Amlotop: instructions for use
ATX Code: C08CA01 (Amlotop).
Release form: tablets.
Dosage form: flat-cylindrical tablets of white or grayish-white color, with risk and a facet.
Clinico-pharmacological group: blocker of slow calcium channels of the II generation.
Pharmacotherapeutic group: antihypertensive, antianginal agent.
Active ingredient: amlodipine besylate.
Excipients: microcrystalline cellulose, lactose monohydrate, aerosil (colloidal silicon dioxide), primelloza (croscarmellose sodium), calcium stearate.
Derivative of dihydropyridine, has a blocking effect on calcium channels, reduces the transmembrane transition of calcium ions into smooth muscle vascular cells. Its ability to expand the coronary vessels is due to the expansion of the arteries and arterioles, a decrease in total peripheral vascular resistance.
The hypotensive effect of amlodipine besylate is caused by a direct vasodilator action. In patients suffering from arterial hypertension, a clinically significant decrease in blood pressure is observed for 24 hours. Orthostatic hypotension rarely develops. Reduces the degree of left ventricular myocardial hypertrophy, does not affect cardiac contractility and conductivity, does not lead to a reflex increase in heart rate. Under the influence of a drug with a weak natriuretic effect, the glomerular filtration rate increases and platelet aggregation is inhibited.
In patients with chronic heart failure III-IV Art. not ischemic etiology when using Amlotop may develop pulmonary edema.
The drug is slowly absorbed from the gastrointestinal tract. The average absolute bioavailability - 60-65%, reaches a maximum concentration in serum after 6-12 hours after administration. 7-8 days of therapy is required to achieve an equilibrium Css concentration.
Plasma protein binding is 90-97%.
The half-life is 35-50 hours. 10% of the drug is excreted by the kidneys unchanged, about 60% - in the form of metabolites, 20-25% - along with the bile, through the intestine. Total clearance - 500 ml / min. The elimination half-life in elderly patients, as well as in patients with severe hepatic and chronic heart failure, increases to 65 hours. The drug penetrates the blood-brain barrier, during hemodialysis is not removed. It is excreted in breast milk.
Indications for use
- Arterial hypertension;
- Stable angina ;
- Vasospastic stenocardia (Prinzmetala).
In the treatment of the initial degree of angina and arterial hypertension - 5 mg once a day. If necessary, the dose is increased to 10 mg / day.
Maintenance dose in hypertension - 5 mg / day, once.
Vasospastic stenocardia and angina of exertion - 5-10 mg / day, once.
From the side of the central nervous system : dizziness, fatigue, headaches, drowsiness, general malaise, sleep disturbance, emotional lability, depression, increased anxiety, increased sweating. Migraine, ataxia, amnesia, convulsions are quite rare.
On the part of the digestive tract : nausea, vomiting, abdominal pain, abnormal stool, flatulence, anorexia, thirst, drying of the oral mucosa. Very rarely - increased appetite, gingival hyperplasia, cholestatic jaundice, hepatitis, pancreatitis .
From the lymphatic and hematopoietic system : thrombocytopenia, thrombocytopenic purpura, leukopenia (very rare).
Cardiovascular : heartbeat, flushing, peripheral edema, excessive lowering of blood pressure, vasculitis , orthostatic hypotension, aggravation of chronic heart failure, shortness of breath, disturbed heart rhythm, fainting, chest pain, pulmonary edema, myocardial infarction myocardium.
From the excretory system : painful urge to urinate, polyuria, dysuria, nocturia, pollakiuria.
On the part of the respiratory system : runny nose, shortness of breath, cough.
From the reproductive system : impotence, gynecomastia.
On the part of the musculoskeletal system : arthralgia, myalgia, muscle cramps, back pain, myasthenia gravis, arthrosis.
On the part of the skin : itching, rash, urticaria , erythema multiforme, angioedema, alopecia.
From the sense organs : visual disturbances, tinnitus, conjunctivitis , eye pain.
Other : hyperglycemia, weight loss or increase, nosebleeds, chills, cold sweat.
Interaction with other drugs
With the simultaneous use of microsomal oxidation inhibitors, the concentration of Amlotop increases, and when microsomal enzymes are taken, it decreases.
NSAIDs, alpha-adrenergic stimulants, sympathomimetics and estrogens weaken the hypotensive effect of the drug. Beta-blockers, diuretics, nitrates, antipsychotics, slow calcium channel blockers and ATP inhibitors increase the vasodilator and hypotensive effect.
The pharmacokinetics of Amlotop have no effect on warfarin, digoxin, cimetidine.
With simultaneous use with lithium preparations, nausea, vomiting, abnormal stool, tinnitus, tremor, ataxia are possible.
The effect of using Amlotop can reduce potassium preparations.
Drugs that prolong the QT interval can increase the negative ionotropic effect.
- Hypersensitivity to the drug;
- Glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
- Cardiogenic shock;
- Severe arterial hypotension (up to 90 mmHg);
- Unstable angina (with the exception of vasospastic);
- Clinically significant aortic stenosis;
- Pregnancy and lactation;
- Age up to 18 years.
During treatment, the patient should follow a special diet, constantly monitor body weight and sodium intake. People of low height and / or low body weight, patients with severe renal insufficiency and older people are given lower doses of the drug. For elderly patients with increasing doses requires constant medical supervision.
When you stop treatment, the dosage decreases gradually.
When driving and working with different mechanisms, special precautions must be observed.
Terms of implementation
Amlotop tablets are prescription drugs, i.e. prescription of a doctor.
Store in a dark, protected from light and moisture, out of the reach of children, at a temperature not exceeding 25 C.
The drug is usable for 3 years from the date of issue. Use of the product after the expiration date indicated on the package is prohibited.
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Amlotop tablets 5 mg, 30 pcs. - from 112r.