Pantogam® tablets


Registration number:  ЛС-000339 (250 mg), ЛП-000860 (500 mg)

Trade name: Pantogam ®

International non-patented name (INN): hopantenic acid  .

Drug form: tablets

Description: White flat cylindric tablets with a line and bevel.

Composition per one tablet:

drug substance: hopantenate calcium (Pantogam®) 250 mg;

excipients: methyl cellulose 0,8 mg, calcium stearate 3,1 mg, magnesium hydroxy carbonate 46,8 mg, talcum 9,3 mg.

Pharmacotherapeutic group: nootropic drug.

АТХ Code: [N06BX].


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Pharmacological properties

Pharmacodynamics. A clinical effect of Pantogam® is related to a presence in its structure gamma-aminobutyric acid. Mechanism of action of the drug is due to a direct interaction with the GABAb-receptor canal complex. Pantogam® has a nootropic and anti-convulsive action. Pantogam® increases a brain resistance to hypoxia and effects of toxic compounds, stimulates anabolic processes in neurons, combines a moderate sedative action with a soft stimulating effect, decreases a motoric excitability, activates a mental activity and workability. It also improves a GABA metabolism in chronic alcohol intoxication and after the alcohol deprivation. It can inhibit acetylation reactions, taking a part in novocain and sulfonamides inactivation reactions, so these drugs will have a prolonged effect. Pantogam produces a braking of pathologically increased bladder reflex and a detrusor tone.

Pharmacokinetics. Pantogam® is quickly absorbed from the gastrointestinal tractus. It penetrates a hematoencephalic barrier, its biggest concentrations are present in liver, kidneys, gastric wall and skin. It does not metabolizes and excretes in an unchanged form during 48 hours: 67,5% of dose – with urine, 28,5% - with faeces.

Indications

• congitive affections due to organic impairments of the brain (including consequences of neuro-infections and craniocerebral traumas) and neurotic disturbances;

• schizophrenia with a cerebral organic insufficiency ;

• • cerebrovascular insufficiency due to aterosclerotic changes of the brain;

  extrapyramid hyper-kinesises (myoclonus epilepsy, Huntingtone's chorea, hepato-lenticular degeneration, Parkinson's disease etc.), for treatment of the extrapyramid syndrome due to a neuroleptics use;

• epilepsy with deceleration of psychic processes and a decrease of a cognitive productivity (in combination with anti-convulsive drugs);

• psycho-emotional overloads, a decrease of the mental and physical workability, for an improvement of an attention concentration and memorization;

• neurogenous disturbances of urination (pollakiuria, imperative feelings of urination, imperative urinary incontinence, enuresis);

• children with a perinatal encephalopathy; mental retardation of a different severity (including that with behavioral disturbances);  psychology state affections in children, like a common psychic development retardation, specific speech disturbances, motoric functions and combined states;  hyperkinetic disturbances, including a hyperactivity syndrome with an attention deficiency;  neurosis-like states (stammering (preferably a clonic form), tics).

The drug is used in children over 3 years old. In earlierr age it is recommended to use a syrup form of the drug.

Contraindications

Hypersensitivity, acute severe diseases of kidneys, pregnancy, lactation,

Method of use and dosages

The drug is used orally, 15-30 minutes after meals.

One time dose for adult patients is 0,25 - 1 g) for children -0,25 - 0,5 g; daily dose for adults - 1,5 - 3 g) for children - 0,75 - 3 g. Treatment duration - 1 - 4 months, sometimes up to 6 months. After 3 - 6 months the treatment can be repeated.

For an epilepsy treatment (in combination with anti-convulsants) from 0,75 to 1 g per day. Treatment duration – up to 1 year and more.

For a neuroleptic syndrome with extrapyramid disturbances treatment (in combined therapy), daily dose is up to  3 g, the treatment duration – some months.

For a extrapyramid hyperkinesises treatment (patients with hereditary diseases of nervous system) from 0,5  to 3 g per day. A treatment course – up to 4 and more months..

For treatment of consequences of neuroinfections and a craniocerebral trauma – 0,25 g 3-4 times a day.

For a renewal of a workability in overloads and asthenic states Pantogam is used in doze 0,25 g 3 times a day.

For an extrapyramid syndrome (due to a neuroleptic use) treatment: adults 0,5-1 f 3 times a day, children 0,25-0,5 g 3-4 times a day. A treatment course – 1-3 months.

For a tics treatment : children 0,25-0,5 g 3-6 times a day during 1-4 months.

For an urination affections treatment: adults -  0,5-1 g 2-3 times a day, children 0,25-0,5 g (daily dose 25-50 mg/kg). A treatment duration – 1-3 months.

For children in dependence on age and disease a dosage 1-3 g is recommended: . The treatment tactics is to increase a dose during 7 - 12 days, then use of a maximal dose during 15 - 40 or more days, then the gradual decrease of the dose until stopping the treatment during 7 - 8 days. A pause between treatment courses for Pantogam (as for any other nootropic drug) is 1-3 months. In prolonged treatment conditions it is not recommended to concomitantly use the drug with other nootropic and stimulating drugs. Taking into an account a nootropic effect of the drug, it has to be used at morning and evening hours.

Side effects

In rare cases allergic reactions are possible (rhinitis, conjunctivitis, skin rash). In these cases a dose has to be decreased or treatment stopped. Sleeping impairments or somnolence, a noise in the head are short-lasting symptoms, the drug withdrawal is not necessary in these cases.

Over-dosage

In the case of over-dosage symptoms of sife effects are increasing.

Treatment: use of a charcoal, gastric lavage, symptomatic treatment.

Interaction with other medicines

Prolonges a barbiturates action, increases anti-convulsants effects, prevents side effects of phenobarbitalum, carbamazepine, neuroleptics. A Pantogam ® effect is increased in combination with glycine, ethydronic acid. The drug potentiates the effect of local anesthetics (procaine).

Drug form

250 mg tablets. 10 tablets in blisters from PVC film and Al foil. 5 blisters are packed into a carton box with an instruction.

Keeping conditions

Keep in protected from direct light place at temperature from15 to 25 °С. Keep out of the reach of children.

Shelf life

4 years. Do not use after the expiry date.

Selling conditions

By prescription.

Manufacturer

PIQ-PHARMA LLC, 12504, Russia, Moscow, Oruzheinyj st., 25/1

 Manufactured by:

PIQ-PHARMA PRO LLC, 188663, Russia, Leningradskaya region, Vsevolozhsky district, Kuzmolovsky, Workshop # 92.

or

 “Ozon” Ltd,  445351, Russia, Samarskaya region, Zhigulevsk, Gidrostroitelej st., 6

 Claims have to be sent to

PIQ-PHARMA LLC. Phone/fax: +7-495-925-57-00.