Cerebrestan (Solution) Instructions for Use

Marketing Authorization Holder

MFC “Arfa”, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Dosage Form

Cerebrestan

Solution for injection: amp. 1 ml, 2 ml, 5 ml, or 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, yellowish-brown color.

Excipients: sodium hydroxide – 2.1 mg, water for injection – 792.7 mg.

1 ml – dark glass ampoules (5) – contour cell packs (2) – cardboard boxes.
2 ml – dark glass ampoules (5) – contour cell packs (2) – cardboard boxes.
5 ml – dark glass ampoules (5) – contour cell packs (2) – cardboard boxes.
10 ml – dark glass ampoules (5) – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Nootropic agent. Contains low molecular weight biologically active neuropeptides that penetrate the BBB and directly reach nerve cells.

It has an organ-specific multimodal effect on the brain, i.e., it provides metabolic regulation, neuroprotection, functional neuromodulation, and neurotrophic activity.

It increases the efficiency of aerobic energy metabolism of the brain, improves intracellular protein synthesis in the developing and aging brain.

It protects neurons from the damaging effects of lactacidosis, prevents the formation of free radicals, increases survival and prevents neuronal death under conditions of hypoxia and ischemia, and reduces the damaging neurotoxic effect of excitatory amino acids (glutamate).

Neurotrophic activity is similar to the action of natural neuronal growth factors, and it manifests itself under conditions of peripheral administration. It has a positive effect on cognitive function impairments and memory processes.

Indications

Alzheimer’s disease; cognitive impairment syndrome of various origins, including dementia; chronic cerebrovascular insufficiency (chronic cerebral ischemia, dyscirculatory encephalopathy); ischemic stroke; traumatic brain injury; mental retardation in children; hyperactivity and attention deficit in children; in complex therapy – for endogenous depression resistant to antidepressants.

ICD codes

Dosage Regimen

Administer parenterally via intramuscular or intravenous routes. Adjust the dose and treatment duration based on the disease severity and patient age.

For intramuscular injection, administer up to 5 ml once daily. For intravenous administration, inject a single dose of up to 10 ml slowly; dilute larger volumes in 0.9% sodium chloride solution or 5% dextrose solution to a maximum of 250 ml and infuse at a rate of 60 drops per minute.

Initiate a treatment course of daily injections for 10 to 20 days. A single dose can be increased to 50 ml for specific conditions, but a course regimen is preferred.

For chronic cerebrovascular insufficiency, administer 5-10 ml daily for 10-20 days. Repeat courses 2-3 times per year if necessary.

For ischemic stroke in the acute phase, administer 10-50 ml daily for 10-20 days. Transition to maintenance therapy.

For traumatic brain injury and its consequences, use 10-50 ml daily.

For Alzheimer’s disease and dementia, administer 5-10 ml daily for 20 days.

For children with mental retardation or attention deficit hyperactivity disorder, administer 0.1-0.2 ml per kg of body weight daily. The maximum single dose must not exceed 5 ml.

In complex therapy for treatment-resistant depression, administer 5-10 ml daily for 10-20 days.

Avoid rapid intravenous injection to prevent tachycardia or arrhythmia.

Adverse Reactions

From the immune system very rarely – increased individual sensitivity, allergic reactions, skin reactions, pain in the neck, head and limbs, fever, mild back pain, shortness of breath, chills, collapse-like state.

From metabolism rarely – loss of appetite.

Psychiatric disorders rarely – the presumed activation effect is accompanied by agitation, manifested by aggressive behavior, confusion, insomnia.

From the nervous system rarely – dizziness; very rarely – generalized epilepsy and one case of seizure development was associated with this agent.

From the cardiovascular system very rarely – tachycardia and arrhythmia with rapid administration.

From the digestive system very rarely – dyspepsia, diarrhea, constipation, nausea, vomiting.

From the skin and subcutaneous tissues rarely – feeling of heat, sweating, itching.

Local reactions very rarely – feeling of heat, sweating, itching.

Contraindications

Hypersensitivity to this agent;
Severe renal failure; epileptic status.

With caution

Allergic diathesis, diseases of an epileptic nature, including generalized epilepsy, due to a possible increase in the frequency of seizures.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after a thorough analysis of the ratio of the positive effect of treatment and the risk associated with its conduct.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age according to indications and in appropriate doses.

Geriatric Use

The drug is approved for use in elderly patients

Drug Interactions

Given the pharmacological profile of this agent, additive effects may develop when used concomitantly with antidepressants or MAO inhibitors. In such cases, it is recommended to reduce the dose of the antidepressant.

The use of this agent in high doses in combination with high doses of MAO inhibitors may cause an increase in blood pressure.

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.