Neupilept® (Neipilept®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCiticolineCiticoline
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    • Dosage form: & nbspROral for oral use
    Composition:

    Per 1 ml:

    Active substance:

    Citicolin sodium (in terms of citicoline)

    100.0 mg

    Excipients:

    Sorbitol

    200.0 mg

    Glycerol

    50.0 mg

    Sodium citrate (sodium citrate dihydrate)

    6.0 mg

    Potassium sorbate

    3.0 mg

    Methyl parahydroxybenzoate

    1.45 mg

    Aromatic Strawberry

    0.408 mg

    Propyl parahydroxybenzoate

    0.25 mg

    Sodium saccharinate

    0.2 mg

    Citric acid monohydrate

    to pH 5.5-6.5

    Purified water

    up to 1 ml
    Description:

    Transparent, colorless or slightly yellowish liquid with a characteristic strawberry odor.

    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.

    Citicoline 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 is effective in treating cognitive disorders such as memory impairment, lack of initiative,The difficulties encountered in performing daily activities and self-service. 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 well absorbed when taken orally.

    Absorption after oral administration is almost complete, and bioavailability is almost the same as after intravenous administration.

    Metabolism: citicoline metabolized in the intestine and liver with the formation of choline and cytidine. After taking the concentration of choline in the blood plasma increases significantly.

    Distribution: citicoline is largely distributed in the structures of the brain, with the rapid introduction of choline fractions into 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 15% The injected dose of citicoline is excreted from the human body: less than 3% - by the kidneys and about 12% - with the exhaled CO2. In the excretion of the drug with urine, two phases are distinguished: 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 deducing from CO2, the rate of excretion 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, 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. 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 during lactation, women should decide whether to stop breastfeeding, since there is no data on the excretion of citicoline into breast milk.

    Dosing and Administration:

    Neupilept ® solution for oral administration is used orally.

    Before using Neupilept ® can be diluted in a small amount of water (100-120 ml or 1/2 cup). Take with meals or between meals.

    Recommended dosing regimen

    Acute period of ischemic stroke and craniocerebral trauma (CCI): 1000 mg (10 ml) every 12 hours. Treatment duration is not less than 6 weeks.

    The recovery period of ischemic and hemorrhagic strokes, recovery period, Cognitive and behavioral disorders degenerative and cerebrovascular diseases of the brain: 500-2000 mg (5-20 ml) per day. Dosage and duration of treatment - depending on the severity of the symptoms of the disease.

    Elderly patients

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

    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 (<1/10000), the frequency is not set.

    Very rarely (<1/10000 (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 indicated in the manual are aggravated, or if 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, even if therapeutic doses are exceeded.

    Interaction:

    Citicoline increases the effects of levodopa.

    Do not use simultaneously with medicines containing meclophenoxate.
    Special instructions:

    In the cold, a small amount of crystals may form due to the temporary partial crystallization of the preservative. With further storage under the recommended conditions, the crystals dissolve within a few months. The presence of crystals does not affect the quality of the drug.

    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 dealing with other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for oral administration, 100 mg / ml.

    Packaging:

    To 30 ml, 50 ml or 100 ml in bottles made of brown glass, sealed with a screw cap made of plastic with the control of the first opening.

    1 a vial with a plastic dispensing pipette and / or a plastic measuring cup and instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 of the year.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003817
    Date of registration:31.08.2016
    Expiration Date:31.08.2021
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp27.06.2018
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