Universal reference book for medicines
Name of the preparation: NEIPILEPT ® (NEIPILEPT)

Active substance: citicoline

Type: Nootropic preparation

Manufacturer: ФармФірма СОТЕКС (Russia)
Composition, form of production and packaging
The solution for intravenous and / or injection is
clear, colorless.

1 ml of 1 amp.

citicoline sodium (in terms of citicoline) 125 mg 500 mg

Auxiliary substances: 1M solution of hydrochloric acid or 1M sodium hydroxide solution to pH 6.5-7.5, water d / u - up to 4 ml.

4 ml - ampoules of colorless glass (3) - packings of cellular contour (1) - packs cardboard.

4 ml - ampoules of colorless glass (5) - packings of cellular contour (1) - packs cardboard.

4 ml - ampoules of colorless glass (5) - packings of cellular contour (2) - packs cardboard.

The solution for intravenous and / or injection is clear, colorless.

1 ml of 1 amp.

citicoline sodium (in terms of citicoline) 250 mg 1000 mg

Auxiliary substances: 1M solution of hydrochloric acid or 1M sodium hydroxide solution to pH 6.5-7.5, water d / u - up to 4 ml.

4 ml - ampoules of colorless glass (3) - packings of cellular contour (1) - packs cardboard.

4 ml - ampoules of colorless glass (5) - packings of cellular contour (1) - packs cardboard.

4 ml - ampoules of colorless glass (5) - packings of cellular contour (2) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Nootropic preparation.
Citicoline is a natural endogenous compound, which is an intermediate metabolite in the synthesis of phosphatidylcholine, one of the basic structural components of the cell membrane.
It has a wide spectrum of action - it helps to restore damaged cell membranes, inhibits the effect of phospholipases, prevents excessive formation of free radicals, and also prevents the death of cells, affecting the mechanisms of apoptosis.
In an acute period of stroke, citicoline reduces the amount of damage to the brain tissue, improves cholinergic transmission. With craniocerebral trauma reduces the duration of post-traumatic coma and the severity of neurologic symptoms, besides, it helps to reduce the duration of the recovery period.
In chronic brain hypoxia, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, difficulties arising from 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 sensitive and motor neurological disorders of degenerative and vascular etiology.

PHARMACOKINETICS

Distribution and Metabolism

After iv introduction, citicoline rapidly hydrolyzes to choline and cytidine and is delivered to various tissues of the body.
After administration, citicoline is widely distributed in brain structures with the rapid inclusion of choline fractions in structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is embedded in the 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 through the intestine (<3%).
About 12% of the dose is excreted with exhaled CO 2 . In the excretion of the drug, the kidneys are separated by two phases: the first phase is about 36 hours, in which the elimination rate decreases rapidly, and the second phase, in which the rate of elimination decreases much more slowly. The same phase is observed when deducing from CO 2 , the rate of excretion of exhaled CO 2 decreases rapidly after about 15 hours, later it decreases much more slowly.
INDICATIONS

- acute period of ischemic stroke (as part of complex therapy);

- the recovery period of ischemic and hemorrhagic strokes;

- craniocerebral trauma, acute (as part of complex therapy) and the recovery period;

- cognitive and behavioral disorders in degenerative and vascular diseases of the brain.

DOSING MODE

Acute period of ischemic stroke and craniocerebral trauma: 1000 mg every 12 hours from the first day after diagnosis, duration of treatment is at least 6 weeks.
The maximum daily dose is 2000 mg.
The recovery period of ischemic and hemorrhagic strokes, the recovery period of TBI, cognitive and behavioral disorders in degenerative and cerebrovascular diseases of the brain: injected IV or I / m 500-2000 mg per day.
Dose and duration of treatment - depending on the severity of the symptoms of the disease.
When prescribing Neupilept ® to elderly patients, dose adjustment is not required.

The drug should be used immediately after opening the ampoule.

Neupilept ® is given in / m, in / in struyno (slowly, for 3-5 min, depending on the prescribed dose) or drip (infusion rate - 40-60 drops per minute).

In / in the route of administration is more preferable than in / m.
With the / m introduction, the repeated administration of the drug in the same place should be avoided.
Neupilept ® is compatible with all types of IV isotonic solutions and dextrose solutions.

SIDE EFFECT

Determination of the frequency of adverse reactions: very often (> 1/10), often (? 1/100 to <1/10), infrequently (? 1/1000 to <1/100), rarely (? 1/10000 to <1 / 1000), very rarely (<1/10 000), the frequency is not established.

Very rarely (including individual cases): allergic reactions (rash, itching, anaphylactic shock), headache, dizziness, heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, decreased appetite, numbness in paralyzed limbs, a change in the activity of hepatic enzymes.
In some cases, citicoline can stimulate the parasympathetic system, as well as provide a short-term change in blood pressure.
If any of the side effects listed in the manual are aggravated or any other side effects occur, the patient should inform the physician about it.

CONTRAINDICATIONS

- hypersensitivity to any of the components of the drug;

- should not be prescribed to patients with severe vagotonia (high tone of the parasympathetic 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.

PREGNANCY AND LACTATION

There is insufficient data on the use of citicoline in pregnant women.
Although no adverse effects have been identified in animal studies, citicoline is prescribed during pregnancy only when the expected benefit to the mother exceeds the potential risk to the fetus.
When citicoline is used during lactation, women should stop breastfeeding, as there is no data on the excretion of citicoline with breast milk.

APPLICATION FOR CHILDREN

The use of the drug for children and adolescents under 18 years is contraindicated.

APPLICATION IN ELDERLY PATIENTS

When prescribing the drug for elderly patients, dose adjustment is not required.

SPECIAL INSTRUCTIONS

In / in the jet Neupilept ® is administered
slowly (3-5 minutes depending on the dose). With IV injection, the infusion rate should be 40-60 drops per minute.
When persisting intracranial hemorrhage, it is recommended not to exceed the dose of Neupilept ® 1000 mg / day, the drug is injected / dripped at a rate of 30 drops per minute.

Influence on ability to drive vehicles, mechanisms

During the use of the drug, caution should be exercised in managing the transport and in dealing with other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

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

DRUG INTERACTION

Citicoline increases the effects of levodopa.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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