Amlodipine Sandoz
Amlodipine Sandoz: 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: Amlodipine Sandoz
ATX code: C08CA01
Active ingredient: amlodipine (Amlodipine)
Manufacturer: Lek d.d. (LEK dd) (Slovenia)
Description and photo update: 2019-08-07
Prices in pharmacies: from 131 rubles.
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Amlodipine Sandoz is a slow calcium channel blocker (BMCC) with antihypertensive and antianginal effects.
Release form and composition
Dosage form - tablets: round, flat, white or yellowish-white in color, with a bevelling, with a risk on one side (in a cardboard box 3 blisters of 10 tablets and instructions for the use of Amlodipine Sandoz).
Composition of 1 tablet:
- active substance: amlodipine (in the form of besylate) - 5 or 10 mg;
- auxiliary components: anhydrous colloidal silicon dioxide, corn starch (dry), microcrystalline cellulose, magnesium stearate, talc, anhydrous lactose.
Pharmacological properties
Pharmacodynamics
Amlodipine is a dihydropyridine derivative, BMCC. Has hypotensive and antianginal effects. It binds to dihydropyridine receptors, as a result of which it blocks calcium channels and reduces the transmembrane transition of calcium ions into the cell (mainly into vascular smooth muscle cells, to a lesser extent - into cardiomyocytes).
It has a long-term dose-dependent effect. The antihypertensive effect is explained by a direct vasodilating effect on vascular smooth muscle. In patients with arterial hypertension, taking a single dose of Amlodipine Sandoz provides a therapeutically significant decrease in blood pressure (BP) both in the supine position and in standing position during the day.
The drug reduces the degree of left ventricular myocardial hypertrophy. With ischemic heart disease (CHD), it has a cardioprotective and antiatherosclerotic effect. It has a weak natriuretic activity. Increases the glomerular filtration rate. Inhibits platelet aggregation. Does not cause a sharp decrease in blood pressure, left ventricular ejection fraction and a reflex increase in heart rate (HR). Does not reduce exercise tolerance. Does not affect myocardial contractility and conductivity.
The antianginal effect of amlodipine is associated with its ability to expand the coronary and peripheral arteries and arterioles, as a result of which the drug reduces myocardial oxygen demand and total peripheral vascular resistance (OPSS), reduces the preload on the heart, the severity of myocardial ischemia in angina pectoris. Expanding the main coronary arteries and arterioles in both ischemic and unchanged areas of the myocardium, Amlodipine Sandoz enhances oxygen supply, especially in vasospastic angina pectoris. Prevents the development of coronary artery constriction, including those caused by smoking. With angina pectoris, taking a single daily dose slows down the development of ischemic depression of the ST segment, reduces the frequency of angina attacks, increases the time it takes to perform physical activity, and reduces the need for nitroglycerin.
In patients with diabetic nephropathy, amlodipine does not increase the severity of microalbuminuria. Does not adversely affect blood plasma lipids and metabolism.
The effect develops within 2-4 hours after taking Amlodipine Sandoz and lasts up to 24 hours.
Pharmacokinetics
The main pharmacokinetic characteristics of amlodipine:
- absorption: getting into the gastrointestinal tract, the drug is absorbed slowly. Food intake does not affect the degree and rate of absorption. The absolute bioavailability averages 64%. The maximum plasma concentration (C max) is reached within 6-9 hours. Equilibrium concentration (C ss) is established after 7 days of regular administration of the drug;
- distribution: the volume of distribution (V d) averages 21 l / kg body weight. This indicates that most of the drug penetrates into the tissues, a relatively smaller amount into the blood. Approximately 95% of amlodipine present in blood binds to plasma proteins. The drug has the ability to penetrate the blood-brain barrier;
- metabolism: amlodipine is slowly but extensively metabolized (90%) in the liver, resulting in the formation of metabolites that do not have pharmacological activity. The drug has the effect of the first passage through the liver;
- elimination: after taking a single dose, the half-life (T 1/2) can be 31–48 hours, with repeated applications - 45 hours. Approximately 60% of the dose received is excreted in the urine mainly in the form of metabolites, unchanged - 10%. About 20-25% of the dose is excreted in the feces, partially in breast milk. The total clearance of amlodipine is 0.116 ml / s / kg (7 ml / min / kg, 0.42 l / h / kg).
Pharmacokinetics in special cases:
- age: in patients over 65 years of age, the excretion of amlodipine slows down (T 1/2 can reach 65 hours), but this difference has no clinical significance;
- liver function: with hepatic insufficiency, T 1/2 is lengthened to 60 hours, with prolonged use of the drug, the accumulation of amlodipine in the body is more pronounced;
- renal function: in renal failure, significant changes in the parameters of the drug are not observed. Hemodialysis does not remove amlodipine from the body.
Indications for use
- arterial hypertension;
- Prinzmetal angina (vasospastic);
- stable exertional angina.
Contraindications
Absolute:
- severe arterial hypotension;
- unstable angina (with the exception of vasospastic angina);
- cardiogenic shock;
- collapse;
- hereditary lactose intolerance, galactosemia (due to the presence of lactose in the tablets);
- age up to 18 years;
- lactation period;
- hypersensitivity to drug components or other dihydropyridine derivatives.
Relative (the use of Amlodipine Sandoz tablets requires special care):
- mild to moderate arterial hypotension;
- hypertrophic obstructive cardiomyopathy;
- aortic stenosis;
- sick sinus syndrome;
- decompensated chronic heart failure;
- acute myocardial infarction and the first month after it;
- liver failure;
- elderly age;
- pregnancy.
Amlodipine Sandoz, instructions for use: method and dosage
Amlodipine Sandoz tablets should be taken orally, once a day, preferably at the same time of the day, regardless of meals.
The initial daily dose for adult patients is 5 mg. If the therapeutic effect is insufficient, the dose is increased to 10 mg.
A dose reduction may be required in patients with severe hepatic impairment, as well as in patients of short stature or low body weight.
There is no need to adjust the dose of Amlodipine Sandoz in elderly people, patients with renal insufficiency, and in the case of concomitant administration of thiazide diuretics, angiotensin converting enzyme (ACE) inhibitors or beta-blockers.
Side effects
- from the central and peripheral nervous system: often (more than 1% of appointments) - mood lability, fatigue, dizziness, drowsiness, headache; rarely (0.1–1% of patients) - increased sweating, asthenia, insomnia, peripheral neuropathy, fainting, depression, convulsions; very rarely (<0.01% of patients) - migraine, ataxia, apathy;
- on the part of the cardiovascular system: often - flushing of the face, shortness of breath, peripheral edema, palpitations; rarely - excessive decrease in blood pressure, chest pain, orthostatic hypotension; very rarely - cardiac arrhythmias (atrial fibrillation, ventricular tachycardia), worsening heart failure, myocardial infarction;
- from the musculoskeletal system: often - back pain; rarely - muscle cramps, myalgia, arthralgia;
- from the genitourinary system: rarely - pollakiuria, gynecomastia, sexual dysfunction;
- from the digestive system: often - abdominal pain, dry mouth, nausea; rarely - gingival hyperplasia, constipation, diarrhea, dyspepsia, pancreatitis; very rarely - increased activity of hepatic transaminases, jaundice, gastritis;
- allergic reactions: rarely - rash, skin itching; very rarely - angioedema, erythema multiforme;
- others: rarely - alopecia, dyspnea, visual impairment; very rarely - hyperglycemia, thrombocytopenia.
Overdose
With a significant excess of the recommended therapeutic dose of Amlodipine Sandoz, excessive peripheral vasodilation usually develops, accompanied by a pronounced decrease in blood pressure, and sometimes reflex tachycardia.
Patients are advised to take a position with raised legs. If no more than 2 hours have passed since taking Amlodipine Sandoz, you should perform a gastric lavage and take activated charcoal. To eliminate the blockade of calcium channels, calcium gluconate is administered intravenously. Active maintenance of the functions of the cardiovascular system is required. To increase blood pressure and restore vascular tone, vasoconstrictors may be prescribed. It is necessary to control the diuresis, the volume of circulating blood, the function of the cardiovascular and respiratory systems. Hemodialysis is ineffective.
special instructions
BMCCs do not cause withdrawal symptoms. However, it is recommended not to suddenly stop taking Amlodipine Sandoz, but to gradually reduce the dose.
Amlodipine Sandoz, if necessary, can be used in combination with the following drugs: thiazide diuretics, alpha and beta blockers, long-acting nitrates, ACE inhibitors, sublingual nitroglycerin, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, oral hypoglycemic agents.
Amlodipine can be prescribed to patients with diabetes mellitus, bronchial asthma and gout, since it does not have a negative effect on blood plasma lipids and metabolism.
Influence on the ability to drive vehicles and complex mechanisms
Amlodipine Sandoz does not affect cognitive and psychomotor functions. However, one should take into account the possible excessive decrease in blood pressure and the development of some side effects (dizziness, increased fatigue, drowsiness, etc.), which can reduce the speed of reactions and the ability to concentrate. In this regard, the degree of restrictions should be considered individually, especially at the beginning of treatment and when changing the dose of the drug.
Application during pregnancy and lactation
Due to the lack of data confirming the absolute safety of amlodipine during pregnancy, the use of the drug is possible only if the benefits exceed the possible risks.
If therapy is indicated during lactation, women are advised to stop breastfeeding, since amlodipine is excreted in mother's milk.
Pediatric use
Due to the lack of data confirming the absolute safety of amlodipine for pediatric patients, Amlodipine Sandoz is not indicated for the treatment of children and adolescents under the age of 18.
With impaired renal function
Patients with renal insufficiency do not need to adjust the dose.
For violations of liver function
Patients with severe hepatic impairment may need to reduce the dose of Amlodipine Sandoz.
Use in the elderly
Elderly people do not need to adjust the dose, but Amlodipine Sandoz should be used with caution.
Drug interactions
- inhibitors of microsomal oxidation and antiviral agents (for example, ritonavir) increase the concentration of amlodipine in plasma, which increases the likelihood of side effects;
- inducers of liver microsomal enzymes are able to reduce the plasma concentration of amlodipine;
- isoflurane and antipsychotics enhance the hypotensive effect of dihydropyridine derivatives;
- calcium preparations reduce the effect of BMCC;
- verapamil, ACE inhibitors, beta-blockers, nitrates, loop and thiazide diuretics enhance the effects of the drug.
There were no clinically significant changes in the pharmacokinetic parameters of drugs with the simultaneous use of amlodipine and NSAIDs (especially indomethacin), digoxin, warfarin, cimetidine.
Analogs
Analogues of Amlodipine Sandoz are: Adalat, Amlonorm, Amlotop, Bisam, Verapamil, Diltiazem, Isoptin, Kalchek, Karmagip, Kordaflex, Lazipil, Nimopin, Norvask, Osmo-Adalat, Plendil, Stamlo M, Tenox, Frizelodip, Tsin FenigidK and etc.
Terms and conditions of storage
Store at temperatures below 25 ° C, out of the reach of children, in a dry place, protected from light.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Amlodipine Sandoz
Reviews of Amlodipine Sandoz are predominantly positive from both doctors and patients. The drug gently and gradually reduces elevated blood pressure, is well tolerated, and can also be used for a long time, therefore, experts often prescribe it for the prevention of angina pectoris and myocardial infarction. Patients note the convenience of admission - 1 time per day, low cost.
However, many patients require a faster decrease in blood pressure, so Amlodipine Sandoz is simply not suitable for them. Also, the drug is not intended for the rapid relief of arterial hypertension.
Side effects include the development of edema in the arms and legs, the appearance of nausea and abdominal pain.
The price of Amlodipine Sandoz in pharmacies
Depending on the region of sale and the pharmacy chain, the approximate price for Amlodipine Sandoz for a pack of 30 tablets may be: 5 mg dosage - 128-165 rubles, 10 mg dosage - 154-279 rubles.
Amlodipine Sandoz: prices in online pharmacies
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Drug name Price Pharmacy |
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Amlodipine Sandoz tablets 5mg 30 pcs. 131 r Buy |
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Amlodipine Sandoz 5 mg tablets 30 pcs. 131 r Buy |
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Amlodipine Sandoz tablets 10mg 30 pcs. 220 RUB Buy |
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Amlodipine Sandoz 10 mg tablets 30 pcs. 220 RUB Buy |
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!
