Amlodipin-Adzhio
Producer: Agio Pharmaceuticals Ltd. (Adzhio Pharmasyyutikals Ltd.) India
Code of automatic telephone exchange: C08CA01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 5 mg or 10 mg of an amlodipin.
Pharmacological properties:
Pharmacodynamics. The selection blocker of calcium channels of the II class. Anti-hypertensive action is caused by the direct weakening impact on unstriated muscles of vessels. It is supposed that anti-anginal action of an amlodipin is connected with its ability to expand peripheral arterioles; it leads to reduction of OPSS, reflex tachycardia at the same time does not arise. Decrease in need of a myocardium for oxygen and energy consumption by a cardiac muscle results. On the other hand, амлодипин, apparently, causes expansion of coronary arteries of large caliber and coronary arterioles of both intact, and ischemic sites of a myocardium. It provides intake of oxygen to a myocardium at spasms of coronary arteries.
Pharmacokinetics. At intake it is absorbed from a GIT slowly and almost completely, Cmax in a blood plasma is reached during 6-9 h. Linkng with proteins makes 95-98%. Is exposed to the minimum metabolism at the first passing through a liver and to slow, but considerable hepatic metabolism with formation of metabolites with insignificant pharmacological activity.
T1/2 averages 35 h and at arterial hypertension can increase on average to 48 h, at elderly patients - to 65 h and at abnormal liver functions - to 60 h. It is removed mainly in the form of metabolites: 59-62% - kidneys, 20-25% - through intestines.
Indications to use:
Arterial hypertension (including as a part of a combination therapy), stable stenocardia, unstable stenocardia, Printsmetal's stenocardia.
Route of administration and doses:
For adults at intake the initial dose makes 5 mg 1 times/days. If necessary the dose can be increased. Maximum dose: at intake - 10 mg/days.
Features of use:
Use during pregnancy. Perhaps at pregnancy if the expected effect of therapy exceeds potential risk for a fruit. Category of action on a fruit on FDA — C. For the period of treatment it is necessary to stop breastfeeding.
With care to apply in operating time to drivers of vehicles and people whose profession is connected with the increased concentration of attention (in an initiation of treatment dizziness and drowsiness are possible).
Side effects:
From cardiovascular system and blood (a hemopoiesis, a hemostasis): dermahemia of the person, heartbeat; seldom — disturbances of a rhythm (bradycardia, ventricular tachycardia, an atrial flutter), thorax pain, hypotension (including orthostatic).
From a nervous system and sense bodys: fatigue, headache, dizziness, drowsiness; seldom — fatigue, an adynamy, change of mood, a visual disturbance.
From urinogenital system: peripheral hypostases (puffiness of anklebones and feet); seldom — increase in frequency of an urination, impotence.
From bodies of a GIT: nausea, abdominal pain; seldom — dyspepsia, change of the mode of defecation, jaundice.
From respiratory system: seldom — an asthma.
From a musculoskeletal system: seldom — an arthralgia, a mialgiya, paresthesia and extremity pain (at prolonged use).
From integuments: rashes, an itch, it is rare — a mnogoformny erythema.
Others: seldom — a hyperplasia of gums, a gynecomastia, increase in level of liver enzymes.
Interaction with other medicines:
At simultaneous use of an amlodipin and blockers of calcium channels strengthening of hypotensive action is possible.
At simultaneous use of sympathomimetics, estrogen reduction of anti-hypertensive action owing to a sodium delay in an organism is possible.
At simultaneous use of means for an inhalation anesthesia strengthening of hypotensive effect is possible.
At simultaneous use of Amiodaronum strengthening of anti-hypertensive action is possible.
At simultaneous use of lithium of a carbonate manifestations of a neurotoxicity are possible (including nausea, vomiting, diarrhea, an ataxy, trembling and/or a sonitus).
At simultaneous use орлистат reduces anti-hypertensive action of an amlodipin that can lead to substantial increase of the ABP, development of hypertensive crisis.
At simultaneous use of indometacin and other NPVS reduction of anti-hypertensive action of an amlodipin owing to oppression of synthesis of prostaglandins in kidneys and liquid delays under the influence of NPVS is possible.
At simultaneous use of quinidine strengthening of anti-hypertensive action is possible.
Contraindications:
Hypersensitivity (including to other dihydropyridines), arterial hypotension (less than 90 mm of mercury.), shock, an acute myocardial infarction (including the period of 1 month after it).
Storage conditions:
List B. In the dry, protected from light place, at a temperature not above 25 °C. A period of validity - 24 months.
Issue conditions:
According to the recipe
Packaging:
Tablets of 5 mg; packaging planimetric cell 10, pack cardboard 1,3. Tablets of 10 mg; packaging planimetric cell 10, pack cardboard 1,3.