Vero-Amlodipine
Vero-Amlodipine: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Instructions for the use of Vero-Amlodipine: method and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews of Vero-Amlodipine
- 16. Price of Vero-Amlodipine in pharmacies
Latin name: Vero-Amlodipine
ATX code: C08CA01
Active ingredient: amlodipine (amlodipine)
Manufacturer: OJSC "VEROPHARM", Russia
Description and photo update: 2018-22-10
Vero-Amlodipine is a calcium antagonist, BMCC (slow calcium channel blocker).
Release form and composition
Dosage form of the drug Vero-Amlodipine - tablets: white or white with a cream shade, slight marbling of the surface is possible, flat-cylindrical (10 pcs. In blisters, in a cardboard box 1 or 3 packages; 10 or 30 pcs. In polymer cans, in a pack of cardboard 1 can; 2 or 2.5 kg of tablets in polymer containers for export).
Composition for 1 tablet:
- active substance: amlodipine besylate (equivalent to the content of amlodipine) - 5 or 10 mg;
- auxiliary components: calcium phosphate dihydrate, primogel (sodium carboxymethyl starch), potato starch, microcrystalline cellulose, aerosil (colloidal silicon dioxide), magnesium stearate.
Pharmacological properties
Pharmacodynamics
Amlodipine - an active component of Vero-Amlodipine - a dihydropyridine derivative, due to its ability to block slow calcium channels, reduces the transmembrane transition of calcium ions into cells (mainly into vascular smooth muscle cells, less into cardiomyocytes), as a result of which it exhibits antianginal and hypotensive activity.
The drug reduces the severity of myocardial ischemia. The antianginal efficacy of amlodipine is due to an expanding effect on coronary and peripheral arteries and arterioles: due to the expansion of peripheral arterioles, it reduces the systemic vascular resistance (total peripheral vascular resistance) and afterload on the heart, thereby reducing myocardial oxygen demand. Contributing to the expansion of coronary arteries and arterioles in ischemic and unchanged areas of the myocardium, the substance increases the supply of oxygen to the myocardium (especially in the treatment of Prinzmetal's vasospastic angina) and prevents the development of spasm of the coronary arteries (including those caused by smoking). In patients with angina pectoris, taking a single daily dose of amlodipine increases the duration of the period of physical activity,during which it delays the development of ischemic depression of the ST segment and angina attacks, reduces the frequency of its attacks and the dose of nitroglycerin.
Vero-Amlodipine has a long-term dose-dependent hypotensive effect due to a direct vasodilating effect on vascular smooth muscle cells. A single dose used for the treatment of arterial hypertension is capable of providing a clinically significant decrease in blood pressure (blood pressure) in a patient lying and standing throughout the day. At the same time, the drug does not cause a sharp drop in blood pressure, does not reduce LVEF (left ventricular ejection fraction) and susceptibility to physical activity, reduces left ventricular myocardial hypertrophy, and has a cardioprotective effect in IHD (ischemic heart disease). It does not affect myocardial contractility and conductivity, does not cause a reflex increase in heart rate (heart rate), inhibits platelet aggregation,increases GFR (glomerular filtration rate) and has a weak natriuretic effect. Does not increase the severity of microalbuminuria in patients with diabetic nephropathy.
In diseases of the cardiovascular system (including coronary atherosclerosis with damage to one vessel and before stenosis of three or more arteries, atherosclerosis of the carotid arteries), after myocardial infarction, percutaneous TLP (transluminal angioplasty) of the coronary arteries or in patients with angina pectoris amlodipine development of thickening of the IM (intima-media complex) of the carotid arteries, reduces the number of deaths from stroke, myocardial infarction, TLP, coronary artery bypass grafting, reduces the number of hospitalizations for unstable angina pectoris and progression of CHF (chronic heart failure), reduces the need for interventions to restore coronary blood flow …
In CHF III – IV functional class according to the NYHA (New York Heart Association) classification, amlodipine does not increase the risk of complications and deaths in patients taking digoxin, diuretics and ACE inhibitors (angiotensin converting enzyme). With non-ischemic etiology of this disease, the use of Vero-Amlodipine can cause pulmonary edema.
Amlodipine does not adversely affect the metabolism and concentration of blood plasma lipids.
The effect of Vero-Amlodipine comes after 2-4 hours from the moment of administration and lasts a day.
Pharmacokinetics
Pharmacokinetic parameters of amlodipine:
- absorption: well absorbed after oral administration (about 90%); food intake has no effect on the absorption of a substance in the intestinal tract; the indicator of absolute bioavailability varies within 64–80%; the maximum concentration in blood plasma is reached after 6-9 hours;
- distribution: the average value of the volume of distribution is 21 l / kg; about 97% of amlodipine binds to plasma proteins; it penetrates the blood-brain barrier, reaching an equilibrium concentration in the body on the 7-8th day of therapy;
- metabolism: occurs in the liver with the formation of inactive metabolites. T 1/2 (half-life) of the drug averages from 35 to 50 hours, which allows you to take it once a day. With arterial hypertension, T 1/2 is 48 hours, in old age (after 65 years) this indicator increases to 65 hours, in patients with hepatic insufficiency - up to 60 hours, a similar increase is observed in severe CHF;
- Excretion: total clearance of amlodipine - 500 ml / min; the kidneys in the form of inactive metabolites are excreted about 60% of the received dose, unchanged - up to 10%. Through the digestive system (choleretic ducts and intestines), 20 to 25% of amlodipine is excreted in the form of metabolites. Hemodialysis has no clinically significant effect on drug elimination.
Impaired renal function does not significantly affect the pharmacokinetics of amlodipine.
Indications for use
Vero-Amlodipine is recommended to be taken for the following diseases:
- arterial hypertension (as monotherapy or as part of a combination treatment with other antihypertensive drugs);
- stable exertional angina, Prinzmetal vasospastic angina (as monotherapy or as part of a combination treatment with other antianginal agents).
Contraindications
Absolute:
- unstable angina, except for Prinzmetal's vasospastic angina;
- severe arterial hypotension with systolic blood pressure less than 90 mm Hg. Art.;
- children and adolescents up to 18 years old;
- individual hypersensitivity to amlodipine, other dihydropyridine derivatives and auxiliary components of the drug.
According to the instructions, Vero-Amlodipine must be used with caution (relative contraindications) for arterial hypotension, liver dysfunction, sick sinus syndrome (severe bradycardia, tachycardia), aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and throughout 1 month after), CHF of non-ischemic etiology of III – IV functional class according to NYHA classification, in old age.
Instructions for the use of Vero-Amlodipine: method and dosage
Vero-Amlodipine tablets are taken orally.
Recommended dosage for the treatment of arterial hypertension and angina pectoris: initial dose - 5 mg per day in one dose; if necessary, the dose can be increased to 10 mg per day in one dose.
With the simultaneous appointment of amlodipine with thiazide diuretics, β-blockers, ACE inhibitors, dose adjustment of amlodipine is not required.
Side effects
Side effects from systems and organs using the following classification of the frequency of their development: often -> 1%, infrequently - from 0.1% to 1%, rarely - from 0.01% to 0.1%, extremely rarely - <0, 01%:
- cardiovascular system: often - palpitations, peripheral edema (mainly swelling of the feet and ankles); infrequently - a strong decrease in blood pressure, vasculitis, orthostatic hypotension; rarely - development / worsening of heart failure; extremely rare - migraine, cardiac arrhythmias (ventricular tachycardia, bradycardia, atrial flutter), chest pain, myocardial infarction;
- central and peripheral nervous system: often - dizziness, headache, a feeling of heat and flushing of the face, drowsiness, increased fatigue; infrequently - asthenia, malaise, fainting, peripheral neuropathy, hypesthesia, paresthesia, tremor, emotional lability, insomnia, unusual dreams, depression, nervousness, anxiety; rarely - apathy, agitation, convulsions; extremely rare - amnesia, ataxia;
- digestive system: often - nausea, pain in the abdominal region; infrequently - constipation, vomiting, diarrhea, flatulence, anorexia, dyspepsia, thirst, dry mouth; rarely - increased appetite, gingival hyperplasia; extremely rare - pancreatitis, gastritis, jaundice (more often cholestatic), hyperbilirubinemia, increased activity of liver enzymes, hepatitis;
- hematopoietic organs: extremely rarely - leukopenia, thrombocytopenic purpura, thrombocytopenia;
- respiratory system: infrequently - rhinitis, shortness of breath; extremely rare - cough;
- genitourinary system: infrequently - painful urination, nocturia, pollakiuria, impotence; extremely rare - polyuria, dysuria;
- musculoskeletal system: infrequently - convulsions, arthralgia, myalgia, arthrosis, back pain; rarely - myasthenia gravis;
- hypersensitivity reactions: infrequently - itching, rash; extremely rarely - erythema multiforme, angioedema, urticaria;
- other reactions: infrequently - ringing in the ears, alopecia, gynecomastia, increase / decrease in body weight, visual impairment, xerophthalmia, conjunctivitis, diplopia, eye pain, impaired accommodation, taste perversion, nosebleeds, chills, hyperhidrosis; rarely - xeroderma, parosmia, cold sweat, skin pigmentation disorders, hyperglycemia.
Overdose
A symptom of an overdose of amlodipine is a pronounced decrease in blood pressure with the likelihood of developing excessive peripheral vasodilation and reflex tachycardia with the risk of developing a pronounced persistent decrease in blood pressure up to shock and death.
For the treatment of the condition, it is advisable in the first 2 hours after an overdose to give the patient a gastric lavage and give activated charcoal, and then put the patient in a horizontal position, ensuring an elevated position of the lower limbs. It is necessary to control the work of the cardiovascular system, to monitor the indicators of heart and lung function, control the BCC (circulating blood volume) and urine output. In order to restore vascular tone, vasoconstrictor agents are used, if there are no contraindications to their use; to eliminate the effects of calcium channel blockade, calcium gluconate is administered intravenously.
Hemodialysis for the treatment of an overdose of Vero-Amlodipine is ineffective.
special instructions
Amlodipine does not affect the concentration in blood plasma of glucose, potassium, thyroid hormones, uric acid, lipids, urea nitrogen, creatinine.
Due to the risk of worsening angina pectoris due to withdrawal of amlodipine, therapy with Vero-Amlodipine should be discontinued gradually.
During treatment, control of body weight is required, as well as regular sanitation of the oral cavity at the dentist to prevent bleeding, soreness, and gingival hyperplasia.
The efficacy and safety of amlodipine therapy against the background of a hypertensive crisis has not been established.
In old age, an increase in T 1/2 and a decrease in drug clearance are possible. This condition does not require a dose adjustment of Vero-Amlodipine, but you should more carefully monitor the well-being of patients in this category.
Influence on the ability to drive vehicles and complex mechanisms
While taking Vero-Amlodipine when performing types of work that require increased concentration of attention and acceleration of psychomotor reactions (driving vehicles, engaging in other potentially hazardous activities), care must be taken.
Application during pregnancy and lactation
The safety and efficacy of Vero-Amlodipine during pregnancy have not been established, therefore, taking the drug during this period is possible only if the benefits to the mother exceed the potential risks to the fetus.
There are no data indicating the release of amlodipine during lactation, but there is reliable information on the excretion of other BMCCs in breast milk - dihydropyridine derivatives. Therefore, if it is necessary to prescribe Vero-Amlodipine to lactating women, the issue of interrupting or stopping breastfeeding should be resolved.
Pediatric use
In pediatric practice, Vero-Amlodipine is contraindicated for the treatment of children and adolescents under the age of 18 years due to limited data on the effectiveness and safety of therapy.
Drug interactions
- inhibitors of microsomal liver enzymes: the risk of developing side effects of amlodipine increases due to a possible increase in the plasma concentration of amlodipine;
- inducers of microsomal liver enzymes: the risk of side effects is reduced due to a possible decrease in the plasma concentration of amlodipine;
- NSAIDs (non-steroidal anti-inflammatory drugs), especially those containing indomethacin: do not show clinically significant interactions with amlodipine (unlike other BMCCs);
- verapamil, thiazide and loop diuretics, nitrates, β-blockers, ACE inhibitors: potentiate the antianginal and hypotensive effect of amlodipine;
- digoxin and warfarin: amlodipine has no effect on their pharmacokinetic parameters;
- cimetidine: has no effect on the pharmacokinetics of amlodipine;
- calcium preparations: a decrease in the effectiveness of BMCC is possible;
- antiviral drugs (for example, ritonavir): increase the concentration of BMCC in blood plasma;
- antipsychotics: potentiate the hypotensive effect of dihydropyridine derivatives;
- lithium preparations: may increase neurotoxicity;
- drugs for inhalation anesthesia (derivatives of hydrocarbons, including isoflurane), amiodarone, quinidine: may increase the hypotensive effect.
Analogs
Analogs of Vero-Amlodipine are: Amlodak, Amlovas, Amlodipharm, Amlodigamma, Amlorus, Amlong, Amlonorm, Cardilopin, Kalchek, Normodipin, Stamlo, etc.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life is 4 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Vero-Amlodipine
Most of the reviews about Vero-Amlodipine are positive, all patients note the low cost of the drug and good efficacy for reducing blood pressure, as well as improving overall well-being. With regular intake of pills, headaches stop, weakness, fatigue, and dizziness disappear.
Price for Vero-Amlodipine in pharmacies
The approximate price for Vero-Amlodipine (5 mg tablets, 30 pcs. In a package) is 50–70 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
