TOP 6 analogues of Ceraxon by active ingredient in ampoules and tablets

Has restrictions during pregnancy

Prohibited during breastfeeding

Prohibited for children

Allowed for older people

Has limitations for liver problems

Has limitations for kidney problems

Ceraxon is a popular effective drug from the group of nootropics. The drug is prescribed for the treatment of various neurological disorders associated with degenerative processes in brain structures or vascular damage. The drug is produced in 2 dosage forms:

• solution for intravenous and intramuscular administration;
• solution for oral administration.

The active ingredient of the drug, citicoline, has a wide spectrum of action. With regular use, it has a positive effect on brain cells - preventing their death, restoring damaged membranes. This helps reduce the severity of neurological symptoms due to brain damage due to stroke, TBI and other factors.

pharmachologic effect

Manufacturer: Ferrer International, Spain
Release form: oral solution, injection solution

Active ingredient: citicoline

Synonyms: Noocil, Recognan, Naypilept, Encetron

The effect of the drug is due to the substance citicoline, which is a natural endogenous compound. The product has a wide spectrum of action:

• restores damaged brain cell walls;
• prevents cell death;
• reduces the volume of affected brain tissue;
• accelerates recovery after traumatic brain injury;
• improves attention and memory.

Once in the body, citicoline is quickly absorbed, reaches the brain cells and is integrated into them.

Ceraxon - instructions for use

The dosage regimen and medication regimen are calculated based on the form of release, the condition and age of the patient.

In the acute period of stroke or TBI, the drug is administered intravenously at 1000 mg twice a day for 3–5 days. Then 1 sachet or 10 ml 2 times a day. The course of treatment is at least 1.5 months.

During recovery, the dosage of Ceraxon is 500-2000 mg per day, and the duration of therapy is set individually.

How to take Ceraxon: before or after meals

According to the instructions for use, Ceraxon is taken between or during meals. If necessary, the solution is diluted in ½ glass of water.

Structural analogues of Citicoline in Russia

Medicines that can be used to replace the original drug are divided into two large groups. One of them includes those developed with the same active ingredient. They have identical mechanisms of action, indications and similar methods of use.

It is worth noting that in Russia Citicoline is not sold under the same name. The trade name of the drug is Ceraxon.

Generic drugs include:

1. Naypilept.
2. Recognan.
3. Ceresil.
4. Somazina.

Before replacing a prescribed drug, you should consult your doctor.

Cerakson

Ceraxon was developed on citicoline and is also included in the group of nootropic drugs. Under its influence, the function of ion exchange pumps in the cell membranes of the central nervous system (CNS) is normalized due to the formation of new phospholipids.

The drug affects the mechanisms of apoptosis, thereby protecting cells from death. In case of oxygen starvation of the brain, the drug helps eliminate cognitive deviations.

Prescribed for diagnosis:

• acute ischemic stroke;
• hemorrhagic stroke;
• vascular diseases of the brain.

LP also helps reduce the duration of post-traumatic coma and is used during the rehabilitation period after a traumatic brain injury.

The list of contraindications includes:

• individual intolerance to components;
• pronounced vagotonia;
• fructose intolerance.

For the treatment of acute stroke, doctors prescribe 1000 mg twice a day. It is recommended to give 50 mg to newborns, and 10 mg to children over 3 months. Treatment of children should be carried out under the supervision of a doctor.

Ceraxon is a structural analogue of Citicoline. These are absolutely identical drugs.

Naypilept

The role of the main active ingredient in the nootropic drug is citicoline. This substance is a natural endogenous compound. After penetration into the body, it restores damaged membranes, prevents excessive release of free radicals, and blocks the effects of phospholipases.

The therapeutic effect occurs when treating:

1. Acute form of ischemic stroke (IS).
2. Cognitive or behavioral disorders that manifest themselves against the background of vascular pathologies.
3. Traumatic brain injuries.

Often drugs are prescribed to eliminate the consequences of a hemorrhagic stroke.

Doctors include the following conditions for which it is not recommended to use Neypilept:

• increased susceptibility to components;
• childhood;
• pregnancy/lactation;
• vagotonia.

When diagnosing an acute period of IS, it is recommended to take the medicine 1000 mg every 12 hours. During the recovery period, the daily dose ranges from 500 to 2000 mg, depending on the severity and characteristics of the disease.

Neypilept and Citicoline are complete analogues. They have the same composition and indications for use. The drugs differ by country of origin. The generic is a domestic drug, and the original is produced in Spain.

Recognan

The drug is included in the pharmacotherapeutic group of nootropics. Its mechanism of action is due to citicoline. It has nootropic and neuroprotective properties. Shows therapeutic activity in chronic forms of cerebral ischemia, cognitive impairment, and dementia. Gently eliminates absent-mindedness, lack of initiative and apathy, normalizes self-care skills and improves memory.

It is recommended to use this medication for the treatment of:

1. Acute AI.
2. Traumatic brain injuries (hereinafter referred to as TBI).
3. Behavioral disorders and cognitive disorders.

In general, the medicine is quite well tolerated by patients, but doctors highlight a list of conditions in the presence of which it can negatively affect the general condition. It includes pregnancy, breastfeeding, childhood, hypersensitivity to components, fructose intolerance and increased tone of the parasympathetic part of the autonomic nervous system.

The solution is intended for oral administration. Should be taken before or after meals. For the treatment of acute stages of IS, 1000 mg is prescribed twice every 24 hours. The maintenance dose is 500-2000 mg. The exact amount of drugs is determined by the attending physician.

Recognan, like the original medication, effectively eliminates unpleasant symptoms and exhibits a high degree of therapeutic activity. These are complete analogues that have no differences except the price.

Ceresil

Ceresil is a nootropic drug. Manufacturers used citicoline as the main component. This natural compound has a fairly wide spectrum of action and is prescribed for vascular diseases, injuries, and motor neurological disorders. It has a nootropic and neuroprotective effect.

Helps improve attention and memory, prevent cell death, and accelerate the recovery process after a TBI.

Main indications for use:

• AI in the acute period;
• TBI and rehabilitation period;
• behavioral/cognitive disorders that manifest themselves with the progression of vascular or degenerative diseases;
• recovery period after hemorrhagic stroke.

Before use, you must read the list of contraindications. It includes:

• obvious signs of vagotonia;
• increased susceptibility to components;
• poor tolerance to fructose.

The standard instructions indicate that the product is not suitable for use in pediatrics. However, doctors often prescribe it to children with problems with speech development and other neurological pathologies.

Syrup for internal use can be diluted with a small amount of water. A single dose for adult patients is 1000 mg. The course of treatment can last for six weeks. To maintain the condition, doctors recommend taking from 500 to 2000 mg per 24 hours. In old age, you do not need to adjust the daily dose if the drug does not cause negative reactions.

The structural analogue fully corresponds to the original drug. They have identical properties and are based on the same substance, but the analogue is slightly cheaper.

Somazina

The nootropic drug is available in the form of syrup for oral administration. It is developed on the basis of citicoline. It has nootropic and psychostimulating properties. Leads to normalization of the functioning of ion pumps and receptors, reabsorption of brain swelling, and reduction in the production of free radicals.

It is advisable to take the medicine when diagnosing:

1. AI in the acute stage.
2. TBI and its consequences.
3. Cognitive deviations.
4. Behavioral disorders under the influence of progressive vascular disease.

If you have vagotonia and hypersensitivity to the components of the medication, taking it is strictly prohibited. It is also not advisable to prescribe the drug to patients who exhibit impaired tolerance to fructose, since it contains sorbitol.

The duration of treatment and dosage are selected by the attending physician, based on the diagnosis. The manufacturer's instructions indicate that the product is taken three times a day, 200 mg. The maximum allowable amount is 2000 mg.

Somazina is a complete analogue of Citicoline. The only difference is the cost.

See also:

TOP 10 analogues of Cerebrolysin - cheap substitutes for the drug in ampoules and tablets

Cerakson's analogs

The modern pharmaceutical market offers a wide range of nootropic drugs analogues of Ceraxon based on the active substance or mechanism of action in tablets, solution for injection and oral administration. Medicines may differ in composition, action and dosage regimen.

List of Ceraxon analogues with prices

There is often a question about what can replace Ceraxon for an adult or which drug is better. All ambiguities associated with the choice of medication should be resolved by the attending physician.

Prices of Citicoline and its analogues

The cost of the medicine depends on many factors: manufacturer, quantity, release form, dosage. The average cost of Citicoline in syrup is 710 rubles (30 ml), and in solution form – 1130 rubles. If the patient is not satisfied with the price of the drug, you can choose an analogue at a more affordable price, after consulting with your doctor.

Substitutes may have the same chemical formula or principle of action.

[compare name=`Cerakson|Neypilept|Recognan|Ceresil|Somazina|Cavinton|Phesam|Vinpotropil|Aminalon`]

Analogs, like the original, are available with a prescription.

See also:

TOP 6 cheap Phezam analogues - structural substitutes for the drug

Ceraxon or Cortexin - which is better for the elderly

Manufacturer: GEROPHARM LLC, Russian Federation
Release form: lyophilisate for preparing a solution for intramuscular administration

Active ingredient: polypeptides of the cerebral cortex of cattle

Synonyms: Cellex

Analog of Ceraxon - Cortexin injections. The medication has a noopropyl and antioxidant effect, improves metabolism in nerve cells and protects them from toxic effects. Cortexin is indicated for cerebrovascular accidents, encephalopathy, head injury, cerebral palsy, and developmental delay in children.

The analogue is administered intramuscularly 1–2 times a day, after dissolving the contents of the bottle.

Cortexin and Ceraxon have different compositions, but similar action and effectiveness, which is confirmed by numerous reviews. Both drugs can be used in older people without dose adjustment.

Substitutes for therapeutic effect

In some cases, medications are required that have a different active substance (for example, if you are intolerant), but have a similar therapeutic effect.

Vinpocetine

The action of a medicine based on vinpocetine is aimed at improving cerebral blood flow and metabolism, as well as normalizing blood viscosity. The spectrum of action of the product is very wide, in particular:

• stroke;
• TBI;
• cerebral atherosclerosis;
• encephalopathy;
• spasm of cerebral vessels;
• vascular dementia;
• motor and cognitive disorders;
• thrombosis of eye vessels, glaucoma, retinal changes;
• hearing impairments of various nature;
• vasovegetative disorders associated with menopause.

This medication is prohibited for use in the presence of heart problems - coronary artery disease, severe arrhythmia, as well as in children under 18 years of age; pregnant and breastfeeding women.

Piracetam

Piracetam, which is the basis of the drug of the same name, is a nootropic substance that is a cyclic derivative of gamma-aminobutyric acid (GABA). Its main effect is to improve connections between the hemispheres of the brain and synaptic transmission in neocortical structures, as well as improve cerebral blood flow. It is used for the symptomatic treatment of intellectual-mnestic disorders (if there is no diagnosis of dementia) and for myoclonus (involuntary muscle contractions).

Contraindications for its use are:

• intolerance to piracetam and pyrrolidone derivatives;
• hemorrhagic stroke;
• Huntington's chorea;
• severe chronic renal failure;
• age up to 3 years;
• severe hemorrhagic disorders.

Noobut

This is a psychostimulant and notropic drug based on phenibut. Available in the form of tablets for oral administration of 100 or 250 mg of the active ingredient. The main advantage is its mild action and lack of pronounced toxicity. It can be prescribed to children to treat stuttering, urinary incontinence, and nervous tics.

For adults, the medicine helps cope with insomnia, emotional lability, stress, nervousness, and asthenia. The drug is also prescribed to prevent motion sickness and to eliminate withdrawal symptoms.

Glycine

Glycine is an amino acid that is produced by the human body. To compensate for its deficiency, a synthesized analogue is used. When consuming the substance, there is an improvement in metabolism in the brain.

Glycine has antidepressant, antitoxic, antioxidant and sedative effects. It is prescribed to improve intellectual and thinking abilities, eliminate neuroses, sleep problems, and also as part of a comprehensive treatment of alcoholism.

Cortexin

A drug based on polypeptides from the cerebral cortex of cattle is classified as a neurostimulant. It is available in the form of a lyophilized powder, from which a solution for injection is prepared. The main actions are nootropic, neuroprotective, antioxidant.

Cortexin is prescribed as an adjuvant for:

• stroke and TBI;
• asthenia;
• encephalopathy;
• epilepsy;
• cerebral palsy;
• delayed speech and psychomotor development in children.

Cerakson or Mexidol - which is better for blood vessels, what is the difference

Manufacturer: ZiO-Zdorovye CJSC, Russian Federation
Release form: tablets, solution for intravenous and intramuscular administration

Active ingredient: ethylmethylhydroxypyridine succinate

Synonyms: Mexicor, Mexicofin, Neurox

Mexidol is a domestic analogue of Ceraxon, produced in ampoules and tablets. The drug has a wide spectrum of effects. The substance that is part of Mexidol has a nootropic, anticonvulsant effect, protects cells from destruction, and eliminates the lack of oxygen in the body.

Mexidol is prescribed for the following conditions:

• cerebral circulatory disorders;
• vegetative-vascular dystonia;
• consequences of concussion;
• stress and anxiety conditions;
• acute period of myocardial infarction;
• poisoning with alcohol, psychotropic drugs.

The dosage and regimen of taking the medication are selected by the doctor individually.

It is impossible to answer which medicine is best for blood vessels. Many years of practice have shown that Ceraxon and Mexidol are complementary drugs. Joint use is used by neurologists for TBI, strokes, and cerebrovascular accidents.

Substitutes from the group of nootropics

The second group of analogues includes drugs that have similar properties and characteristics, but differ in chemical formulas. They may only partially coincide in their readings.

You need to be as careful as possible with such substitutes. To avoid complications of the situation, you cannot replace the prescribed drug yourself. You can purchase another medicine only with the permission of your doctor.

A qualified specialist, taking into account the patient’s condition and the characteristics of his illness, will help choose the most optimal remedy.

Among the substitutes that are popular today are:

1. Phezam.
2. Aminalon.
3. Cavinton.
4. Vinpotropil.

These drugs are also available by prescription. Before use, you must familiarize yourself with the features of the drug and the instructions.

Cavinton

Cavinton represents a pharmacological group of drugs that help improve cerebral blood flow. The mechanism of action is determined by the active component of the drug, vinpocetine. After penetration into the body, the substance normalizes brain metabolism, saturates the brain with oxygen and glucose, and increases the ability of neurons to withstand hypoxia. The medication also has an inhibitory effect on platelet aggregation and reduces excessive blood viscosity.

Widely used in the fields of ophthalmology, neurology and otolaryngology. Main indications for use:

• secondary glaucoma;
• atherosclerosis;
• vasospasms of the retina;
• embolism;
• age-related decrease in hearing acuity;
• ischemia;
• vascular dementia;
• mental and neurological disorders;
• vertebrobasilar insufficiency.

Contraindications include increased susceptibility, pregnancy, breastfeeding, coronary artery disease, arrhythmia.

The method of use of the drug depends on its dosage form:

1. The solution is intended for intravenous administration. To prepare an infusion solution, you need to add 20 mg of the drug to 500 ml of saline solution. It is important to ensure that the rate of administration into the body does not exceed 80 drops. in a minute.
2. The drug in the form of tablets is taken after meals three times a day, one tablet at a time.

Cavinton and Citicoline differ in composition, release form and administration characteristics. Moreover, they both have a positive effect on brain function.

Fezam

This nootropic has a combined composition. The role of the active component is performed by two substances at once: cinnarizine and piracetam. It is characterized by nootropic, vasodilating, antihypoxic properties.

Under the influence of the drug, brain function is activated, metabolism is improved and the rate of glucose consumption increases. Helps relax smooth muscles and increase their ability to resist the effects of factors that provoke narrowing of blood vessels.

It is recommended to take the medication for:

1. Atherosclerosis of blood vessels.
2. Intoxication.
3. Asthenic syndrome.
4. AI.
5. Meniere's syndrome.
6. TBI.
7. Pathologies of the central nervous system.
8. Asthenia.
9. Psychoorganic syndrome in children, which leads to a decrease in the degree of learning.

Experts do not prescribe medications to patients with:

• Huntington's chorea;
• hypersensitivity to components;
• manifestations of psychomotor agitation;
• renal or liver failure.

The list of contraindications also includes pregnancy and lactation. In the field of pediatrics, it is used to treat patients over 5 years of age.

It is prescribed with extreme caution in the presence of Parkinson's disease, impaired hemostasis, liver or kidney dysfunction.

The instructions from the pharmaceutical manufacturing company indicate that you need to take 1-2 capsules three times a day. Children over 5 years old are prescribed 1-2 capsules twice. The duration of the course depends on the severity of the pathology.

Unlike the original medicine, the substitute is developed on the basis of two active ingredients at once. It has a wider range of effects. They also differ in dosage forms.

Vinpotropil

Due to its combined composition, the medicine is included in the group of nootropic and cerebrovasodilating agents. Helps improve blood circulation in the brain, dilates blood vessels, supplies the brain with oxygen and glucose, and increases blood supply to the ischemic area. Leads to a decrease in platelet formation and blood viscosity.

Acting as a nootropic drug, Vinpotropil enhances beta and alpha activity, protects the brain from hypoxia or intoxication. Leads to an increase in the rate of glucose utilization, improves memory and the ability to reproduce new information, and facilitates the learning process.

Doctors recommend taking the drug for:

1. Ischemic stroke.
2. Cerebrovascular insufficiency.
3. Asthenic syndrome.
4. Meniere's syndrome.
5. TBI.
6. Intoxications.
7. Labyrinthopathies.
8. Psychoorganic syndrome.

Experts identify a number of conditions for which this remedy cannot be used. These include intolerance to the main components, childhood (up to 14 years), arrhythmia, liver and kidney failure, and an acute period of hemorrhagic stroke.

The recommended single dose is 1-2 capsules. Two to three doses per day are allowed. It is advisable to distribute them in such a way that the last one is before 18 hours.

The spectrum of influence of Vinpotropil is somewhat wider than that of the original product, since it contains several main components. Medicines differ in the form of release.

Aminalon

The nootropic drug is produced on the basis of gamma-aminobutyric acid. It has nootropic and neurostimulating properties. Leads to the restoration of metabolic processes, stimulates memory, increases the productivity of thinking, and normalizes high blood pressure.

The product also has antihypoxic and anticonvulsant properties. When used by patients with diabetes, it normalizes blood glucose levels.

The effectiveness of the drug is manifested in the treatment of:

• arterial hypertension;
• TBI;
• encephalopathy;
• cerebral palsy;
• atherosclerosis;
• polyneuritis;
• kinetosis.

This product has a high degree of safety. Do not use only if you are allergic to the components.

The daily adult dose is 3-3.75 g. It should be divided into three doses.

The substitute has a number of differences from the original drug. First of all, they consist of different components. Aminalon is a safer medication. They also differ in dosage form.

See also:

TOP 7 analogues of Picamilon - Russian and foreign substitutes for the drug

Ceraxon or Cerepro - which is better?

Manufacturer: JSC Veropharm, Russian Federation
Release form: capsules, solution for intravenous and intramuscular administration

Active ingredient: choline alfoscerate

Synonyms: Noocholin, Nooprin, Cereton

Cerepro is a substitute for Ceracson in sachets and ampoules. The medicine has a nootropic effect, stimulates the production of an important compound, choline, in the brain, improves memory and attention. The analogue is used in the acute and recovery period for stroke and concussion, encephalopathy, dementia and senile dementia.

Treatment with Cerepro begins with injections, administering 1 ampoule per day for 10–14 days, and then taking 1 capsule. 3 times a day. The course of treatment is up to six months.

If we compare both drugs, Ceraxon is more effective, faster therapy and has many positive reviews from doctors.

Ceraxon or Recognan - which is better for the elderly

Manufacturer: SAG Manufacturing, Spain
Release form: solution for oral administration and injection

Active ingredient: citicoline

Synonyms: Ceraxon, Citicoline, Neuropol, Noocil

Recognan is an analogue of Ceraxon in terms of the active substance, produced in ampoules, bottles and sachets. Medicines have the same effects, indications and contraindications. Recognan is well tolerated in old age and does not require additional dose adjustment.

The advantages and disadvantages of the drugs are shown in the table.

The treating neurologist should decide which medication to give preference.

Reviews from doctors and patients about the choice of Citicoline analogues

It is quite difficult to say with certainty which product is better. The choice of a suitable drug depends on many factors: characteristics of the disease, patient’s condition, personal preferences. With the help of reviews from doctors and people who have encountered the problem of selecting drugs, you can form a certain idea about them:

Lotsmanova O.O., pediatric neurologist: “Among analogues, Ceraxon (Citicoline) stands out for its convenient dosage form. It is quite difficult for kids to take pills, not to mention injections or IVs. It is much easier to drink a pleasant-tasting and aromatic syrup. The medicine has high rates of effectiveness. In my practice, I prescribe it to premature babies or after difficult births. The only drawback is the high cost."

Svetlana, 37 years old: “After a stroke in the hospital, my mother was prescribed Cerakson (iv). Symptoms included weakness in the left arm and leg. The drug eliminated sensory disorders. However, in addition to the positive effect, side effects appeared in the form of diarrhea. I also had to take antidiarrheal drugs. After some time it was replaced with Fezam. The form is more convenient and there were no side effects.”

Vladimir, 47 years old: “I went to the doctor with unpleasant symptoms. Severe and incessant dizziness developed. The pressure jumped. I was prescribed a 5-day course of Ceraxon. After a couple of days, anxiety, irritability and panic appeared. The pressure became even higher. I consulted the doctor again, and he replaced the drug with Aminalon. This effective and safe remedy helped me return to my normal lifestyle.”

Many patients prefer to use analogues, since the original often causes side effects. There are also people who took it and were satisfied with the results. It should be understood that the selection of drugs is a purely individual matter. Only with the help of a doctor can you create an optimal treatment regimen. Citicoline (Cerakson) and its substitutes are based on high-quality raw materials and are characterized by a mild effect.

Ceraxon or Cereton - which is better and more effective, what is the difference

Manufacturer: Sotex CJSC, Russian Federation
Release form: capsules, solution for intravenous and intramuscular administration

Active ingredient: choline alfoscerate

Synonyms: Cerepro, Gliatilin, Noocholin

Cereton is an analogue of Ceraxon, produced in solution for injection and capsules. The main component of the drug is choline alfoscerate. The substance exhibits a nootropic effect, promotes the production of choline, and enhances metabolic processes in the central nervous system. Cereton is used for traumatic brain injuries, strokes, disorders of consciousness, memory and disorientation.

During the recovery period after a concussion or stroke, take 800 mg in the morning and 400 mg in the afternoon. If dementia manifests itself, 1 capsule is prescribed 3 times a day.

The main advantages of the analogue are:

• more pronounced therapeutic effect;
• a small number of contraindications and adverse reactions;
• convenient form for reception.

Prices of the drug and its main analogues, average in Russia

Ceraxon is a high-quality medicine that is produced in Spain.
It is freely available, but is quite expensive. On pharmacy shelves you can find other, no less effective, but cheaper analogues of the drug. The table shows the main analogues of Ceraxon in terms of composition and mechanism of action, as well as their prices in different pharmacies in Russian cities.

Ceraxon or Cerebrolysin - which is better and more effective?

Manufacturer: EVER Pharma Jena, Germany
Release form: injection solution

Active ingredient: peptide complex

Cerebrolysin is an imported analogue of Ceraxon for oral administration and injection. The medication contains active neuropeptides that have a nootropic effect, protect nerve cells from damage, and improve metabolic processes in them. Cerebrolysin improves consciousness and memory.

The medication is used for traumatic brain injuries, strokes, dementia, developmental delays, memory and attention disorders in children, and Alzheimer's disease.

The dosage regimen and duration of treatment depend on the patient's condition. No additional dose adjustment is required for elderly patients.

A comparison of medications is shown in the table.

Contraindications for use

If, as a result of diagnosing the patient’s condition, the following features are revealed, Cerakson is not prescribed:

• individual intolerance to one of the components of the drug;
• tone of the autonomic nervous system, in its parasympathetic part;
• hereditary fructose intolerance.

Adverse reactions during treatment with Cerakson are extremely rare, among them are:

• coordination problems;
• pain in the occipital region;
• diarrhea;
• appetite disorders;
• insomnia;
• rash.

Sometimes short-term changes in blood pressure are observed, as well as loss of sensation, mainly in the arm and leg on the paralyzed side, if the patient has suffered a stroke.

If any of these reactions occur, you should discuss changing the course of therapy with your doctor.

Citicoline or Ceraxon - which is better?

Manufacturer: Ozon LLC, Russian Federation
Release form: solution for intravenous and intramuscular administration

Active ingredient: citicoline

Synonyms: Ceraxon, Noocil

Citicoline is a Russian analogue of Ceraxon 1000 mg in a sachet, which is available in ampoules. The drugs have the same active ingredient, mechanism of action, indications and contraindications for use.

Citicoline is administered intravenously or intramuscularly during the acute and recovery periods for traumatic brain injuries, strokes, and cognitive and behavioral disorders.

The main differences between the domestic analogue include:

• lack of oral form;
• reasonable price.

If the question is what is cheaper to replace Ceraxon in a sachet, then after consulting a doctor, preference is given to Citicoline.

The problem of the coexistence of reproduced (generic or generic) and original medicines (medicines) is very relevant for various countries of the world, incl. and Russia. Discussions are constantly taking place on the comparability of the effectiveness and safety of generic and original drugs. Various arguments and arguments are given in favor of the preferential use of both one and the other. Unfortunately, in Russia, not all doctors still clearly understand the difference between original and generic drugs, how they are created, and what advantages and/or weaknesses they have.

Let us give a definition of the concepts of original and reproduced (generic) drugs. These definitions are formulated in various paragraphs of the Federal Law of the Russian Federation “On the Circulation of Medicines” No. 61 of 04/12/2010. This law today is the fundamental regulatory legal act for all processes related to the study, registration and use of drugs in Russia.

The law defines that an “original drug” is a drug containing a pharmaceutical substance obtained for the first time or a new combination of pharmaceutical substances, the effectiveness and safety of which have been confirmed by the results of preclinical studies of the drug and clinical trials of drugs. “Reproduced medicinal product” is a medicine containing a similar pharmaceutical substance or a combination of the same pharmaceutical substances in the same dosage form as the original medicine, which came into circulation after the original medicine went into circulation.

Based on these definitions, let’s remember how doctors’ arsenal includes new medicines, which are called original? There are a relatively small number of large pharmaceutical companies in the world engaged in the development of new (innovative, original) drugs. This is due to the fact that the process of creating a new drug is very labor-intensive, high-tech, expensive and lengthy. From the moment the idea of ​​creating a new drug arises to the moment it is registered and begins widespread clinical use, many sequential events occur. It all starts with the search for new pharmacologically active compounds that can solve the problem set by researchers of effectively influencing the designated pharmacological target. The selection of the most promising molecules and assessment of their potential are carried out using a large number of in silico, in vitro and in vivo models. A procedure for assessing the acute, chronic and specific toxicity of the most promising molecules is mandatory. The pharmacokinetic parameters of the new drug are being studied in animals. If extensive preclinical studies are successful, the most successful molecule of a potential drug, enclosed in one or another dosage form, becomes the object of long-term clinical trials in accordance with all international requirements and standards of good clinical practice (GCP). This process includes three sequential phases of clinical trials (CTs). If a drug successfully passes trials in three phases of a clinical trial, it receives a marketing authorization and begins to be widely used in medical practice to treat patients [5–7].

Phase I clinical trials typically involve 20 to 100 healthy volunteers. Sometimes the high toxicity of a drug (for example, drugs for the treatment of cancer or HIV infection) makes such a study of healthy volunteers unethical. In this case, it is carried out with the participation of patients suffering from the corresponding disease. The purpose of the Phase I clinical trial is to establish the tolerability, pharmacokinetic (absorption, distribution, metabolism, excretion) and pharmacodynamic parameters of the drug, as well as to provide a preliminary assessment of its safety.

Having assessed the pharmacokinetics and pharmacodynamics, as well as the preliminary safety of the drug during a phase I clinical trial, the company developing the original drug initiates phase II studies on a patient population of 100–500 people. Phase II clinical trials are usually performed on a patient population selected according to strict criteria. An important goal of this study is to obtain evidence of the effectiveness of the new drug, to select its optimal dose and dosage regimen for phase III CT. The doses of the drug that patients receive in phase II studies are typically lower than the highest doses given to participants in phase I.

The Phase III CT is a randomized controlled multicenter trial involving a patient population of 300–3000 or more depending on the disease. It is designed to demonstrate the safety and effectiveness of a drug for a specific indication in a specific patient population.

Phase III clinical trials can study the dose-dependent effect of the drug. Having confirmed the effectiveness and safety of the drug in phase III studies, the company forms the so-called. registration dossier of the drug, which describes the methodology and results of preclinical and clinical studies, production features, composition, shelf life. The totality of this very voluminous information is submitted to the authorized health authority that carries out the registration.

Phase IV studies are conducted after the registration of the original drug. As part of phase IV, the clinical trials necessary to optimize its use are carried out. An important task of phase IV is to collect additional information about the safety of the drug in a sufficiently large population of patients over a long period of time. The goals of phase IV clinical trials may include assessment of parameters such as treatment duration, interaction with other drugs or food products, comparative analysis of standard courses of treatment, analysis of drug use in patients of different age groups, economic indicators of treatment and long-term results of therapy. In observational (non-interventional) CTs, after registration, information is collected on how the drug is used by doctors in their daily clinical practice, which makes it possible to judge its effectiveness and safety in “real life” conditions. If rare but serious adverse events are detected during phase IV clinical trials or post-marketing observational studies, the drug may be withdrawn from the market or its use may be limited.

It is believed that on average, all stages of the development of an original drug take up to 12–15 years, and costs can significantly exceed $1 billion. It is no coincidence that in the last decade there has been a concentration of the pharmaceutical industry, a merger of the largest pharmaceutical companies, which allows them to bear the enormous costs of research and the introduction of new drugs. The company that developed the original drug receives a patent for it. The validity period of the latter provides the company with the right to exclusive production and distribution (sale) of the drug in the first years after its registration. This should offset the cost of developing the drug and also enable the company to make a profit. Thus, the undoubted advantage of the original drugs is that they are new, high-quality modern drugs, studied on thousands of patients in compliance with all GCP requirements; the effectiveness and safety of these drugs have actually been proven both at the stages of clinical trials before registration and in large clinical trials after registration . A relative disadvantage of original drugs is the fact that they can be quite expensive. However, it should be taken into account that, according to pharmacoeconomic studies, the final cost of treatment when using a new, expensive, high-quality original drug can often be less than when using alternative drugs. This is achieved by reducing the patient’s time in the hospital, improving his ability to work, reducing the number of adverse events, hospitalizations, incl. repeated

How do generic drugs appear in the arsenal of doctors? These drugs go through a completely different path from the synthesis stage to the moment of registration and the beginning of widespread clinical use. After the expiration of the patent for the original medicine, it becomes an “international property”, i.e. the active principle of the drug and dosage forms containing it can be legally reproduced by other pharmaceutical companies (generics). The main question that is the subject of heated debate is: how interchangeable are original and generic drugs? It is absolutely clear that generic drugs do not undergo the multi-stage procedure for studying the effectiveness and safety for animals and humans, which was described above. What is offered in return? In various countries of the world, incl. in Russia, various types of equivalence of original and generic drugs are being studied. There is a concept of “pharmaceutical equivalence”. Pharmaceutical equivalents (pharmaceutically equivalent drugs) are drugs that contain identical pharmaceutical substances in the same doses (concentrations), dosage forms and chemical modifications (for example, identical salts or esters), meet established standards of identity, strength, quality and purity. Pharmaceutical equivalents may differ in appearance, notches on tablets, packaging, composition of excipients (including dyes, flavors and preservatives), expiration date, etc. Pharmaceutical equivalence does not guarantee pharmacokinetic bioequivalence, and therefore does not replace the assessment of bioequivalence - the main study underlying the registration of a drug that has a systemic bioavailability parameter.

The Federal Law “On the Circulation of Medicines” defines that “a study of the bioequivalence of a medicinal product is a type of CT of a medicinal product, which is carried out to determine the rate of absorption and excretion of a pharmaceutical substance, the amount of a pharmaceutical substance reaching the systemic bloodstream, the results of which allow us to draw a conclusion about the bioequivalence of the reproduced medicinal product in a certain dosage form and dosage corresponding to the original medicinal product.” It is generally accepted that bioequivalent drugs are therapeutically equivalent and, therefore, interchangeable. Assessment of the bioequivalence of a generic to the original drug is based on a pharmacokinetic study. The results of the study allow us to compare the bioavailability of original and generic drugs, i.e. comparison of indicators characterizing the rate and extent to which the active pharmaceutical substance is absorbed from the drug and enters the systemic circulation, which implies entry into the site of action [4].

A pharmacokinetic bioequivalence study is carried out in two stages using a crossover randomized trial design of two drugs in a limited number of healthy volunteers (from 18 to 50 people). The subjects are administered single doses of generic and original drugs and the level of the drug in the blood plasma is measured at specified time intervals. At the same time, at the first stage of the study, half of the test volunteers randomly receive the original drug, the other half - the generic one. At the second stage of the study, the opposite order of drug administration is used. As part of the statistical analysis of the results of bioequivalence studies, mean values ​​and 90% confidence intervals are calculated for a number of pharmacokinetic parameters (Cmax, TCmax and AUC). For each indicator, the ratio of the corresponding values ​​of generic and original drugs is calculated. Based on the results of the bioequivalence study, a detailed report and other documentation are drawn up in accordance with existing requirements. These documents form the basis of the registration dossier of the drug. Further, the process of registration of the reproduced drug occurs within the framework of the procedures provided for by the law of the Russian Federation “On the Circulation of Medicines”. The main and only advantage of reproduced drugs over original ones is their lower cost. The low price of a generic drug is explained by the fact that its creation and registration do not require such colossal costs as when creating an original drug. However, it should be emphasized once again that these drugs do not undergo actual efficacy testing in patients, but are subjected only to comparative pharmacokinetic testing with the original drugs.

The most reliable criterion for comparative assessment of the effectiveness of generic and original drugs remains the assessment of therapeutic equivalence. A therapeutic equivalence study is a type of clinical trial, which is carried out to identify the same properties of drugs of a certain dosage form, as well as the presence of the same indicators of safety and effectiveness of drugs, the same clinical effects when used. In the Russian Federation, this study is not mandatory for generic drugs and is almost never carried out. At the same time, in the USA, generic drugs that have passed therapeutic equivalence studies are included in the so-called. FDA Orange Book. Accordingly, generic drugs are divided into category “A” (that have passed therapeutic equivalence studies) and category “B” (that have not passed these studies). Category A drugs are preferable for use.

A therapeutic equivalence study involves 70–150 patients. It is advisable that the study be conducted in two or three clinical centers. The nosological homogeneity of the study group of patients, the adequacy of the method for assessing therapeutic effectiveness and statistics are important. The number of patients included in the study is determined by its design, the potential spread of indicator values ​​that reflect the effects of the drugs being compared during the study. The “non-inferiority” hypothesis is tested. The main criterion for including patients in a therapeutic equivalence study is the indication for use, regulated in the instructions for medical use of the original drug, i.e. the indication for which the original and generic drugs will be compared. Both bioequivalent and therapeutically equivalent drugs may differ in tablet form, notches, packaging, excipients (including colors, flavors and preservatives), expiration date, storage conditions and stability under adverse storage conditions. It should be borne in mind that if the original drug taken by the patient is replaced with a generic one with the above differences, patients may become disoriented due to a different shape or color of the tablets, or the inability to measure the required dose when using part of the tablet if there are no notches. There may be a taste aversion to certain drugs due to the filler, or the development of an allergic reaction to the dye or preservative. If such differences are important to the treatment of a particular patient, the treating physician should prefer to dispense a drug with a specific brand name on a medical necessity basis. This can be done by decision of the medical commission of the medical organization.

Ceraxon® (citicoline) is a striking example of an original drug used in neurology. The presence of a full range of preclinical (in vitro and in vivo on laboratory animals) and clinical (on healthy volunteers and various patient populations) studies is the main difference between the original citicoline (Ceraxon®) and its generic versions. Details of the mechanism of action of citicoline, pharmacokinetic parameters, optimal doses and modes of administration, interaction with other drugs in complex drug therapy have been studied in depth and in detail using the original drug Ceraxon®. All this data is presented in detail in the registration dossier of the drug. After the study of Cerakson® according to all the rules of preclinical studies and GCP, it began to be widely used by patients with various pathologies. Citicoline (cytidine-5-diphosphocholine) is an organic substance of a group of nucleotides, biomolecules that play an important role in cellular metabolism. Citicoline can be endogenous or exogenous. The endogenous formation of citicoline is a step in the synthesis of phosphatidylcholine from choline. Citicoline is an essential precursor of phosphatidylcholine (lecithin), the main phospholipid of all cell membranes, including neuronal ones. Choline also takes part in the synthesis of acetylcholine, and citicoline acts as a donor of choline in the processes of its synthesis. Exogenous citicoline allows you to save choline reserves in the body, inhibit the breakdown of membrane phospholipids, and improve the transmission of nerve impulses [3, 23, 26, 27]. When entering the gastrointestinal tract, exogenous citicoline is hydrolyzed in the small intestine. As a result of hydrolysis, choline and cytidine are formed in the intestinal wall and in the liver (the latter is then transformed into uridine). After absorption, they enter the systemic circulation, participate in various biosynthetic processes and penetrate the blood-brain barrier into the brain, where citicoline is resynthesized from choline and cytidine. Citicoline resynthesized in the brain activates the biosynthesis of phosphatidylcholine and prevents its catabolism from neuronal membranes. It maintains normal levels of cardiolipin (a major component of mitochondrial membranes) and sphingomyelin. Citicoline inhibits the synthesis of phospholipase A2, reduces the accumulation of free fatty acids, enhances the activity of antioxidant systems (stimulates the synthesis of glutathione), prevents the processes of oxidative stress and apoptosis, has a positive effect on cholinergic transmission, stimulating the formation of acetylcholine, and also modulates dopamine and glutamatergic neurotransmission. All these effects contribute to the activation of energy processes in neurons, normalize tissue respiration processes, and lead to a decrease in apoptotic cell death [10]. For more than 40 years, Ceraxon® (citicoline) has been used in the USA, Japan and European countries for the treatment of cerebral stroke (ischemic and hemorrhagic), traumatic brain injury (TBI), and cognitive impairment. Citicoline today is one of the few neuroprotectors with high evidence of effectiveness in studies [2, 8, 11].

All large CTs with a high level of evidence were conducted with the original citicoline drug Ceraxon®. Thanks to a wealth of evidence-based research, Ceraxon® (citicoline) is the only neuroprotector included in the 2008 European guidelines for the treatment of stroke [20]. The first double-blind, multicenter, placebo-controlled study to study the effect of Ceraxon® in cerebral infarction was conducted in Japan in 1988 [28].

It demonstrated that Ceraxon® is effective for the treatment of acute stroke. Similar results were obtained later in research centers in other countries [18]. In 1997, the first double-blind, randomized, multicenter clinical trial using oral Ceraxon® (citicoline) for the treatment of acute ischemic stroke was launched in the United States, assessing the effectiveness of different doses of the drug [14]. The results of the study indicated the clinical effectiveness of oral administration of Ceraxon®, and the dose of 500 mg was the most effective and justified. A large study examining the effectiveness of Ceraxon® (citicoline) in ischemic stroke, ECCO-2000, was conducted in the USA in 2000–2001. it included 899 patients with moderate to severe stroke [15]. The ECCO study assessed the effect of Ceraxon® on lesion volume in cerebral infarction using the latest neuroimaging techniques. In a fairly large number of patients treated with Ceraxon® (citicoline), a decrease in lesion volume was noted, which significantly correlated with clinical improvement. A number of reviews have also drawn conclusions about the feasibility of prescribing Ceraxon® for stroke, its safety and good tolerability by patients [16, 26]. The multicenter, randomized, placebo-controlled ICTUS trial involving 2298 patients was conducted in 59 centers in Spain, Germany and Portugal. The study assessed the effectiveness of treatment with Ceraxon® (citicoline) for acute moderate and severe ischemic stroke [13]. The effect of the drug was pronounced in subgroups of patients over 70 years of age with moderate stroke severity, as well as those who did not receive concomitant treatment with tissue plasminogen activator.

Many studies have been conducted that have established the effectiveness of Ceraxon® (citicoline) in the treatment of cognitive disorders of neurodegenerative, involutional and vascular origin [9, 19, 24, 25]. In 2005, a Cochrane review was published on the use of citicoline for the correction of cognitive and behavioral disorders in chronic cerebrovascular pathology in the elderly, which concluded that this drug is useful for the correction of such disorders [17]. Extensive clinical experience has been accumulated in the use of citicoline in the treatment of TBI and its consequences. So, starting from the 1980s. A large number of clinical studies, including double-blind studies, have been conducted on TBI patients with various impairments in level of consciousness. The results of these studies, summarized in a meta-analysis, indicate that the use of Ceraxon® for TBI is clinically and pathogenetically justified, the drug accelerates the leveling of cerebral edema and the restoration of both consciousness and neurological functions, helps reduce the duration of hospitalization and improve rehabilitation results [ 22].

The study of the original Ceraxon® citicoline continues to this day, almost 50 years after its registration. Experimental, as well as randomized controlled and open clinical studies are being conducted to evaluate the effectiveness of the drug in people with various pathologies, including ischemic stroke, cognitive impairment of various origins, methamphetamine and alcohol addiction.

There are quite a lot of generic drugs containing citicoline on the pharmaceutical market today. However, all of them, unlike the original drug Ceraxon®, did not undergo a large number of clinical trials for various types of neurological pathology before and after registration. Their registration relied on the traditional equivalence studies described above. It is very important that in the case of citicoline, a correct bioequivalence study is quite difficult to conduct, since it is a natural compound found in the human body. In such a study, it is extremely difficult to differentiate exogenous and endogenous citicoline and determine their quantity.

It should also be noted that in the case of Cerakson® and its generics, the isomeric composition of the molecules included in the active substance of the drug is important for the implementation of the therapeutic effect. It is known that the contribution of the phenomenon of optical isomerism to the therapeutic non-equivalence of generics is sometimes very significant [1, 12, 21]. The citicoline molecule is capable of forming more than 4 stereoisomers with different biological activities. Depending on the method of synthesis, different manufacturers produce a mixture with different ratios of citicoline isomers, which can affect the pharmacological activity of the drugs they produce. Differences in the synthesis method can also lead to the production of a product with a higher content of degradation products and technological impurities than in the original preparation [29].

There is no doubt that the confrontation and at the same time the coexistence of original and generic drugs in the pharmaceutical market will continue. It is dialectical and inevitable. However, there is also no doubt that a doctor’s choice of a drug for drug therapy should be based on confidence in the proven effectiveness and safety of the drug. This is especially true for drugs whose pharmacodynamics and pharmacokinetics are closely intertwined with natural biochemical processes in the body, due to which evidence of pharmacokinetic equivalence for them is not absolutely convincing. The use of the original Ceraxon® citicoline allows the doctor to be confident in the full implementation of the pharmacodynamic effects of the drug, and therefore in the potentially successful treatment of a wide range of neurological diseases for which it is indicated and used.

Ceraxon or Gliatilin - which is better?

Manufacturer: Italpharmaco, Italy
Release form: solution for injection, solution for oral administration, capsules

Active ingredient: choline alfoscerate

The imported analogue of Ceraxon is Gliatilin. The medication contains choline alfoscerate and has a nootropic effect, improves metabolism in nerve cells, and stimulates the formation of choline. The drug is used after stroke and TBI, for cognitive impairment and dementia, to improve attention and performance.

Gliatilin is taken orally, 1 capsule or 7 ml 2-3 times a day, and injections are administered at 1000 mg once.

The advantages of the analogue include:

• accelerated absorption;
• variety of release forms;
• convenient dosing;
• reception allowed while driving a car;
• numerous positive reviews from doctors.

In addition, Gliatilin has wider indications for use, so it is better to choose it for older people.

Ceraxon or Cytoflavin - which is better and more effective

Manufacturer: POLYSAN NTFF LLC, Russian Federation
Release form: tablets, solution for intravenous administration

Active ingredient: riboflavin, nicotinamide, inosine, succinic acid

Cytoflavin is an analogue of the drug Ceraxon, which can be purchased cheaper. The vitamins included in the drug improve metabolic processes in brain cells and improve cellular respiration. Cytoflavin exhibits antioxidant and antihypoxic effects.

It is impossible to say which is better, Cerakson or an analogue. Cytoflavin is used as part of complex therapy, including with Ceraxon, for ischemia, cerebral infarction, encephalopathy and other pathologies.

The regimen for taking Cytoflavin is as follows:

• 2 tablets twice a day with an interval of 10 hours;
• 10 ml intravenous drip is diluted in 100–200 ml of saline and administered 2 times a day with an interval of 8–10 hours.

The duration of treatment is 10–25 days.

Cavinton

Manufacturer: JSC GEDEON RICHTER-RUS, RF
Release form: tablets, concentrate for the preparation of solution for infusion

Active ingredient: vinpocetine

Cavinton is a Russian analogue of Ceraxon in tablets. Vinpocetine, which is part of the medication, improves metabolic processes in the brain, increases blood circulation and oxygen supply. Cavinton is prescribed for disorders of cerebral blood flow, dementia, hearing and vision impairment caused by vascular pathologies.

The analogue in tablet form is taken 5–10 mg 3 times a day for 30–90 days. And intravenous drip is administered once at a dosage of 25–50 mg.

special instructions

Treatment with Cerakson is often prescribed to premature babies and newborns with brain tissue injuries received during childbirth. The treatment regimen is determined by the attending physician and depends on the Apgar assessment of the child’s condition. Storing the medicine in the refrigerator may cause crystals to form in the solution. It will take at least two months at room temperature to dissolve them. Despite the fact that this does not reduce the quality of the active substance, the drug should still be stored at room temperature not exceeding +30 C.

The empty packaging of the drug must be used within three years from the date of release.