Neupilept, 100 mg/ml 100 ml

Indications

acute period of ischemic stroke (as part of complex therapy);
recovery period of ischemic and hemorrhagic strokes;
traumatic brain injury, acute (as part of complex therapy) and rehabilitation
period;
cognitive and behavioral disorders in degenerative and vascular diseases
brain.

Pharmacological effect

Pharmacotherapeutic group: nootropic agent.

ATX code: N06BX06

Pharmacological properties

Pharmacodynamics

Citicoline is a natural endogenous compound that is an intermediate meta-
pain in the synthesis of phosphatidylcholine – one of the main structural components
cell membrane.

Has a wide spectrum of action – helps restore damaged
cell membranes, inhibits the action of phospholipases, prevents excessive formation
free radicals, and also prevents cell death by affecting the mechanisms
apoptosis. In the acute period of stroke, citicoline reduces the volume of tissue damage to the heads –
brain, improves cholinergic transmission. In case of traumatic brain injury it reduces
duration of post-traumatic coma and severity of neurological symptoms, except
This helps to reduce the duration of the recovery period.

In case of chronic cerebral hypoxia, citicoline is effective in the treatment of cognitive symptoms
disorders such as memory impairment, lack of initiative, difficulties arising
when performing daily activities and self-care. Increases the level of attention and
consciousness, and also reduces the manifestation of amnesia.

Citicoline is effective in the treatment of sensory and motor neurological disorders –
tions of degenerative and vascular etiology.

Pharmacokinetics

Metabolism: after intravenous administration, citicoline is rapidly hydrolyzed into choline and
cytidine and is delivered to various tissues of the body.

Distribution: after administration, citicoline is widely distributed in the structures of the head-
brain with rapid incorporation of the choline fraction into structural phospholipids and fractions
cytidine into cytidine nucleotides and nucleic acids. Having reached the brain,
Citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes,
taking part in the construction of the phospholipid fraction.

Excretion: Only a small amount of the dose is excreted by the kidneys and intestines (< 3%).
About 12% of the dose is excreted with exhaled CO2. In excretion of the drug by the kidneys,
two phases: the first phase is about 36 hours, in which the rate of elimination decreases rapidly, and
the second phase, in which the rate of elimination decreases much more slowly. Same phasicity
observed when excreted from CO2, the rate of excretion of exhaled CO2 decreases rapidly
after approximately 15 hours, thereafter it decreases much more slowly.

Special instructions

NEIPYLEPT® is administered intravenously as a slow injection (3-5 minutes depending on the dose).
When administered intravenously, the infusion rate should be 40-60 drops per minute.
For persistent intracranial hemorrhage, it is recommended not to exceed the dose
drug NEYPILEPT® 1000 mg per day, the drug is administered intravenously by drip with rapid-
30 drops per minute.
Impact on the ability to drive vehicles and machinery
During use of the drug, caution should be exercised when administering trans-
port and when engaging in other potentially hazardous activities requiring
increased concentration of attention and speed of psychomotor reactions.

Active ingredient

Citicoline

Composition

Active ingredient:
citicoline sodium (in terms of citicoline) 500 mg
Excipients:
concentrated hydrochloric acid
or
sodium hydroxide to pH 6.5-7.5
water for injections up to 4 ml

Pregnancy

There are insufficient data on the use of citicoline in pregnant women. Although in
Animal studies have not revealed any negative effects during pregnancy
Citicoline is prescribed only in cases where the expected benefit to the mother exceeds
potential risk to the fetus.
When using citicoline during lactation, women should stop breastfeeding
feeding, since there is no data on the excretion of citicoline in breast milk.

Contraindications

– hypersensitivity to any of the components of the drug;
– should not be prescribed to patients with severe vagotonia (high parasympathetic tone).
checal part of the autonomic nervous system);
– due to the lack of sufficient clinical data, it is not recommended for use in
children under 18 years of age.

Side Effects

Side effects are grouped by frequency of occurrence: very often (> 1/10), often
(≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare
(< 1/10000), frequency not set.
Very rare (including individual cases): allergic reactions (rash, itching,
anaphylactic shock), headache, dizziness, feeling of heat, tremor, nausea,
vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite,
numbness in paralyzed limbs, changes in the activity of liver enzymes. B
In some cases, citicoline can stimulate the parasympathetic system, as well as
produce a short-term change in blood pressure.
If any of the side effects indicated in the instructions get worse or you notice
Any other side effects not listed in the instructions, tell your doctor.

Interaction

Citicoline enhances the effects of levodopa.

Overdose

Given the low toxicity of the drug, cases of overdose have not been described.

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

PharmFirma Sotex, Russia