REGISTRATION NUMBER
ЛП-№(000086)-(РГ-RU) [LP-№(000086)-(РГ-RU)]
TRADE NAME
Mexidol®
INTERNATIONAL NON-PROPRIETARY NAME (INN)
Mexidol (Emoxypine)
DOSAGE FORM
Film-coated tablets
COMPOSITION PER TABLET
Active ingredient: Ethylmethylhydroxypyridine succinate – 125 mg
Excipients: Lactose monohydrate, povidone K-30, magnesium stearate.
Film coating: Hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin.
DESCRIPTION
Round, biconvex film-coated tablets, white to off-white in color; characteristic odor may be present.
PHARMACOLOGICAL GROUP
Antioxidant
ATC CODE
[N07XX]
PHARMACOLOGICAL PROPERTIES
Mechanism of action:
The mechanism of action is determined by its antioxidant, antihypoxic, and membrane-protective effects. It inhibits lipid peroxidation, increases superoxide dismutase activity, improves lipid-protein ratio, reduces membrane viscosity, and increases membrane fluidity. Mexidol® modulates membrane-bound enzyme activity (calcium-independent phosphodiesterase, adenylate cyclase, acetylcholinesterase) and receptor complexes (benzodiazepine, GABA, acetylcholine), enhancing their ligand-binding capacity.
Pharmacodynamic effects:
Mexidol® is a free radical process inhibitor and membrane protector with antihypoxic, stress-protective, nootropic, anticonvulsant, and anxiolytic effects. The drug increases organism resistance to various damaging factors (shock, hypoxia and ischemia, cerebral circulation disorders, alcohol and antipsychotic drug intoxication).
PHARMACOKINETICS
Absorption and distribution:
Rapidly absorbed after oral administration. Cmax at doses of 400-500 mg is 3.5-4.0 μg/ml. Mean retention time after oral administration is 4.9-5.2 hours.
Metabolism:
Metabolized in the liver through glucuronide conjugation. Five metabolites identified.
Elimination:
T½ after oral administration is 2-2.6 hours. Rapidly excreted in urine, mainly as metabolites with minor amounts unchanged. Most intensive excretion occurs within first 4 hours after administration.
INDICATIONS
- Post-stroke conditions, including after TIA
- Mild traumatic brain injury and its consequences
- Various encephalopathies (circulatory, metabolic, post-traumatic, mixed)
- Autonomic dysfunction syndrome
- Mild cognitive disorders of atherosclerotic origin
- Anxiety disorders in neurotic conditions
- Coronary heart disease (as part of complex therapy)
- Alcohol withdrawal syndrome
- Antipsychotic drug intoxication
- Asthenic conditions
- Stress factors exposure
- ADHD in children (hyperactivity, attention deficit, impulsivity)
DOSAGE AND ADMINISTRATION
Oral use with water.
Adults:
Recommended dose: 125-250 mg (1-2 tablets) 3 times daily
Maximum daily dose: 750 mg (6 tablets)
Treatment duration: 2-8 weeks; for alcohol withdrawal – 5-7 days
Children:
ADHD (6 years and older): 125 mg (1 tablet) twice daily for 6 weeks
CONTRAINDICATIONS
- Hypersensitivity to components
- Acute liver dysfunction
- Acute kidney dysfunction
- Children under 6 years
- Pregnancy
- Breastfeeding
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption
SIDE EFFECTS
Frequency classification: Very rare (<0.01%)
Immune system: Angioedema, urticaria
Psychiatric: Drowsiness
Nervous system: Headache
Gastrointestinal: Dry mouth, nausea, epigastric pain/burning/discomfort, heartburn, flatulence, diarrhea
Skin and subcutaneous tissue: Rash, pruritus, hyperemia
OVERDOSE
Symptoms: Drowsiness, insomnia
Treatment: Generally not required due to low toxicity. Symptoms resolve spontaneously within 24 hours.
DRUG INTERACTIONS
Compatible with medications used for somatic diseases
Enhances effects of benzodiazepines, antidepressants, anxiolytics, anticonvulsants, and antiparkinsonian drugs
Reduces ethanol toxic effects
STORAGE CONDITIONS
Store at temperature not exceeding 25°C in a light-protected place
Keep out of reach of children
SHELF LIFE
3 years
Do not use after expiration date
DISPENSING CONDITIONS
Prescription only
MANUFACTURER
PHARMASOFT, Russia. https://pharmasoft.ru/