Pantoham^® (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 with anticonvulsant action

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

The spectrum of action is associated with the presence of gamma-aminobutyric acid (GABA) in its structure. The mechanism of action is due to a direct influence on the GABA_B receptor-channel complex.

It has nootropic and anticonvulsant action.

It increases brain resistance to hypoxia and the effects of toxic substances, stimulates anabolic processes in neurons, combines a moderate sedative effect with a mild stimulating effect, reduces motor excitability, and activates mental and physical performance.

It improves GABA metabolism in chronic alcohol intoxication and after ethanol withdrawal. It is capable of inhibiting acetylation reactions involved in the mechanisms of inactivation of procaine (novocaine) and sulfonamides, thereby prolonging the action of the latter.

It causes inhibition of pathologically increased bladder reflex and detrusor tone.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract.

The highest concentrations are found in the liver, kidneys, stomach wall, and skin. It penetrates the blood-brain barrier.

It is not metabolized and is excreted unchanged within 48 hours. 67.5% of the administered dose is excreted by the kidneys, 28.5% – with feces.

Indications

• Cognitive impairments in organic brain lesions, including consequences of neuroinfections and traumatic brain injuries, and neurotic disorders;
• As part of complex therapy for organic cerebral insufficiency in patients with schizophrenia;
• Extrapyramidal disorders (including myoclonus epilepsy, Huntington’s chorea, hepatolenticular degeneration, Parkinson’s disease), as well as for the treatment and prevention of extrapyramidal syndrome (hyperkinetic and akinetic) caused by the intake of neuroleptics;
• Epilepsy with slowing of mental processes in complex therapy with anticonvulsants;
• Psychoemotional overload, decreased mental and physical performance, to improve concentration and memory;
• Neurogenic urinary disorders (pollakiuria, imperative urges, urge incontinence, enuresis);
• Children with developmental delays (mental, speech, motor, or their combination), including against the background of a history of perinatal encephalopathy;
• Various forms of infantile cerebral palsy;
• Hyperkinetic disorders in children (including attention deficit hyperactivity disorder);
• Neurosis-like conditions in children (with tics, stuttering, predominantly in the clonic form).

ICD codes

Dosage Regimen

Solution

It is taken orally 15-30 minutes after meals.

Considering the nootropic effect, it should preferably be taken in the morning and daytime hours (until 5 PM).

For adults, a single dose is 0.25-1.5 g, the daily dose is 0.5-3 g.

For children, a single dose is 0.1-1.5 g, the daily dose is 0.1-3 g.

The course of treatment is 1-4 months, in some cases – up to 6 months. After 3-6 months, a repeat course of treatment can be conducted.

For children with various pathologies of the nervous system, depending on age, it is recommended to prescribe 30-50 mg/kg of body weight/day. The frequency of drug administration is 1-2 times/day.

The treatment strategy involves increasing the dose over 7 days, taking the recommended dose during the main course of treatment with a gradual dose reduction until drug withdrawal over 7 days. The course of treatment is 1-3 months (for certain diseases – up to 6 months or more).

For schizophrenia in combination with psychotropic drugs: 0.5-3 g/day. The course of treatment is 1-3 months.

For epilepsy in combination with anticonvulsants: 0.75-1 g/day. The course of treatment is up to 1 year or more.

For neuroleptic syndrome accompanied by extrapyramidal disorders, the daily dose is up to 3 g (30 ml), treatment for several months.

For extrapyramidal hyperkinesis in patients with organic diseases of the nervous system: 0.5-3 g/day. The course of treatment is up to 4 months or more.

For consequences of neuroinfections and traumatic brain injuries: 0.5-3 g/day.

For restoring performance under increased loads and asthenic conditions: 0.25-0.5 g 3 times/day.

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

Tablets

It is taken orally 15-30 minutes after meals. In children over 3 years old, tablets are used; at an earlier age, syrup is recommended.

Considering the nootropic effect, it should preferably be taken in the morning and daytime hours (until 5 PM).

For adults, a single dose is 0.25-1 g, the daily dose is 1.5-3 g.

For children, a single dose is 0.25-0.5 g, the daily dose is 0.75-3 g.

The course of treatment is 1-4 months, in some cases – up to 6 months. After 3-6 months, a repeat course of treatment can be conducted.

For cognitive impairments in organic brain lesions, including consequences of neuroinfections and traumatic brain injuries, neurotic disorders, 0.25 g 3-4 times/day is prescribed.

For extrapyramidal disorders (myoclonus epilepsy, Huntington’s chorea, hepatolenticular degeneration, Parkinson’s disease and others), a dose from 0.5 to 3 g/day is prescribed. The course of treatment is up to 4 or more months.

For the treatment and prevention of extrapyramidal syndrome (hyperkinetic and akinetic) caused by the intake of neuroleptics, for schizophrenia with cerebral organic insufficiency, adults are prescribed a dose from 0.5 to 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 with slowing of mental processes in complex therapy with anticonvulsants, adults are prescribed a dose of 0.5-1 g 3 times/day; children – at a dose of 0.25-0.5 g 3-4 times/day. The course of treatment is up to 6 months.

For psychoemotional overload, decreased mental and physical performance, to improve concentration and memory – 0.25 g 3 times/day.

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

For children with various pathologies of the nervous system, depending on age, it is recommended to take up to 3 g/day. Prescription strategy: dose increase over 7-12 days, intake at the maximum dose for 15-40 days and gradual dose reduction until withdrawal over 7-8 days. The break between course administrations, as for any other nootropic agent, is 1-3 months.

For children with developmental delay, 0.5 g 3-4 times/day is prescribed. The course of treatment is 2-3 months.

For children with attention deficit hyperactivity disorder, a dose of 0.25-1 g 1-2 times/day in the morning and afternoon with dose titration over the first 5-7 days (the average therapeutic dose is 30 mg/kg of the child’s body weight per day) is prescribed. The course of treatment is 3-4 months.

For children with neurosis-like conditions (tics, stuttering, predominantly in the clonic form), a dose of 0.25-0.5 g 3-6 times/day is prescribed. The course of treatment is 1-4 months.

Adverse Reactions

The adverse reactions listed below are presented according to the affected organs and systems and frequency of occurrence. Frequency of occurrence is defined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000, including isolated cases).

From the immune system very rarely – allergic reactions (rhinitis, conjunctivitis, skin allergic reactions).

From the nervous system very rarely – hyperexcitability, headache, dizziness, noise in the head.

Mental disorders very rarely – lethargy, retardation, sleep disorders, drowsiness.

In case of disorders from the immune system, the drug is discontinued. In other cases, the dose is reduced.

Contraindications

• Acute severe kidney diseases;
• Pregnancy;
• Breastfeeding period;
• Children under 3 years of age;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated due to the lack of clinical experience in this category of patients.

Use in Renal Impairment

Use in acute severe kidney diseases is contraindicated.

Pediatric Use

Use in children under 3 years of age is contraindicated.

Special Precautions

During long-term treatment, the simultaneous prescription of other nootropic drugs and agents that stimulate the central nervous system is not recommended.

Effect on the ability to drive vehicles and machinery

In the first days of administration, caution should be exercised when driving vehicles and machinery, considering the possible occurrence of drowsiness.

Drug Interactions

It prolongs the action of barbiturates and enhances the effects of anticonvulsants.

It prevents the side effects of phenobarbital, carbamazepine, and neuroleptics.

The effect of the drug is enhanced when used simultaneously with glycine and etidronic acid.

It potentiates the action of local anesthetics (procaine).

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.