Amlodipine-Sandoz 10mg tab 30 pc


Amlodipine-Sandoz 10mg tab 30 pc



Active substance:
amlodipine besylate 13.868 mg (corresponds to 10 mg amlodipine).
Anhydrous lactose 219.732 mg microcrystalline cellulose 133.600 mg corn starch (dried) 26,400 mg, 2.000 mg of talc, colloidal anhydrous silica 2.000 mg Magnesium stearate 2.400 mg.
Round flat tablets white or white color with a yellowish shade with the mark on one side and a facet.
Product form:
Tablets 10 mg.
10 tablets in Al. / Al. blister.
Hypersensitivity to amlodipine and other dihydropyridine derivatives and to support components of the formulation;
severe hypotension;
collapse, cardiogenic shock;
unstable angina (except Prinzmetal angina);
hemodynamically unstable heart failure after acute myocardial infarction;
obstruction of the left ventricular outflow tract (e.g., expressed aortic stenosis);
Rare hereditary forms of lactose intolerance, lactase deficiency or malabsorption of glucose / galactose (as in the composition contains lactose);
age 18 years (effectiveness and safety have been established).
Caution should be used in patients with liver failure, chronic heart failure decompensation, elderly simultaneous application with inhibitors and inducers isoenzyme CYP3A4.
As with other reception BCCI care must be taken against application of amlodipine in patients with sick sinus syndrome, mitral valve stenosis, hypertrophic obstructive cardiomyopathy, mild to moderate arterial hypertension, acute myocardial infarction (and within 1 month after). Pregnancy
10 mg
Arterial hypertension (in both monotherapy and in combination with other antihypertensive agents).
Coronary heart disease: stable angina, vasospastic angina (Prinzmetal’s angina) (both in monotherapy and in combination with other antianginal drugs).
Interaction with other drugs
In the appointment of amlodipine in combination with thiazide and “loop” diuretics, verapamil, ACE inhibitors, beta-blockers and nitrates may increase antianginal and antihypertensive effect. The combined use of BCCI and beta-blockers in patients with myocardial infarction patients may lead to the re-emergence and the development of severe heart failure.
Aluminum / magnesium containing antacids: Their single dose has no significant effect on the pharmacokinetics of amlodipine.
Sildenafil: single dose of 100 mg sildenafil in patients with essential hypertension have not effect on the pharmacokinetic parameters of amlodipine.
Atorvastatin: re-use of amlodipine 10 mg and atorvastatin 80 mg is not accompanied by a significant change in the pharmacokinetics of atorvastatin.
Digoxin: while amlodipine with digoxin in healthy subjects, serum concentrations and renal clearance of digoxin are not changed.
Ethanol (alcoholic beverages): with a single and repeated administration in a dose of 10 mg amlodipine had no significant effect on the pharmacokinetics of ethanol.
Warfarin: amlodipine does not affect changes in prothrombin time induced by warfarin.
Clarithromycin is an inhibitor of CYP3A4. Observed increased risk of hypotension in patients receiving clarithromycin with amlodipine. Careful monitoring is recommended for patients with concomitant use of amlodipine and clarithromycin.
Studies of drug interactions of cyclosporine and amlodipine in healthy volunteers and other populations are not carried out, except for kidney transplant patients, who observed an increase in variable quantities of residual concentration of cyclosporin (average 0% – 40%). the question of the level of cyclosporine control in patients after renal transplantation should be considered to take amlodipine, and to reduce the dose of cyclosporine, if necessary.
Simvastatin: simultaneous application of multiple dose amlodipine and 10 mg simvastatin into a multiple dose of 80 mg resulted in increased exposure of simvastatin by 77% compared with that when simvastatin monotherapy. the dose of simvastatin should be limited in patients receiving amlodipine and 20 mg per day.
Unlike other BCCI it was not found clinically significant interaction amlodipine when combined with nonsteroidal antiinflammatory drugs (NSAIDs), especially indomethacin.
Cimetidine does not affect the pharmacokinetics of amlodipine.
Grapefruit juice is not recommended for use of amlodipine with grapefruit or grapefruit juice, as in some patients it may increase the bioavailability and, consequently, enhances the hypotensive effect.
Dantrolene (infusion administration):
Fatal cases of ventricular fibrillation and cardiovascular disease combined with hyperkalemia have been observed in animals following intravenous administration of verapamil and dantrolene. Due to the risk of hyperkalemia, it is recommended to avoid the simultaneous use of calcium channel blockers such as amlodipine, in patients prone to the development of malignant hyperthermia during treatment and malignant hyperthermia.
There is a risk of increasing the concentration of tacrolimus in the blood plasma while the use of amlodipine, but the mechanism of pharmacokinetic interaction is not fully understood. To avoid the toxicity of tacrolimus, when using amlodipine in patients receiving tacrolimus treatment should be conducted to control the concentration of tacrolimus in the blood plasma and to adjust the dose of tacrolimus, if necessary.
Amiodarone, quinidine, alpha1-adrenergic blockers, antipsychotic drugs (neuroleptics) and BCCI may enhance the hypotensive effect of amlodipine. With simultaneous use of amlodipine with antiarrhythmic drugs causing prolongation of the interval QT (e.g., amiodarone and quinidine) may increase the severity of the negative inotropic effects. When combined with preparations of lithium may be increased manifestations of neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
Inhibitors of the enzyme CYP3A4: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors such as ritonavir, antifungals of the azole group, macrolide antibiotics such as erythromycin, or clarithromycin; verapamil or diltiazem) can significantly increase the exposure of amlodipine, which leads to an increase in risk of arterial hypotension. Clinical manifestations of these changes of pharmacokinetic parameters may be more pronounced in the elderly. Thus, it may be necessary to clinical observation and dose adjustment.
Inducers of CYP3A4 enzyme (dexamethasone, phenobarbital, rifampin, carbamazepine, rifabutin, phenytoin, nevirapine, St. John’s wort (Hypericum perforatum)) can affect the concentration of amlodipine in the blood plasma. It is therefore necessary to monitor blood pressure and to adjust the dose both during and after co-application with strong inducers of CYP3A4.
marked reduction of blood pressure with possible development of reflex tachycardia and excessive peripheral vasodilation (there is a probability of occurrence of severe and persistent hypotension, including the development of shock and death).
assignment of activated carbon (the first 2 hours after the overdose), gastric lavage (in some cases), giving elevated position extremities function control of the cardiovascular and respiratory systems, active maintenance function of the cardiovascular system, control of the volume of circulating blood and diuresis.
To restore vascular tone and blood pressure increase, if there are no contraindications, you can assign vasopressors. Use intravenous administration of calcium gluconate. Hemodialysis is ineffective, since amlodipine is largely bound to plasma proteins.
pharmachologic effect
Pharmacological group:
BCCI (blocker “slow” calcium channel)
Dihydropyridine derivative – blocker “slow” calcium channels, has antianginal and hypotensive action. Communicating with the dihydropyridine receptor, blocks calcium channels, reduces the transmembrane passage of calcium ions into the cell (mainly in vascular smooth muscle cells than cardiac myocytes). Antianginal effect due to the expansion of the coronary and peripheral arteries and arterioles: angina reduces the severity of myocardial ischemia; expanding peripheral arterioles, reducing the total peripheral vascular resistance, reduces preload on the heart, reducing myocardial oxygen demand. Expanding the major coronary arteries and arterioles in the unaltered and ischemic areas of myocardium, increase oxygen supply to the myocardium (especially with vasospastic angina pectoris); It prevents the development of constriction of the coronary arteries (including those caused by smoking). In patients with angina single daily dose increases the run-time physical activity slows the development of angina and ‘ischemic’ ST segment depression, reduces the frequency of angina attacks and nitroglycerin consumption. It has a long dose-dependent hypotensive effect. Hypotensive effect caused by the direct vasodilating effect on vascular smooth muscle. When hypertension single dose provides a clinically significant decrease in blood pressure (BP) over 24 hours (at the position of the patient “lying” and “standing”). Does not cause a sharp decrease in blood pressure, reduction of exercise tolerance, left ventricular ejection fraction. Reduces the degree of left ventricular hypertrophy, has anti-atherosclerotic and cardioprotective effect in ischemic heart disease. 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 concentration of plasma lipids. Time of onset of effect – 2-4 hours, duration of effect of 24 hours.
After oral administration, amlodipine is slowly absorbed from the gastrointestinal tract. The mean absolute bioavailability of 64-80%, the maximum plasma concentration occurs within 6-12 hours. A stable equilibrium concentration achieved 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 relatively smaller – in the blood. Most of the drug present in the blood (97.5%), binds to plasma proteins. Amlodipine undergoes slow but extensive metabolism (90%) in the liver into inactive metabolites, has the effect of “primary” passing through the liver. Metabolites not possess significant pharmacological activity. After a single oral half-life (T1 / 2) ranges from 35 to 50 hours, with repeated use of T1 / 2 of approximately 45 hours. About 60% of an oral dose is excreted mainly by the kidneys as metabolites, 10% unchanged, and 20-25% through the intestine. Excretion in breast milk is unknown. 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 of 65 hours) compared to younger patients, but this difference has no clinical significance.
In patients with hepatic failure half-life of amlodipine is increased dosage recommendations are not defined, therefore amlodipine in these patients should be used with caution.
In patients with renal insufficiency, the half-life increased to 60 hours. Changing amlodipine plasma concentration does not correlate with the degree of renal impairment.
The drug penetrates the blood-brain barrier. When hemodialysis is not removed.
Pregnancy and breast-feeding
Safety of application of amlodipine during pregnancy has not been established. In animal manifestations reproductive toxicity was observed when used in high doses studies. Use during pregnancy is recommended only in cases when there is no safer alternative and when the disease itself contributes to increase the risk to mother and fetus.
Amlodipine is released in breast milk. The percentage dose transmitted breastfeeding child, interquartile range estimated at 3 – 7%, and a maximum – 15%. Effect of amlodipine has not been studied in infants. Decision on the continuation / cessation of breast-feeding or to continue / termination of therapy with amlodipine should be taken in view of the benefits of breastfeeding for the child and the benefit of amlodipine therapy to the mother.
reproductive function
Reversible biochemical changes in the sperm heads were seen in some patients treated by calcium channel blockers. Clinical data are insufficient to assess the potential effect of amlodipine on fertility. One study in rats adverse effects were found in relation to male fertility.
Conditions of supply of pharmacies
side effects
Among the adverse reactions during treatment with the most frequently reported: somnolence, dizziness, headache, palpitations, a burst of heat, abdominal pain, nausea, swelling in the ankles, edema and fatigue. According to the World Health Organization (WHO), undesirable effects are classified according to their rate of development as follows: very common (> 1/10), common (> 1/100,
special instructions
The efficacy and safety of amlodipine have not been established for hypertensive crisis.
Patients with heart failure
Treatment of patients with heart failure should be performed with caution. In the long, placebo-controlled study in patients with severe heart failure (III and IV NYHA functional class classification) registered incidence of pulmonary edema was higher in the amlodipine group than in the placebo group.
Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they subsequently may lead to an increased risk of events associated with the cardiovascular system, and mortality.
Patients with impaired liver function
In patients with impaired liver function is extended half-life of amlodipine and AUC increased performance; recommendations on the doses are not established. Therefore amlodipine application should begin with the lower dose level range and to be careful when using both the initial treatment and during dose escalation. Patients with impaired liver function severe you may need to slow dose titration and careful monitoring.
Elderly patients
Elderly patients increasing the dose should be made with caution.
Patients with impaired renal function
Amlodipine may be used in such patients at standard doses. Changes amlodipine plasma concentration does not correlate with the severity of renal dysfunction. Amlodipine is not dialyzed.
Optimally use the drug Amlodipine Sandoz® every day at the same time. Despite the lack of BCCI syndrome “cancel”, the gradual reduction in dose is recommended before the termination of treatment.
Sandoz® Amlodipine may be administered in combination with a thiazide diuretic, alpha- and beta-blockers, ACE inhibitors, long-acting nitrates, nitroglycerin sublingual, nonsteroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic agents. Amlodipine Sandoz® no adverse effects on lipids metabolism and blood plasma, therefore, can be used in patients with asthma, diabetes, and gout, as well as in those cases when the patient is predisposed to vasospasm / vasoconstriction.
Patients with low weight, small stature patients and patients with severe hepatic dysfunction may require a smaller dose. During treatment requires control of body weight and observing the dentist (to prevent pain, bleeding and gingival hyperplasia).
The effect on the ability to operate vehicles, machinery
In applying Amlodipine Sandoz® any adverse effect on the ability to drive or other technical means was not observed, however, because of possible excessive loss of blood pressure, the reaction rate due to deceleration of dizziness, headache, fatigue, etc. side effects should be attentive to the individual action of the drug at the beginning of treatment and when changing the dose regimen.
Storage conditions
In a dry, dark place at a temperature not higher than 25 ° C. Keep out of the reach of children.
Dosing and Administration
Inside, once a day, drinking sufficient amount of water (100-200 ml), regardless of the meal.
For the treatment of hypertension and prevention of attacks of angina pectoris and vasospastic angina initial daily dose of amlodipine Sandoz® is 5 mg at one time. If necessary, the dose may be increased to a maximum daily dose – 10 mg / day dose.
Use in elderly patients
Recommended for use in normal doses, dose adjustment is required.
Use in patients with impaired renal function
correction dose is not required.
Use in patients with impaired hepatic function
Amlodipine half-life Sandoz® increased in patients with this pathology, recommended dosages are not defined, therefore amlodipine in these patients should be used with caution. Patients with low weight or short, and also with severe hepatic insufficiency may require lower doses of the drug.
Not required dose change while the appointment with thiazide diuretics, beta blockers and angiotensin converting enzyme (ACE).
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

Sandoz RX

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