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Emoxibel (Solution, Drops) Instructions for Use

ATC Code

C05CX (Drugs reducing capillary permeability, other)

Active Substance

Methylethylpiridinol (Grouping name)

Clinical-Pharmacological Group

Antioxidant drug

Pharmacotherapeutic Group

Antioxidant agent

Pharmacological Action

Emoxibel has a favorable effect on the blood coagulation system: it inhibits platelet aggregation, reduces the overall coagulation index, and prolongs blood clotting time.

It stabilizes the membranes of blood vessel cells and erythrocytes, increases the resistance of erythrocytes to mechanical trauma and hemolysis. It has angioprotective properties. It improves microcirculation. It effectively inhibits free-radical lipid peroxidation of biomembranes and increases the activity of antioxidant enzymes.

It stabilizes cytochrome P450 and has an antitoxic effect. In extreme situations accompanied by increased lipid peroxidation and hypoxia, it optimizes bioenergetic processes. It increases the brain’s resistance to hypoxia and ischemia.

In cases of cerebral circulation disorders (ischemic and hemorrhagic), it helps correct autonomic dysfunctions, facilitates the restoration of the brain’s integrative activity, and improves mnestic functions. It has a hypolipidemic effect, reducing the synthesis of triglycerides.

It dilates coronary vessels and reduces ischemic damage to the myocardium. In myocardial infarction, it limits the size of the necrosis focus, accelerates reparative processes, and promotes normalization of myocardial metabolism. It has a favorable effect on the clinical course of myocardial infarction, reducing the incidence of acute heart failure. It promotes the regulation of the redox system in circulatory insufficiency.

Pharmacokinetics

After intravenous administration at a dose of 10 mg/kg, a low T1/2 of 18 minutes was noted, indicating a high rate of elimination of the drug from the blood.

The elimination constant is 0.041 min; total clearance Cl is 214.8 ml/min; apparent volume of distribution Vapp is 5.2 L. The drug quickly penetrates into organs and tissues, where it is deposited and metabolized.

Five metabolites of Emoxibel have been identified, represented by dealkylated and conjugated products of its transformation. The metabolites of Emoxibel are excreted by the kidneys. Significant amounts of 2-ethyl-6-methyl-3-hydroxypyridine phosphate are found in the liver.

In pathological conditions, for example, in the case of coronary occlusion, the pharmacokinetics of Emoxibel change. The elimination rate decreases, thereby increasing the bioavailability of the drug. The time Emoxibel remains in the bloodstream increases, which may be associated with its reverse entry from depots, including from the ischemic myocardium.

Indications

In neurology and neurosurgery

  • Hemorrhagic stroke;
  • Ischemic stroke in the internal carotid artery basin and in the vertebrobasilar system;
  • Transient cerebral circulation disorders;
  • Chronic cerebral circulation insufficiency;
  • Traumatic brain injury accompanied by brain contusions;
  • Postoperative period in patients with traumatic brain injury operated on for epidural, subdural, and intracerebral hematomas combined with brain contusions.

In cardiology

  • Acute myocardial infarction;
  • Prevention of “reperfusion syndrome”;
  • Unstable angina.

ICD codes

ICD-10 code Indication
G45 Transient cerebral ischemic attacks [TIAs] and related syndromes
I20.0 Unstable angina
I21 Acute myocardial infarction
I61 Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type)
I63 Cerebral infarction
I69 Sequelae of cerebrovascular diseases
S06 Intracranial injury
T90 Sequelae of injuries of head
Z98.8 Other specified postprocedural states
ICD-11 code Indication
8B00.Z Intracerebral hemorrhage of unspecified site, unspecified
8B10.Z Transient ischemic attack, unspecified
8B11 Cerebral ischemic stroke
8B25.Z Sequelae of cerebrovascular disease, unspecified
BA40.0 Unstable angina
BA41.Z Acute myocardial infarction, unspecified
NA07.Z Intracranial injury, unspecified
NA0Z Head injury, unspecified
QB6Z Surgical or postprocedural conditions, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

In neurology and neurosurgery Emoxibel is administered intravenously by drip at a daily dose of 5-10 mg/kg for 10-12 days. It is administered at a rate of 20-30 drops per minute. Subsequently, switch to intramuscular administration of 2-10 ml of 30 mg/ml solution (60-300 mg) 2-3 times a day for 10-30 days.

In cardiology start with intravenous drip (20 – 40 drops per minute) administration of 120-180 ml (600-900 mg) 1-3 times a day for 5-15 days depending on the course of the disease, then switch to intramuscular administration of 2 -10 ml of the drug with a concentration of 30 mg/ml (60-300 mg) 2-3 times a day for 10-30 days.

Treatment with Emoxibel should be carried out under the control of blood pressure and the functional state of the blood coagulation and anticoagulation systems.

Drops

The drug is instilled into the conjunctival sac, 1-2 drops 2-3 times a day. The duration of the treatment course depends on the course of the disease (usually 3-30 days) and is determined by the doctor. If indicated and well tolerated, the duration of the treatment course can be up to 6 months. Repeated treatment courses can be conducted 2-3 times a year.

Adverse Reactions

  • With intravenous administration – a burning sensation along the vein;
  • Increased blood pressure, agitation (short-term) or drowsiness;
  • Headache, pain in the heart area;
  • Nausea, discomfort in the epigastric region;
  • Itching and redness of the skin;
  • Allergic reactions.

Contraindications

  • Increased individual sensitivity to Emoxibel;
  • Pregnancy, lactation period;
  • Children under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

At the beginning of treatment with the drug, it is advisable to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

It is necessary to constantly monitor blood pressure and blood coagulability during treatment.

Emoxibel solution for infusion is not recommended to be mixed with other medicinal products.

Overdose

In case of overdose, an increase in the drug’s side effects (occurrence of drowsiness and sedation), a short-term increase in blood pressure is possible.

Treatment is symptomatic, including the prescription of antihypertensive drugs under blood pressure control. There is no specific antidote.

Drug Interactions

α-tocopherol acetate potentiates the antioxidant effect of Emoxibel.

Storage Conditions

In a place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Bottle Rx Icon Emoxibel Solution for intravenous and intramuscular administration 30 mg/1 ml: 5 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration 1 ml
Methylethylpyridinol hydrochloride (emoxypine) 30 mg

5 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Bottle Rx Icon Emoxibel Solution for infusion 5 mg/ml: 100 ml bottle 1 or 56 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

1 ml
Methylethylpyridinol hydrochloride (emoxypine) 5 mg

Excipients : sodium chloride, water for injections.

100 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (56) – cardboard boxes.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Bottle Rx Icon Emoxibel Ophthalmic drops 1%: bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Ophthalmic drops 1% transparent, colorless or with a yellow tint.

1 ml
Methylethylpyridinol hydrochloride (emoxypine) 10 mg

Excipients : sodium sulfate, sodium benzoate, potassium phosphate monobasic, sodium phosphate dibasic dodecahydrate, water for injections.

5 ml – bottles (1) – cardboard packs.

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