductive dry cough, interstitial pneumonitis, bronchospasm, dyspnea, rhinorrhea, pharyngitis.
Allergic reactions: skin rash, angioneurotic edema of face and extremities, lips, tongue, glottis and / or throat, dysphonia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, rash, photosensitivity, serositis, vasculitis, myositis, arthralgia, arthritis, stomatitis, glossitis.
From the laboratory parameters: hypercreatininemia, increasing urea content, increased activity of “liver” transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia. There have been, in some cases, decrease in hematocrit and hemoglobin, increased erythrocyte sedimentation rate, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia.
From the urinary system: renal dysfunction, proteinuria.
Other: alopecia, decreased libido, hot flashes.
special instructions
Care must be taken when administered to patients with reduced circulating blood volume (as a result of diuretic therapy, while limiting the consumption of salt, hemodialysis, diarrhea and vomiting) – increased risk of sudden and pronounced blood pressure lowering even after applying the initial dose of ACE inhibitor.
Transient hypotension is not a contraindication for the continuation of treatment after stabilization of arterial pressure (BP). In the case of re-expressed BP reduction should reduce or stop the drug dose.
With the development of excessive reduction in blood pressure of the patient to the supine position with a low headboard, saline-treated and plasma-drugs as necessary.
Application vysokoprotochnyh dialysis membranes increases the risk of an anaphylactic reaction. Correction of dosing regimen in days free from dialysis, should be carried out, depending on the level of blood pressure. Before and after the treatment with ACE inhibitors requires control of blood pressure, blood parameters (hemoglobin, potassium, creatinine, urea, the activity of “liver” enzymes), protein in the urine.
Should be carefully observed for patients with severe heart failure, coronary heart disease and diseases of the brain, in which a sharp decrease in blood pressure can lead to heart attack, stroke, or renal dysfunction. The sudden cancellation of treatment does not lead to the syndrome of “lifting” (a sharp rise in blood pressure).
In patients with an indication for the development of angioedema in history, there is an increased risk of developing cancer while taking ACE inhibitors.
For newborns and infants who have been exposed in utero ACE inhibitors should be closely monitored for early detection of significant decrease in blood pressure, oliguria, hyperkalemia and neurological disorders, possible due to the reduction of renal and cerebral blood flow with a decrease in blood pressure caused by ACE inhibitors. When oliguria necessary to maintain blood pressure and renal perfusion by introducing the liquids and vasoconstrictors.
In patients with renal function decline, reduce single dose or increase the interval between doses of the drug.
Before examining the function of the parathyroid glands Berlipril® should be abolished.
During the period of treatment is not recommended to drink alcohol the beverage, because Alcohol enhances the hypotensive effect of the drug.
In the period of treatment should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and speed of psychomotor reactions, because dizziness, especially after the initial dose of ACE inhibitor in patients receiving diuretics.
Use caution when exercising in hot weather (risk of development of dehydration and excessive loss of blood pressure due to a decrease in blood volume). Prior to surgery (including dental), you must notify the surgeon / anesthetist on the use of ACE inhibitors.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of reach of children !.
Dosing and Administration
Berlipril® administered orally, regardless of mealtime.
In monotherapy hypertension – an initial dose of 5 mg 1 time per day (one tablet Berlipril® 5 1/2 10 Berlipril® tablets, pills 1/4 Berlipril® 20).
In the absence of clinical effect after 1-2 weeks the dose was raised to 5 mg. After receiving the initial dose, patients should be under medical observation for a further 2 hours and 1 hour until it stabilizes blood pressure. If necessary and sufficient good tolerability, the dose can be increased to 40 mg / day in 2 divided doses (8 Berlipril® 5 tablets, 4 tablets Berlipril® 10 2 tablets Berlipril® 20). After 2-3 weeks, transferred to a maintenance dose – 10-40 mg / day, divided into 1-2 doses. At moderate hypertension average daily dose is about 10 mg (2 tablets Berlipril® 5, 1 tablet Berlipril® 10 1/2 20 Berlipril® tablet).
The maximum daily dose of 40 mg / day.
In the case of appointment to patients concomitantly receiving diuretics, diuretic therapy should be discontinued for 2-3 days prior to the appointment Berlipril®. If this is not possible, the initial dose should be 2.5 mg / day.
Patients with hyponatremia (concentration of sodium ions in serum of less than 130 mmol / l) or creatinine concentration in the serum of more than 0.14 mmol / l initial dose – 2.5 mg 1 time per day.
When renovascular hypertension initial dose – 2.5-5 mg / day. The maximum daily dose – 20 mg (4 tablets Berlipril® 5, 2 tablets Berlipril® 10, 20 Berlipril® 1 tablet).
In chronic heart failure the initial dose Berlipril® – 2.5 mg once, then increase the dose of 2.5-5 mg every 3-4 days according to the clinical response to the maximum tolerable doses depending on the blood pressure value, but not above 40 mg / day in single or 2 divided doses. Patients with low systolic blood pressure (less than 110 mm Hg. V.) Therapy should be initiated with a dose of 1.25 mg. dose selection should be carried out for 2-4 weeks or more in a short time. The mean maintenance dose – 5-20 mg / day in 1-2 doses.
The elderly often observed more pronounced hypotensive effect and an elongation time of the drug, due to the decrease in elimination rate enalapril, however recommended initial dose elderly – 1.25 mg.
In asymptomatic left ventricular dysfunction – 2.5 mg 2 times a day. The dose is selected taking into account the tolerance of up to 20 mg / day, divided into 2 doses.
In chronic renal failure accumulation occurs at lower filtration less than 10 ml / mil. If creatinine clearance (CC) 80-30 ml / min dose is usually 5-10 mg / day with CC to 30-10 ml / min – 2.5-5 mg / day, with CC less than 10 ml / min – 1, 25-2,5 mg / day only on the days of dialysis. The duration of treatment depends on the effectiveness of therapy. Too marked decrease in blood pressure dose gradually.
The drug used in both monotherapy and in combination with other antihypertensive agents.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist