Amlodipine 5mg tabs 30 pcs vertex


Amlodipine 5mg tabs 30 pcs vertex


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Active substance:
1 tablet contains: amlodipine besylate, amlodipine, based on – 5 mg or 10 mg ;.
Microcrystalline cellulose, lactose (milk sugar), sodium croscarmellose (primelloza), calcium stearate (calcium octadecanoate).
Tablets white or nearly white, Valium chamfered.
Product form:
Tablets 5 mg, 10 mg. 10 tablets in blisters or 10, 20 or 30 tablets in a polymeric jar. 1, 2 or 3 blisters or each bank together with instructions for use in a stack of cardboard.
Hypersensitivity to amlodipine and other dihydropyridine derivatives; severe hypotension; collapse, cardiogenic shock; unstable angina (except Prinzmetal angina); pregnancy and lactation; age 18 years (effectiveness and safety have been established).
Precautions: liver, sick sinus syndrome (bradycardia, tachycardia), chronic heart failure decompensation, mild to moderate arterial hypotension, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and for 1 months after), diabetes mellitus, lipid profile, old age.
5 mg
Arterial hypertension (monotherapy or in combination with other antihypertensive agents).
Angina, vasospastic angina (Prinzmetal’s angina).
Interaction with other drugs
Inhibitors of microsomal oxidation increase the concentration of amlodipine in the blood plasma, increasing the risk of side effects, and inducers of microsomal liver enzymes decrease.
The hypotensive effect of weakening the non-steroidal anti-inflammatory drugs, especially indomethacin (sodium retention and renal prostaglandin synthesis block), alpha-adrenostimulyatorov, estrogens (sodium retention), sympathomimetics.
Thiazide and “loop” diuretics, beta-blockers, verapamil, ACE inhibitors and nitrates increase antianginal and antihypertensive effects.
Amiodarone, quinidine, alpha1-adrenergic blockers, antipsychotic drugs (neuroleptics) and blockers “slow” calcium channels may increase the hypotensive action.
No impact on the pharmacokinetic parameters of digoxin and warfarin.
Cimetidine does not affect the pharmacokinetics of amlodipine.
When combined with preparations of lithium may be increased manifestations of neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
Calcium blockers can reduce the effect of “slow” calcium channels.
Procainamide, quinidine and other drugs causing prolongation of the interval QT, reinforce the negative inotropic effect and may increase the risk of significant lengthening of the QT interval.
Grapefruit juice may reduce the plasma concentration of amlodipine, but this decrease is so small that it does not significantly alter the effect of amlodipine.
Symptoms: marked reduction of blood pressure, tachycardia, excessive peripheral vasodilation.
Treatment: gastric lavage, the appointment of activated carbon, the maintenance of the cardiovascular system, the control parameters of the heart and lung function, control of blood volume and diuresis, giving the patient a horizontal position with raised legs. To restore vascular tone – application of vasoconstrictive drugs (in the absence of contraindications for their use); to eliminate the effects of calcium channel blockade – intravenous calcium gluconate. Hemodialysis is not effective.
pharmachologic effect
Pharmacological group:
BCCI (blocker “slow” calcium channel).
Dihydropyridine derivative – blocker “slow” calcium channels II generation, 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) for 24 hours (in 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, antiatherosclerotic and cardioprotective effect in ischemic heart disease (CHD). No effect on the myocardial contractility and conductivity, does not cause reflex increase of heart rate (HR), inhibits platelet aggregation and increases glomerular filtration rate, has a weak natriuretic action. In diabetic nephropathy does not increase the severity of microalbuminuria. It does not have adverse effects on lipid metabolism and blood plasma. Time of onset of effect – 2-4 hours, duration of effect of 24 hours.
After oral administration of amlodipine slowly absorbed from the gastrointestinal tract. Mean absolute bioavailability is 64%, the maximum concentration in serum is observed after 6-9 hours. The concentration of stable equilibrium is reached after 7 days of treatment. Food 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 (95%), binds to plasma proteins.
Amlodipine undergoes slow but extensive metabolism (90%) in the liver into inactive metabolites, has the effect of “first pass” through the liver. Metabolites not possess significant pharmacological activity.
After a single oral half-life (T1 / 2) ranges from 31 to 48 hours on repeated administration of T1 / 2 of approximately 45 hours. About 60% of an oral dose is excreted in the urine primarily as metabolites, 10% unchanged, and 20-25% of the feces, as well as in breast milk. 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. Patients with liver failure elongation assumed T1 / 2, and with long-term administration drug accumulation in the body is higher (T1 / 2 to 60 hours). Renal failure does not significantly affect the kinetics of amlodipine. The drug penetrates the blood-brain barrier. When hemodialysis is not removed.
Conditions of supply of pharmacies
side effects
With the cardiovascular system: heart rate, shortness of breath, marked reduction in blood pressure, fainting, vasculitis, edema (swelling of the ankles and feet), “tides” of blood to the face, rarely – arrhythmias (bradycardia, ventricular tachycardia, atrial flutter), pain chest, orthostatic hypotension, very rarely – the development or exacerbation of congestive heart failure, arrythmia, migraine.
Central nervous system: headache, dizziness, fatigue, drowsiness, mood changes, seizures, rare – loss of consciousness, hypoesthesia, nervousness, paresthesia, tremor, vertigo, fatigue, malaise, insomnia, depression, abnormal dreams, very rarely – ataxia , apathy, agitation, amnesia.
From the digestive system: nausea, vomiting, epigastric pain, rarely – increased level of “liver” transaminases and jaundice (caused by cholestasis), pancreatitis, dry mouth, flatulence, gingival hyperplasia, constipation or diarrhea, rarely – gastritis, increased appetite , anorexia, hyperbilirubinemia.
With the genitourinary system: rare – pollakiuria, tenesmus, nocturia, sexual dysfunction (including reduced potency); very rarely – dysuria, polyuria.
For the skin: very rarely – dermatoxerasia, alopecia, dermatitis, purpura, skin discoloration.
Allergic reactions: itching, rash (including erythematous, maculopapular rash, urticaria), angioedema.
On the part of the musculoskeletal system: rarely – arthralgia, arthrosis, myalgia (with prolonged use); very rarely – myasthenia gravis.
Other: rarely – gynecomastia, hyperuricemia, an increase / decrease in body weight, thrombocytopenia, leukopenia, hyperglycemia, impaired vision, diplopia, conjunctivitis, eye pain, tinnitus, back pain, dyspnoea, epistaxis, increased sweating, thirst; very rarely – a cold clammy sweat, cough, rhinitis, parosmiya, taste disturbance, disturbance of accommodation, xerophthalmia.
special instructions
The treatment requires control of body weight and sodium intake, assigning appropriate diet.
It is necessary to maintain dental hygiene and frequent visits to the dentist (to prevent soreness, bleeding and gingival hyperplasia).
The dosage regimen for the elderly is the same as for patients in other age groups. After increasing the dose should be closely monitored for elderly patients.
Despite the absence of blockers “slow” calcium channels syndrome “cancel” before the termination of treatment is recommended a gradual reduction in dose.
Amlodipine has no effect on plasma concentrations of K +, glucose, triglycerides, total cholesterol, LDL cholesterol, uric acid, creatinine and uric acid nitrogen.
Impact on the ability to drive a car and mechanisms
There were no reports on the effect of amlodipine on driving or using machinery. However, in some patients, mainly in the beginning of treatment may occur drowsiness and dizziness. If this happens, the patient must take special precautions when driving and operating machinery.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Inside, the initial dose for the treatment of hypertension and angina is 5 mg Formulation 1 time per day. The dose may be increased to a maximum of 10 mg once a day. When hypertension maintenance dose can be 5 mg per day.
In angina pectoris and vasospastic angina – 5.10 mg / day one; for the prevention of angina attacks – 10 mg / day.
Not required dose change while the appointment with thiazide diuretics, beta blockers and angiotensin converting enzyme (ACE). It does not require dose modification in patients with renal insufficiency.
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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