ARMADIN (ARMADIN)

MEXIDOLUM * N07X X12 **

Mikrokhy

STRUCTURE AND PACKAGING:

Solution for infection. 50 mg/ml of amp. 2 ml, the blister in a pack, No. 10

2-ethyl-6-methyl-3-hydroxypyridine succinate of 50 mg/ml

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics . Armadin is inhibitor of free radical processes, a membranoprotektor, renders anti-hypoxemic, stressoprotektorny, nootropic, anticonvulsant and anxiolytic action. Drug increases resistance of an organism to influence of various disturbing factors, to kislorodzavisimy morbid conditions (shock, a hypoxia and ischemia, violation of cerebral circulation, intoxication alcohol and antipsychotic means (neuroleptics)).

Drug improves brain metabolism and blood supply of a brain, microcirculation and rheological properties of blood, reduces aggregation of platelets. Stabilizes membrane structures of blood cells (erythrocytes and platelets) at hemolysis. Has hypolipidemic effect, reduces keeping of the general by XC and LDL. Reduces an enzymatic toxaemia and endogenous intoxication at sharp pancreatitis.

Mechanism of effect of medicine is caused by its antioxidant and membranoprotektorny action. Inhibits the FLOOR, increases activity of a superoxide scavenger, the lipid — protein raises a ratio, reduces viscosity of a membrane, increases its fluidity. Modulates activity of membrane-bound enzymes (kaltsiynezavisimy FDE, adenylatecyclase, acetylcholinesterase), receptor complexes (benzodiazepine, GAMK, atsetilkholinovy) that enhances their ability to linking with ligands, promotes preservation of the structurally functional organization of biomembranes, transportation of neurotransmitters and to improvement of synoptic transfer. Armadin increases contents in a head brain of dopamine. Causes strengthening of compensatory activation of aerobic glycolysis and decrease in extent of oppression of oxidizing processes in a tricarbonic acid cycle in the conditions of a hypoxia with increase in content of ATP and creatine phosphate, activation of the power synthesizing functions of mitochondrions, stabilization of cellular membranes.

Armadin normalizes metabolic processes in an ischemic myocardium, reduces a necrosis zone, restores and improves electric activity and contractility of a myocardium and also increases a coronary blood-groove in an ischemia zone, reduces consequences of a reperfusion syndrome at sharp coronary insufficiency. Increases anti-anginal activity of nitromedicines. Armadin promotes preservation of ganglionic cells of a retina and fibers of an optic nerve at the progressing neuropathy which consequences are chronic ischemia and a hypoxia. Improves functional activity of a retina and optic nerve, increasing visual acuity.

Pharmacokinetics. At introduction in oil medicine is defined in blood plasma during 4 h after introduction. Time of achievement of Cmax is 0.45-0.5 h Cmax at doses of 400-500 mg — 3.5-4.0 mkg/ml. Armadin quickly passes from the blood course into bodies and fabrics and is quickly brought from an organism. Drug is removed from an organism with urine, generally in a glyukuronkonjyugirovanny form and in insignificant quantities — in not changed look.

succinate is quickly soaked up by Etilmetilgidroksipiridin's

in a GIT with the period of semi-absorption of 0.08-0.1 h. Time of achievement of Cmax in blood plasma — 0.46-0.5 h Cmax in blood plasma is in range of 50-100 ng/ml. Т½ makes respectively 4.7-5 and 4.9-5.2 h Etilmetilgidroksipiridin succinate in a human body is intensively metabolized with recovery of its glyukuronokonjyugat. On average for 12 h with urine 0.3% of not changed medicine and 50% in the form of the glyukuronokonjyugat are removed. Most intensively ethylmethylhydroxypyridine succinate and it glyukuronokonjyugat are excreted during the first 4 h after administration of drug. Excretion indicators with urine of ethylmethylhydroxypyridine of succinate and its metabolites have considerable individual variability.

INDICATION:

Solution for injections:

• acute disorders of cerebral circulation;
• craniocereberal injury, consequences of craniocereberal injuries;
• distsirkulyatorny encephalopathy;
• neurocirculatory dystonia;
• easy cognitive violations of atherosclerotic genesis;
• anxiety disorders at neurotic and neurosis-like states;
• a sharp myocardial infarction (since the first day), as a part of complex therapy;
• primary open angle glaucoma of various stages, as a part of complex therapy;
• stopping of an abstinence syndrome at alcoholism with prevalence of neurosis-like and neurocirculatory violations;
• sharp intoxication antipsychotic means;
• sharp pyoinflammatory processes in an abdominal cavity (sharp necrotic pancreatitis, peritonitis), as a part of complex therapy.

Tablet

Neurology:

• a consequence of an acute disorder of cerebral circulation;
• neurotic and neurosis-like states with alarm symptoms;
• neurocirculatory dystonia;
• easy cognitive disorders of various genesis (at the psychoorganic syndrome and asthenic violations caused by acute and chronic disorders of cerebral circulation, craniocereberal injuries, neuroinfections and intoxication, senile and atrophic processes);
• encephalopathy of various genesis (distsirkulyatorny, dismetabolichesky, posttraumatic, mixed);
• slight craniocereberal injury, consequences of craniocereberal injuries;
• violation of memory and intellectual insufficiency at elderly people;
• asthenic states, influence of extreme (stressful) factors;
• an abstinence syndrome at alcoholism with prevalence of neurosis-like and vegetovascular frustration;
• a state after intoxication anti-psychotropic drugs.

Cardiology as a part of complex therapy:

• an ischemic heart disease (stable angina of exertion; unstable stenocardia; sharp myocardial infarction);
• an ischemic heart disease, the complicated AG of a krizovy current, chronic heart failure, ventricular arrhythmias;
• a dislipoproteinemiya of atherogenous type.

USE:

Solution for injections. Armadin appoint in oil or in/in (struyno, by drop infusion). Doses select individually. At an infusional method of administration medicine should be dissolved in physiological solution of sodium of chloride (200 ml). To begin treatment of adults with a dose of 50-100 mg 1–3 times a day, gradually raising it to obtaining therapeutic effect. Struyno Armadin enter slowly within 5–7 min., by drop infusion — with a speed of 40-60 thaws a minute. The maximum daily dose should not exceed 800 mg.

Armadin to appoint

In acute disorders of cerebral circulation in complex therapy in the first 2–4 days in in by drop infusion adult on 200–300 mg of 1 times a day, then 3 times, in oil on 100 mg, a day. Duration of treatment is 10–14 days

In a craniocereberal injury and consequences of craniocereberal injuries Armadin to apply within 10–15 days in the way in to drop introductions on 200–500 mg 2–4 times a day.

Armadin should appoint

In distsirkulyatorny encephalopathy in a decompensation phase in/in by drop infusion in a dose of 100 mg 2–3 times a day within 14 days. Then to administer the medicament in oil on 100 mg/days during 2 weeks

For course prevention of distsirkulyatorny encephalopathy the medicament by the adult to administer 2 times, in oil on 100 mg, a day within 10–14 days.

and at disturbing states medicine to appoint

At easy cognitive violations at patients of advanced age in oil in a dose of 100-300 mg/days within 14–30 days.

Armadin to enter

In a sharp myocardial infarction as a part of complex therapy in/in or in oil within 14 days, against the background of the traditional therapy of a myocardial infarction including nitrates, blockers of β-adrenoceptors, APF inhibitors, trombolitik, anticoagulating and antiagregantny means and also symptomatic means according to indications. In the first 5 days for achievement of the maximum effect introduction of Armadin perhaps in oil is desirable in/in Armadin's introduction, in the subsequent 9 days. In to Armadin's introduction to carry out by drop infusion, slowly (in order to avoid development of side effects), to 0.9% solution of sodium chloride or 5% solution of a dextrose (glucose) of 100–150 ml within 30–90 min. In case of need

Armadin's Introduction (in/in or in oil) to carry out perhaps slow jet introduction of Armadin within not less than 5 min.

3 times a day in each 8 h. The daily therapeutic dose makes 6–9 m/kg of body weight, a single dose — 2–3 mg/kg of body weight. The maximum daily dose should not exceed 800 mg, single — 250 mg.

Armadin to enter

In an open angle glaucoma of various stages as a part of complex therapy 1–3 times, in oil on 100–300 mg/days, a day within 14 days.

In an abstinence alcoholic syndrome Armadin to enter in a dose 100–200 mg in oil 2–3 times a day or in/in by drop infusion 1–2 once a day within 5–7 days.

antipsychotic means medicine to enter

In sharp intoxication in/in in a dose of 50-300 mg/days within 7–14 days.

medicine to appoint

At sharp pyoinflammatory processes in an abdominal cavity (sharp necrotic pancreatitis, peritonitis) in the first day both in preoperative, and during the postoperative period. Doses depend on a form and disease severity, prevalence of process, a clinical current. Drug withdrawal should be carried out gradually, only after steady positive clinical laboratory effect. In sharp edematous (interstitial) pancreatitis Armadin to appoint the adult 100 mg 3 times a day in/in by drop infusion (in isotonic solution of sodium of chloride) and in oil. Light severity of necrotic pancreatitis: on 100–200 mg 3 times a day in/in by drop infusion (in isotonic solution of sodium of chloride) and in oil. Moderate severity: the adult — on 200 mg 3 times a day in/in by drop infusion (in isotonic solution of sodium of chloride). Heavy course: in pulse dosage of 800 mg in the 1st day at double introduction, further — on 300 mg 2 times a day with gradual decrease in a daily dose. Very heavy course: in an initial dose of 800 mg/days before steady knocking over of manifestations of pankreatogenny shock, after stabilization of a state — on 300–400 mg 2 times a day in/in by drop infusion (in isotonic solution of sodium of chloride) with gradual decrease in a daily dose.

Tablet. Appoint inside. Therapeutic doses and a course of treatment define depending on sensitivity of the patient to drug. Begin treatment with a dose of 250-500 mg, the average daily dose makes 250–500 mg, maximum — 800 mg. The daily dose is divided into 2–3 receptions within a day.

Sick with disturbing states, neurocirculatory dysfunction and cognitive violations is accepted Armadin during 2–6 weeks

For knocking over of an alcoholic abstinence syndrome use medicament within 5–7 days.

therapy course Duration at ischemic heart disease patients — not less than 1.5-2 months. Carrying out two 2-month courses of therapy within a year, during the spring and autumn period is recommended.

After purpose of parenteral administration of Armadin at an ischemic heart disease for maintenance of the reached effect the use of medicine inside in the form of tablets on 125 mg 3 times a day is recommended to continue

.

by

At Armadin's application for the purpose of correction of a dislipoproteinemiya, in complex therapy of the ischemic heart disease complicated by AG of a krizovy current, chronic heart failure, ventricular arrhythmias, medicine 3–4 times a day appoint without restriction of a course of treatment on duration in a dose 125 mg.

Course therapy with the medicine Armadin is finished gradually, reducing a dose during 2–3 days

CONTRAINDICATION:

Increased individual sensitivity to drug, a liver or renal failure.

SIDE EFFECTS:

from a cardiovascular system: increase or decrease in the ABP.

from nervous system: drowsiness, backfilling process violation, feeling of alarm, emotional reactivity, headache, lack of coordination.

from digestive organs: nausea, dryness of a mucous membrane of an oral cavity.

from the immune system: at individual hypersensitivity to medicament the emergence of allergic reactions, including skin rashes, a small tortoiseshell, the naggers, a Quincke's disease is possible.

Others: distal hyperhidrosis.

At in in introduction, especially jet, emergence of metal smack in a mouth, feeling of heat in all body, an unpleasant smell, irritation in a throat and discomfort in a thorax, asthmas, heartbeat, tachycardia, a tremor, hyperaemia of the person is possible

. As a rule, the specified phenomena are connected with the excess rate of administering of medicine and have short-term character.

Against the background of long use of medicine the emergence of such side effects is possible

: meteorism, weakness, peripheral hypostases.

SPECIAL INSTRUCTIONS:

Special attention is required by prescribing of medicine the patient with the burdened allergological anamnesis. In some cases at patients with OH at hypersensitivity to sulfates the development of heavy reactions of hypersensitivity is possible. After completion of parenteral administration for maintenance of the reached effect recommend to continue use of medicine inside in the form of tablets.

Use during pregnancy and feeding by a breast. Strictly controlled clinical trials of safety of use of medicine during pregnancy and feeding by a breast were not carried out therefore Armadin it is not necessary to apply during this period.

Children. Strictly controlled clinical trials of safety of use of medicine for children were not conducted therefore Armadin it is not necessary to apply at this category of patients.

Ability to influence speed of response at control of vehicles or other mechanisms. during treatment needs to be careful at control of vehicles or work with mechanisms, considering a likelihood of development of side effects which can influence the speed of response and ability to concentration of attention.

INTERACTION:

Armadin strengthens effect of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), protivoparkinsonichesky means (levodopa). Reduces expressiveness of toxic effect of alcohol.

Increases anti-anginal activity of nitromedicines and atigipertenzivny activity of APF inhibitors and blockers of β-adrenoceptors. The combined application with nibentany, propranolol and verapamil reduces risk of development of aritmogenny effects of the last, simultaneous application with neuroleptics reduces risk of development and severity of side effects of the last.

OVERDOSE:

At overdose the drowsiness, insomnia are possible

, at in in introduction in rare instances perhaps short-term and slight increase of the ABP.

Development of symptoms of overdose, as a rule, does not demand application of the stopping means. The specified symptoms of a sleep disorder disappear independently within a day. In especially hard cases the application of one of the tableted sleeping and anxiolytic medicines (nitrazepam of 10 mg, oxazepam of 10 mg, diazepam of 5 mg) is recommended. At excessive increase in the ABP apply antihypertensive medicaments under control of the ABP and/or supplement therapy with the nitrocontaining medicines. Treatment — disintoxication therapy.

STORAGE CONDITIONS:

In original packing at a temperature not above 30 °C.