Instructions for Armadin Long prolonged-release tablets 500 mg No. 30
Composition
active ingredient: mexidol (synonym);
the tablet contains armadine (2-ethyl-6-methyl-3-hydroxypyridine succinate) 300 mg or 500 mg;
Excipients: hydroxypropylcellulose, hypromellose (hydroxypropylmethylcellulose), colloidal anhydrous silicon dioxide, succinic acid, magnesium stearate, talc, titanium dioxide (E 171).
Dosage form
Extended-release tablets.
Main physicochemical properties: white or white with a creamy tint tablets with a biconvex smooth surface, film-coated, possibly with a specific odor.
Pharmacotherapeutic group
Drugs affecting the nervous system. ATX code N07X X.
Pharmacological properties
Pharmacodynamics.
Ethylmethylhydroxypyridine succinate belongs to heteroaromatic antioxidants. It has a wide range of pharmacological effects: increases the body's resistance to stress, has anxiolytic effects that are not accompanied by drowsiness and muscle relaxant effects; has nootropic properties, prevents and reduces memory impairments that occur due to aging and under the influence of various pathogenic factors, has an anticonvulsant effect; exhibits antioxidant and antihypoxic properties; increases concentration and performance; weakens the toxic effect of alcohol. The drug improves the metabolism of brain tissues and their blood supply, improves microcirculation and rheological properties of blood, reduces platelet aggregation. Stabilizes the membrane structures of blood cells (erythrocytes and platelets); reduces the content of total cholesterol and low-density lipoproteins.
The mechanism of action is due to its antioxidant and membrane protective activity. It inhibits lipid peroxidation, increases the activity of superoxide oxidase, increases the lipid/protein ratio, reduces membrane viscosity. Modulates the activity of membrane-bound enzymes (calcium-independent phosphodiesterase, adenylate cyclase, acetylcholinesterase), receptor complexes (benzodiazepine, γ-aminobutyric acid (GABA), acetylcholine), which enhances their ability to bind to ligands, contributes to the preservation of the structural and functional organization of biomembranes, the transport of neurotransmitters and the improvement of synaptic transmission.
Ethylmethylhydroxypyridine succinate increases the content of dopamine in the brain. In conditions of tissue ischemia, it enhances the compensatory activation of aerobic glycolysis and reduces the degree of inhibition of oxidative processes in the Krebs cycle.
Pharmacokinetics.
ARMADYN® LONG is a prolonged-release dosage form that provides a uniform release of the active substance for 10–12 hours and reduces the likelihood of side effects due to a sharp increase in its content in the blood plasma. The effect of the drug begins to manifest itself 3–4 hours after administration, when the concentration of the active substance in the blood plasma reaches a therapeutic level, a stable improvement in the condition is noted after 2–3 days when a steady-state level of pharmacokinetic parameters is established. After discontinuation of the drug, its effect persists for another 3–5 days.
Absorption of the drug begins in the stomach and occurs in the small and large intestines. The rate of release and absorption of the active substance from ARMADYN® LONG tablets is practically independent of the section of the gastrointestinal tract, pH and composition of the chyme.
Ethylmethylhydroxypyridine succinate in humans is metabolized mainly in the liver by intensive conjugation with glucuronic acid and is excreted in the urine both unchanged and as glucuronide conjugates. Renal excretion rates of the unchanged drug and its conjugated metabolites are characterized by significant individual variability.
Indication
Consequences of acute cerebrovascular accident;
neurotic and neurosis-like conditions with anxiety symptoms;
neurocirculatory dystonia;
mild cognitive disorders of various genesis (in psychoorganic syndrome and asthenic disorders caused by acute and chronic cerebral circulation disorders, craniocerebral injuries, neuroinfections and intoxication, senile and atrophic processes);
encephalopathies of various genesis (dyscirculatory, dysmetabolic, post-traumatic, mixed);
mild traumatic brain injury, consequences of traumatic brain injuries;
memory impairment and intellectual disability in the elderly;
asthenic conditions, exposure to extreme (stress) factors;
ischemic heart disease (as part of complex therapy);
alcohol withdrawal syndrome with a predominance of neurosis-like and neurocirculatory disorders;
conditions after intoxication with antipsychotic drugs.
Contraindication
Acute hepatic or renal failure, increased individual sensitivity to the components of the drug, children's age, pregnancy, breastfeeding.
Interaction with other medicinal products and other types of interactions
ARMADYN® LONG enhances the effect of benzodiazepine anxiolytics, antiparkinsonian drugs and carbamazepine, potentiates the effect of anticonvulsants, tranquilizers and analgesics. ARMADYN® LONG reduces the toxic effect of ethyl alcohol. Increases the hypotensive activity of angiotensin-converting enzyme (ACE) inhibitors, β-blockers. Increases the antianginal activity of nitro drugs. Under the influence of the drug, the effect of sedatives, neuroleptics, antidepressants, hypnotics and anticonvulsants is enhanced, which makes it possible to reduce their doses and reduce side effects.
Application features
In rare cases, severe hypersensitivity reactions may develop, especially in patients with bronchial asthma and hypersensitivity to sulfites.
It should be used with caution in patients with diabetic retinopathy (the course should not exceed 7–10 days) due to its ability to potentiate proliferative processes.
Use during pregnancy or breastfeeding
Strictly controlled clinical studies of the safety of the drug during pregnancy and breastfeeding have not been conducted, therefore ARMADYN® LONG is contraindicated for use during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
During the treatment period, caution should be exercised when driving or operating complex machinery, given the likelihood of side effects that may affect reaction speed and ability to concentrate.
Method of administration and doses
It is prescribed to adults orally, regardless of meals. To ensure gradual and uniform release of the active substance from the tablet, it should be swallowed whole, washed down with a glass of water.
Due to the production technology of the extended-release form, a soft, jelly-like base is excreted along with the feces, which resembles a tablet in shape, but does not contain the active ingredient.
Doses and duration of treatment are determined taking into account the patient's sensitivity to the drug and medical indications.
In the first 2–3 days, ARMADIN® LONG is prescribed 1 tablet of 300 mg or 500 mg, then the daily dose is increased to 600 mg. The drug is taken 1 tablet every 12 hours.
For ischemic heart disease, ARMADYN® LONG is used for 2–3 months.
Patients with anxiety, neurocirculatory dysfunctions, and cognitive disorders take ARMADYN® LONG for 2–6 weeks.
To relieve alcohol withdrawal syndrome, the drug is used for 5–7 days.
Course therapy with ARMADYN® LONG is completed gradually, reducing the dose over 2–3 days.
Children.
Strictly controlled clinical studies of the safety of the drug in children have not been conducted, therefore ARMADYN® LONG is contraindicated for use in this category of patients.
Overdose
Overdose may cause drowsiness and sedation.
Treatment – detoxification therapy, symptomatic therapy.
Adverse reactions
From the cardiovascular system: increased blood pressure, decreased blood pressure.
From the nervous system: drowsiness, difficulty falling asleep, anxiety, emotional reactivity, headache, impaired coordination.
Gastrointestinal: nausea, dry mouth.
On the part of the immune system: allergic reactions, including hyperemia, skin rash, itching.
Other: distal hyperhidrosis.
Expiration date
3 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging.
Keep out of reach of children.
Packaging
40 tablets in a polymer jar in a cardboard pack.
20 tablets (10×2) or 30 tablets (10×3) or 40 tablets (10×4) in blisters in a cardboard pack.
Vacation category
According to the recipe.
Manufacturers
LLC NVF "MICROCHEM"
AT "Lubnypharm"
Location of manufacturers and address of their place of business.
Ukraine, 01013, Kyiv, Budindustrii St., 5.
Ukraine, 37500, Poltava region, Lubny, Barvinkova st., 16
You can report an adverse event when using a medicinal product by calling +38 (050) 309-83-54 (24 hours a day).
