Cortexin: appointment in pediatric practice, instruction manual

Cortexin peptide drug,which is used in medical practice in the treatment of neurological diseases, including acute disorders of blood circulation in the brain.

The drug is a lyophilisate (frozen dried substance) from the cerebral cortex of cattle, contains low-molecular active neuropeptides – a kind of protein molecules.

Drugs of peptide nature is characterized by targeting, high efficiency, selectivity of the effects on the body compatibility with different methods and ways of treatment, optimal pharmacokinetics, a lack of, or insignificant amount of side effects.

In addition to the main active ingredient in the peptide Cortexin present:

• stimulating amino acids – glutamic acid, glycine, aspartic acid and others;
• water soluble vitamins – thiamine, Riboflavin, nicotinic acid;
• fat-soluble vitamins – retinol, tocopherol;
• essential minerals – micro and macro.

Vitamin and mineral composition of the drug are balanced to neurons in the brain.

Cortexin was introduced to the production company “GEROPHARM” (St.-Petersburg) in 1999. The drug was developed as a medicine to mitigate/prevent the effects of concussions of the brain, has been successfully applied in the course of hostilities in Afghanistan. The practice of using Cortexin showed efficacy in a variety of pathological disorders of the brain, which led to its wide purpose in the national healthcare.

Cortexin optimizes the energy exchange process of the brain cells, improves the intracellular protein synthesis. In addition to the nootropic action (correction of cognitive functions), the drug exhibits the following effects:

• regulation of immunological reactivity (immunomodulatory effect);
• anticonvulsant and antiepileptic effects;
• neuroprotective effect;
• antistress and neurometabolic effects;
• an antioxidant effect.

Administration of low doses of drugs serves as a signal for the activation of the body’s own regenerative mechanisms. This kind of therapy is more effective and sparing for the patient. These features of the drug and its high bioavailability promoted the use of the drug in pediatric practice: neurology, neonatology, rehabilitation, emergency medicine, traumatology. Cortexin for babies is focused on age first day of life.

The main indication for the purpose of Cortexin – pathology associated with different types of cerebral ischemia and injury of various origins, violates the metabolic processes in neurons.

Medication is effective for a number of diseases, ranging from epilepsy, the treatment of which it has established itself very well, and ending with an extensive therapeutic pathology, where in practice attention to the treatment of many abnormalities of the brain activity weakened – vegetovascular dystonia, hypertonic disease, the many manifestations of cognitive impairment in elderly patients. The objective of this course of Cortexin on the background of conventional treatment gives positive results.

During practical use of the drugs has never been observed any side effects due to manufacturing technology and high degree of purification of organic drug. Similar properties foreign counterparts do not possess.

The application of Cortexin in children

Cortexin in children is successfully applied in the treatment of perinatal lesions of the nervous system and their outcomes, neuroinfections, epilepsy, hydrocephalus, migraine, tension headache, cerebral palsy, acute and recovery periods of traumatic brain injury, asthenia, delayed psychomotor and speech development.

There are several reports on the effectiveness of the drug in the treatment of attention deficit disorder and hyperactivity, General underdevelopment of speech, the specific speech disorders, reduced learning ability, multiple sclerosis, and also other varieties of primary and secondary headaches in addition to migraine and tension-type headaches.
In the clinics of the Scientific center of children health Russian Academy of medical Sciences has accumulated extensive experience in the application of Cortexin on the above and other testimony from children of different ages.

The application of Cortexin in children for correction of developmental disorders in perinatal lesions of the nervous system(PNS)

The basis of mental, motor, emotional and speech development in children is acquired in the period before birth (perinatal), pathology of the nervous system. Perinatal lesions of the nervous system is a frequent indication for prescription of Cortexin. The drug has a positive effect in almost all the syndromes are disorders of the nervous system in the acute and recovery periods.

Damage to the nervous system in the period before birth is accompanied by a delay in early development (to the year) and distant – after 2 – 3 years. The outcome of the damage may be the development of cerebral palsy (CP), epilepsy, hydrocephalus.

However, often the child suffers from delayed physical, mental (or psychomotor), emotional, speech development. There may be a number of pathological conditions of the psychoneurological sphere:

• specific developmental disorders of motor functions;
• General disorders of intellectual development;
• specific developmental disorders of speech;
• specific disorder of reading skills.
• specific disorders of numeracy skills;
• violations of activity and attention;
• other developmental disorders of school skills.

Anomalies noted in the first months of life, should guide pediatricians on the early provision of child medical care in full and achieve the best possible results. The early treatment and rehabilitation allows us to achieve more favorable outcomes acquired pathologies of the nervous system in the period before birth or later.

If such violations the role of Cortexin in the correction of neurological deficits is well established. Delayed psychomotor and speech development in children is a direct indication for the drug. One or two courses of treatment with Cortexin or other drug is usually insufficient. Provides dynamic observation of the child. Rehabilitation activities include an integrated approach, combining medical treatment with speech therapy techniques and pedagogical correction. For the gradual formation of speech involves speech therapists (speech pathologists).

The use of drugs allows to effectively exclude neurologic deficit, preventing a physiological and harmonious development of higher mental functions in the child. This is one of the most commonly prescribed drugs nootropic actions used in the medical activities of the staff of the Department of pathology in young children.

Also has experience in the application of Cortexin in the correction of behavior and impairments in the syndrome of attention deficit and hyperactivity, delay of psychomotor development in children with various food allergies associated with disorders of the nervous system with somatic (bodily) diseases.

Assigned Cortexin in complex treatment of infants with celiac disease, lactase deficiency, galactosemia type I or intolerance to cow milk protein in combination with pathology of the Central nervous system.

Cytoprotector peptide Cortexin firmly occupied the deserved place among the pharmacological agents used in the treatment and neurorehabilitation of children with delay of motor, mental, speech development.

The application of Cortexin in children with acute violation of cerebral circulation

To acute disorders of cerebral circulation (cerebral ischemia) include stroke and transient disorders of cerebral circulation. Indirectly related to the disorder also has a migraine.

Cerebral ischemia and migraine is also characteristic of some types of food intolerance, particularly celiac disease. Described strokes (including venous sinus thrombosis) in children with gluten intolerance.

Strokes in children

Neonatal strokes occur with a frequency of one in 4000 births a timely manner. Aged 1 month to 18 years, the average incidence of strokes is on the order of 7.8 cases per hundred thousand population.

Children’s (pediatric) stroke differs from similar pathology in patients over the age of 18. The main reason of a stroke of an adult is mainly atherosclerosis. Risk factors for stroke in a child are many and varied:

• birth injury;
• pathology of the cardiovascular system;
• infection;
• congenital and acquired prothrombotic/coagulation disorders;
• anomalies of development of vessels of the brain;
• the moyamoya disease;
• diseases of the blood;
• diabetes type 1 and others.

Although approaches to neuroprotection in paediatric stroke are very diverse, it is based on the use of pharmacological drugs with proven neuroprotective effect.

The main drug of neuroprotective actions in Russia is Cortexin. The study of high level of evidence (prospective, double-blind, placebo-controlled) showed that the use of the drug during the first 6 hours from stroke (early application) was accompanied by a significantly better recovery of neurological functions – docked and focal cerebral symptoms. Medication was prescribed 10 mg twice a day intramuscularly.
Cortexin has a positive effect on immunological parameters (in particular tumor necrosis factor alpha) in the acute period of ischemic stroke.
Has experience in the application of Cortexin:

• in complex therapy of children with cerebral ischemia;
• in the treatment of children with hypoxic-ischemic lesion of the Central nervous system;
• the nootropic and neuroprotective therapy for newborns with Natal cervical trauma (cervical spondylogenic lesions).

There is experience of application of Cortexin in the complex treatment of post-stroke epilepsy. The drug positively affects the bioelectric activity of the brain.

Transient ischemic attack

Transient ischemic attack is a sudden and relatively short-term (within 24 hours) disorders in the brain. Like the strokes, appear focal and/or cerebral symptoms occur in childhood, although reliable information about their prevalence in children in the available literature is not represented. Transient ischemic attack predict the development of stroke.

Causes of transient ischemic attacks in children and adolescents varied: hypertension, antiphospholipid syndrome, autoimmune and systemic diseases, obesity, coronary heart disease, physical inactivity, cervical osteochondrosis, migraine, infectious diseases, traumatic brain injury, acute and chronic intoxication, metabolic disorders, diabetes and more. Less to the development of transient ischemic attacks in a child cause hereditary coagulation disorders, the moyamoya disease, CADASIL syndrome.

Treatment of transient ischemic disorders of cerebral circulation is not fundamentally different from therapeutic strategies in ischemic stroke. To prevent the development of cerebral infarction needs long-term application of neuro – and angioprotectors. Cortexin described provides bi-directional, therefore, is the basis of treatment of the child with this pathology. One of the main reasons for the wide use of the drug – the lack of age restrictions and contraindications.

Migraine

Migraine is a paroxysmal severe headaches. At the basis of neurovascular disease are vascular, nervous, endocrine and humoral mechanisms. The patient has migraines accompanied by an increase in the risk of ischemic stroke in average 2.3 – 2.9 times.

In clinical practice, describes the experience of application of Cortexin in the treatment of migraine in child to prevent the progression of disease. The drug used in the treatment of migraine in 32 children. A positive result of treatment is to reduce the frequency and reducing the intensity of headaches was observed in 87.5% of cases. At the same time the observed children showed positive changes in heart rate variability.

The best results are achieved application of Cortexin in the treatment of traumatic brain injury, epilepsy, cerebral vascular pathology. The effect is less pronounced in disorders of the autonomic nervous system, migraine.

The application of Cortexin in critical conditions in newborns

A study in 2001 – 2005, possibilities of application of Cortexin in critical conditions in newborns allowed to draw the following conclusions:

1. Cortexin is an effective stress-limiting factor in the treatment of children of early age with acute cerebral insufficiency.
2. In acute cerebral insufficiency at newborns and children of early age Cortexin addresses pathophysiological responses activated by the sympathetic system. Under the influence of drugs reduces the tension of cardiac rhythm in neonates, mobilized endogenous cortisol, normal consumption of glucose by brain tissue.
3. In diseases manifesting with generalized brain damage inflammatory and reperfusion (damage to the Central nervous system in the neonatal period, neuroinfections), Cortexin in children improves the final result of treatment.

In diseases beginning with local damage of the brain, the effect of the medication on the final result is not obvious and requires research in large groups.

For Cortexin characteristic tkanespecificescoe, high bioavailability, the almost complete absence of adverse effects and good tolerance by patients of any age. Pharmacological properties of the drug allows the treating physician to increase the dose and duration of therapy, without fear of unwanted effects.
Cortexin is an innovative drug substance and dosage forms which are protected by patents of the Russian Federation.

Cortexin: instructions for use

Pharmacological action

Cortexin contains a complex of low molecular weight water-soluble polypeptide fractions that penetrate through the blood-brain barrier directly to the nerve cells. The drug has nootropic, neuroprotective, antioxidant and tissue-specific action.

Nootropic action
Improves higher functions of the brain, learning and memory, concentration, stability under different stress conditions.

Neuroprotective effects
Protects neurons from neurotoxic lesions of various endogenous factors, glutamate, calcium ions, free radicals, reduces the toxic effects of psychotropic substances.

Antioxidant effect
Inhibits lipid peroxidation in neurons, increases survival of neurons under conditions of oxidative stress and hypoxia.

Tissue-specific action
Activates metabolism of neurons of the Central and peripheral nervous system, reparative processes, improves the function of the cerebral cortex and the overall tone of the nervous system.

The mechanism of action of the drug due to activation of peptide neurons and neurotrophic factors brain; optimizing the balance of the metabolism of excitatory and inhibitory amino acids, dopamine, serotonin; GABA-ergic effects; reduction in the level of paroxysmal convulsive activity of the brain, the ability to improve its bioelectric activity, preventing the formation of free radicals – products of peroxide oxidation of lipids.

Dosage forms

Cortexin is made in the form of a lyophilized (dried and frozen substances) for solution preparation for intramuscular administration in the form of powder or porous mass of white or white with a yellowish sheen color.

Composition

One vial contains the active substance Cortexin (complex of water-soluble polypeptide fractions) 5 mg or 10 mg; excipients – glycine 6 mg or 12 mg (stabilizer).

Testimony

In the complex therapy of the following conditions and diseases:

• violations of cerebral circulation and their consequences;
• traumatic brain injury and its consequences;
• encephalopathy of different Genesis;
• cognitive disorders (disorders of memory and thinking);
• acute and chronic encephalitis and encephalomyelitis;
• epilepsy;
• scenicheskoe condition;
• suprasegmental autonomic disorders;
• reduced learning ability;
• delayed psychomotor and speech development in children;
• critical condition in newborns with perinatal lesions of the nervous system;
• various forms of cerebral palsy.

Contraindications

Individual intolerance of the drug.
Pregnancy and lactation.
The drug is contraindicated in pregnancy due to the lack of clinical trial data. If necessary, the appointment of the drug during lactation should stop breastfeeding due to the lack of clinical trial data.

Method of application and dosing

The drug is administered intramuscularly.
The contents of the vial before injection dissolved in 1 – 2 ml of 0.5% solution of procaine (novocaine), water for injection or 0.9% sodium chloride solution by guiding the needle to the wall of the vial to avoid foaming, and is administered once daily:

• adult dose 10 mg for 10 days;
• children with body weight under 20 kg a dose of 0.5 mg per kilogram of body weight for 10 days;
• children weighing more than 20 kg at a dose of 10 mg for 10 days.

If necessary, carry out repeated treatment after 3 to 6 months.
When polyarnom ischemic stroke in the acute and early recovery periods adults drug administered in a dose of 10 mg twice a day (morning and afternoon) for 10 days with a repeated course of therapy in 10 days.

Side effects

Information about side effects were reported. Possible individual hypersensitivity to the drug.

Overdose

Currently, the cases of drug overdose were reported.

Special instructions

Candles should only be used in accordance with the physician’s prescription.
The vial with the dissolved drug can not be stored and used after storage. The solution of the drug Cortexin is not recommended to mix with other solutions.

Peculiarities of action of the medicinal product at first use or withdrawal thereof do not exist.
In the case of missing injections do not inject a double dose, and spend the next injection as usual on the scheduled day.
Special precautions for disposal of unused drugs is not required.

Interaction with other drugs

Drug interactions drug Cortexin is not described.
Cortexin is released on prescription. The use of the drug does not affect the performance of potentially hazardous activities that require special attention and fast reactions (driving vehicles, work with moving machinery).

Analogues Of Cortexin

Cortexin is a nootropic drug mixed with a wide range of effects (neuroprotectant). Medicamental correction with use of the drugs in this group is one of the leading trends in the treatment of consequences of violations of cerebral circulation in children.

In pediatric practice for this purpose apply the following medications: Actovegin, Aminalon (Gammalon), Biotredin has Vazobral, Gliatilin (Cerepro), Glycine, Dimephosphone (12 years), Instenon, Kogitum (7 years), Cortexin, Qudesan (after 1 year with care), MiniCAM (three months), Noben, Pantogam (syrup from birth), Pikamilon, Piracetam, Semax (5 years), TenTen children (from 3 years), Phenibut (2 years), Cerebrolysin, Cinnarizine (12 years), Encephabol (suspension).

In connection with the deficit of clinical research in Pediatrics within the same international nonproprietary names (INN) of the drug unable to meet permitted and non-permitted for use in baby trade names.

There is also a list of the most popular drugs commonly appointed by the neurologists in pediatric patients who do not have special permission for use in children and used in violation of the age indications specified in the instructions for use. This Akatinol memantine, Kaviton, Mexidol, Mildronate, Milgamma, Noopept, Sermion, Tanakan, Phenotropil, Ceraxon, Cerebrum-compositum, Cereton.

The largest evidence base of clinical studies among drugs neurotrophic number of adults have gopantenova acid (Pantogam), Nooclerin, TenTen children, Actovegin, Cerebrolysin, Cortexin. These drugs razresheny to use neuropediatria.

Attention! Description of the preparation is simplified and augmented version of the official instructions for use. Information about the drug provided solely for informational purposes and should not be used as a guide to self-healing.

International nonproprietary name	The trade name of the drug	Price	Release form	Manufacturer
no	Cortexin	734 RUB.	Lyophilized powder for injection 5 mg, 10 bottles	Russia
	Cortexin	1200 RUB.	Lyophilized powder for injection 10 mg 10 vials
D,L-gopantenova acid	Pantogram	363 RUB.	Syrup 10 %, 100 ml	Russia
Deanol aceglumate	Nooclerin	397 RUB.	The oral solution 20 %, 100 ml	Russia
D	TenTen children	215 RUB.	Lozenges, 40 pieces	Russia
	Actovegin	230 RUB.	Solution for injection 40 mg, 2 ml ampoule, 5 ampoules	Austria
	Cerebrolysin	994,50 RUB.	Solution for injections, 2 ml in ampoule, 10 ampoules	Austria