Amlodipine-Biocom - Instructions For The Use Of Tablets, Reviews, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Amlodipine-Biocom

Amlodipine-Biocom: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Amlodipine-Biocom

ATX code: C08CA01

Active ingredient: amlodipine (Amlodipine)

Manufacturer: CJSC "Biocom" (Russia)

Description and photo update: 2019-10-07

Prices in pharmacies: from 34 rubles.

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Amlodipine-Biocom is a slow calcium channel blocker (BMCC).

Release form and composition

Dosage form - tablets: flat-cylindrical, white or white with a yellowish tinge, with a bevel (in blister contour packs of 10 and 12 pcs., In a cardboard box 1, 2, 3, 4, 5, 6 or 9 packs and instructions for the use of Amlodipine-Biocom).

Composition of 1 tablet:

• active substance: amlodipine (in the form of besylate) - 5 or 10 mg;
• auxiliary components: croscarmellose sodium (primellose), potato starch, lactose monohydrate (milk sugar), magnesium stearate, pregelatinized starch.

Pharmacological properties

Pharmacodynamics

Amlodipine is a derivative of dihydropyridine, II-generation BMCC. Has hypotensive and antianginal effects. Due to the connection with the S6 segment of the III and IV domains of the alpha ₁ -subunit of the L-type calcium channel, the drug blocks calcium channels and reduces the transmembrane transition of Ca ²⁺ into the cell (to vascular smooth muscle cells to a greater extent than to cardiomyocytes).

The mechanism of antihypertensive action is due to the ability of amlodipine to have a direct relaxing effect on vascular smooth muscle.

Amlodipine-Biocom dilates the coronary and peripheral arteries and arterioles in the myocardium (both in unchanged and ischemic areas), reduces total peripheral vascular resistance (OPSR), myocardial oxygen demand and afterload, thereby reducing myocardial ischemia.

With vasospastic angina (Prinzmetal's angina), the supply of oxygen to the myocardium increases. In smokers, it prevents the development of coronary spasm. In patients with angina pectoris, taking a single daily dose increases the time of exercise, delays the development of ST segment depression (by 1 mm) during exercise, reduces the frequency of angina attacks and delays the development of another attack, and reduces the need for nitroglycerin.

Amlodipine-Biocom is characterized by a long-term dose-dependent hypotensive effect. In patients with arterial hypertension, taking a daily dose provides a clinically significant decrease in blood pressure (BP) within 24 hours (both in the supine position and standing).

For angina pectoris and diseases of the cardiovascular system (including with coronary atherosclerosis with damage to one vessel and up to stenosis of three or more arteries, atherosclerosis of the carotid arteries) in patients who have undergone percutaneous transluminal angioplasty or myocardial infarction, amlodipine prevents medically thickening of the intima carotid arteries. It also reduces the frequency of hospitalizations for the progression of chronic heart failure (CHF) and unstable angina pectoris, reduces the number of interventions aimed at restoring coronary blood flow, mortality from coronary artery bypass grafting, transluminal angioplasty, stroke and myocardial infarction.

In CHF III – IV functional class according to NYHA (classification of the New York Heart Association), Amlodipine-Biocom does not increase the risk of complications and mortality during therapy with angiotensin-converting enzyme (ACE) inhibitors, diuretics, digoxin. In CHF III – IV class of non-ischemic etiology, the drug increases the risk of developing pulmonary edema.

The use of the drug helps to reduce the degree of left ventricular myocardial hypertrophy.

Amlodipine does not decrease exercise tolerance. Does not cause a sharp decrease in blood pressure, left ventricular ejection fraction, reflex increase in heart rate. Does not affect the conductivity and contractility of the myocardium. Does not adversely affect metabolism and plasma lipids. In patients with diabetic nephropathy, it does not increase the severity of microalbuminuria.

Amlodipine-Biocom increases the glomerular filtration rate, inhibits platelet aggregation, and has a weak natriuretic effect.

After taking the drug, the effect develops within 2-4 hours and lasts for 24 hours.

Pharmacokinetics

After oral administration, amlodipine is absorbed slowly and well (~ 90%), the degree and rate of absorption does not depend on food intake. Bioavailability is approximately 60-65%. With _max (maximum concentration in the blood) is noted 6-12 hours after administration. With regular intake, C _ss (steady-state concentration in the blood) builds up in 7–8 days. Plasma proteins bind 90–97%. V _d (volume of distribution) is equal to 21 l / kg. The drug crosses the blood-brain barrier and into breast milk.

About 90% of the received dose of amlodipine is metabolized in the liver, as a result of which inactive metabolites are formed. The drug is characterized by the effect of the first passage through the liver. The total clearance is 500 ml / min.

T _½ (half-life) - an average of 35 hours, with arterial hypertension - 48 hours, in the elderly - 65 hours, in patients with hepatic insufficiency - 60 hours. Similar changes in T _½ are observed in patients with severe CHF. With functional impairment of the kidneys, the duration of T _½ does not change.

Hemodialysis does not remove the drug from the body.

Amlodipine is excreted in the urine (10% - unchanged, 60% - in the form of metabolites), bile and feces (20-25% in the form of metabolites).

Indications for use

• arterial hypertension - as a monopreparation or in combination with other antihypertensive drugs;
• vasospastic angina pectoris and stable exertional angina - as a monopreparation or together with other antianginal agents.

Contraindications

Absolute:

• clinically significant aortic stenosis;
• unstable angina (with the exception of Prinzmetal's angina);
• severe arterial hypotension (systolic blood pressure <90 mm Hg);
• age up to 18 years;
• lactation period;
• pregnancy (except in cases where the benefits to the mother outweigh the harm to the fetus);
• hypersensitivity to any component of the drug or other dihydropyridine derivatives.

Relative (Amlodipine-Biocom tablets are used with caution):

• arterial hypotension;
• CHF (III – IV functional class according to NYHA classification) of non-ischemic etiology;
• mitral stenosis;
• aortic stenosis;
• sick sinus syndrome;
• hypertrophic obstructive cardiomyopathy;
• acute myocardial infarction and a period of 1 month after it;
• liver failure;
• elderly age.

Amlodipine-Biocom, instructions for use: method and dosage

Amlodipine-Biocom tablets are taken orally: swallowed whole and washed down with a sufficient amount of water. The daily dose should be taken in one dose.

The initial recommended dose is 5 mg, if necessary, it is increased to 10 mg.

When using the drug as part of a combination therapy (together with beta-blockers, thiazide diuretics, ACE inhibitors), dose adjustment is not required.

A decrease in the dose of Amlodipine-Biocom may be required for patients with severe hepatic impairment, patients of short stature, and persons with low body weight.

Side effects

Taking Amlodipine-Biocom may be accompanied by the following side effects (according to the frequency of development, they are classified as follows:> 1/10 - very often, from> 1/100 to 1/1000 to 1/10 000 to <1/1000 - rarely, <1 / 10,000, including individual messages - very rare):

• on the part of the cardiovascular system: often - rush of blood to the skin of the face, peripheral edema (feet and ankles), palpitations; infrequently - excessive decrease in blood pressure; very rarely - chest pain, orthostatic hypotension, fainting, vasculitis, shortness of breath, heart rhythm disturbances (including bradycardia, ventricular tachycardia, atrial fibrillation), development or aggravation of CHF, myocardial infarction;
• on the part of the hematopoietic organs: very rarely - thrombocytopenia, thrombocytopenic purpura, leukopenia;
• from the digestive system: often - abdominal pain, nausea; infrequently - thirst, dryness of the oral mucosa, dyspepsia, flatulence, diarrhea or constipation, anorexia, vomiting; rarely - increased appetite, gingival hyperplasia; very rarely - gastritis, pancreatitis, jaundice (caused by cholestasis), increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis;
• from the central nervous system: often - increased fatigue, dizziness, drowsiness, headache; infrequently - unusual dreams, insomnia, peripheral neuropathy, paresthesia, hypesthesia, general malaise, asthenia, anxiety, increased excitability, mood lability, tremor, depression; very rarely - increased sweating, ataxia, apathy, amnesia, agitation, migraine;
• from the respiratory system: infrequently - rhinitis, shortness of breath; very rarely - cough;
• from the genitourinary system: infrequently - nocturia, painful or frequent urination, impotence; very rarely - polyuria, dysuria;
• from the musculoskeletal system: infrequently - back pain, arthralgia, myalgia, arthrosis, muscle cramps; rarely - myasthenia gravis;
• on the part of the skin: rarely - dermatitis; very rarely - cold sweat, xeroderma, alopecia, skin pigmentation disorders;
• allergic reactions: itching, skin rash (including urticaria, erythematous and maculopapular rash), erythema multiforme, angioedema;
• others: infrequently - eye pain, diplopia, conjunctivitis, impaired accommodation, xerophthalmia, ringing in the ears, nosebleeds, chills, gynecomastia; very rarely - hyperglycemia, parosmia.

Overdose

If a too high dose of Amlodipine-Biocom is taken, an excessive decrease in blood pressure is noted, the development of reflex tachycardia and excessive peripheral vasodilation (the risk of persistent and severe arterial hypotension, up to shock and death) is possible.

First of all, gastric lavage and the intake of activated charcoal are indicated, especially in cases where no more than 2 hours have passed since the overdose. The patient should be laid on a horizontal surface and the lower extremities should be raised. It is necessary to ensure the maintenance of the function of the cardiovascular system, as well as control of urine output, circulating blood volume, heart and lung performance. To restore vascular tone, vasoconstrictors are prescribed (if there are no contraindications to their use), to eliminate the effects of calcium channel blockade - intravenous calcium gluconate. Hemodialysis is ineffective.

special instructions

During treatment with the drug, it is necessary to follow the diet prescribed by the doctor, control body weight and sodium intake.

In a hypertensive crisis, the effectiveness and safety of Amlodipine-Biocom have not been established.

The drug can cause soreness, bleeding and gingival hyperplasia, therefore, during the period of therapy, oral hygiene should be carefully maintained and monitored by a dentist.

BMCCs do not cause withdrawal symptoms. However, you should not stop treatment abruptly, you must gradually reduce the dose.

Influence on the ability to drive vehicles and complex mechanisms

Amlodipine-Biocom does not adversely affect the speed of reactions and the ability to concentrate. However, with a pronounced decrease in blood pressure, adverse reactions (dizziness, drowsiness, etc.) may occur, therefore, care must be taken when driving a car and working with complex mechanisms, especially at the initial stage of therapy and during the period of increasing the dose.

Application during pregnancy and lactation

During pregnancy, the safety of Amlodipine-Biocom has not been established, therefore, the drug may be prescribed only if the benefit to the mother exceeds the risk to the fetus.

Dihydropyridine derivatives pass into breast milk, therefore, lactation should be interrupted if drug treatment is clinically justified.

Pediatric use

Children and adolescents under 18 years of age are not prescribed Amlodipine-Biocom, since there are no data on its safety and efficacy in pediatric patients.

With impaired renal function

In patients with impaired renal function, there is no need to reduce the dose of Amlodipine-Biocom, but an increase in its T _½ should be taken into account.

For violations of liver function

Patients with impaired liver function usually do not need to adjust the dose of Amlodipine-Biocom, but an increase in its T _½ should be taken into account.

With pronounced functional disorders of the liver, a dose reduction may be required.

Use in the elderly

The dose of amlodipine for the elderly is not adjusted, however, the possibility of an increase in its T _½ and a decrease in clearance is taken into account. Treatment is recommended under close medical supervision.

Drug interactions

Amlodipine-Biocom can be combined with the following drugs:

• arterial hypertension: beta-blockers, alpha-blockers, thiazide diuretics, ACE inhibitors;
• stable angina pectoris: other antianginal drugs, for example, beta-blockers, short-acting or prolonged-acting nitrates.

Possible effects of other drugs on the pharmacokinetics of amlodipine:

• antiviral agents (eg, ritonavir) increase plasma concentration;
• calcium preparations reduce the effect;
• isoflurane and antipsychotics enhance the antihypertensive effect;
• nitrates, beta-blockers, ACE inhibitors, loop and thiazide diuretics enhance the antianginal and hypotensive effect;
• antipsychotics and alpha ₁ -adrenergic blockers enhance the hypotensive effect.

When used concomitantly with lithium preparations, amlodipine may increase the manifestations of neurotoxicity (diarrhea, nausea, vomiting, tinnitus, tremor, ataxia).

When studying amlodipine, no negative inotropic effect was detected, however, it should be borne in mind that some BMCCs can enhance the severity of the negative inotropic effect of antiarrhythmic drugs that contribute to the lengthening of the QT interval (for example, quinidine, amiodarone).

Unlike other BMCCs, amlodipine is not characterized by clinically significant drug interactions with non-steroidal anti-inflammatory drugs (NSAIDs), including indomethacin.

Used in a daily dose of 10 mg, amlodipine does not alter the pharmacokinetics of ethanol, including alcoholic beverages.

A single dose of 100 mg of sildenafil has no effect on the pharmacokinetic characteristics of amlodipine in patients diagnosed with essential hypertension.

Amlodipine does not affect the pharmacokinetics of cyclosporine and warfarin (prothrombin time), the concentration of digoxin in the blood serum and its renal clearance.

In vitro, amlodipine did not affect the binding of indomethacin, phenytoin, digoxin, warfarin to plasma proteins.

Regular use of amlodipine at a dose of 10 mg together with atorvastatin at a dose of 80 mg was not accompanied by significant changes in the characteristics of the drugs.

A single intake of antacids containing magnesium or aluminum does not significantly affect the pharmacokinetics of amlodipine.

Simultaneous single dose of 10 mg of amlodipine and 240 mg of grapefruit juice is not accompanied by a significant change in the parameters of amlodipine. Does not affect the characteristics of the drug cimetidine.

Analogs

Amlodipine-Biocom analogs are: Adalat, Amlodak, Bisam, Verapamil, Diltiazem, Kalchek, Kordaflex, Kordi Cor, Corinfar, Nimotop, Norvask, Osmo-Adalat, Stamlo M, Tenox, Felodipin, Cinnarizin, EsCordi Cor, etc.

Terms and conditions of storage

Store out of the reach of children, dry and protected from light at a temperature not exceeding 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Amlodipine-Biocom

According to reviews, Amlodipine-Biocom is an inexpensive and effective agent that has antihypertensive and antianginal effects. Patients indicate that the drug is well tolerated, however, they note a large list of possible side effects described in the instructions for medical use.

The price of Amlodipine-Biocom in pharmacies

The approximate price for Amlodipine-Biocom in a dosage of 5 mg is 30–36 rubles. per pack of 30 pcs. You can buy a package (30 pcs.) Of tablets in a dosage of 10 mg for 46-54 rubles.

Amlodipine-Biocom: prices in online pharmacies

Drug name Price Pharmacy

Amlodipine-Biocom 5 mg tablets 30 pcs. 34 rbl. Buy

Amlodipine-Biocom 10 mg tablets 30 pcs. RUB 49 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!