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Pikogam (Tablets) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda, CJSC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Nicotinoyl gamma-aminobutyric acid (Grouping name)

Dosage Form

Bottle Rx Icon Pikogam Tablets 50 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
N-nicotinoyl-gamma-aminobutyric acid sodium salt 50 mg

60 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

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 cerebral vascular resistance, 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 mainly excreted by the kidneys unchanged. T1/2 is 0.51 hours.

Indications

Cerebrovascular insufficiency, asthenia, depressive disorders in old age.

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, neuroinfection.

Improving tolerance to physical and mental stress (for persons in stressful and extreme conditions of activity; to restore the 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

ICD-10 code Indication
F07 Personality and behavioral disorders due to disease, damage or dysfunction of the brain
F07.1 Postencephalitic syndrome
F10.2 Chronic alcoholism
F31 Bipolar affective disorder
F32 Depressive episode
F33 Recurrent depressive disorder
F40 Phobic anxiety disorders (including agoraphobia, social phobias)
F40.9 Phobic anxiety disorder, unspecified
F41.0 Panic disorder [episodic paroxysmal anxiety]
F41.2 Mixed anxiety and depressive disorder
F41.9 Anxiety disorder, unspecified
F48.0 Neurasthenia
F48.9 Unspecified neurotic disorder
G02 Meningitis in other infectious and parasitic diseases classified elsewhere
G05.2 Encephalitis, myelitis and encephalomyelitis in other infectious and parasitic diseases classified elsewhere
G31.2 Degeneration of nervous system caused by alcohol (including alcoholic encephalopathy)
G43 Migraine
G45 Transient cerebral ischemic attacks [TIAs] and related syndromes
G93.4 Unspecified encephalopathy
H40.1 Primary open-angle glaucoma
H40.3 Secondary post-traumatic glaucoma
H40.4 Glaucoma secondary to inflammatory eye disease
H40.5 Glaucoma secondary to other eye disorders
I61 Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type)
I63 Cerebral infarction
N31 Neuromuscular dysfunction of the bladder, not elsewhere classified
S06 Intracranial injury
T51 Toxic effect of alcohol
Z73.0 Burn-out
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
1D01.Z Infectious meningitis, not elsewhere classified, unspecified
1H0Z Unspecified infection
6A60.Z Bipolar type I disorder, unspecified
6A61.Z Bipolar type II disorder, unspecified
6A6Z Bipolar or similar disorder, unspecified
6A70.Z Single episode depressive disorder, unspecified
6A71.Z Recurrent depressive disorder, unspecified
6A73 Mixed depressive and anxiety disorder
6A8Z Affective disorders, unspecified
6B01 Panic disorder
6B0Z Anxiety or fear-related disorders, unspecified
6B6Z Dissociative disorders, unspecified
6C40.2Z Alcohol dependence, unspecified
6C40.Z Disorders due to alcohol use, unspecified
6C9Z Disruptive behavior or dissocial disorders, unspecified
6E68 Secondary emotionally labile personality disorder
6E6Z Unspecified secondary mental or behavioral syndromes
8A80.Z Migraine, unspecified
8A8Z Headache disorders, unspecified
8B00.Z Intracerebral hemorrhage of unspecified site, unspecified
8B10.Z Transient ischemic attack, unspecified
8B11 Cerebral ischemic stroke
8D44.Y Other specified alcohol-related neurological disorders
8D44.Z Neurological disorders associated with alcohol, unspecified
8E47 Encephalopathy, not elsewhere classified
8E4A.0 Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord
8E63 Post-cardiopulmonary bypass encephalopathy
9C61.0Z Primary open-angle glaucoma, unspecified
9C61.24 Glaucoma due to ocular inflammation
9C61.29 Traumatic glaucoma
9C61.2Z Secondary open-angle glaucoma, unspecified
GC01.4 Neuromuscular dysfunction of the bladder, not elsewhere classified
NA07.Z Intracranial injury, unspecified
NE61 Toxic effect of poisonous substances, chiefly nonmedicinal, not elsewhere classified
QD85 Burn-out
QE01 Stress, not elsewhere classified

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.

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 of late 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.

To relieve acute uncomplicated ethanol intoxication as part of complex therapy, it is administered in a saturating dose of 5 mg/kg and a maintenance dose of 1.56 mg/kg/hour 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.

Medical Disclaimer

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