Bemitil® (Metaprot) Instruction

International Non-Proprietary Name (INN): bemethyl
Dosage form: capsules (250 mg)
Structure
1 capsule contains:
Active ingredient: ethylthiobenzimidazole hydrobromide 250 mg;
Excipients: hydroxypropyl cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate;
Capsule shell composition: gelatin, glycerin, purified water, titanium dioxide (E171), sodium lauryl sulphate.
Description
Hard-shelled gelatin capsules of white color.
Pharmacological classification: adaptogen
ATC code: A1ЗА
Pharmacological action: antihypoxic, adaptogenic, anti-asthenic, antioxidant, nootropic


Pharmacodynamics

Bemitil® or Metaprot is an adaptogenic drug with nootropic, regenerative, antihypoxic, antioxidant, and immunomodulatory effects. It activates the synthesis of RNA and then proteins, including enzymes and ones related to the immune system. It results in activation of the synthesis of gluconeogenesis enzymes; it ensures lactate utilization (the limiting performance factor) as well as the resynthesis of carbohydrates (a source of energy leading to an increase in physical performance). Enhanced synthesis of mitochondrial enzymes and structural proteins of the mitochondria increase energy production and maintain a high degree of conjugation of oxidation with phosphorylation.

Antihypoxic and anti-ischemic activity of Bemitil® maintains a high level of ATP synthesis under the conditions of oxygen deficiency. The drug enhances the synthesis of antioxidant enzymes and has therefore a pronounced antioxidant activity.

Bemitil increases the body’s resistance to extreme factors like physical activity, stress, hypoxia, hyperthermia.
The drug increases working capacity during physical activity. It has a pronounced anti-asthenic effect and accelerates recovery processes after extreme effects. It does not cause psychomotor agitation.

Pharmacokinetics

After oral administration, Bemitil® is well absorbed from the intestinal tract and metabolized in the liver. It can be found in the blood in 30 minutes, the maximum concentration is achieved after 1.5 hours and the pronounced effect lasts for 4–6 hours. The therapeutic effect of the drug usually develops within 3–5 days and then persistently maintained at the achieved level. Long constant course application of Bemitil® up to 10–12 days can course the cumulation effect, especially with big dosages (500–700 mg per day).

Intended uses

  • increase and recovery of working capacity, especially under extreme conditions (hypoxia, severe physical exercises, overheating);
  • better adaptation to a variety of extreme factors;
  • asthenic disorders of diverse nature (with somatic diseases, neurasthenia, after infections/severe intoxication and in the pre- and post-operative periods);
  • (as a part of multicomponent therapy) craniocerebral trauma, encephalitis, meningitis, cerebrovascular disorders, cognitive disorders.


Contraindications

  • pronounced liver dysfunction;
  • individual intolerance to the components of the drug;
  • hypoglycemia;
  • epilepsy;
  • glaucoma;
  • arterial hypertension;
  • ischemic heart disease;
  • psychomotor agitation;
  • lactose intolerance;
  • lactase deficiency;
  • glucose-galactose malabsorption;
  • arrhythmias;
  • age below 18 years;
  • pregnancy and lactation.


Dosage and administration

Bemitil® should be taken orally after meals.

The standard dosage is 250 mg twice a day. If necessary, the dosage can be increased up to 750 mg (500 mg in the morning and 250 mg in the daytime) for adults with body mass below 80 kg, and up to 1000 mg (500 mg twice a day) for adults with body mass above 80 kg. Duration of the treatment course should not exceed 5 days to prevent cumulation of the drug; the interval between treatment courses is 2 days. The number of courses depends on the therapeutic effect and is usually 2-3 courses.

To increase working performance in extreme conditions 500–750 mg of the drug should be taken one hour before the expected load. If these conditions are maintained, the second dose of 250 mg can be taken in 6-7 hours.
The maximum daily dosage should not exceed 1500 mg and 1000 mg the day after.

In order to maintain a high level of performance for a long time and to improve the adaptation processes, Bemitil® can be prescribed 250 mg twice a day. The maximum duration of such a therapy is two 5-day courses with a 2-day break in-between.

If the patient has severe hepatic disorders (cirrhosis, acute hepatitis of the viral etiology, toxic changes in the liver, etc.), the drug should be taken with caution and in lower doses.

Side effects

The frequency of side effects: very often (above 10%), often (1–10%), infrequent (0.1–1%), rare (0.01–0.1%), very rare (<0.01%, including isolated cases with undefined frequency).

Central nervous system
Very often: Headaches, facial hyperemia, sleep disturbances, anxiety.
Very rare: Paresthesia, convulsions.

Cardiovascular system
Very rare: Hypertension, tachycardia.

Digestive system
Rare: Nausea, vomiting, liver and stomach discomfort.

Allergic reactions
Often: Hives, allergic conjunctivitis, allergic rhinitis.

If the side effects occur, including those that are not listed above, the administration of Bemitil should be discontinued. Consult your doctor.

Overdose

Overdose can lead to increased excitability and sleep disturbance. Treatment: gastric lavage, absorbent carbon administration, if necessary – symptomatic therapy. You should reduce the dosage or discontinue taking the drug.

Interaction with other drugs

Bemitil® enhances the effects of metabolic drugs: nootropics (Piracetam, etc.), antioxidants (Alpha-tocopherol, etc.), antihypoxic drugs (Trimetazidine), non-steroid anabolic drugs (Riboxin), Asparcam, glutamic acid, magnesium and potassium asparaginate, vitamins and antianginal drugs (nitrates, beta-adrenergic blocking agents). Simultaneous administration with drugs that reduce the activity of liver microsomal enzymes (for example Cimetidine) can increase the concentration of Bemitil® in the blood.

Consult your doctor before using the drug with other medications.

Special instructions

Do not take the drug in the evening time as it may cause sleep disturbances.

During the therapy, it is recommended to monitor arterial pressure on a regular basis.

Bemitil® is not recommended for people with suicidal behavior and for those who experienced suicidal thoughts before treatment. In case of behavior alteration or appearance of suicidal thoughts, patients should inform their doctor immediately.

During the treatment, it is recommended to keep to a diet rich in carbohydrates.

Pregnancy and lactation

The use of Bemitil® is contraindicated during pregnancy and lactation.

Influence on the ability to drive vehicles and operate mechanisms

If during the course of Bemitil® treatment there occur adverse side effects from the nervous system, it is recommended to avoid carrying out potentially dangerous activities that require an increased concentration of attention and quick psychomotor reactions, as well as driving vehicles.

Terms of release from pharmacy

On prescription.

Storage conditions

Store in a dry dark place at temperatures no higher than 25°C. Keep out of reach of children.

Shelf life

2 years. Do not use beyond the expiration date printed on the package.

Manufacturer

Belmedpreparaty RUE, Belarus. https://belmedpreparaty.com/

Instructions