Cerebrolysin

The drug for intramuscular and / or intravenous injection of cerebrolysin (cerebrolysin) for its pharmaceutical belong to psychostimulating and nootropic drugs.

[1], [2], [3], [4]

Indications of the cerebrolysin

The drug is intended for the treatment of dementia of various genesis, acute cerebrovascular accident of the ischemic type, chronic disorder of cerebral hemodynamics, traumatic brain injury, spinal trauma, endogenous manic-depressive state (psychosis) (included in the treatment regimen), inflammation of the cerebral membranes, cerebrovascular encephalopathy, cognitive backwardness in children. Cerebrolysin can also be prescribed during the rehabilitation stage after the ONMK for hemorrhagic type, surgical operations on the brain and ADHD.

[5], [6]

Release form

Liquid for intravenous and / or intramuscular administration of amber-colored water-based ampoules of dark glass.

One milliliter of the drug contains 215.2 mg of hydrolyzate of a peptide fraction made from the brain of pigs.

Additional components: Natrii hydroxidum, aqua pro injectioni.

The pharmaceutical industry of cerebrolysin is produced:

• in ampoules of dark glass with a volume of 1 ml, 2 ml of 10 pcs. Packed in plastic honeycomb inserts of factory cardboard boxes;
• in ampoules of dark glass in volume of 5 ml, 10 ml, 20 ml on 5 pieces in a cardboard packing with plastic cellular inserts;
• in bottles of dark glass with a volume of 30 ml, 50 ml, closed with a special stopper with an aluminum clip, are packed in original boxes of cardboard.

[7], [8], [9]

Pharmacodynamics

Low-molecular biologically active neuropeptides contained in cerebrolysin overcome the BBB (blood-brain barrier) and enter the nervous tissue providing a stimulating and activating effect on functionality and trophism.

Under the action of the drug, protein synthesis within the cell is accelerated, by improving the productivity of energy metabolism of brain tissues.

The neuroprotective effect on CNS cells is to protect neurons from the harmful effects of free radicals and toxins, which significantly increases the survival of cells under conditions of ischemic or hypoxic factors. Cerebrolysin has the ability to prevent excessive swelling in the lesion of the brain. Normalizes microcirculation in tissues. Due to its neurotrophic activity, which has a similar effect to the natural neuronal growth factor (NGF), Cerebrolysin inhibits the development of degenerative processes of the nervous tissue. The effect of the drug on immunity, formation of glycoproteins has not been established. Has no stimulating properties of H1 - histamine receptors and accordingly does not affect erythrocyte agglutination.

Positive dynamics with the use of cerebrolysin for a month was obtained in the complex treatment of dementia and Alzheimer's disease. In all patients with vascular dementia, the results of electroencephalography indicated a significant dose-dependent increase in neuronal activity (amplitude increase in alpha-rhythm and beta-rhythm height), a positive cognitive response to therapy was observed (self-service skills, memory and intellectual abilities improved significantly). Positive dynamics began to manifest after a two-week course and progressed during further treatment. The positive effect was observed regardless of the cause that caused dementia. This is relevant for the long-term normalization of the ability for daily activities. The need for constant care and monitoring of patients is reduced.

After a single application, a specific neurostimulating action is manifested about 8 hours (EEG results).

[10], [11], [12], [13]

Pharmacokinetics

The biochemical composition of cerebrolysin does not allow to study the way of moving the active components of the drug in the human body. A complex of low molecular weight peptides contains protein compounds identical to those produced in the human brain. It is not possible to measure the pharmacokinetic values. Neurotrophic activity of the drug is detected throughout the day after a single application.

Dosing and administration

It is allowed to use an exceptionally clear solution without color change and without sediment.

Concentrated cerebrolysin is allowed to be applied in a dosage of 1 ml and up to 10 ml for intramuscular or intravenous injection. Starting with a volume of more than 10 ml and up to 50 ml (maximum dosage), the drug is used for slow drip infusions. Before the procedure, the total volume of the drug is adjusted to 100 ml. For dilution, solutions for infusion (isotonic NaCl solution) are used. The duration of the drip infusion lasts from 15 minutes to 1 hour.

The prepared infusion solution should be used immediately, since sunlight adversely affects the active ingredients that make up cerebrolysin, reducing their effectiveness.

With a standard scheme of injections of cerebrolysin, the duration of therapy is 10-20 days of daily intake of the drug.

A variant of therapy with a single drop administration of the drug in a dosage of 50 ml is possible, but smaller amounts of cyclic treatment are preferable and effective.

Recommended daily doses for different conditions:

• With organic destructive changes in the brain, neurodegenerative disorders - 5 ml - 30 ml per day.
• The states after the ONMK for hemorrhagic type, acute violation of cerebral circulation according to the ischemic type (acute period), transient ischemic attack are used 10 ml - 50 ml per day.
• TBM - 10 ml - 50 ml per day.
• Children in the age of half a year are recommended dosage in the amount of 0.1 ml per kilogram of body weight, but not more than two ml per day.
• In acute children's neurological disorders, 1-2 ml of the drug are prescribed as standard.

The maximum benefit with cerebrolysin therapy is in the case of cyclic application. Reception of the drug continues until the time when there is no positive dynamics. At the end of the first cycle of therapy, the frequency of cerebrolysin administration can be reduced to a maintenance dose at a frequency of two to three times over seven days. Between the cycles of treatment it is necessary to make a pause, the duration equal to the course of treatment.

[18], [19], [20], [21], [22]

Use of the cerebrolysin during pregnancy

Care must be taken when administering cerebrolysin in the first trimester of pregnancy.

The negative effect of the drug on the fetus was not detected experimentally. In clinical conditions, no studies have been performed.

The appointment in the gestational and lactation periods is justified only when the benefit to the mother exceeds the possible negative consequences for the fetus or newborn.

Contraindications

Contraindications to the use of cerebrolysin are:

• individual intolerance to the components of the drug;
• allergic conditions;
• severe renal lesions with a violation of the filtration function;
• pregnancy;
• convulsive alertness.

[14], [15], [16]

Side effects of the cerebrolysin

Side effects with the introduction of cerebrolysin are almost not observed, but the following features may occur:

• with a rapid IV or / or injection of the drug sometimes there is pain in the area of injection, a feeling of heat throughout the body, dizziness, sweating, tachyarrhythmia. The drug is injected slowly and smoothly!
• digestive system - anorexia, nausea, vomiting, manifestation of dyspeptic symptoms (flatulence, constipation, diarrhea).
• CNS - psychomotor agitation manifested in aggressive behavior, confusion, insomnia, tremor of hands, dizziness, lethargy, apathy, depression, single episyndroma cases during treatment.
• local reactions - itching, redness and pain at the injection site.
• the immune system - increased sensitivity, allergic reactions such as headache, paresis of the cervical spine or limbs, back pain, spasm of the superficial (cutaneous) blood vessels, dyspnea.
• common manifestations of arterial pressure (hypo- or hypertension).

But it is necessary to take into account that the cases of undesirable effects manifested in the form of instability of arterial pressure, lethargy, weakness, nausea, vomiting, apathetic-depressive states, etc. Were detected both in the group of patients injected with cerebrolysin and in the placebo group.

Cerebrolysin does not affect the ability to control both the vehicle and the complex mechanisms in which attention is needed.

[17]

Overdose

There have been no reported adverse health effects from the use of large amounts of cerebrolysin.

[23], [24], [25]

Interactions with other drugs

It should be borne in mind that when combined with the use of MAO inhibitors (monoamine oxidase) or antidepressants, the use of cerebrolysin may cause additive synergism. In this combination, the dosage of antidepressants is reduced.

The mixing of a solution of cerebrolysin and amino acids in one vial is inadmissible.

Perhaps a joint one-stage use of the drug with vitamin complexes and cardiovascular drugs.

[26], [27], [28]

Storage conditions

Cerebrolysin is stored in its original packaging, in a dry, dark place that is not accessible to children. The room temperature should not exceed 25 ° C. Do not freeze. The end date of the permitted period of use is present on the packaging of the cardboard of factory production, the label of each ampoule and vial. 

[29], [30]

Shelf life

Cerebrolysin in ampoules persists for 5 years, and in vials - 4 years. It is not recommended to use the drug after the expiration date.

[31]