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

Composition per one ampoule	500 mg / 4 ml	1000 mg / 4 ml
Active substance:
citicoline sodium	522.5 mg	1045.0 mg
in terms of citicoline	500.0 mg	1000.0 mg
Excipients:
1M hydrochloric acid solution or 1 M sodium hydroxide solution	to pH 6.5-7.5	to pH 6.5-7.5
Water for injections	up to 4.0 ml	up to 4.0 ml

Description:Transparent colorless liquid.

Pharmacotherapeutic group:Nootropic remedy

ATX: & nbsp

N.06.B.X.06 Citicoline

Pharmacodynamics:

Citicoline, being the forerunner of the key ultrastructural components cell membrane (mainly phospholipids), has a wide spectrum of action - 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, in addition, contributes to a reduction in the duration of the recovery period. With chronic hypoxia of the brain 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:

Suction: Citicoline is well absorbed by intravenous and intramuscular injection.

Metabolism: for intravenous and intramuscular injection citicoline metabolized in the liver with the formation of choline and cytidine. After administration, the concentration of choline in the blood plasma is significantly increased.

Distribution: Citicoline is largely distributed in the structures of the brain, with the rapid introduction of the choline fraction into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates into the brain and actively integrates into cellular, cytoplasmic and mitochondrial membranes, forming part of the fraction of structural phospholipids.

Excretion: Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% - by the kidneys and about 12% - with exhaled CO₂.

In excretion of citicoline with urine, two phases can be identified: the first phase, lasting about 36 hours, during which the rate of elimination rapidly decreases, and the second phase, during which the rate of excretion decreases much more slowly. The same is observed in exhaled CO₂ - the elimination rate decreases rapidly after about 15 hours, and then decreases much more slowly.

Indications:

- Acute period of ischemic stroke (as part of complex therapy).

- Reconstructive period of ischemic and hemorrhagic strokes.

- Craniocerebral trauma (TBI), acute (as part of complex therapy) and recovery period.

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

Contraindications:

Do not prescribe to patients with severe vagotonia (predominance of the parasympathetic part of the autonomic nervous system) and hypersensitivity to any of the components of the drug.

The drug is not recommended for use in children under 18 years due to the lack (lack) of data on efficacy and safety.

Pregnancy and lactation:

Sufficient data on the use of citicoline in pregnant women are absent. Although in studies on animals there was no adverse effect, during the period of pregnancy the drug citicoline appoint only in those cases when the expected benefit for the mother exceeds the potential risk to the fetus.

When citicoline is prescribed during lactation, women should stop breastfeeding, as there is no data on the isolation of citicoline with human milk.

Dosing and Administration:

The drug is administered intravenously or intramuscularly.

Intravenously, the drug is given in the form of a slow intravenous injection (for 3-5 minutes, depending on the prescribed dose) or intravenous drip infusion (40-60 drops per minute). The drug is compatible with all types of intravenous isotonic solutions and dextrose solutions.

Intravenous route of administration is preferable to intramuscular. When intramuscular introduction should be avoided repeated administration of the drug in the same place.

Recommended dosing regimen

Acute period of ischemic stroke and craniocerebral trauma (CCI):

1000 mg every 12 hours from the first day after the diagnosis, duration of treatment is not less than 6 weeks.

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:

500-2000 mg per day.Dosage and duration of treatment, depending on the severity of the symptoms of the disease.

Use in special patient groups

Elderly patients

When appointing citicoline to elderly patients, dose adjustment is not required.

Side effects:

Frequency of adverse reactions: very rare (less than 1/10 000, including individual cases).

Allergic reactions: rash, skin itching, anaphylactic shock.

Other: feeling of heat, swelling, shortness of breath.

From the side of the central nervous system and the peripheral nervous system: insomnia, headache, dizziness, tremor, numbness in the paralyzed limbs, stimulation of the parasympathetic nervous system.

From the side of mental disorders: hallucinations, excitement.

From the cardiovascular system: short-term change in blood pressure.

From the digestive system: nausea, decreased appetite, vomiting, diarrhea, changes in hepatic enzyme activity.

If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions were noticed, you should inform your doctor about it.

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

Interaction:

Citicoline increases the effects of levodopa.

Do not use simultaneously with medicines containing meclophenoxate.

Special instructions:

The solution in the ampoule is intended for single use. It should be used immediately after opening the ampoule.

In high doses citicoline is able to aggravate the blood flow in the brain with persistent hemorrhagic stroke.

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

During the treatment period, care should be taken when performing potentially hazardous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).

Form release / dosage:

Solution for intravenous and intramuscular injection 500 mg / 4 ml and 1000 mg / 4 ml.

Packaging:

By 4 ml in ampoules of colorless neutral glass (hydrolytic type I) with a color fracture ring or with a colored dot and a notch. The ampoules can have one, two or three color rings or without additional colored rings.

By 3 or 5 ampoules are placed in a contour mesh package made of a polyvinyl chloride film.

1 or 2 contour squares, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004434

Date of registration:29.08.2017

Expiration Date:29.08.2022

The owner of the registration certificate:BINNOFARM, CJSC BINNOFARM, CJSC Russia

Manufacturer: & nbsp

BINNOFARM, CJSC Russia

Information update date: & nbsp29.09.2017

Illustrated instructions

Instructions

Neurocholine (Neurocholine)