Ceregamon^® (Tablets) Instructions for Use

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Nicotinoyl gamma-aminobutyric acid (Grouping name)

Dosage Form

Ceregamon®

Tablets 50 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical in shape, with a bevel and a score line.

Excipients: ludipress [consisting of lactose monohydrate from 91% to 95%, povidone (kollidon 30) from 3% to 4%, crospovidone (kollidon-CL) from 3% to 4%] – 0.195 g, calcium stearate monohydrate – 0.0025 g, talc – 0.0025 g.

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

It is a nootropic agent that dilates the blood vessels of the brain. It also has tranquilizing, psychostimulant, antiplatelet, and antioxidant effects.

It improves the functional state of the brain by normalizing tissue metabolism and affecting cerebral circulation (increases volumetric and linear velocity of cerebral blood flow, reduces resistance of cerebral vessels, suppresses platelet aggregation, improves microcirculation).

With course administration, it increases physical and mental performance, reduces headache, improves memory, normalizes sleep; contributes to the reduction or disappearance of feelings of anxiety, tension, fear; improves the condition of patients with motor and speech disorders.

Pharmacokinetics

Absorption is rapid and complete, regardless of the route of administration. Penetrates the blood-brain barrier, is retained in body tissues for a long time. Bioavailability is 50-88%. It is excreted mainly by the kidneys unchanged. T_1/2 is 0.51 hours.

Indications

Cerebrovascular insufficiency, asthenia, depressive disorders in the elderly.

Conditions accompanied by anxiety, fear, increased irritability, emotional lability. Asthenic conditions caused by various neuropsychiatric diseases.

As part of complex therapy – for the relief of acute alcohol intoxication; in chronic alcoholism – to reduce asthenic, astheno-neurotic, postpsychotic, pre-relapse conditions, as well as alcoholic encephalopathy.

As part of complex therapy – migraine (prevention), traumatic brain injury (TBI), neuroinfection.

Improving tolerance to physical and mental stress (for persons in stressful and extreme conditions of activity; to restore physical performance of athletes, to increase resistance to physical and mental stress).

Open-angle glaucoma (to stabilize visual function).

In urological practice (in children over 3 years of age and in adults with urination disorders) to improve the adaptive function of the bladder (reduction of detrusor hypoxia).

ICD codes

Dosage Regimen

It is taken orally, regardless of meals.

For cerebrovascular diseases: a single dose is 20-50 mg 2-3 times/day, the daily dose is 60-150 mg. The course of treatment is 1-2 months. A repeated course is after 5-6 months.

Depressive states in old age: 40-200 mg/day in 2-3 doses, the optimal dose range is 60-120 mg/day for 1.5-3 months. As an antiasthenic and anxiolytic agent – 40-80 mg/day, if necessary – up to 200-300 mg/day, for 1-1.5 months.

For alcoholism during withdrawal, it is prescribed at a dose of 100-150 mg/day, in a short course of 6-7 days; for more persistent disorders outside of withdrawal – 40-60 mg/day for 4-5 weeks.

To restore working capacity and under increased loads – 60-80 mg/day for 1-1.5 months, for athletes in the same dose, for 2 weeks of the training period.

For parenteral administration, it is administered intravenously (drip or stream, slowly), intramuscularly.

For chronic cerebrovascular disorders – intravenously or intramuscularly, 100-200 mg, 1-2 times/day, daily dose is 200-400 mg. Depending on the patient’s condition, it is used in the morning intravenously (drip), in the evening – intramuscularly; or for 10 days intravenously, then intramuscularly. The course of treatment is 15-30 days.

For the relief of acute uncomplicated ethanol intoxication as part of complex therapy, it is administered in a loading dose of 5 mg/kg and a maintenance dose of 1.56 mg/kg/h in a volume of 2.5 liters of infusion solution, for 4 hours, in the morning and evening.

For asthenic conditions, depending on the severity of the disease, in addition to oral administration, it is administered intramuscularly at a daily dose of 200-400 mg for 1 month.

Adverse Reactions

From the central nervous system: irritability, agitation, anxiety, dizziness, headache.

Allergic reactions: skin rash, itching.

Other: nausea.

Contraindications

Chronic renal failure, pregnancy, lactation period, hypersensitivity to nicotinoyl gamma-aminobutyric acid.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and during the lactation (breastfeeding) period.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Drug Interactions

Reduces the duration of action of barbiturates.

Enhances the effect of narcotic analgesics.

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.