Amlodipine-Teva
Amlodipine-Teva: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Amlodipin-Teva
ATX code: C08CA01
Active ingredient: amlodipine (Amlodipine)
Producer: Teva Pharmaceutical Works Private Limited Company (Hungary)
Description and photo update: 2019-10-07
Prices in pharmacies: from 81 rubles.
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Amlodipine-Teva is a drug with antihypertensive and antianginal action.
Release form and composition
Dosage form - tablets: round, biconvex, white, one side is smooth, the other has an engraving "AB 5" (dosage 5 mg) or "AB 10" (dosage 10 mg) (10 pcs. In blisters, in cardboard a pack of 1 or 3 blisters with 5 mg tablets or 1, 2 or 3 blisters with 10 mg tablets and instructions for the use of Amlodipine-Teva).
Composition of 1 tablet:
- active ingredient: amlodipine besylate - 6.944 or 13.888 mg, which is equivalent to 5 or 10 mg of amlodipine, respectively;
- excipients: sodium carboxymethyl starch (type A), anhydrous calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate.
Pharmacological properties
Pharmacodynamics
Amlodipine is a dihydropyridine derivative, a second-generation slow calcium channel blocker (BMCC) with antianginal and hypotensive effects.
Amlodipine-Teva blocks calcium channels and reduces the transmembrane transition of calcium ions into the cell (to vascular smooth muscle cells to a greater extent than to cardiomyocytes).
Amlodipine has a long-term dose-dependent hypotensive effect, which is due to its ability to have a direct vasodilating effect on vascular smooth muscle. Taking one therapeutic dose of Amlodipine-Teva for hypertension provides a clinically significant decrease in blood pressure (BP) within 24 hours (both in the supine position and in the standing position).
A significant decrease in blood pressure is noted after 6-10 hours, the effect lasts up to 24 hours. Amlodipine-Teva rarely causes the development of orthostatic hypotension.
The antianginal effect of the drug develops due to the expansion of the coronary and peripheral arterioles and arteries. With angina pectoris, due to the expansion of peripheral arterioles, the total peripheral vascular resistance (OPSR), cardiac afterload and myocardial oxygen demand decrease. In addition, the severity of myocardial ischemia decreases. Due to the expansion of the coronary arteries and arterioles in the ischemic and unchanged areas of the myocardium, oxygen supply to the myocardium increases (especially in the case of vasospastic angina pectoris), and spasm of the coronary arteries, including those caused by smoking, is prevented. With stable angina pectoris, taking a single daily dose of Amlodipine-Teva provides an increase in exercise tolerance, an increase in the time before the onset of ischemic depression of the ST segment and the next attack of angina pectoris,reducing the need for nitroglycerin (or other nitrates) and the frequency of angina attacks.
In patients with angina pectoris, as well as in patients with diseases of the cardiovascular system [including coronary atherosclerosis (from lesions of one vessel to stenosis of three or more arteries), atherosclerosis of the carotid arteries] who have had myocardial infarction or percutaneous transluminal angioplasty (PTCA) of coronary arteries, regular the use of Amlodipine-Teva prevents the development of thickening of the intima-media of the carotid arteries, reduces the frequency of interventions aimed at restoring coronary blood flow, and the frequency of progression of chronic heart failure (CHF) or the development of unstable angina pectoris, reduces mortality from stroke, myocardial infarction, coronary artery bypass grafting and PTCA.
Amlodipine reduces the degree of left ventricular myocardial hypertrophy, while not reducing the left ventricular ejection fraction. Increases the rate of glomerular filtration. Inhibits platelet aggregation. Shows weak natriuretic activity.
Does not contribute to a reflex increase in heart rate (HR). Does not affect myocardial contractility and conductivity. Does not increase the severity of microalbuminuria in diabetic nephropathy. It does not have a negative effect on the concentration of blood plasma lipids and metabolism, therefore it can be used in patients with gout, diabetes mellitus and bronchial asthma.
Amlodipine-Teva does not increase the incidence of complications and mortality in patients with severe CHF (NYHA functional classes III and IV) receiving diuretics, digoxin and ACE (angiotensin converting enzyme) inhibitors. However, with a disease of non-ischemic etiology, the risk of developing pulmonary edema increases.
Pharmacokinetics
When administered orally, amlodipine is slowly absorbed from the gastrointestinal tract. Simultaneous food intake does not affect the rate and degree of absorption. The drug reaches its maximum concentration (C max) in the blood serum after 6-9 hours. The absolute bioavailability averages 64%. Equilibrium concentrations (C ss) are observed after 7-8 days of regular intake of Amlodipine-Teva. Penetrates the blood-brain barrier.
The volume of distribution (V d) is an average of 21 l / kg of body weight. This indicates that more of the drug is in the tissues than in the blood. Most of the drug circulating in the blood (95%) binds to plasma proteins. Amlodipine is slowly but highly metabolized in the liver, without having a significant first pass effect. As a result of biotransformation, metabolites are formed that do not have significant pharmacological activity.
It is excreted mainly by the kidneys - 60% (unchanged only about 10%, the rest in the form of metabolites), through the intestines with bile - 20-25%. The total clearance of amlodipine is 0.116 ml / s / kg (7 ml / min / kg; 0.42 l / h / kg).
The half-life (T ½) after a single dose of Amlodipine-Teva varies from 35 to 50 hours, with repeated administration it is about 45 hours. Excretion of the drug is slowed down in elderly patients (T ½ - 65 hours), but this difference has no significant clinical significance. T ½ increases up to 60 hours with liver failure, which suggests an increase in the accumulation of the drug in the body with its long-term use.
In renal failure, no significant changes in the pharmacokinetics of amlodipine have been identified. The plasma concentration of the drug does not correlate with the degree of renal failure. Slight lengthening T ½ is possible.
Amlodipine is not removed during hemodialysis.
Indications for use
Amlodipine-Teva is indicated for the treatment of arterial hypertension, vasospastic angina pectoris and stable exertional angina pectoris.
Contraindications
Absolute:
- unstable angina (except for Prinzmetal's angina);
- severe arterial hypotension (systolic blood pressure <90 mm Hg);
- acute myocardial infarction (period 28 days after the attack);
- obstruction of the outflow tract of the left ventricle;
- clinically significant aortic stenosis;
- cardiogenic shock;
- lactation period;
- age up to 18 years;
- hypersensitivity to any component of the drug or other dihydropyridine derivatives.
Amlodipine-Teva tablets should be used with caution in the following cases (due to the risk of complications):
- elderly age;
- pregnancy;
- impaired renal function;
- liver dysfunction;
- arterial hypotension;
- aortic / mitral stenosis;
- sick sinus syndrome (severe bradycardia, tachycardia);
- severe stages of CHF (III ‒ IV functional class according to NYHA classification) of non-ischemic etiology;
- acute myocardial infarction (after the first 28 days after the attack).
Amlodipine-Teva, instructions for use: method and dosage
Amlodipine-Teva tablets should be taken orally 1 time per day, swallowed whole and washed down with a small amount of water (100 ml).
Treatment is usually started with a daily dose of 5 mg. If the required therapeutic effect is absent within 2-4 weeks, the dose of Amlodipine-Teva is increased to 10 mg.
Side effects
Taking Amlodipine-Tev may be accompanied by the development of the following side effects (according to the classification of the World Health Organization, the frequency of their development is distributed as follows: ≥ 10% - very often; from 1% to 10% - often; from 0.1% to 1% - infrequently; from 0.01% to 0.1% - rarely; <0.01%, including individual messages - very rarely):
- on the part of the heart and blood vessels: often - a feeling of palpitations, rushes of blood to the skin of the face, peripheral edema (feet and ankles); infrequently - vasculitis, excessive decrease in blood pressure, orthostatic hypotension; rarely - the development or aggravation of the course of CHF; very rarely - chest pain, heart rhythm disturbances (including bradycardia, atrial fibrillation, ventricular tachycardia), shortness of breath, fainting, pulmonary edema, myocardial infarction;
- from the side of metabolism: very rarely - hyperglycemia;
- from the digestive system: often - abdominal pain, nausea; infrequently - thirst, dryness of the oral mucosa, vomiting, anorexia; rarely - increased appetite, gingival hyperplasia; very rarely - hyperbilirubinemia, gastritis, pancreatitis, increased activity of hepatic transaminases, jaundice (usually cholestatic), hepatitis;
- from the hematopoietic and lymphatic systems: very rarely - leukopenia, thrombocytopenia, thrombocytopenic purpura;
- from the central nervous system: often - increased fatigue, headache (especially at the beginning of treatment), drowsiness, dizziness; infrequently - emotional lability, peripheral neuropathy, hypesthesia, unusual dreams, insomnia, hyperexcitability, paresthesia, asthenia, general malaise, increased sweating, nervousness, anxiety, tremor, depression; rarely - agitation, convulsions, apathy; very rarely - migraine, ataxia, amnesia;
- from the musculoskeletal system: infrequently - arthralgia, myalgia, arthrosis, muscle cramps, back pain; rarely - myasthenia gravis;
- from the respiratory system: infrequently - rhinitis, shortness of breath; very rarely - cough;
- from the mammary glands, urinary and reproductive systems: infrequently - gynecomastia, painful urge to urinate, pollakiuria, nocturia, impotence; very rarely - polyuria, dysuria;
- on the part of the sense organs: infrequently - pain in the eyes, impaired accommodation, diplopia, xerophthalmia, visual impairment, conjunctivitis, ringing in the ears; very rarely - parosmia;
- skin and allergic reactions: infrequently - alopecia; rarely - skin rashes (including erythematous and maculopapular rashes), itching of the skin, dermatitis; very rarely - cold clammy sweat, urticaria, xeroderma, alopecia, skin pigmentation disorders, Quincke's edema, erythema multiforme;
- others: infrequently - nosebleeds, weight gain, chills, taste perversion, weight loss.
Overdose
An overdose of Amlodipine-Tev is manifested by an excessive decrease in blood pressure. Perhaps the development of reflex tachycardia and excessive peripheral vasodilation, which is accompanied by the risk of persistent and severe arterial hypotension, up to shock and death.
In case of taking an excessive dose of Amlodipine-Teva, first of all, especially if no more than 2 hours have passed, you need to rinse the stomach, drink activated charcoal, take a horizontal position with raised legs.
Hemodialysis is ineffective. To restore vascular tone, the use of vasoconstrictor agents is indicated (if they are not contraindicated). The blockade of calcium channels is eliminated by intravenous administration of calcium gluconate. It is shown that measures are taken to maintain the function of the cardiovascular system. It is necessary to monitor the performance of the heart and lungs, the volume of urine output and circulating blood.
special instructions
In acute myocardial infarction, Amlodipine-Teva can be prescribed only after stabilization of hemodynamic parameters.
During the period of therapy, compliance with an appropriate diet is indicated, it is necessary to control body weight and sodium intake. It is also required to carefully maintain oral hygiene and be observed by the dentist (to prevent bleeding, soreness and gingival hyperplasia).
BMCC does not have a withdrawal syndrome, however, treatment should not be stopped abruptly, it is recommended to gradually reduce the dose of Amlodipine-Tev.
The efficacy and safety of amlodipine in hypertensive crisis have not been established.
Influence on the ability to drive vehicles and complex mechanisms
During the period of use of Amlodipine-Tev, no negative effect on the speed of reactions and the ability to control complex mechanisms (including vehicles) was found. However, given the likelihood of an excessive decrease in blood pressure, the appearance of drowsiness, the development of dizziness or other undesirable reactions, it is recommended to be careful when performing potentially hazardous work, especially at the initial stage of therapy during the period of increasing the dose.
Application during pregnancy and lactation
According to experimental studies, amlodipine does not have embryotoxic and fetotoxic effects, however, there is no clinical experience of using the drug in pregnant women. In this regard, Amlodipine-Teva is prescribed only in cases where the intended benefit to the woman outweighs the possible risks to the fetus.
There are no data indicating the release of amlodipine in breast milk, but it has been reliably established that other BMCCs, which are derivatives of dihydropyridine, are excreted in mother's milk. For this reason, when prescribing Amlodipine-Teva, women are advised to stop breastfeeding.
Pediatric use
In childhood and adolescence (up to 18 years), Amlodipine-Teva is not used due to the lack of data confirming its effectiveness and safety.
With impaired renal function
Amlodipine-Teva in patients with impaired renal function is used in usual doses. Careful monitoring of the condition is recommended.
For violations of liver function
Amlodipine-Teva should be used with caution in patients with hepatic impairment. Treatment must be accompanied by medical supervision, since an increase in T ½ of the drug is possible.
Use in the elderly
There is no need to change the dose of Amlodipine-Teva for elderly patients, however, close medical supervision should be ensured, since a decrease in the clearance of amlodipine and an increase in its T ½ is possible.
Drug interactions
Amlodipine-Teva can be safely used in combination with the following drugs (increased action is noted):
- ACE inhibitors, thiazide diuretics, alpha-blockers - in the treatment of hypertension;
- other antianginal agents (for example, nitrates of short or prolonged action) - in the treatment of stable angina pectoris.
Amlodipine, unlike other BMCCs, has not shown drug interactions with nonsteroidal anti-inflammatory drugs, including indomethacin.
With the simultaneous use of erythromycin increases Cmax of amlodipine by 22%, in elderly patients - by 50%.
When combined with amlodipine, beta-blockers can exacerbate the course of heart failure.
It is known that some BMCCs are capable of enhancing the severity of the negative inotropic effect of antiarrhythmic drugs that prolong the QT interval (for example, amiodarone, quinidine). In amlodipine, this effect has not been identified, but cannot be completely excluded.
Antiretroviral drugs (ritonavir) increase plasma concentrations of BMCA, including amlodipine.
Calcium preparations can reduce the severity of the effect of BMCC.
Isoflurane and antipsychotics enhance the hypotensive effect of dihydropyridine derivatives.
Amlodipine-Teva is able to increase the manifestations of neurotoxicity in patients receiving lithium preparations (tremor, ataxia, diarrhea, nausea, vomiting, tinnitus).
A single dose of sildenafil 100 mg did not cause changes in the pharmacokinetics of amlodipine in patients with arterial hypertension.
With repeated joint use, amlodipine at a dose of 10 mg does not cause clinically significant changes in the kinetics of atorvastatin used at a dose of 80 mg.
Amlodipine-Teva does not affect the pharmacokinetics of cyclosporine, the concentration of digoxin in the blood serum and its renal clearance, or the action of warfarin (prothrombin time).
A single dose of magnesium or aluminum-containing antacids does not significantly affect the pharmacokinetics of amlodipine.
There were no changes in the pharmacokinetic characteristics of Amlodipine-Teva with the simultaneous use of cimetidine.
According to in vitro studies, amlodipine does not affect the binding of indomethacin, phenytoin, digoxin and warfarin to plasma proteins.
Amlodipine used in a daily dose of 10 mg does not affect the pharmacokinetics of ethanol (including alcoholic beverages).
The simultaneous intake of 10 mg of amlodipine and grapefruit juice in a volume of 240 mg is not accompanied by a significant change in the kinetics of amlodipine.
Analogs
Amlodipine-Teva analogs are: Amlovas, Amlonorm, Amlodipine Cardio, Amlodipharm, Amlorus, Amlotop, Verapamil, Diltiazem, Isoptin SR 240, Kardilopin, Karmagip, Corinfar, Cordaflex, Norvask, Nebilong AM, Omelendurde Cardio XL Felodipine, Fenigidin, Felodip, EsCordi Cor and others.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C, out of reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Amlodipine-Teva
According to reviews, Amlodipine-Teva is an effective tool for maintaining normal blood pressure levels. The drug needs to be taken only once a day, which, according to most patients, is very convenient. There are 30 tablets in the package, that is, just for a month of treatment, they are small in size, so they are easy to swallow. Amlodipine-Teva is suitable for long-term use.
Of the side effects, the appearance of edema is most often mentioned.
The price of Amlodipine-Teva in pharmacies
Depending on the pharmacy chain, the approximate price for Amlodipine-Teva in a dosage of 5 mg is 93-146 rubles. per pack of 30 tablets. You can buy a package of tablets (30 pcs.) In a dosage of 10 mg for 148-177 rubles.
Amlodipine-Teva: prices in online pharmacies
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Drug name Price Pharmacy |
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Amlodipine-Teva 5 mg tablets 30 pcs. RUB 81 Buy |
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Amlodipine-Teva 5mg tablets 30 pcs. RUB 103 Buy |
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Amlodipine-Teva 10 mg tablets 30 pcs. 132 RUB Buy |
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Amlodipine-Teva 10mg tablets 30 pcs. RUB 176 Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, 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!
