Amlodipine 5mg tab Biocom-30 pcs


Amlodipine 5mg tab Biocom-30 pcs


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Active substance:
amlodipine besylate – 0.00694 g of amlodipine is calculated as – 0.0050 g
monohydrate lactose (milk sugar) – 0.07953 g, potato starch – 0.00058 g, pregelatinized starch – 0.00895 g magnesium stearate – 0.001 g of sodium croscarmellose (primelloza) – 0,003 g
Tablets white or white color with a yellowish shade, Valium chamfered.
Product form:
Tablets of 5 mg.
10 tablets in blisters. 3 the contour of cellular packaging together with instructions for medical use in a cardboard pack.
– increased sensitivity to amlodipine, to other dihydropyridine derivatives and other components of the drug (the drug included lactose monohydrate);
– marked hypotension (systolic blood pressure less than 90 mmHg);
– unstable angina (except Prinzmetal angina);
– clinically significant aortic stenosis;
– the age of 18 years (effectiveness and safety have been established);
– Pregnancy and lactation.
Hypotension, aortic stenosis, CHF nonischemic etiology (III-IV functional class NYHA classification), mitral stenosis, hepatic failure, acute myocardial infarction (and for 1 month after), hypertrophic obstructive cardiomyopathy, sick sinus syndrome, old age.
5 mg
Arterial hypertension (alone or in combination with other antihypertensive agents).
Stable angina, and vasospastic angina (in monotherapy or in combination with other antianginal drugs).
Interaction with other drugs
Amlodipine can be safely used for the therapy of hypertension with thiazide diuretics, alpha blockers, beta-blockers or ACE inhibitors. In patients with stable angina pectoris, amlodipine can be combined with other antianginal agents, such as nitrates, prolonged or short-acting beta-blockers.
Unlike other BCCI clinically significant interaction amlodipine (III BCCI generation) was not detected in the combined use with nonsteroidal anti-inflammatory agents, including indomethacin.
May increase antianginal and hypotensive action BCCI when combined with thiazide and “loop” diuretics, ACE inhibitors, beta-blockers and nitrates, as well as strengthening their hypotensive effect when combined with alpha 1-blockers, neuroleptics.
Although the study of amlodipine negative inotropic action is usually not observed, nevertheless, some BCCI may increase the severity of the negative inotropic effects of antiarrhythmic agents causing the lengthening of the interval QT (e.g., amiodarone and quinidine).
A single dose of 100 mg sildenafil in patients with essential hypertension have not effect on the pharmacokinetic parameters of amlodipine.
Repeated application of amlodipine 10 mg and atorvastatin 80 mg is not accompanied by a significant change in the pharmacokinetics of atorvastatin.
Ethanol (drinks containing alcohol): amlodipine with single and repeated administration in a dose of 10 mg did not affect the pharmacokinetics of ethanol.
Antiviral agents (ritonavir) increase the plasma concentrations of BCCI, including amlodipine.
Neuroleptics and isoflurane – strengthen hypotensive action dihydropyridine derivatives.
Calcium can reduce the effect of BCCI.
When combined with amlodipine drugs lithium may increase the neurotoxicity symptoms (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
Amlodipine does not change the pharmacokinetics of cyclosporine.
It has no effect on serum digoxin concentration in the blood and its renal clearance.
It does not significantly affect the action of warfarin (prothrombin time).
Cimetidine does not affect the pharmacokinetics of amlodipine.
In in vitro studies, amlodipine has no effect on protein binding of digoxin plasma blood, phenytoin, warfarin and indomethacin.
Grapefruit juice: simultaneous single dose of 240 mg of grapefruit juice and 10 mg amlodipine inwardly not accompanied by a significant change in the pharmacokinetics of amlodipine.
Aluminum- or magnesium-containing antacids: their single dose has no significant effect on the pharmacokinetics of amlodipine.
Symptoms: marked reduction of blood pressure with possible development of reflex tachycardia and excessive peripheral vasodilation (the risk of severe and persistent hypotension, including the development of shock and death).
Treatment: gastric lavage, appointment of activated carbon (especially in the first 2 hours after the overdose), maintaining the function of the cardiovascular system, raised position the lower extremities, monitoring parameters of the heart and lungs, control blood volume and diuresis. To restore vascular tone – the use of vasoconstrictors (in the absence of contraindications for their use); to eliminate the effects of calcium channel blockade – intravenous calcium gluconate. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
blocker “slow” calcium channels.
Dihydropyridine derivative – blocker “slow” calcium channel (BCCI) II generation, has antianginal and antihypertensive action. Contacting segment S6 III and domain IV alpha1 subunit calcium channel L-type blocks calcium channels, reduces the transmembrane passage Ca2 + into the cell (mainly in vascular smooth muscle cells than cardiac myocytes). It has hypotensive and antianginal effects.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxing effect on vascular smooth muscle.
Reduction of myocardial ischemia is due to expansion of the coronary and peripheral arteries and arterioles in the unaltered and in ischemic areas of the myocardium, reducing the total peripheral vascular resistance, decrease in afterload, myocardial oxygen demand.
Increases the flow of oxygen to the myocardium in patients with vasospastic angina (Prinzmetal’s angina); It prevents the development of coronary spasm caused by smoking. In patients with angina single daily dose increases execution time of exercise, retards the development of the next attack of angina and S-T segment depression (1 mm) on exertion, reduces the frequency of angina attacks and nitroglycerine consumption.
It has a long dose-dependent hypotensive effect. Hypotensive effect caused by the direct vasodilating effect on vascular smooth muscle. When hypertension single daily dose provides a clinically significant decrease in blood pressure (BP) for 24 hours (in the position of the patient “lying” and “standing”).
Patients with diseases of the cardiovascular system (including coronary atherosclerosis lesion with one vessel to the stenosis and 3 or more arteries, carotid atherosclerosis), myocardial infarction (MI), percutaneous transluminal angioplasty of coronary arteries, or in patients with angina pectoris. Use of amlodipine prevents intima-media thickening of carotid arteries, reducing mortality from myocardial infarction, stroke, transluminal angioplasty, coronary artery bypass surgery; leads to a decrease in the number of hospitalizations for unstable angina and progression of chronic heart failure (CHF); It reduces the frequency of interventions aimed at restoring coronary blood flow.
It does not increase the risk of death or complications and mortality in patients with chronic heart failure (III-IV functional class according to the classification of New York Heart Association (NYHA)) during therapy with digoxin, diuretics and angiotensin-converting enzyme (ACE) inhibitors. In patients with CHF (III-IV NYHA functional class classification) with nonischemic etiology amlodipine exists the likelihood of pulmonary edema.
Does not cause a sharp decrease in blood pressure, reduction of exercise tolerance, left ventricular ejection fraction (LV). Reduces the degree of left ventricular hypertrophy.
No effect on the myocardial contractility and conductivity, does not cause reflex increase in heart rate, inhibits platelet aggregation and increases glomerular filtration rate, it has a weak natriuretic action. In diabetic nephropathy does not increase the severity of microalbuminuria. It does not have adverse effects on metabolism and plasma lipids.
Time of onset of effect – 2-4 hours; duration – 24 hours.
Absorption – slow, regardless of the meal, is about 90%, bioavailability – 60-65%. Maximum concentration in blood (TCmax) orally achieved in 6-12 hours. When a constant stationary receiving blood concentration (Css) is generated after 7-8 days. The volume of distribution – 21 l / kg. Relationship to plasma proteins – 90-97%. It penetrates the blood-brain barrier.
Intensively (90%) is metabolized in the liver to inactive metabolites, it has the effect of “first pass” through the liver. The half-life (T1 / 2) in average – 35 hr Total clearance -. 500 ml / min.
T1 / 2 in patients with hypertension – 48 hours, in elderly patients increased to 65 h, liver failure – up to 60 hours, similar parameters are observed increase in T 1/2 and in severe CHF with impaired renal function – no change. When hemodialysis is not removed.
Excreted by the kidneys – 60% in the form of metabolites to 10% in an unmodified form; through the bile and gut – 20-25% in the form of metabolites, and in breast milk.
Pregnancy and breast-feeding
Safety of amlodipine in pregnancy has not been established, therefore use during pregnancy is possible only when the benefit to the mother outweighs the potential risk to the fetus.
There is no evidence of amlodipine excretion in breast milk. However, we know that other BCCI – dihydropyridine derivatives are excreted in breast milk. In this connection, if necessary, the appointment of amlodipine during lactation should decide the issue of termination of breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of adverse reactions listed below, was determined according to the following (World Health Organization): very often – 1/10 more often – from more than 1/100 to 1/10 less infrequently – from more to less than 1/1000 1/100 rarely – from more than 1/10000 and less than 1/1000, very rare – from less than 1/10000, including isolated reports.
Central nervous system: often – headache, dizziness, fatigue, drowsiness; rarely – fatigue, malaise, hypoesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, mood lability, abnormal dreams, anxiety, depression, anxiety; very rarely – headache, increased sweating, lethargy, agitation, ataxia, amnesia.
From the digestive system: often – nausea, stomach pain; infrequently – vomiting, constipation or diarrhea, flatulence, dyspepsia, anorexia, dryness of the oral mucosa, thirst; rarely – gingival hyperplasia, increased appetite; very rarely – pancreatitis, gastritis, jaundice (caused by cholestasis), hyperbilirubinemia, increased activity of “liver” transaminases, hepatitis.
With the cardiovascular system: often – heartbeat, peripheral edema (ankles and feet), “tides” of blood to the facial skin; rare – an excessive fall in blood pressure; very rarely – fainting, shortness of breath, vasculitis, orthostatic hypotension, development or exacerbation of current CHF, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), heart attack, chest pain.
From the side of hematopoiesis: rarely – thrombocytopenia purpura, leukopenia, and thrombocytopenia.
With the genitourinary system: Infrequent – frequent urination, painful urination, nocturia, impotence; very rarely – dysuria, polyuria.
The respiratory system: rarely – dyspnea, rhinitis; very rarely – cough.
On the part of the musculoskeletal system: rarely – muscle cramps, myalgia, arthralgia, back pain, arthritis; rarely – myasthenia gravis.
For the skin: rarely – dermatitis; very rare – alopecia, dermatoxerasia, cold sweat, violation of skin pigmentation.
Allergic reactions: itching, rash (including erythematous, maculopapular rash, hives), angioedema, erythema multiforme.
Other: rarely – ringing in the ears, diplopia, disturbance of accommodation, xerophthalmia, conjunctivitis, eye pain, chills, nasal bleeding, gynecomastia; very rarely – parosmiya, hyperglycemia.
special instructions
During therapy with amlodipine-Biocom necessary to control body weight and intake of sodium, shows the assignment of an appropriate diet.
It is necessary to maintain dental hygiene and observation at the dentist (to prevent pain, bleeding and gingival hyperplasia).
Elderly patients may increase the T1 / 2 and to decrease the clearance of the drug. Changes in dose are not required, but patients should be more carefully monitored in this category.
Patients with low weight, small stature patients and patients with severe hepatic dysfunction may require a smaller dose of the drug.
Efficacy and safety of amlodipine-Biokoma not been established for hypertensive crisis.
Despite the lack of BCCI syndrome “cancel”, discontinuation of treatment with amlodipine-Biokomom it is desirable to gradually reducing the dose of the drug.
Effects on ability to management of motor vehicles and other complex mechanisms.
In patients receiving amlodipine any negative effect on the ability to drive vehicles or other complex mechanisms were observed, however, due to the possible excessive reduction in blood pressure, development of dizziness, drowsiness and other side effects, caution should be exercised in these situations, especially at the beginning of treatment and at increasing the dose.
Storage conditions
In a dry, dark place at a temperature no higher than 25 degrees.
Keep out of the reach of children.
Dosing and Administration
Inside, once a day, washing down the necessary amount of water (100 mL).
When hypertension and angina is 5 initial dose of 1 mg once a day. When necessary, the daily dose may be increased to 10 mg, in one step.
Elderly patients
Amlodipine is recommended in high therapeutic doses, dose adjustment is required.
In patients with impaired liver function
Despite the fact that T1 / 2 amlodipine, as well as all BCCI, is increased in patients with hepatic impairment, dose adjustment is usually not necessary (see. Section “Special Instructions”).
In patients with renal insufficiency
Amlodipine is recommended to use conventional doses but must take into account the possible slight increase in T1 / 2.
It does not require dose adjustment with concomitant administration with thiazide diuretics, beta-blockers and ACE inhibitors.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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