Bemitil [Metaprot] instruction

Bemitil® [Metaprot®]

International Non-Proprietary Name (INN): none
Dosage Form: capsules (250 mg)
Structure: 1 capsule contains:
Active ingredient: ethylthiobenzimidazole hydrobromide 250 mg;
Excipients: giprolase, silicon dioxide, lactose monohydrate, magnesium stearate.
Capsule shell composition: gelatin, yellow iron oxide, red iron oxide, titanium dioxide.
Description:
Hard-shelled gelatin capsules of white color.
Pharmacological classification: adaptogens
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 the 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 increases energy production and maintain high degree of conjugation of oxidation with phosphorylation.

 Antihypoxic and anti-ischemic activity of Bemitil maintains 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 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 (Pyracetam, 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 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.

Country of manufacture: Belarus