Pantogam

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTOHAM (PANTOHAMUM)

Composition:

Active substance: hopantenic acid;

1 tablet contains 250 mg of hopantenic acid;

Excipients: magnesium carbonate, calcium stearate, talc.

Pharmaceutical form. Tablets.

Main physicochemical properties: white, round, flat-cylindrical tablets with a bevel and a score line.

Pharmacotherapeutic group. Psychostimulants and nootropics.

ATC code N06B X.

Pharmacological properties.

Pharmacodynamics.

The spectrum of action of hopantenic acid is associated with the presence of gamma-aminobutyric acid (GABA) in its structure. The mechanism of action is due to the direct effect of hopantenic acid on the GABAB receptor complex. The drug exerts a nootropic and anticonvulsant effect. It increases brain resistance to hypoxia and toxic substances, stimulates anabolic processes in neurons, combines moderate sedative action with a mild stimulating effect, and reduces motor excitability. It enhances mental and physical performance. Promotes normalization of GABA levels in chronic alcohol intoxication and during subsequent ethanol withdrawal. Prolongs the action of procaine and sulfonamides by inhibiting their acetylation reactions. Causes inhibition of the pathologically increased micturition reflex and detrusor tone.

Pharmacokinetics.

Hopantenic acid is rapidly absorbed from the gastrointestinal tract and penetrates the blood-brain barrier. Higher concentrations are formed in the liver, kidneys, gastric wall, and skin. The drug is not metabolized and is excreted unchanged within 48 hours: 67.5% of the administered dose is excreted in urine, 28.5% in feces.

Clinical characteristics.

Indications.

As part of combination therapy in the following conditions:

• cognitive disorders due to organic brain lesions (including sequelae of neuroinfections and traumatic brain injuries);
• cerebrovascular insufficiency caused by atherosclerotic changes in cerebral vessels;
• extrapyramidal disorders (myoclonic epilepsy, Huntington's chorea, hepatolenticular degeneration, Parkinson's disease);
• epilepsy with slowed mental processes, as part of combination therapy with anticonvulsant drugs;
• psychoemotional overload, decreased mental and physical performance (to improve concentration and memory);
• neurogenic urinary disorders: enuresis, polyuria, imperative urges, imperative urinary incontinence;
• children aged 3 years and older with perinatal encephalopathy, intellectual disability of varying severity, developmental delay (mental, speech, motor, or their combination), various forms of cerebral palsy, hyperkinetic disorders (attention deficit hyperactivity syndrome), neurosis-like conditions (in stuttering, predominantly clonic form; tics).

Contraindications.

Hypersensitivity to any component of the drug, acute severe kidney diseases, pregnancy, lactation period, children under 3 years of age.

Interaction with other medicinal products and other types of interactions.

During long-term treatment, concomitant use of the drug with other nootropic and stimulant agents is not recommended.

The drug prolongs the effect of barbiturates, enhances the action of anticonvulsant drugs and agents stimulating the central nervous system (CNS), prevents the adverse effects of phenobarbital, carbamazepine, and antipsychotic drugs (neuroleptics), and enhances the effect of local anesthetics (procaine, procaïne).

The drug may inhibit acetylation reactions involved in the inactivation mechanisms of procaine and sulfonamides, thereby achieving a prolonged effect of the latter.

The action of hopantenic acid is enhanced when combined with glycine, ethidronic acid, and xidiphon.

Special precautions for use.

During prolonged treatment, concomitant administration of the drug with other nootropic and stimulating agents is not recommended. Due to the nootropic effect of the drug, it should be taken predominantly in the morning and during daytime hours.

The drug can be used in children aged 3 years and older. In younger children, administration of the drug in the form of syrup is recommended.

Use during pregnancy or breastfeeding.

Contraindicated during pregnancy and breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Caution should be exercised when driving or operating machinery during treatment due to the possible occurrence of drowsiness.

Method of Administration and Dosage

Administer as part of combination therapy. For oral use in adults and children aged 3 years and older, taken 15–30 minutes after eating.

Single dose:

• For children aged 12 years and older and adults: 250 mg–1 g
• For children aged 3 to 12 years: 250–500 mg

Daily dose:

• For children aged 12 years and older and adults: 1.5–3 g
• For children aged 3 to 12 years: 750 mg–3 g

The treatment course lasts from 1 to 4 months; in individual cases, up to 6 months. A repeat course of treatment may be conducted after 3–6 months.

• In sequelae of neuroinfections and traumatic brain injuries: 250 mg three to four times daily for children aged 3 years and older and adults.
• In cerebrovascular insufficiency: 250 mg three to four times daily for adults.
• For treatment of extrapyramidal disorders caused by neuroleptics: 500 mg–1 g three times daily for children aged 12 years and older and adults; 250–500 mg three to four times daily for children aged 3 to 12 years. The treatment course lasts 1–3 months.
• In epilepsy, in combination with anticonvulsant agents: 250–500 mg three to four times daily for children aged 3 to 12 years; 500 mg–1 g three to four times daily for children aged 12 years and older and adults, administered daily over a prolonged period (up to 6 months).
• In psycho-emotional overload and decreased mental and physical performance: 250 mg three times daily for children aged 3 years and older and adults.
• In urinary disorders: 500 mg–1 g two to three times daily for children aged 12 years and older and adults; 250–500 mg (daily dose: 25–50 mg/kg body weight) two to three times daily for children aged 3 to 12 years. The treatment course lasts 1 to 3 months.
• In children aged 3 to 12 years with perinatal encephalopathy, intellectual disability, developmental delay, cerebral palsy: the drug is administered at 500 mg four to six times daily for 3 months; in delayed speech development: 500 mg three to four times daily for 2–3 months.
• In hyperkinetic disorders, tics, stuttering, neurosis-like conditions: the drug is administered to children aged 3 to 12 years at 250–500 mg three to six times daily for 1–4 months; to children aged 12 years and older and adults: 1.5–3 g daily for 1–5 months.

Dosing regimen: The dose should be gradually increased over 7–12 days, maintained at the maximum dose for 15–40 days, followed by a gradual dose reduction over 7–8 days until complete discontinuation of hopantenic acid. The interval between treatment courses should be 1 to 3 months.

Children

The drug is indicated for children aged 3 years and older.

Overdose

Exacerbation of adverse reaction symptoms. Symptoms: sleep disturbances or drowsiness, headache, tinnitus.

Treatment: activated charcoal, gastric lavage, symptomatic therapy.

Adverse reactions.

Immune system side effects: allergic reactions are possible, including rhinitis, conjunctivitis, skin rash. If allergic reactions occur, the drug should be discontinued.

Nervous system side effects: neurological disorders are possible, including hyperexcitability, sleep disturbances or drowsiness, lethargy, inhibition, headache, dizziness, tinnitus, which are usually transient and do not require discontinuation of the drug. In such cases, the dose should be reduced.

Reporting of adverse reactions

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life. 3 years.

Storage conditions.

Store in a place protected from light at a temperature not exceeding 30 °C.

Packaging.

10 tablets per blister, 5 blisters per cardboard box.

Prescription status.

Prescription only.

Marketing Authorization Holder.

LLC "ROKET-PHARM".

Address of the Marketing Authorization Holder and location of its business activities.

6 Mykhaila Boichuka Street, Office 103, Kyiv, 01103, Ukraine.

Manufacturer.

JSC "Monfarm".

Address of the Manufacturer and location of its manufacturing site.

8 Zavodska Street, Avramivka, Uman District, Cherkasy Oblast, 19161, Ukraine.