Neapilept - instructions for use, dose, side effects, contraindications

Composition per one ampoule:	125 mg / ml	250 mg / ml
Active substance:
citicoline sodium (in terms of citicoline)	500 mg	1000 mg
Excipients:
hydrochloric acid, concentrated or sodium hydroxide	to pH 6.5-7.5	to pH 6.5-7.5
water for injections	up to 4 ml	up to 4 ml

Description:Transparent colorless liquid.

Pharmacotherapeutic group:Nootropic remedy

ATX: & nbsp

N.06.B.X.06 Citicoline

Pharmacodynamics:

Citicoline - the 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 promotes the restoration of 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 a 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.

With chronic hypoxia of the brain citicoline effective in the treatment of cognitive disorders such as memory loss, lack of initiative, the difficulties encountered in carrying out 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:

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

Distribution: after the introduction citicoline widely distributed in the structures of the brain with a rapid inclusion of the choline fraction 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 night and through the intestine (<3%). About 12% of the dose is excreted with exhaled CO₂. 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 elimination rate decreases much more slowly. The same phase is observed when excreted from CO₂, rate of excreted CO₂ rapidly decreases 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.

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, 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 in animal studies there was no adverse effect, during pregnancy citicoline appoint only in those cases when the expected benefit for the mother exceeds the potential risk to the fetus.

When using citicoline in lactation, women should stop breastfeeding,since there is no data on the excretion of citicoline with breast milk.

Dosing and Administration:

Recommended dosing regimen

Acute period of ischemic stroke and craniocerebral trauma (CCT): 1000 mg of citicoline every 12 hours from the first day after the diagnosis, duration of treatment 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:

Enter in / in or / m 500-2000 mg of citicoline per day. Dosage and duration of treatment, depending on the severity of the symptoms of the disease.

Elderly patients

When prescribing NEIPILEPT® to elderly patients, dose adjustment is not required.

The drug should be used immediately after opening the ampoule.

NEYPILEPT® is administered intramuscularly, intravenously by striae (slowly, in for 3-5 minutes, and depending on the prescribed dose) or drip (infusion rate - 40-60 drops per minute).

Intravenous (IV) route of administration is preferable to intramuscular (IM).With the / m introduction, the repeated administration of the drug in the same place should be avoided.

Neupilept ® is compatible with all kinds of intravenous isotonic solutions and dextrose solutions.

Side effects:

Side-effects are grouped according to the frequency of occurrence: very often (≥ 1/10), often (≥ 1/100 to <1/10), infrequently (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to < 1/1000), very rarely (</ 10000), the frequency is not set.

Very rarely (including individual cases): allergic reactions (rash, itchy skin, anaphylactic shock), headache, dizziness, heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, dyspnea, insomnia, agitation, decreased appetite, numbness in paralyzed limbs, changes in hepatic enzyme activity . In some cases citicoline can stimulate the parasympathetic system, and also have a short-term change in blood pressure.

If any of the side effects listed in the manual are aggravated or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

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

Interaction:Citicoline increases the effect of levodopa.

Special instructions:

Intravenously, neyipilept® is injected slowly (3-5 minutes depending on the dose). When intravenous drip introduction, the infusion rate should be 40-60 drops per minute,

When persisting intracranial hemorrhage, it is recommended not to exceed the dose of the drug NEIPILEPT® 1000 mg per day, the drug is injected intravenously at a rate of 30 drops per minute.

Effect on the ability to drive transp. cf. and fur:

During the use of the drug, caution should be exercised in managing the transport and in the employment of other potentially dangerous activity forks that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection, 125 mg / ml and 250 mg / ml.

Packaging:

To 4 ml in ampoules of colorless glass with a color fracture ring or with a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding are additionally applied to the ampoules.

By 3 or 5 ampoules in a contoured cell pack of a polyvinylchloride film and aluminum foil or a polymer film or without a foil and without a film.

1 contour pack of 3 or 5 ampoules together with instructions for use in a pack of cardboard.

2 contour mesh packs of 5 ampoules together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003116

Date of registration:29.07.2015 / 17.01.2018

Expiration Date:29.07.2020

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

FarmSirma Soteks, ZAO Russia

Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia

Information update date: & nbsp27.06.2018

Illustrated instructions

Instructions

Neupilept® (Neipilept®)