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

Citicoline, being the predecessor of the key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action - it helps to repair damaged cell membranes, inhibits the effect of phospholipases, prevents excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis. In the acute period stroke citicoline reduces the amount of damage to the brain substance, improves cholinergic transmission. In case of craniocerebral trauma it reduces the duration of post-traumatic coma and the severity of neurologic symptoms, in addition, it helps to shorten 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,The emergence of daily activities and self-service. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia.

Citicoline is used in the treatment of sensory and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics:

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.

Metabolism

The drug is metabolized in the liver with the formation of choline and cytidine. After administration, the concentration of choline in the blood plasma increases significantly.

Excretion

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% - by the kidneys and through the intestine 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 quickly decreases after about 15 hours, and then decreases much more slowly.

Indications:

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

- The recovery period of ischemic and hemorrhagic stroke.

- Craniocerebral trauma (CCI): acute (as part of complex therapy) and recovery period.

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

Contraindications:

- Hypersensitivity to any of the components of the drug,

- patients with severe vagotomy (predominance of the parasympathetic part of the autonomic nervous system),

- children under 18 years (due to the lack of sufficient clinical data).

Pregnancy and lactation:

Sufficient data on the use of citicoline in pregnant women are absent. Although no adverse effects have been identified in animal studies, the drug is prescribed during pregnancy only when the expected benefit to the mother exceeds the potential risk to the fetus.

When appointing the drug during lactation, women should stop breastfeeding, since there is no data on the isolation of citicoline with human milk, the risk to the child can not be completely ruled out.

Dosing and Administration:

The drug is administered intravenously or intramuscularly.

Intravenously, the drug is administered in the form of a slow intravenous injection (within 3-5 minutes, depending on the prescribed dose) or intravenous drip infusion (40-60 drops per minute).

Intravenous route of administration is preferable to intramuscular. When intramuscular introduction should avoid injecting the drug in the same place.

Recommended dosage regimen.

Acute period of ischemic stroke and craniocerebral trauma (CCI): 1000 mg every 12 hours. Treatment duration is not less than 6 weeks. 3-5 days after the start of treatment (if the swallowing function is not broken), it is possible to switch to oral forms of citicoline.

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 (1-2 times a day).

Dosage and duration of treatment, depending on the severity of the symptoms of the disease.

Elderly patients.

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

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

The drug is compatible with all types of intravenous isotonic solutions and dextrose solutions.

Side effects:

Undesirable phenomena (AEs) are grouped according to systems and bodies in accordance with the vocabulary MedDRA and classification of the frequency of development of AE WHO:

Very often (≥1 / 10)

Often (≥1 / 100 to <1/10)

Infrequently (≥1 / 1000 to <1/100)

Rarely (≥1 / 10000 to <1/1000)

Very rarely (<1/10000)

The frequency is unknown (the frequency can not be determined from the available data).

From the nervous system

Very rarely: headache, dizziness, reactions from the parasympathetic system, tremor, numbness in the paralyzed limbs.

From the side of the psyche

Very rarely: hallucinations, insomnia, agitation.

From the side of the vessels

Very rarely: arterial hypotension, arterial hypertension.

Disturbances from the respiratory system, chest and mediastinal organs

Very rarely: dyspnea.

From the digestive system

Very rarely: decreased appetite, nausea, vomiting, diarrhea.

From the skin and subcutaneous tissues

Very rarely: hyperemia, purpura, anaphylactic shock, urticaria, rash, itchy skin.

General disorders and disorders at the site of administration

Very rarely: chills, a feeling of heat, swelling.

Disturbances from the liver and bile ducts

Very rarely: a change in the activity of "liver" enzymes.

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. In case of an accidental overdose, treatment is symptomatic.

Interaction:

Citicoline increases the effects of levodopa.

Do not use simultaneously with medicines containing meclophenoxate.

Special instructions:

When persistent intracranial bleeding is recommended not to exceed a dose of 1000 mg per day, the drug is administered intravenously slowly (30 drops per minute).

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 speed of psychomotor reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).

Form release / dosage:

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

Packaging:By 4 ml into ampoules of colorless neutral glass type I with a colored break ring or with a colored dot and a notch or without a kink ring, a colored dot and a notch. One, two or three color rings and / or a two-dimensional barcode, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding can additionally be applied to ampoules.

By 3 or 5 ampoules per circuit cell packaging made of a polyvinylchloride film and aluminum foil foil or a polymer film or without foil and without a film. Or by 3, 5 The ampoule is placed in a preformed form (tray) made of cardboard with cells for laying ampoules.

1 or 2 contour squares or cardboard trays, together with an instruction for use and a scarifier, ampoule orwith a knife ampoule, or without a scarifier ampoule and a knife ampullum placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ⁰C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004515

Date of registration:31.10.2017

Expiration Date:31.10.2022

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp21.11.2017

Illustrated instructions

Instructions

Citicoline (Citicoline)