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Neurox® (Tablets, Solution) Instructions for Use

ATC Code

N07XX (Other drugs for the treatment of nervous system diseases)

Active Substance

Ethylmethylhydroxypyridine acethylglutaminate (Grouping name)

Clinical-Pharmacological Group

Antioxidant drug

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases

Pharmacological Action

It has antihypoxic, neuroprotective, antiamnesic, antioxidant, and membrane-protective effects, and has the ability to improve cognitive functions and reduce neurological deficit.

The mechanism of action is due to the inhibitory effect on lipid peroxidation and the presence of proven antiradical activity, which contributes to the preservation of the structural and functional organization of biomembranes and normalizes neurotransmitter transport.

Pharmacokinetics

It intensively penetrates into all organs and tissues upon intramuscular and intravenous administration.

The T1/2 after intravenous administration is about 20 minutes, and the mean residence time is also about 20 minutes.

It does not accumulate in the body during a course of use for 14 days.

The elimination kinetics are linear.

It is rapidly eliminated from the bloodstream and is excreted unchanged in small amounts (1.4%).

More than 75% of the substance excreted unchanged is determined in the urine within the first two hours.

Indications

Cognitive impairments in degenerative and vascular diseases, including in the late recovery period of stroke and the consequences of traumatic brain injuries.

ICD codes

ICD-10 code Indication
F07 Personality and behavioral disorders due to disease, damage or dysfunction of the brain
G45 Transient cerebral ischemic attacks [TIAs] and related syndromes
I61 Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type)
I63 Cerebral infarction
I69 Sequelae of cerebrovascular diseases
T90 Sequelae of injuries of head
ICD-11 code Indication
6E68 Secondary emotionally labile personality disorder
6E6Z Unspecified secondary mental or behavioral syndromes
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
NA0Z Head injury, 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.

Administer Neurox® orally. The dosage regimen is individual and must be strictly determined by a physician based on the specific indication, the patient’s age, and the clinical situation.

For cognitive impairments in degenerative and vascular diseases, including the late recovery period of stroke and consequences of traumatic brain injuries, the typical adult dose is 125 mg to 250 mg taken three times daily.

The maximum daily dose should not exceed 750 mg. The duration of treatment is typically 2 to 6 weeks, depending on the severity of the condition and the patient’s response to therapy.

For geriatric patients, initiate therapy at the lower end of the dosing range due to a potential for increased sensitivity and the presence of concomitant chronic diseases. Adjust the dose cautiously based on tolerability and clinical effect.

Take tablets with a sufficient amount of water, with or without food. Adhere to a consistent daily schedule for administration. Do not chew or crush the tablets.

If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose. Do not double the dose to make up for a forgotten one.

Do not discontinue therapy abruptly without consulting your physician. The course of treatment should not be extended without medical supervision.

Adverse Reactions

Nervous system disorders frequent – headache, infrequent – dizziness.

Cardiovascular system disorders: infrequent – increased BP.

Respiratory, thoracic and mediastinal disorders frequent – cough.

Gastrointestinal system disorders frequent – nausea, infrequent – pain in the epigastric region, abdominal distension, diarrhea, loose stools, vomiting.

Skin and subcutaneous tissue disorders: infrequent – psoriasis (exacerbation of the disease).

Allergic reactions hypersensitivity reactions may develop due to individual intolerance to the drug.

Contraindications

Hypersensitivity to the active substance; acute renal failure; hepatic failure; children and adolescents under 18 years of age; pregnancy, lactation (breastfeeding).

With caution history of allergic reactions.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and during breastfeeding.

Use in Hepatic Impairment

The drug is contraindicated for use in hepatic impairment.

Use in Renal Impairment

The drug is contraindicated for use in renal impairment.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Special Precautions

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Drug Interactions

Enhances the effect of benzodiazepine anxiolytics, antiepileptic (carbamazepine), antiparkinsonian (levodopa) drugs, nitrates.

Reduces the toxic effects of ethanol.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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

Pharmfirma Sotex, CJSC (Russia)

Dosage Form

Bottle Rx Icon Neurox® PRO Solution for intravenous and intramuscular injection 50 mg/1 ml: amp. 4 ml 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular injection

Ethylmethylhydroxypyridine acethylglutaminate 50 mg/ml

4 ml – ampoules (10 pcs.) – cardboard packs – By prescription
4 ml – ampoules (20 pcs.) – cardboard packs – By prescription
4 ml – ampoules (50 pcs.) – cardboard packs – By prescription

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Or

Rapharma, JSC (Russia)

Dosage Form

Bottle Rx Icon Neurox®PRO Enteric-coated film-coated tablets 100 mg

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets

1 tab.
Ethylmethylhydroxypyridine acethylglutaminate 100 mg

10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription

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