Pantogam® syrup

       Registration number: ЛС-001667.

Trade name: Pantogam ®

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

Chemical name: (R)-4-[(2,4-Dihydroxy-3,3-dimethyl-butyril)amino]butyrate calcium (2:1)

Drug form: syrup.

Composition:

drug substance: hopantenate calcium (Pantogam®) - 10,0 mg;

вспомогательные вещества: glycerol (adjusted to 100%) 25,8 g, sorbitol 15,0 g, citric acid monohydrate 0,1 g, sodium benzoate 0,1 g, aspartam 0,05 g, food flavor «Cherry 667» 0,01 g, water purified – up to 100 ml.

Description: clear or slightly yellowish liquid with a cherry flavor.

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. The drug 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

• children with a perinatal encephalopathy from first days of life;

• different forms of an infantile cerebral paralysis ;

• 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 stated; development of school skills (reading, writing, counting etc.);

hyperkinetic disturbances, including a hyperactivity syndrome with an attention deficiency;

• neurosis-like states (stammering (preferably a clonic form), non-organic encopresis and enuresis);

• a decrease of mnestic and intelligence productivity due to aterosclerotic changes of brain vessels, in initial forms of the senile demention, organic affections of brain (traumatic, toxic, neuro-infectious);

• schizophrenia with a cerebral organic insufficiency (in a combination with psychotropic drugs);

• extrapyramid affections in organic diseases of brain (myoclonus epilepsy, Huntingtone's chorea, hepato-lenticular degeneration, Parkinson's disease etc.), for treatment and prevention 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);

Contraindications

Hypersensitivity, acute severe diseases of kidneys, pregnancy (1st trimester), phenylcetonuria (syrup contains aspartame)

Method of use and dosages

Pantogam syrup 100 mg/ml is used orally 15-30 minutes after meals. One time dose for adult patients is 2,5 - 10 ml (0,25 - 1 g), for children -2,5 - 5 ml (0,25 - 0,5 g); daily dose for adults - 15 -30 ml (1,5 - 3 g), for children - 7,5 - 30 mg (0,75 - 3 g). Treatment duration - 1 - 4 months, sometimes up to 6 months. After 3 - 6 months the treatment can be repeated.

For children in dependence on age and disease these dosages are recommended: children of 1st year of life - 5 - 10 ml (0,5 -1 g) per day, under 3 years - 5 - 12,5 ml (0,5 - 1,25 g) per day, from 3 to 7 years - 7,5-15 ml (0,75 - 1,5 g), over 7 years - 10 - 20 ml (1 - 2 g.). 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 total duration of the treatment - 30 - 90 days (in some instances – up to 6 months and more).

For a schizophrenia treatment (in combination with psychotropic drugs) – from 5 to 30 ml (0,5 - 3 g) per day. The treatment duration  1-3 months. For an epilepsy treatment (in combination with anti-convulsants) from 7,5 to 10 ml (0,75 - 1 g) per day. The treatment duration up to 1 year and more. For a neuroleptic syndrome with extrapyramid disturbances treatment, daily dose up to 30 ml (up to 3 g), the treatment duration – some months. For a extrapyramid hyperkinesises treatment (patients with organic disease of nervous system) from 5 to 30 ml (0,5 - 3 g) per day. A treatment course – up to 4 and more months.

For treatment of consequences of neuroinfections and a craniocerebral trauma - from 5 to 30 ml (0,5 - 3 g) per day.

For a renewal of a workability in overloads and asthenic state Pantogam is used from 2,5 to 5 ml (0,25 -0,5 g) 3 times a day.

For an urination disturbances treatment (in children) 2,5 - 5 ml (0,25 - 0,5 g), a daily dose 25 - 50 mg/kg, the treatment duration 1 - 3 months; for adult patients -5 - 10 ml (0,5 - 1 g) 2 - 3 times a day.

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.

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 activ® effect is increased in combination with glycine, ethydronic acid. The drug potentiates the effect of local anesthetics (procaine).

Drug form

Syrup 100 mg/ml – 100 ml dark glass bottles with threaded neck, sealed by threaded aluminum or plastic caps.

A bottle with a measurement spoon with nominal volume of 5 ml, and a line with subscript  «1/2» (means 2,5 ml) or a measurement spoon with nominal volume of 5 ml, and a lines with subscripts «1/4» и «1/2» (means 1,25 ml and 2,5 ml) are packed into a carton box with an instruction.

Keeping conditions

Keep in protected from direct light place at temperature from15 to 25 °С. After the opening store a bottle not longer than 1 month in a refrigerator. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiry date.

Selling conditions

By prescription.

 Registration certificate holder

PIQ-PHARMA LLC, 129010, Russia, Moscow, Spassky blind alley, 2/1.

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

www.pantogam.ru

 

Manufactured by:

«VIPS-Med Firm» Ltd. 141190, Russia, Moscowskaya region, Fryazino, Zavodskoy way, 3A

or

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