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medicalmeds.eu Medicines Blocker of "slow" calcium channels. Amlodipin

Amlodipin

Препарат Амлодипин. СООО "Лекфарм" Республика Беларусь


Producer: SOOO "Lekfarm" Republic of Belarus

Code of automatic telephone exchange: C08CA01

Release form: Firm dosage forms. Tablets.

Indications to use: Arterial hypertension. Stable stenocardia. Printsmetal's stenocardia.


General characteristics. Structure:

Active ingredient: 10 mg of an amlodipin (in the form of a besilat).

Excipients: starch corn, aerosil, microcrystallic cellulose, magnesium stearate, lactose. Release form: tablets of 10 mg.

The cardiological drug possessing anti-hypertensive and anti-anginal action.




Pharmacological properties:

Pharmacodynamics. Possesses anti-hypertensive and anti-anginal action. After administration of drug inside амлодипин it is quickly and completely soaked up, reaching the maximum concentration in a blood plasma in 6-12 h after reception. The concomitant use of food does not influence absorption of an amlodipin. An elimination half-life – 35-50 h that allows to appoint амлодипин 1 time a day. Equilibrium concentration in a blood plasma is reached in 7-8 days of constant reception of an amlodipin.


Indications to use:

Arterial hypertension (including as a part of a combination therapy); stable and vasospastic stenocardia (Printsmetal's stenocardia) (including as a part of a combination therapy).


Route of administration and doses:

The initial dose makes 5 mg of 1 times/days. Depending on individual reaction of the patient the dose can be increased to 10 mg/days. Side effect the Headache, peripheral hypostases, increased fatigue, drowsiness, nausea, pain in a stomach, feeling of rushes of blood, heartbeat, dizziness, is more rare – a skin itch, rash, an asthma, an adynamy, spasms, dyspepsia, a hyperplasia of gums, a polymorphic erythema.


Features of use:

With care appoint амлодипин to patients with an abnormal liver function, chronic heart failure (the III-IV functional class NYHA) of not ischemic etiology, an aortal stenosis, an acute myocardial infarction (and within 1 month after it).

It is necessary to be careful at reception of an amlodipin by patients with SSSU, a mitral stenosis, a hypertrophic subaortic stenosis, arterial hypotension.

At treatment of arterial hypertension амлодипин it is possible to apply in a combination with thiazide diuretics, alpha and beta adrenoblockers, APF inhibitors, nitrates of the prolonged action, sublingual nitroglycerine, antibiotics and peroral hypoglycemic means.

For treatment of stenocardia амлодипин it is possible to appoint in the form of monotherapy or in a combination with other anti-anginal drugs, including at patients, refractory to treatment by nitrates and/or beta adrenoblockers in adequate doses.

To patients of low growth and patients with the expressed abnormal liver function reduction of a dose can be required by patients with small body weight. Efficiency and safety of use of an amlodipin for children and teenagers aged up to 18 years are definitely not established. As in an initiation of treatment амлодипин can cause decline in the ability to concentration of attention (dizziness and drowsiness), it is necessary to be careful in the situations demanding the increased concentration of attention.


Side effects:

At use of an amlodipin side effects are registered with the following frequency: very often - 1/10 and more; often from 1/100 to <1/10; infrequently - from 1/1000 to 1/100; seldom - from 1/10 000 to 1/1000; very seldom - less than 1/10000.

From blood and lymphatic system: very seldom - a leukopenia, thrombocytopenia.

From immune system: very seldom - allergic reactions.

From a metabolism and food: very seldom - a hyperglycemia. Increase or degrowth of a body.

Mental disorders: seldom - sleeplessness, changes of mood (including alarm), a depression, a disorientation.

From a nervous system: often - drowsiness, dizziness, a headache (especially in an initiation of treatment); seldom - a tremor, a food faddism, a faint, a hypesthesia, paresthesia; very seldom - a hyper tone, peripheral neuropathy.

From sense bodys: seldom - a vision disorder, including a diplopia, a ring in ears.

From cardiovascular system: seldom – heartbeat; very seldom - a myocardial infarction, arrhythmias (including bradycardia, ventricular tachycardia and fibrillation of auricles); often - a hyperemia of the person; seldom – hypotension; very seldom - a vasculitis.

From respiratory tracts, lungs and thorax: seldom - short wind, rhinitis; very seldom - cough.

From a GIT: often - an abdominal pain, nausea; seldom - vomiting, dispepsichesky frustration, bowel emptying changes (including, diarrhea and a lock), dryness in a mouth; very seldom - pancreatitis, gastritis, a hyperplasia of gums.

From a liver and biliary tract: seldom - hepatitis, jaundice, increase in activity of transaminases.

From skin and hypodermic cellulose: seldom - an alopecia, a purpura, track discoloration, perspiration, an itch, rash, a dieback; very seldom - a Quincke's edema, a multiformny erythema, a small tortoiseshell, exfoliative dermatitis, Stephens-Johnson's syndrome, a photosensitization.

From a musculoskeletal system, connecting fabric: often - hypostasis of area of an ankle joint; seldom - arthralgias, mialgiya, muscular spasms, dorsodynias.

From kidneys and urinary tract: seldom - frustration of an urination, a nocturia, increase in frequency of an urination.

From reproductive system and mammary glands: seldom - impotence, a gynecomastia.

General disturbances: often - hypostases, fatigue; seldom - a stethalgia, weakness, pain, an indisposition.


Interaction with other medicines:

Let's combine with the main groups of antihypertensives (diuretics, APF inhibitors, beta adrenoblockers), nitrates and hypoglycemic drugs.
 
Means for an inhalation anesthesia (derivatives of hydrocarbons), Amiodaronum, quinidine, etc. antagonists of calcium can strengthen action.
 
NPVS (especially indometacin) reduce hypotensive effect (slow down synthesis of prostaglandins in kidneys and a natriuresis).

Contraindications:

— heavy arterial hypotension;

— shock (including, cardiogenic shock);

— obstruction of an exit from a left ventricle (a dekompensirovanny stenosis of the mouth of an aorta);

— instability of a hemodynamics after an acute myocardial infarction;

— hypersensitivity to an amlodipin and other derivatives of dihydropyridine


Overdose:

Purpose of absorbent carbon (especially in the first 2 h after overdose), a gastric lavage, giving of sublime situation to extremities, active maintenance of function of cardiovascular system, monitoring of indicators of cardiac performance and lungs, control of volume of the circulating blood and a diuresis. For recovery of a tone of vessels and arterial pressure if there are no contraindications, use of vasoconstrictive drugs is possible. Use in/in introduction of a gluconate of calcium. As амлодипин substantially contacts serum proteins - the hemodialysis is inefficient.

Overdose symptoms: the expressed lowering of arterial pressure with possible development of reflex tachycardia and an excessive peripheral vazodilatation (there is a probability of emergence of the expressed and persistent arterial hypotension, including with development of shock and a lethal outcome).


Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C. List B. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe


Packaging:

Dosage of 5 mg. On 10 tablets in blister strip packagings. On 2, 3 or 6 blister strip packagings in a cardboard pack together with the application instruction.

Dosage of 10 mg. On 10 or 15 tablets in blister strip packagings. On 2, 3 or 6 blister strip packagings on 10 tablets in a cardboard pack together with the application instruction. On 2 or 4 blister strip packagings on 15 tablets in a cardboard pack together with the application instruction.



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