Vero amlodipine 5mg tabs 30 pcs

Description

Composition
Active substance:
1 tablet contains: amlodipine besylate, amlodipine, based on – 5 mg and 10 mg; .
Excipients:
Calcium phosphate dihydrate, potato starch, natriyakarboksimetilkrahmal (Primogel), microcrystalline cellulose, colloidal silicon dioxide (Aerosil), magnesium stearate. .
Description:
Tablets white or white to cream color shade, ploskotsilindricheskoy form.
Slight marbling. .
Product form:
Tablets of 5 mg and 10 mg. 10 tablets in blisters. 10 or 30 tablets in a jar made of polymeric materials. Each bank 1 or 3 blisters together with instructions for use in a stack of cardboard. At 2.0 or 2.5 kg of tablets in a container made of polymeric materials (for export). .
Contraindications
Hypersensitivity to amlodipine and / or other components of the drug as well as other derivatives of dihydropyridine; marked hypotension (systolic blood pressure less than 90 mmHg..); unstable angina (except Prinzmetal angina); age 18 years (efficacy and safety data are limited).
Precautions: hypotension, liver dysfunction, sick sinus syndrome (bradycardia, tachycardia), aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and within 1 month after), CHF nonischemic etiology (III-IV NYHA functional class classification), advanced age. .
Dosage
5 mg
Indications
Arterial hypertension (monotherapy or in combination with other antihypertensive agents); stable angina, vasospastic angina (Prinzmetal’s angina) (monotherapy or in combination with other antianginal drugs).
Interaction with other drugs
Inhibitors of microsomal liver enzymes may increase the plasma concentration of amlodipine, increasing the risk of side effects, and inducers of microsomal liver enzymes – reduce. Unlike other BCCI not observed clinically significant interaction with non-steroidal anti-inflammatory drugs (NSAIDs), particularly with indomethacin. Thiazide and “loop” diuretics, beta-blockers, verapamil, ACE inhibitors and nitrates increase antianginal and antihypertensive action of amlodipine. It does not affect the pharmacokinetic parameters of digoxin and warfarin. Cimetidine does not affect the pharmacokinetics of amlodipine. Calcium can reduce the effect of BCCI. Antivirals (ritonavir) increase the plasma concentrations of BCCI, including amlodipine. Antipsychotics increase the hypotensive effect of dihydropyridine derivatives. In a joint application with lithium BCCI drugs may be increased neurotoxicity. Means for inhalation anesthesia (hydrocarbon derivatives including isoflurane), amiodarone, quinidine, BCCI may enhance the antihypertensive effect. Repeated application of amlodipine 10 mg and atorvastatin 80 mg is not accompanied by a significant change in the pharmacokinetics of atorvastatin. Simultaneous administration of grapefruit juice 240 ml, and 10 mg of amlodipine is not accompanied by a significant change in the pharmacokinetics of amlodipine. Simultaneous administration of 100 mg of sildenafil in patients with arterial hypertension has no effect on the pharmacokinetic parameters of amlodipine. .
Overdose
Symptoms: marked decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilatation (risk of pronounced and persistent reduction in blood pressure, including with the development of shock and death).
Treatment: gastric lavage, administration of activated carbon (especially in the first 2 hours after the overdose), the patient should take a horizontal position to an elevated position of the lower extremities. Maintaining the function of the cardiovascular system, monitoring indicators of the heart and lungs, monitoring blood volume (CBV), and urine output. 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), a dihydropyridine derivative. Blocks “slow” calcium channels, reduces the transmembrane passage of calcium ions into the cell (mainly in the vascular smooth muscle cells than in cardiomyocytes). It has antianginal and hypotensive action. It reduces the severity of myocardial ischemia. Antianginal effect due to the expansion of the coronary and peripheral arteries and arterioles: extending peripheral arterioles, decreases total peripheral vascular resistance (TPR), reduce afterload on the heart, thereby 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 Prinzmetal) prevents the development of coronary artery spasm (including those caused by smoking). In patients with angina single daily dose of amlodipine increases the run-time physical activity, retards the development of angina and “ischemic” ST segment depression during exercise, 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 amlodipine provides a clinically significant decrease in blood pressure (BP) for 24 hours (in the position of the patient “lying” and “standing”). It does not cause a sharp decrease in blood pressure, left ventricular ejection fraction and reducing exercise intolerance. Reduces the degree of left ventricular hypertrophy, exerts a cardioprotective effect in ischemic heart disease (CHD). 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. 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 angioplasty (TLO) of the coronary arteries or in patients with angina pectoris, amlodipine It prevents the development of thickening intima-media carotid arteries, reduces mortality from myocardial infarction, stroke, TLO, 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 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. No adverse effects on metabolism and lipid concentration in blood plasma. Time of onset of effect – 2-4 hours; duration – 24 hours. The.
Pharmacokinetics:
After ingestion of amlodipine is well absorbed (about 90%), food intake has no influence on amlodipine absorption, absolute bioavailability – 64-80%. reaching maximum concentration in the blood plasma of 6-9 hours. The mean volume of distribution of 21 l / kg body weight. Communication with plasma proteins, about 97%. It penetrates the blood-brain barrier. The equilibrium concentrations are reached after 7-8 days of drug therapy. Amlodipine is metabolized in the liver to inactive metabolites. The half-life (T1 / 2) of the drug on the average – 35-50 hours, allowing to take the drug once a day. Total clearance – 500 ml / min. In patients with hypertension T1 / 2 – 48 hours, in elderly patients (over 65 years) – increases to 65 hours, during liver failure – up to 60 hours, similar parameters to increase T1 / 2 are observed in severe CHF. Impaired renal function has no significant effect on the kinetics of amlodipine. About 60% of the dose is excreted by the kidneys in the form of inactive metabolites, 10% – unchanged; through the bile and gut – 20-25% in the form of metabolites. When hemodialysis is not removed. .
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 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 Vero- during lactation should decide the issue of termination of breastfeeding. .
Conditions of supply of pharmacies
On prescription. .
side effects
Classification of adverse reactions frequency: frequent (more than 1%), rare (0.1% – 1%), rare (0.01% – 0.1%) and very rarely (less than 0.01%).
With the cardiovascular system: often – peripheral edema (swelling of the ankles and feet), palpitations; rare – an excessive fall in blood pressure, orthostatic hypotension, vasculitis; rarely – the development or exacerbation of congestive heart failure; very rarely – an abnormal heart rhythm (bradycardia, ventricular tachycardia, atrial flutter), heart attack, chest pain, migraine.
On the part of the central and peripheral nervous system: often – headache, dizziness, fatigue, feeling hot and “tides” of blood to the face, drowsiness; infrequently – malaise, fainting, fatigue, hypoesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, emotional lability, abnormal dreams, anxiety, depression, anxiety; rarely – seizures, lethargy, agitation; very rarely – ataxia, amnesia.
From the digestive system: often – nausea, abdominal pain; rarely – vomiting, constipation, diarrhea, flatulence, dyspepsia, anorexia, dry mouth, thirst; rarely – gingival hyperplasia, increased appetite; very rarely – gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of “liver” transaminases, hepatitis.
From the side of hematopoiesis: rarely – thrombocytopenia purpura, leukopenia, and thrombocytopenia.
The respiratory system: rarely – dyspnea, rhinitis; very rarely – cough.
With the genitourinary system: rare – pollakiuria, painful urination, nocturia, impotence; very rarely – dysuria, polyuria.
On the part of the musculoskeletal system: rarely – arthralgia, muscle cramps, myalgia, back pain, arthritis; rarely – myasthenia gravis.
Allergic reactions: rarely – itching, rash; very rarely – angioedema, erythema multiforme, urticaria.
Other: rare – alopecia, tinnitus, gynecomastia, increase / decrease in body weight, blurred vision, diplopia, disturbance of accommodation, xerophthalmia, conjunctivitis, eye pain, taste perversion, chills, nasal bleeding, increased sweating; rarely – parosmiya, dermatoxerasia, violation of skin pigmentation, cold sweat, hyperglycemia. .
special instructions
Amlodipine has no effect on plasma concentrations of potassium, glucose, thyroid hormones, lipids, uric acid, creatinine, urea nitrogen. Avoid abrupt withdrawal of amlodipine due to risk of worsening of angina. The period of treatment is necessary to control body weight and observed at the dentist (preventing pain, bleeding and gingival hyperplasia). The efficacy and safety of amlodipine use in hypertensive crisis has not been established. Elderly patients may increase the T1 / 2 and to decrease the clearance of the drug. No dose adjustment is necessary, but patients should be more carefully monitored in this category. The treatment should be careful when driving and occupation of other activities that require concentration and speed of psychomotor reactions. .
Storage conditions
At a temperature of not higher than 30 C.
Keep out of the reach of children.
Dosing and Administration
Inside. 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. It does not require dose adjustment with concomitant administration with thiazide diuretics, beta-blockers and ACE inhibitors. In elderly patients, amlodipine recommended for use in high therapeutic doses, dose adjustment is not required. Patients with impaired hepatic function Dose adjustment is not normally required. In patients with renal impairment dose adjustment is required. .
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist