Neipilept solution for injection 250mg / ml, No. 5

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

• the recovery period of ischemic and hemorrhagic strokes;

• traumatic brain injury, acute (as part of complex therapy) and recovery period;

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

Acute period of ischemic stroke and traumatic brain injury (TBI): 1000 mg every 12 hours from the first day after diagnosis, the 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 vascular diseases of the brain: administered intravenously or intramuscularly at 500-2000 mg per day. The dose and duration of treatment - depending on the severity of the symptoms of the disease.

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

The drug should be used immediately after opening the ampoule.

NeipileptЃ is administered intramuscularly, intravenously by jet (slowly, over 3-5 minutes, depending on the prescribed dose) or by drip (infusion rate - 40-60 drops per minute).

The intravenous route of administration is more preferable than the intramuscular route. With intramuscular administration, repeated administration of the drug in the same place should be avoided.

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

in 1 ml:

Active ingredient: citicoline sodium (in terms of citicoline) - 250 mg

Excipients: 1M hydrochloric acid solution or 1M sodium hydroxide solution - up to pH 6.5-7.5, water d / i - up to 4 ml.

• hypersensitivity to any component 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.

Clinical and pharmacological group: Nootropic drug

Pharmaco-therapeutic group: Nootropic agent

pharmachologic effect

Nootropic drug. Citicoline is a natural endogenous compound that is an intermediate metabolite in the synthesis of phosphatidylcholine, one of the main structural components of the cell membrane.

It has a wide spectrum of action - it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, prevents the excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis. In the acute period of stroke, citicoline reduces the amount of damage to the brain tissue, improves cholinergic transmission. In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, in addition, it helps to reduce the duration of the recovery period.

In chronic hypoxia of the brain, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, difficulty in performing 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 sensory and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics

Distribution and metabolism

After intravenous administration, citicoline is rapidly hydrolyzed to choline and cytidine and is delivered to various tissues of the body. After administration, citicoline is widely distributed in the structures of the brain with the rapid incorporation of the choline fraction into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is incorporated into the cellular, cytoplasmic and mitochondrial membranes, taking part in the construction of the phospholipid fraction.

Withdrawal

Only a small amount of the dose is excreted by the kidneys and intestines (<3%). About 12% of the dose is excreted with exhaled CO2. In the excretion of the drug by the kidneys, two phases are distinguished: the first phase - about 36 hours, in which the rate of excretion decreases rapidly, and the second phase, in which the rate of excretion decreases much more slowly. The same phasicity is observed during excretion with CO2, the rate of excretion of exhaled CO2 rapidly decreases after about 15 hours, and then it decreases much more slowly.

Indications

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

• the recovery period of ischemic and hemorrhagic strokes;

• traumatic brain injury, acute (as part of complex therapy) and recovery period;

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

Dosage regimen

Acute period of ischemic stroke and traumatic brain injury (TBI): 1000 mg every 12 hours from the first day after diagnosis, the 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 vascular diseases of the brain: administered intravenously or intramuscularly at 500-2000 mg per day. The dose and duration of treatment - depending on the severity of the symptoms of the disease.

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

The drug should be used immediately after opening the ampoule.

NeipileptЃ is administered intramuscularly, intravenously by jet (slowly, over 3-5 minutes, depending on the prescribed dose) or by drip (infusion rate - 40-60 drops per minute).

The intravenous route of administration is more preferable than the intramuscular route. With intramuscular administration, repeated administration of the drug in the same place should be avoided.

NeipileptЃ is compatible with all types of intravenous isotonic 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 rare (<1/10 000), frequency not established.

Very rare (including individual cases): allergic reactions (rash, pruritus, anaphylactic shock), headache, dizziness, fever, tremors, nausea, vomiting, diarrhea, hallucinations, edema, shortness of breath, insomnia, agitation, decreased appetite, numbness in paralyzed limbs, changes in the activity of liver enzymes. In some cases, citicoline can stimulate the parasympathetic system, as well as produce a short-term change in blood pressure.

If any of the side effects indicated in the instructions are aggravated or any other side effects appear, the patient should inform the doctor about it.

Contraindications for use

• hypersensitivity to any component 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.

Application during pregnancy and lactation

There are insufficient data on the use of citicoline in pregnant women. Although no adverse effects have been found in animal studies, citicoline is prescribed during pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus.

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

Application in children

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

Use in elderly patients

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

special instructions

IV stream NeipileptЃ is injected slowly (3-5 minutes depending on the dose). With intravenous drip, the infusion rate should be 40-60 drops per minute.

In case of persistent intracranial hemorrhage, it is recommended not to exceed the dose of NeipileptЃ 1000 mg / day, the drug is injected intravenously at a rate of 30 drops per minute.

Influence on the ability to drive vehicles, mechanisms

During the use of the drug, care should be taken when driving transport and when engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

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

Drug interactions

Citicoline enhances the effects of levodopa.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 2 years.

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

PHARMFIRMA SOTEX CJSC (Russia)