Pantogam 100 mg/ml 100 ml syrup
Instructions for medical use of the drug PANTOGAM Trade name Pantogam International nonproprietary name Hopanthenic acid Dosage form Syrup 100 mg/ml COMPOSITION 100 ML OF THE PREPARATION CONTAINS: ACTIVE SUBSTANCE – CALCIUM HOPANTHENATE (PANTOGAM) 10.0 G; EXCIDIENTS: GLYCERIN (100% equivalent), SORBITOL, CITRIC ACID MONOHYDRATE, SODIUM BENZOATE, ASPARATE, FOOD FLAVORS “CHERRY 667”, PURIFIED WATER DESCRIPTION COLORLESS OR Slightly YELLOWISH LIQUID WITH CHERRY SMELL PHARMACOTHERAPEUTIC GROUP PSYCHOSTIMULANTS AND OTHER NOOTROPICS. ATC CODE N06BX PHARMACOLOGICAL PROPERTIES PHARMACOKINETICS PANTOGAM IS RAPIDLY ABSORBED FROM THE GASTROINTESTINAL TRACT, PENETRATES THE BLOOD BRAIN BARRIER, THE HIGHEST CONCENTRATIONS ARE CREATED IN THE LIVER, KIDNEYS, AND INTO THE WALL E STOMACH AND SKIN. THE DRUG IS NOT METABOLIZED AND IS EXCRETED UNCHANGED WITHIN 48 HOURS: 67.5% OF THE TAKEN DOSE IS EXCRETED BY THE KIDNEYS, 28.5% IS EXCRETED IN THE FECES. PHARMACODYNAMICS THE ACTION SPECTRUM OF PANTOGAM IS ASSOCIATED WITH THE PRESENCE OF GAMMA-AMINO-BUTYRY ACID IN ITS STRUCTURE. THE MECHANISM OF ACTION IS DUE TO THE DIRECT INFLUENCE OF PANTOGAM ON THE GABA RECEPTOR-CHANNEL COMPLEX. THE DRUG HAS NOOTROPIC AND ANTICONVATSUAL EFFECT. PANTOGAM INCREASES THE BRAIN'S RESISTANCE TO HYPOXIA AND THE INFLUENCE OF TOXIC SUBSTANCES, STIMULATES ANABOLIC PROCESSES IN NEURONS, COMBINES MODERATE SEDATIVE EFFECT WITH A MILD STIMULATING EFFECT, REDUCES MOTOR EXCITATION PROPERTY, ACTIVATS MENTAL AND PHYSICAL PERFORMANCE. IMPROVES GABA METABOLISM IN CHRONIC ALCOHOL INTOXICATION AND AFTER ETHANOL CANCELLATION. IT IS CAPABLE OF INHIBITING ACETYLATION REACTIONS INVOLVED IN THE MECHANISMS OF INACTIVATION OF NOVOCAINE AND SULPHANAMIDES, DUE TO WHICH PROLONGES THE ACTION OF THE LATTER. CAUSES INHIBITION OF PATHOLOGICALLY INCREASED VESCICAL REFLEX AND DETRUSOR TONE. INDICATIONS FOR USE: - CHILDREN WITH PERINATAL ENCEPHALOPATHY FROM THE FIRST DAYS OF LIFE - DIFFERENT FORMS OF CEREBRAL PALSY - MENTAL RETARDATION OF VARYING DEGREES OF SEVERITY, INCLUDING WITH BEHAVIORAL DISORDERS - PSYCHOLOGICAL DISORDERS CHILDREN'S MENTAL STATUS IN THE FORM OF GENERAL DELAY OF MENTAL DEVELOPMENT, SPECIFIC SPEECH DISORDERS, MOTOR DISORDERS FUNCTIONS AND THEIR COMBINATIONS, FORMATION OF SCHOOL SKILLS (READING, WRITING, COUNTING, ETC.) - HYPERKINETIC DISORDERS, INCLUDING HYPERACTIVITY SYNDROME WITH ATTENTION DEFICIT - NEUROSIS-LIKE CONDITIONS (IN STUNNING, MOSTLY CLONIC FORM, TIKS, INORGANIC ENCOPRESS AND ENURESIS) - DECREASE MNESTIC-INTELLECTUAL PRODUCTIVITY DUE TO ATHEROSCLEROTIC CHANGES IN THE BRAIN VESSELS, IN INITIAL FORMS OF SENILIA DEMENTIA, ORGANIC BRAIN LESIONS OF TRAUMATIC, TOXIC, NEUROINFECTIOUS GENESIS - SCHIZOPHRIS CONDITIONS WITH CEREBRAL ORGANIC INSUFFICIENCY (IN COMPLEX WITH PSYCHOMOTOR DRUGS) - EXTRAPYRAMIDAL DISORDERS IN ORGANIC BRAIN DISEASES (MYOCLONUS- EPILEPSY, HUNTINGTON'S CHOREA, HEPATOLENTICULAR DEGENERATION, PARKINSON'S DISEASE, ETC.), AND ALSO FOR THE TREATMENT AND PREVENTION OF EXTRAPYRAMIDAL SYNDROME CAUSED BY TAKEN NEUROLEPTICS - EPILEPSY WITH MENTAL Slowness CESSES AND REDUCED COGNITIVE PRODUCTIVITY TOGETHER WITH ANTICONVULSANTS - PSYCHOEMOTIONAL OVERLOAD, REDUCED MENTAL AND PHYSICAL PERFORMANCE, TO IMPROVE CONCENTRATION AND MEMORY - NEUROGENIC URINARY DISORDERS (POLLAKYURIA, urge, urge incontinence) DOSES AND ADMINISTRATION PANTOGAM SYRUP 100 MG/ML TAKE ORALLY AFTER 15 -30 MIN AFTER MEAL. A SINGLE DOSE FOR ADULTS IS USUALLY 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 ML (0.75-3 G). COURSE OF TREATMENT – 1-4 MONTHS, SOMETIMES UP TO 6 MONTHS. AFTER 3-6 MONTHS, A REPEATED COURSE OF TREATMENT IS POSSIBLE. FOR CHILDREN, DEPENDING ON THE AGE AND PATHOLOGY OF THE NERVOUS SYSTEM, THE FOLLOWING DOSAGE RANGE IS RECOMMENDED: FOR CHILDREN OF THE FIRST YEAR – 5-10 ML (0.5-1 G) PER DAY, UP TO 3 YEARS – 5-12.5 ML (0.5- 1.25 G) PER DAY, CHILDREN FROM 3 TO 7 YEARS OLD – 7.5-15 ML (0.75-1.5 G), OVER 7 YEARS OLD – 10-20 ML (1-2 G). TREATMENT TACTICS INCLUDES INCREASED DOSE OVER 7-12 DAYS, TAKEN AT THE MAXIMUM DOSE FOR 15-40 OR MORE DAYS WITH A GRADUAL DECREASE IN THE DOSE UNTIL CANCELLATION WITHIN 7-8 DAYS. COURSE OF TREATMENT – 30-90 DAYS (FOR SOME DISEASES, UP TO 6 MONTHS OR MORE). FOR SCHIZOPHRENIA IN COMBINATION WITH PSYCHOTROPIC DRUGS - FROM 5 TO 30 ML (0.5-3 G) PER DAY. COURSE OF THERAPY – FROM 1 TO 3 MONTHS. FOR EPILEPSY IN COMBINATION WITH ANTICONVULSANTS - IN A DOSE OF 7.5 TO 10 ML (0.75-1 G) PER DAY. COURSE OF THERAPY – UP TO 1 YEAR OR MORE. FOR NEUROLEPTIC SYNDROME ACCOMPANIED BY EXTRAPYRAMIDAL DISORDERS, DAILY DOSE – UP TO 30 ML (UP TO 3 G), TREATMENT FOR SEVERAL MONTHS. FOR EXTRAPYRAMIDAL HYPERKINESIS IN PATIENTS WITH ORGANIC DISEASES OF THE NERVOUS SYSTEM - FROM 5 TO 30 ML (0.5-3 G) PER DAY. COURSE OF TREATMENT – UP TO 4 MONTHS OR MORE. FOR THE CONSEQUENCES OF NEUROINFECTIONS AND TRANO-BRAIN INJURIES - FROM 5 TO 30 ML (0.5-3 G) PER DAY. TO RESTORATION OF PERFORMANCE IN INCREASED LOAD AND ASTHENIC CONDITIONS, PANTOGAM IS PRESCRIBED 2.5-5 ML (0.25-0.5 G) 3 TIMES A DAY. FOR URINATION DISORDERS FOR CHILDREN - 2.5-5 ML (0.25-0.5 G), DAILY DOSE IS 25-50 MG/KG, COURSE OF TREATMENT 1-3 MONTH; ADULTS – 5-10 ML (0.5-1 G) 2-3 TIMES A DAY. IN CONDITIONS OF LONG-TERM TREATMENT, SIMULTANEOUS PRESCRIPTION OF THE DRUG WITH OTHER NOOTROPIC AND STIMULATIVE DRUGS IS NOT RECOMMENDED. CONSIDERING THE NOOTROPIC EFFECT OF THE DRUG, ITS TAKEN PREFERABLY IN THE MORNING AND AFTERNOON HOURS. SIDE EFFECTS RARE: – ALLERGIC REACTIONS POSSIBLE (RHINITIS, CONJUNCTIVITIS, ALLERGIC SKIN REACTIONS). IN THIS CASE, REDUCE THE DOSE OR DISCONTINUE THE DRUG. VERY RARE: – CNS DISORDERS (HYPER Arousal, SLEEP DISTURBANCE OR Drowsiness, Lethargy, Lethargy, HEADPACH, Dizziness, NOISE IN THE HEAD). IN THIS CASE, REDUCE THE DOSE OF THE DRUG. CONTRAINDICATIONS – INCREASED SENSITIVITY TO THE DRUG – ACUTE SEVERE KIDNEY DISEASES – PREGNANCY (1ST TRIMESTER) AND LACTATION – PHENYLKETONURIA (SYRUP CONTAINS ASPARTAME) DRUG INTERACTIONS PROLONGES THE EFFECT OF BARBITURATES, STRENGTHENS THE EFFECT OF ANTICONVULSATIVE DRUGS, PREVENTS SIDE EVENTS OF PHENOBARBITAL, CARBAMAZEPINE, NEUROLEPTICA. THE EFFECT OF PANTOGAM IS INCREASED IN COMBINATION WITH GLYCINE, ETIDRONIC ACID. POTENTIATES THE EFFECT OF LOCAL ANESTHETICS (PROCAINE). SPECIAL INSTRUCTIONS IN THE FIRST DAYS OF TAKING THE DRUG, CAUTION SHOULD BE USED WHEN DRIVING VEHICLES AND MACHINES, CONSIDERING THE POSSIBLE OCCURENCE OF Drowsiness. OVERDOSE SYMPTOMS: INCREASED SYMPTOMATICS OF SIDE EFFECTS (SLEEP DISTURBANCES OR DROWSINESS, NOISE IN THE HEAD). TREATMENT: ACTIVATED CHARCOAL, GASTRIC WASH, SYMPTOMATIC THERAPY. RELEASE FORM AND PACKAGING OF 100 ML IN DARK GLASS BOTTLES, SEALED WITH COVERS WITH A CONTROL RING FOR THE FIRST OPENING. EACH BOTTLE WITH A MEASURING SPOON WITH A NOMINAL VOLUME OF 5 ML AND WITH A RISK MARKED “½” (WHICH CORRESPONDS TO 2.5 ML) OR WITH A MEASURING SPOON WITH A NOMINAL VOLUME 5 ML WITH RISKS MARKED “¼” AND “½” (WHICH IS WITH ANSWER 1, 25 ML AND 2.5 ML), WITH INSTRUCTIONS FOR USE IN THE STATE AND RUSSIAN LANGUAGES, ARE PLACED IN A PACK OF CARDBOARD. STORAGE CONDITIONS STORE IN A PLACE PROTECTED FROM LIGHT AT A TEMPERATURE NOT EXCEEDING 25 °C. AFTER OPENING THE PACKAGING, STORE IN THE REFRIGERATOR. KEEP OUT OF THE REACH OF CHILDREN! STORAGE LIFE 2 YEARS PERIOD OF APPLICATION AFTER OPENING – 1 MONTH. DO NOT USE AFTER EXPIRATION. CONDITIONS FOR DISCHARGE FROM PHARMACIES WITH A PRESCRIPTION. OWNER OF REGISTRATION CERTIFICATES LLC "PIK-PHARMA", RUSSIA, 125047, MOSCOW, PER. ORZHEYNYY, 25, Bldg. 1. , RUSSIA, 188663, LENINGRAD REGION, VSEVOLOZHSKY DISTRICT, G. P. KUZMOLOVSKY, SHOP BUILDING No. 92. ADDRESS OF THE ORGANIZATION RECEIVING CLAIMS FROM CONSUMERS FOR PRODUCT QUALITY IN THE TERRITORY OF THE REPUBLIC OF KAZAKHSTAN CI (PRODUCT): PIK-PHARMA LLC
Possibilities of using gopantam (pantogam) in pediatric practice
The pharmaceutical market annually offers practitioners new types and forms of medicines, often displacing medicines that are already well known to us. The domestic drug Pantogam avoided this fate. Many years of experience in using Pantogam not only confirms its traditional effectiveness, but also reveals new positive properties of this drug, which allows expanding the possibilities of its use in medicine. Under the trade name "Gopantam" the drug is produced by a pharmaceutical company (Biysk). Appearing on the domestic market in 1980, gopantam (pantogam) does not lose its popularity today, occupying a strong place in neuropediatrics, clinical psychiatry and neurology, neurogerontology, urology and nephrology.
Gopantam (pantogam, calcium gopanthenate) is a calcium salt of dioxydimethylbutyryl-GABA, similar in structure and pharmacological properties to both GABA and pantothenic acid. The drug has a mild stimulating effect on the nervous system, has antihypoxic and antioxidant properties, increases the brain's resistance to the effects of toxic substances, and stimulates anabolic processes in neurons. In pediatric practice, this drug is prescribed more often than other nootropics, since it practically does not cause side effects and has important additional properties: anticonvulsant activity, moderate sedative effect, the ability to reduce motor excitability while simultaneously enhancing performance and mental activity, the ability to increase the overall tone of the body, improve metabolic processes [1].
Indications for prescribing Pantogam in pediatrics were initially limited. It was used to treat children with mental disabilities, mental retardation, delayed speech development, stuttering (mainly clonic form), as well as in the rehabilitation of children who suffered neuroinfections or suffered traumatic brain injury [2].
In addition, the drug has been successfully used and is currently used to treat children suffering from epilepsy with slow mental processes, polymorphic seizures or minor epileptic seizures, usually in combination with anticonvulsants; for various mental disorders in combination with antipsychotics and antidepressants. Gopantam is prescribed for the correction of side effects of neuroleptic drugs, for neuroleptic extrapyramidal syndrome (hyperkinetic and akinetic), as well as for prophylactic purposes simultaneously with neuroleptic drugs as “cover therapy” [3].
The drug reduces reactions to painful stimuli, providing a moderate analgesic effect, and potentiates the effect of local anesthetics (novocaine). It is known that gopantam also has a short-term hypotensive effect [4].
Gopantam (pantogam) has been widely used in neonatology and early childhood neurology, in particular, in the treatment of perinatal encephalopathy in its early and late periods. At the same time, metabolic processes in the nervous tissue noticeably improve, the brain’s resistance to hypoxia increases, and convulsive readiness decreases [5]. Clinically, children’s anxiety disappears or is significantly reduced, sleep, muscle tone, speech functions are normalized, and psychomotor development approaches the age norm. It has been noted that the earlier the treatment of perinatal encephalopathy with nootropics is started, the fewer the consequences of ischemic-traumatic damage to the central nervous system in the child in the long-term period.
When taken orally, the drug is quickly absorbed from the gastrointestinal tract and penetrates well through the blood-brain barrier, reaching maximum concentration in the brain an hour after administration. It does not accumulate in the body and has low toxicity, which is especially valuable in pediatric practice.
In older children, gopantam is prescribed for psycho-emotional overload, decreased mental and physical performance (to facilitate concentration and improve memory), as well as for severe forms of school maladjustment in children, usually due to hyperkinetic disorders leading to academic failure, behavioral disorders, and aggressiveness etc.
Gopantam is included in the complex therapy of cerebral palsy and other diseases of the central nervous system accompanied by convulsive syndrome.
For psychoneurological pathology, gopants are recommended for children in a single dose of 0.25 - 0.5 g, a daily dose of 0.5 - 3 g in courses of 1 - 4 months, sometimes up to 6 months. Repeated courses of treatment are usually prescribed after 3 to 6 months. Taking into account the nootropic effect of the drug, it is taken in the morning and afternoon [3]. In this case, it is practiced to increase the dose of gopantam over 7–12 days, take the maximum dose for 15–40 days or more, and gradually reduce the dose over 7–8 days. until the drug is completely discontinued. The minimum break between courses is 1 month.
In pediatric nephrurology, gopantam (pantogam) has been used for more than 10 years, as it has been discovered to have a corrective effect on detrusor-sphincter dyssynergia with the cessation of urination disorders during the day and night, to normalize bladder function in case of pollakiuria, urgency, imperative urination , urinary incontinence and enuresis [6]. I.B. Osipov and L.P. Smirnova (2001) recommend using pantogam for severe detrusor hyperreflexia in children with neurogenic bladder dysfunction at a dosage of 0.25 - 0.5 g 3 times a day after meals in courses from 1 to 3 months.
It is also known that when using gopantam (pantogam), the function of the colon is often restored, fecal incontinence and stool loss cease [1].
In our studies, gopantam (pantogam) showed high effectiveness (83.7%) when included in the treatment regimens of 43 children with neurogenic bladder dysfunction (versus 53.2% overall effectiveness in 47 children who received traditional therapy using anticholinergics) [7 ]. It was noted that in the group of children who received pantogam at a dose of 0.25 - 0.5 g 3 times a day in combination with physiotherapeutic methods of treatment (warming the bladder area, DDT courses according to Kuznetsova, etc.), in 6 enuresis was stopped more often than in the control group (37.2% versus 6.4%). This effect was especially noticeable in the subgroup of children aged 4 to 7 years (30% versus 4.8%), when doctors in most cases first begin to interpret enuresis as a symptom of the disease.
As a result of studying the anamnesis of examined children with neurogenic bladder dysfunction, a probable influence of pantogam on the maturation of the structures responsible for the full act of urination was revealed. From a retrospective analysis of the medical records of children, it follows that among patients who were under dispensary observation for perinatal encephalopathy in the 1st year of life and received courses of monotherapy with Pantogam or in combination with other drugs (Cavinton, B vitamins, etc.), after 3.5 - 4 years of age, enuresis was observed only in 6.7% of cases, while in children who did not undergo such treatment in the 1st year of life, enuresis was subsequently recorded in 85.7% of cases, the same as served as a reason to consult a doctor [7].
Of the side effects possible when taking gopantam (pantogam), only rare allergic reactions in the form of rhinitis, conjunctivitis, and skin rashes have been reported [2, 4]. In our studies over the entire period of use of Pantogam in children with neurogenic bladder dysfunction, we did not observe any unwanted side effects of this drug. There are few contraindications for the use of gopantam. It should not be used in cases of severe kidney disease in children or in cases of hypersensitivity to the drug [3–4].
It should be remembered that the effect of gopantam is enhanced by its simultaneous use with glycine and xydiphone. Gopantam prolongs the effect of barbiturates, enhances the effects of anticonvulsants, nootropics and other stimulants of the central nervous system. When used together, gopantam prevents the side effects of phenobarbital, finlepsin and, as mentioned above, neuroleptics.
Undoubtedly, gopantam can be classified as a “socializing” drug, since it can significantly improve the quality of life of children, and in a variety of situations that cause psychological and social discomfort for the child: from increased aggressiveness, “unfriendliness” in a team to inconvenience associated with enuresis. The data obtained allow us to recommend wider use of this drug in pediatric practice.
Pantogam®
Inside, 15-30 minutes after eating.
A single dose for adults is usually 0.25-1 g (1-4 tablets), for children - 0.25-0.5 g (1-2 tablets); daily dose for adults - 1.5-3 g (6-12 tablets), for children - 0.75-3 g (3-12 tablets). The course of treatment is from 1 to 4 months, in some cases up to 6 months. After 3-6 months, a second course of treatment is possible.
For cognitive impairment with organic brain lesions, including the consequences of neuroinfections and traumatic brain injuries, and neurotic disorders: 0.25 g (1 tablet) 3-4 times a day.
For extrapyramidal disorders (myoclonus epilepsy, Huntington's chorea, hepatolenticular degeneration, Parkinson's disease, etc.): in a dose of 0.5 to 3 g (2-12 tablets) per day. The course of treatment is up to 4 months or more.
In the treatment and prevention of extrapyramidal syndrome (hyperkinetic and akinetic) caused by taking antipsychotics, in schizophrenia with cerebral organic failure: adults - in a dose of 0.5 to 1 g (2-4 tablets) 3 times a day; children - in a dose of 0.25 to 0.5 g (1-2 tablets) 3-4 times a day. The course of treatment is 1-3 months.
For epilepsy with slowing of mental processes in complex therapy with anticonvulsants and drugs: adults - in a dose of 0.5 to 1 g (2-4 tablets) 3 times a day; children - in a dose of 0.25 to 0.5 g (1-2 tablets) 3-4 times a day. The course of treatment is up to 6 months.
For psycho-emotional overload, decreased mental and physical performance, to improve concentration and memory: 0.25 g (1 tablet) 3 times a day.
For neurogenic urination disorders: adults - in a dose of 0.5 to 1 g (2-4 tablets) 2-3 times a day; children - in a dose of 0.25 to 0.5 g (1-2 tablets) 3 times a 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 the drug up to 3 g per day (12 tablets). Tactics for prescribing the drug: increasing the dose over 7-12 days, taking the maximum dose for 15-40 days and gradually reducing the dose until Pantogam® is discontinued over 7-8 days. The break between courses of Pantogam®, as for any other nootropic drug, ranges from 1 to 3 months.
For children with developmental delay: 0.5 g (2 tablets) 3-4 times a day. The course of treatment is 2-3 months.
Children with attention deficit hyperactivity disorder: in a dose of 0.25 to 1 g (1-4 tablets) 1-2 times a day in the morning and afternoon with dose titration over the first 5-7 days (the average therapeutic dose is 30 mg/day) kg of the child’s body weight per day). The course of treatment is 3-4 months.
For children with neurosis-like conditions (tics; stuttering, mainly in the clonic form): in a dose of 0.25 to 0.5 g (1-2 tablets) 3-6 times a day. The course of treatment is 1-4 months.
Taking into account the nootropic effect of the drug, it is preferably taken in the morning and afternoon (up to 17:00).
The drug is used in children over 3 years of age. At an earlier age, it is recommended to take the drug in syrup form.