Pantogam® active capsules

       Registration number: .ЛСР-003873/08

Trade name: Pantogam® activ

International non-patented name (INN): D,L – hopantenic acid

Drug form: capsules

Description: Capsules contents is a white or yellowish-white powder. Hard yellow gelatin capsules #1 are for 200 mg dosage; hard white gelatine capsules #0 are for 300 mg dosage.

Composition for 200 mg dosage:

drug substance rac-hopantenic acid (D,L-hopantenic acid) 200 mg, excipients: cellulose micro-crystalline 13,98 mg, magnesium stearate 1,02 mg;

hard gelatin capsules #1: composition : gelatine, glycerol, methyl paraxydroxybenzoate,     propyl paraxydroxybenzoate, sodium lauret sulfate, water purified, titanium dioxide, yellow iron oxide.

Composition for 300 mg dosage:

drug substance rac-hopantenic acid (D,L-hopantenic acid) 300 mg, excipients: cellulose micro-crystalline 20,97 mg, magnesium stearate 1,53 mg;

hard gelatin capsules #0: composition : gelatine, glycerol, methyl paraxydroxybenzoate,     propyl paraxydroxybenzoate, sodium lauret sulfate, water purified, titanium dioxide.

Pharmacotherapeutic group: nootropic drug.

АТХ Code: [N06BX].

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Pharmacological properties

Pharmacodynamics. A clinical effect of Pantogam activ® is related to a presence in its structure gamma-aminobutyric acid that directly interacts with the GABAb-receptor canal complex. Pantogam activ® is a racemic mix of equal quantities of the R-form of hopantenic acid and its S-isomer. An isomer presence improves a transport and interaction of the drug with GABA receptor. Pantogam activ® has a more prominent nootropic and anti-convulsive action that gopantenic acid preparations of the first generation.

Pantogam activ® 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. It has an anti-asthenic and a slight anxiolytic effect, decreases a motoric excitability, collates a behavior, activates a mental activity and workability, 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. It does not metabolizes and excretes in an unchanged form during 48 hours: 70% of dose – with urine, 30% - with faeces.

Indications

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

• 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 (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);

• schizophrenia (as a component of the complex treatment).

Contraindications

Hypersensitivity, acute severe diseases of kidneys, pregnancy (1st trimester), lactation, patient's age under 18 years (there are no clinical data of the drug use for younger patients).

Method of use and dosages

The dug is used orally, 15-20 minutes after meals, 2-3 times a day, preferably at morning or evening.

200 mg capsules - 1-4 capsules per one time (0,2 - 0,8 g). Maximal daily dose - 12 capsules (2,4 g). 300 mg capsules - 1-3 capsules per one time (0,3 - 0,9 g). Maximal daily dose - 8 capsules (2,4 g). Full duration of the treatment - 1-4 months, sometimes up to 6-12 months. After 3-6 months a treatment can be performed again.

Precautions

In prolonged treatment conditions it is not recommended to concomitantly use the drug with other nootropic and CNS-stimulating drugs.

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

Drug form

200mg and 300 mg capsules.

For FSME «CSCB»  60 capsules (for 200 mg dosage) or 30 or 50 capsules (for 300 mg dosage) in sealed polymer can. Can is packed into a carton box with an instruction.

For  «Pik-pharma Pro» Ltd.  60 capsules (for 200 mg dosage) or 30 or 50 capsules (for 300 mg dosage) in sealed polymer can. 10 or 15 capsules in blister from PVC film and Al foil with coating and printing.

2 or 4 blisters with 15 capsules or 3 or 6 blisters with 10 capsules (for 300 mg dosage) or 4 blisters with 15 capsules or 6 blisters with 10 capsules (for 200 mg dose) or can are packed into a carton box with an instruction.

Keeping conditions

Keep in protected from direct light place at temperature not higher than 25 °С. Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiry date.

Selling conditions

By prescription.

 

Manufacturer

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

Manufactured by:

FSME «Central scientific constructor bureau» (FSME «CSCB»), 109240, Russia, Moscow,  Goncharnaya st., 20

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

 

Claims have to be sent to

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