Cortexin® Instruction

International Non-Proprietary Name (INN): none
Dosage form: lyophilisate for preparation of solution for intramuscular injections (3 or 5 ml)
Structure
In 1 vial:
Active substance: Cortexin® (complex of water-soluble polypeptide fractions): 5 mg in a 3 ml vial, and 10 mg in a 5 ml vial;
Excipients: glycine (stabilizer).
Description
Lyophilized powder or porous mass of white or white-yellowish color.
Pharmacological classification: nootropics
ATC code: N06BX
Pharmacological action: neuroprotective, nootropic, antioxidant, tissue-specific


Pharmacodynamics

Cortexin® improves brain metabolism. The drug is a lyophilisate obtained by acetic acid extraction from the cerebral cortex of cattle or pigs. It contains low-molecular active neuropeptides (molecular weight does not exceed 10,000 daltons) which penetrate easily the blood-brain barrier and directly affect nervous cells.

Cortexin® has a tissue-specific multifunctional effect on the brain. It promotes metabolic regulation, neuroprotection, functional neuromodulation, neurotrophic activity.

Cortexin® improves the energy metabolism of brain cells as well as intracellular protein synthesis.

Cortexin® regulates the processes of lipid peroxidation in brain cells, reduces the formation of free radicals and blocks the processes of free radical oxidation. The drug eliminates the imbalance of inhibitory and excitatory amino acids and possesses a moderate GABAergic effect.

Cortexin® has a positive effect in the violation of cognitive functions. It improves the concentration of attention, short-term memory, learning ability, accelerates recovery of brain functions after stress, and regulates serotonin and dopamine levels. Cortexin® stimulates mental activity (no excessive activating influence) and reparative processes in the brain as well as restores cerebral bioelectrical activity.

Pharmacokinetics

The complexity of the drug’s composition does not allow for the conducting of the usual pharmacokinetic analysis of individual components, since the Cortexin® active substance consists of a complex of polypeptide fractions.

Intended uses

  • cerebral circulation disorders;
  • encephalopathy of various genesis;
  • acute and chronic encephalitis and encephalomyelitis;
  • vegetative-vascular dystonia;
  • epilepsy;
  • craniocerebral trauma and its consequences;
  • asthenia;
  • viral and bacterial neuroinfections;
  • infantile cerebral palsy;
  • psychomotor and speech retardation in children;
  • cognitive disorders (dysfunction of memory and ideation);
  • reduced learning capacity.


Contraindications

Individual intolerance, pregnancy and lactation.

Dosage and administration

The drug is available in packs containing 10 vials. There are two forms of release: 

  1. Vials containing 5 mg of active ingredient (neuropeptides) – for children.
  2. Vials containing 10 mg of active ingredient (neuropeptides) – for adults. 

Before injection dissolve the content of the vial in 1-2 ml of water for injection, 0.5% procaine (novocaine) solution or 0.9% sodium chloride solution.

The route of administration of the drug is intramuscular (IM). 

The medicine is used in the following dosages: 

  • Adults – 10 mg once a day for 10 days.
  • Adults in the acute and early recovery periods of stroke – 10 mg twice a day for 10 days, the course is repeated after 10 days.
  • Children weighing less than 20 kg – 0.5 mg / kg once a day for 10 days.
  • Children weighing more than 20 kg – 10 mg once a day for 10 days.

These courses can be repeated in 3-6 months.

How to prepare the mixture correctly?

  1. With a sterile syringe, draw up 2-4 ml of water for injection, saline, or local anesthetic. By injecting the mixture diluted with local anesthetic, the injection will be less painful. But in this case, the risk of developing undesired allergic reactions is higher.
  2. Remove the foil from the Cortexin bottle and insert the needle through the stopper. It is recommended to lower it to the middle of the bottle and lean against the wall to reduce foaming. Then slowly push the plunger until the contents of the syringe are inside.
  3. Without removing the needle, shake the bottle with the mixture until all the powder is dissolved.
  4. Pull the plunger towards you until the contents of the vial are inside the syringe.

It is also recommended to prepare the solution right before an injection.

How to inject Cortexin correctly?

All manipulations are carried out in gloves.

First, you need to choose the site where the injection will be made:

  • Hip,
  • Deltoid,
  • Femoral, front thigh.

It is preferable to choose the gluteal region. The buttock is mentally divided into four squares. The injection is placed in the upper outer square. It is better to alternate the injection sites. For example if yesterday you made an injection in the right buttock, today – do it in the left one.

  1. Before injection, treat the selected site with a cotton swab dipped in medical alcohol. Wipe in a circular motion from center to periphery.
  2. Before starting the procedure, tap the syringe slightly, lifting it with the needle up. Then press the plunger until all the air is out of the syringe.
  3. Stretch the skin at the site of the intended injection with your hand. Take the syringe in another hand, lift it up a little and sharply insert the needle at 2/3 of its length. During injection, insert the needle perpendicular to the surface of the body.
  4. The injection should be quick, because if you insert the needle slowly, it will be more painful.
  5. Then press down on the plunger to slowly get the medicine into the muscle. The optimal injection rate is 1 ml in 10 seconds.
  6. After that, quickly remove the needle and put the cap on it. Only in this form can the syringe be thrown away.
  7. It is recommended to massage the injection site so that the drug is better absorbed into the tissue. Re-treat the area into which the injection was made with a cotton swab dipped in an alcohol solution. This is done in order to prevent infection.

The medicine is best taken before lunch, like any nootropic drugs.

Cortexin begins to take effect only a few days after the start of use, so you should not stop injections if you do not see a quick result.

Side effects

No side effects are detected. Possible individual hypersensitivity to the components of the drug.

Overdose

No cases of drug overdose have been reported.

Interaction with other drugs

No data.

Special instructions

Consult with your doctor before use.

Do not store/use after storage the dissolved preparation. It is not recommended to mix Cortexin® with other solutions.

In case you have missed an injection, it is not recommended to administer a double dose, just carry out the next injection as usual on the target day.

Pregnancy and lactation

There have been no records of undesirable effects when using Cortexin during pregnancy or lactation. However, since the data from clinical trials are insufficient to establish the safety of the drug during these time intervals, these groups of women are not yet recommended to use the drug. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Influence on the ability to drive vehicles and operate machines

Cortexin® does not affect the ability to drive vehicles and operate machines.

Terms of release from pharmacy

On prescription.

Storage conditions

Store in a dry dark place at temperatures of 2°C to 20°C. Keep in a safe place out of reach of children.

Shelf life

3 years. Do not use beyond the expiration date printed on the package.

Manufacturer

Geropharm, Russia. https://geropharm.com/

Instructions