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Hopantomide® (Tablets, Solution) Instructions for Use

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Hopantenic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Nootropic agent with neurometabolic, neuroprotective, and neurotrophic properties. It increases the brain’s resistance to hypoxia and exposure to toxic substances, stimulates anabolic processes in neurons, combines a moderate sedative effect with a mild stimulating effect, has anticonvulsant activity, and reduces motor excitability while regulating behavior.

It enhances mental and physical performance. It helps normalize GABA levels in chronic alcohol intoxication and subsequent ethanol withdrawal. It exhibits an analgesic effect.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Tmax is 1 hour. The highest concentrations are found in the liver, kidneys, stomach wall, and skin.

It penetrates the blood-brain barrier. It is not metabolized. It is excreted unchanged within 48 hours: 67.5% of the administered dose in urine and 28.5% in feces.

Indications

Cerebrovascular insufficiency caused by atherosclerotic changes in cerebral vessels, senile dementia (initial forms), residual organic brain lesions in adults and the elderly, cerebral organic insufficiency in patients with schizophrenia, extrapyramidal hyperkinesis in patients with hereditary nervous system diseases (including Huntington’s chorea, hepatocerebral dystrophy, Parkinson’s disease), residual effects of past neuroinfections, post-vaccinal encephalitis, traumatic brain injury (as part of complex therapy); extrapyramidal neuroleptic syndrome (hyperkinetic and akinetic), as a corrector for the side effects of antipsychotic agents (neuroleptics) and for prophylactic purposes simultaneously as “cover therapy”; epilepsy (with mental slowness in combination with anticonvulsants).

Psychoemotional overload, decreased mental and physical performance (improving concentration and memory). Urination disorders: enuresis, daytime urinary incontinence, pollakiuria, imperative urges (adults and children from 2 years).

Children: perinatal encephalopathy, intellectual disability (delay in mental, speech, motor development, or their combination), infantile cerebral palsy, stuttering (predominantly clonic form), epilepsy (as part of combination therapy with anticonvulsants, especially in polymorphic seizures and minor epileptic fits).

ICD codes

ICD-10 code Indication
E83.0 Disorders of copper metabolism (Wilson’s disease)
F01 Vascular dementia
F03 Unspecified dementia
F07 Personality and behavioral disorders due to disease, damage or dysfunction of the brain
F20 Schizophrenia
F21 Schizotypal disorder
F22 Chronic delusional disorders
F23 Acute and transient psychotic disorders
F25 Schizoaffective disorders
F29 Unspecified nonorganic psychosis
F79 Unspecified intellectual disabilities
F98.0 Nonorganic enuresis
F98.5 Stuttering [stammering]
G04 Encephalitis, myelitis and encephalomyelitis
G09 Sequelae of inflammatory diseases of the central nervous system
G10 Huntington’s chorea
G20 Parkinson’s disease
G21.0 Malignant neuroleptic syndrome
G25 Other extrapyramidal and movement disorders
G40 Epilepsy
G80 Cerebral palsy
G93.4 Unspecified encephalopathy
I67.2 Cerebral atherosclerosis
I69 Sequelae of cerebrovascular diseases
P91 Other disturbances of cerebral status of newborn
R32 Urinary incontinence
R35 Polyuria (including frequent micturition, nocturia)
S06 Intracranial injury
T88.1 Other complications following immunization, not elsewhere classified
T90 Sequelae of injuries of head
Y49.3 Phenothiazine antipsychotics and neuroleptics
Y49.4 Butyrophenone and thioxanthene derivative neuroleptics
Y49.5 Other antipsychotics and neuroleptics
Z73.0 Burn-out
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
1D00.Z Infectious encephalitis, not elsewhere classified, unspecified
1D02.Z Infectious myelitis, not elsewhere classified, unspecified
1D0Z Non-viral and unspecified infections of the central nervous system, unspecified
5C64.0Z Disorders of copper metabolism, unspecified
6A00.Z Disorders of intellectual development, unspecified
6A01.1 Developmental speech fluency disorder
6A20.Z Schizophrenia, unspecified episode
6A21.Z Schizoaffective disorder, unspecified
6A22 Schizotypal disorder
6A23.Z Acute and transient psychotic disorder, unspecified
6A24.Z Delusional disorder, unspecified
6A2Z Schizophrenia or other primary psychotic disorders, unspecified
6C00.Z Enuresis, unspecified
6D81 Dementia due to cerebrovascular disease
6D8Z Dementia, unknown or unspecified cause
6E68 Secondary emotionally labile personality disorder
6E6Z Unspecified secondary mental or behavioral syndromes
8A00.0Z Parkinson’s disease, unspecified
8A00.2Y Other specified secondary parkinsonism
8A01.10 Huntington’s chorea
8A0Y Other specified movement disorders
8A0Z Motor impairments, unspecified
8A6Z Epilepsy or epileptic seizures, unspecified
8B25.Z Sequelae of cerebrovascular disease, unspecified
8B41 Myelitis
8D2Z Cerebral palsy, 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
8E7Z Diseases of the nervous system, unspecified
BD55 Asymptomatic stenosis of intracranial or extracranial artery
KB0Z Neurological disorders specific to the perinatal or neonatal period, unspecified
LD90.1 Early-onset parkinsonism-mental retardation
MF50.0 Frequent micturition
MF50.1 Pollakiuria
MF50.2Z Unspecified urinary incontinence
MF55 Polyuria
NA07.Z Intracranial injury, unspecified
NA0Z Head injury, unspecified
NE80.Z Injury or harm arising from infusion, transfusion, or therapeutic injection, not elsewhere classified, unspecified
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use
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.

Tablets, Solution

Take orally. A single dose for adults is 0.5-1 g, for children – 0.25-0.5 g; the daily dose for adults is 1.5-3 g, for children – 0.75-3 g. The course of treatment is 1-4 months, in some cases – up to 6 months. A repeat course of treatment is possible after 3-6 months.

For children with intellectual disability and oligophrenia – 0.5 g 4-6 times/day daily for 3 months; for delayed speech development – 0.5 g 3-4 times/day for 2-3 months.

As a corrector for neuroleptic syndrome, adults – 0.5-1 g 3 times/day, children – 0.25-0.5 g 3-4 times/day. The course of treatment is 1-3 months.

For epilepsy, children – 0.25-0.5 g 3-4 times/day, adults – 0.5-1 g 3-4 times/day, daily, for a long time (up to 6 months).

For tics, adults – 1.5-3 g/day, daily, for 1-5 months; children – 0.25-0.5 g 3-6 times/day daily for 1-4 months.

For urinary disorders, adults – 0.5-1 g 2-3 times/day, daily dose – 2-3 g; for children, a single dose of 0.25-0.5 g, daily – 25-50 mg/kg. The course of treatment is 0.5-3 months.

Adverse Reactions

Allergic reactions rhinitis, conjunctivitis, skin rash.

Contraindications

Acute severe kidney diseases, first trimester of pregnancy.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy.

Use in Renal Impairment

The drug is contraindicated in acute severe kidney diseases.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Long-term therapy with hopantenic acid in combination with other nootropic and CNS-stimulating agents is not recommended.

Drug Interactions

It prolongs the action of barbiturates, enhances the effects of anticonvulsants, nootropic and CNS-stimulating agents, and the action of local anesthetics (procaine).

It prevents the side effects of phenobarbital, carbamazepine, and antipsychotic agents (neuroleptics).

The action of hopantenic acid is enhanced in combination with glycine and xydiphone.

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

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

Bottle Rx Icon Hopantomide® Tablets 250 mg: 10, 20, 30, 40, or 50 pcs.
Tablets 500 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, flat-cylindrical, with a bevel and a score line.

1 tab.
Calcium hopantenate 250 mg

Excipients: magnesium hydroxycarbonate – 46.77 mg, calcium stearate – 3.1 mg, talc – 6.2 mg, potato starch – 3.93 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (100) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (200) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (300) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (400) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (600) – cardboard packs (for hospitals).

Tablets are white, round, flat-cylindrical, with a bevel and a score line.

1 tab.
Calcium hopantenate 500 mg

Excipients: magnesium hydroxycarbonate – 93.54 mg, calcium stearate – 6.2 mg, talc – 12.4 mg, potato starch – 7.86 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (100) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (200) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (300) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (400) – cardboard packs (for hospitals).
10 pcs. – contour cell packaging (600) – cardboard packs (for hospitals).

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Hopantomide® Oral solution 100 mg/ml: 50 ml or 100 ml bottle.

Dosage Form, Packaging, and Composition

Oral solution is a clear liquid from light pink to pink in color, with a faint strawberry odor.

1 ml
Calcium hopantenate 100 mg

Excipients: glycerol (calculated as 100%) – 258 mg, sorbitol – 150 mg, citric acid monohydrate – 1 mg, sodium benzoate – 1 mg, aspartame – 0.5 mg, food flavor “Strawberry” – 0.1 mg, food coloring “Pink” – 0.1 mg, purified water – up to 1 ml.

50 ml – bottles (1) with a measuring spoon – cardboard packs.
100 ml – bottles (1) with a measuring spoon – cardboard packs.

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