Amlodipine-Teva 10 mg 30 pcs Table

$4.38

Amlodipine-Teva 10 mg 30 pcs Table

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Description

Composition
Active substance:
amlodipine besylate (amlodipine) – 6.944 mg / 13.888 mg (5.00 mg / 10.00 mg)
Excipients:
microcrystalline cellulose – 127.056 mg / 254.112 mg calcium hydrophosphate (anhydrous) –
60.00 mg / 120.00 mg Sodium carboxymethylstarch (type A) – 4.00 mg / mg 8.00 magnesium stearate – 2.00 mg / 4.00 mg.
Description:
Round biconvex white tablets. On one side of the separation of risk and engraving “AB 10”. The other side is smooth.
Product form:
Tablets, 10 mg.
10 tablets in a blister made of PVC / PVDC and aluminum foil film. 3 in the blister pack carton along with instructions for use.
Contraindications
– Increased sensitivity to amlodipine, to other dihydropyridine derivatives and the excipients included in the formulation.
– Severe hypotension (systolic blood pressure less than 90 mmHg).
– obstruction of the left ventricular outflow tract (including severe aortic stenosis).
– Shock (including cardiogenic).
– haemodynamically unstable heart failure after myocardial infarction.
– Age 18 years (effectiveness and safety have been established).
Carefully
In patients with liver failure, heart failure nonischemic etiology III-IV NYHA functional class classification, unstable angina, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and for 1 month after), sick sinus syndrome (pronounced tachycardia, bradycardia), hypotension, while the use of inhibitors or inducers isoenzyme CYP3A4.
Dosage
10 mg
Indications
– Hypertension (both in monotherapy and in combination with other antihypertensive agents).
– stable angina pectoris and vasospastic angina (Prinzmetal angina or variant angina), both in monotherapy and in combination with other antianginal agents.
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 while the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including indomethacin.
May increase antianginal and hypotensive action BCCI while the use of thiazide and “loop” diuretics, ACE inhibitors, beta – blockers and nitrates, as well as strengthening their hypotensive action while the use of 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).
Amlodipine may also safely be used in conjunction with antibiotics and hypoglycemic agents for oral administration. A single dose of 100 mg sildenafil in patients with essential hypertension have not effect on the pharmacokinetic parameters of amlodipine.
Atorvastatin: simultaneous multiple use of amlodipine 10 mg and atorvastatin 80 mg is not accompanied by a significant change in the pharmacokinetics of atorvastatin.
Simvastatin: simultaneous multiple use of amlodipine 10 mg of simvastatin and 80 mg resulting in increased exposure of simvastatin by 77%. In such cases it is necessary to limit the dose to 20 mg of simvastatin.
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: increased hypotensive effect of dihydropyridine derivatives.
Calcium can reduce the effect of BCCI.
When applied simultaneously with BCCI lithium drugs (for amlodipine no data), may be increased neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
Research simultaneous use of amlodipine and ciclosporin in healthy volunteers and patients of all groups, except in patients after kidney transplantation, were not carried out. Various studies amlodipine interaction with cyclosporine in patients after kidney transplantation showed that the use of this combination may not lead to any effect or increase the minimum concentration of cyclosporine to varying degrees up to 40%. It should be appreciated that data and control the concentration of cyclosporin in this patient group, while the application of cyclosporine and amlodipina.Ne influences the serum digoxin concentration in blood and 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. However, it is not recommended to use grapefruit juice and amlodipine at the same time, since the genetic polymorphism of CYP3A4 may increase the bioavailability of amlodipine and, consequently, increased hypotensive effect.
Aluminum- or magnesium-containing antacids: their single dose has no significant effect on the pharmacokinetics of amlodipine.
Inhibitors of the isoenzyme CYP3A4: while applying diltiazem dose of 180 mg, and amlodipine 5 mg in patients 69 to 87 years with arterial hypertension marked increase in systemic exposure to 57% amlodipine. The simultaneous use of amlodipine and erythromycin in healthy volunteers (18 to 43 years) does not lead to significant changes amlodipine exposure (increase in area under the curve “concentration-time» (AUC) 22%). Despite the fact that the clinical significance of these effects is not completely clear, they may be more pronounced in older patients.
Potent inhibitors isoenzyme CYP3A4 (e.g., ketoconazole, itraconazole) may lead to an increase amlodipine plasma concentration to a greater extent than diltiazem. Should be used with caution and amlodipine inhibitors isoenzyme CYP3A4.
Clarithromycin: an inhibitor of CYP3A4 isoenzyme. Patients taking both clarithromycin and amlodipine increased risk of lowering blood pressure. Patients receiving this combination is recommended to be kept under close medical supervision.
Inducers of CYP3A4: data on the effect of inducers of CYP3A4 on the pharmacokinetics of amlodipine is not. One should carefully monitor blood pressure while the use of amlodipine and inductors isoenzyme CYP3A4.
Tacrolimus: while the use of amlodipine is a risk of increasing the concentration of tacrolimus in the blood plasma. To avoid the toxicity of tacrolimus while the use of amlodipine, should control the concentration of tacrolimus in the blood plasma of patients and to adjust the dose of tacrolimus, if necessary.
Overdose
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, administration 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 circulating blood volume (CBV) 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.
Pharmacodynamics:
Blocker “slow” calcium channel (BCCI) L-type from the group of 1,4-dihydropyridine derivatives having anti-anginal and antihypertensive action. Due to the blockade of the “slow” calcium channels reduces the transmembrane passage of calcium ions into the cell (mainly in vascular smooth muscle cells than cardiac myocytes).
Antianginal due to increased coronary and peripheral arteries and arterioles:
– angina reduces the severity of myocardial ischemia; expanding peripheral arterioles, reducing the total peripheral vascular resistance, reduces afterload on the heart, reducing myocardial oxygen demand;
– expanding the coronary arteries and arterioles in the unaltered and in ischemic areas of myocardium, increase oxygen supply to the myocardium (especially with vasospastic angina pectoris); prevents coronary artery spasm (including those caused by smoking).
In patients with stable angina single daily dose increases exercise tolerance, slows the development of angina and ‘ischemic »ST-segment depression, reduces the frequency of angina attacks and consumption of nitroglycerin and other nitrates.
It has a long dose-dependent antihypertensive effect due to the direct vasodilating effect on vascular smooth muscle. When hypertension single dose provides a clinically significant decrease in blood pressure (BP) over 24 hours (in the patient supine and standing).
Orthostatic hypotension in the appointment of amlodipine is quite rare.
Amlodipine does not cause reduction of exercise tolerance, does not cause reduction in left ventricular ejection fraction, decreases the degree of left ventricular hypertrophy. The drug has no effect on the myocardial contractility and conductivity, does not cause reflex increase of heart rate (HR), moderately 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 any adverse effect on metabolism and lipid concentration in blood plasma and can be used in therapy of patients with asthma, diabetes and gout. A significant decrease in blood pressure was observed after 6-10 hours duration of effect – 24 hours.
Patients with diseases of the cardiovascular system (including coronary atherosclerosis with a lesion of the vessel and to the stenosis 3 or more arteries, carotid atherosclerosis), myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or in patients with angina pectoris, amlodipine prevents the development of IMT thickening of the carotid arteries; reduces the mortality from myocardial infarction, stroke, PTCA, coronary 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 mortality or development of complications and mortality in patients with CHF (III-IV functional class NYHA classification) 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.
Pharmacokinetics:
After oral administration, amlodipine is slowly absorbed from the gastrointestinal tract. Mean absolute bioavailability is 64%, the maximum concentration (Cmax) in the serum observed in 6-12 hours. The equilibrium concentrations are reached after 7-8 days of therapy.
Food intake does not affect the absorption of amlodipine. The mean volume of distribution of 21 l / kg of body weight, indicating that most of the drug is in the tissues, and smaller – in the blood. Most of the drug present in the blood (97.5%), binds to plasma proteins. Amlodipine undergoes slow but actively metabolized in the liver in the absence of a significant effect of “first pass” through the liver. Metabolites not possess significant pharmacological activity.
After receiving a single half-life (T 1/2) ranges from 35 to 50 hours, with repeated use T 1/2 of about 45 hours. About 60% of the ingested dose excreted by the kidneys mainly as metabolites, 10% – unchanged, and 20-25% – through the intestine in bile. Total Amlodipine clearance is 0.116 ml / sec / kg (7 mL / min / kg, 0.42 L / h / kg).
In elderly patients (over 65 years) the excretion of amlodipine slowed down (T1 / 2 – 65 hours) compared to younger patients, but this difference has no clinical significance.
Elongation T 1/2 in patients with hepatic failure suggests that prolonged application of drug accumulation in the body is higher than (T 1/2 – 60 hours).
Renal failure does not significantly affect the kinetics of amlodipine.
In patients with impaired renal function changes in amlodipine concentration in plasma does not correlate with the degree of renal insufficiency. Perhaps a slight increase in T 1/2.
Amlodipine penetrates the blood-brain barrier. When hemodialysis is not removed.
Pregnancy and breast-feeding
In experimental studies, embryotoxic and foetotoxic effects of the drug have not been established, but the 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 the drug-Amlodipine Teva during lactation should decide the issue of termination of breastfeeding.
When the fertility study in rats, the effect of amlodipine on fertility has not been revealed.
Conditions of supply of pharmacies
Prescription.
side effects
The frequency of side effects is given in accordance with the following gradation (World Health Organization): very common (> 1/10), common (> 1/100,
special instructions
It is necessary to maintain oral hygiene and dental observation y (to prevent pain, bleeding and gingival hyperplasia).
Against the background of the drug Amlodipine-Teva in patients with chronic heart failure III and IV functional class NYHA classification of non-ischemic origin, an increase in frequency of lung edema.
Patients with liver failure if appropriate dosing Amlodipine-Teva should be supervised by a doctor.
Elderly patients may increase the T1 / 2 and to decrease the clearance of the drug.
Changes in dose are not required, but must be more careful monitoring of elderly patients.
Efficacy and safety of drug-Amlodipine Teva has not been established for hypertensive crisis.
Despite the lack of BCCI syndrome “cancel” the cessation of treatment with Amlodipine-Teva it is desirable to gradually reducing the dose of the drug.
Effect on the ability to drive mechanisms and
Although patients receiving the drug Amlodipine-Teva any negative impact 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 when the dose is increased.
Storage conditions
Store at a temperature not higher than 25 ° C.
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 initial dose of 5 mg depending upon the therapeutic response can be increased to a maximum daily dose – 10 mg.
Use in elderly patients
Amlodipine drug-Teva is recommended in high therapeutic doses, dose adjustment is required.
Use in patients with impaired hepatic function
Despite the fact that the T 1/2 drug-Amlodipine Teva, as well as all the BCCI, is increased in patients with hepatic impairment, dose adjustment is usually not necessary (see. Section “Special Instructions”).
Use in patients with impaired renal function
It is recommended to apply the preparation Amlodipine-Teva in normal doses, however, must take into account the possible slight increase in T 1/2.
No dose adjustment is required while the use of thiazide diuretics, beta-blockers and ACE inhibitors.
Information
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
Manufacturer

TEVA

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