Neipilept oral solution 100mg / ml, 30 ml

• 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.

NEUPILEPTЃ oral solution is administered orally. Before use, NEUPILEPT Ѓ can be diluted in a small amount of water (100-120 ml or 1/2 cup). It is taken with meals or between meals.

Recommended dosage regimen
Acute period of ischemic stroke and traumatic brain injury (TBI): 1000 mg (10 ml) every 12 hours. Duration of treatment is at least 6 weeks.
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: 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 citicoline is prescribed to elderly patients, dose adjustment is not required.

Active ingredient:
Citicoline 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
Strawberry flavor 0.408 mg
Propyl parahydroxybenzoate 0.25 mg
Sodium saccharinate 0.2 mg
Citric acid monohydrate pH 5.5-6.5
Purified water up to 1 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.

Trade name: NEUPILEPTЃ

International non-proprietary name: citicoline

Dosage form: oral solution

Composition for 1 ml

Active ingredient:
Citicoline 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
Strawberry flavor 0.408 mg
Propyl parahydroxybenzoate 0.25 mg
Sodium saccharinate 0.2 mg
Citric acid monohydrate 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 agent.

ATX code: N06BX06

Pharmacological properties

Pharmacodynamics
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.

Citicoline has a wide spectrum of action - it helps to restore damaged cell membranes, inhibits the action of phospholipases, prevents 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
Absorption: Citicoline is well absorbed when taken orally.
Absorption after oral administration is almost complete, and bioavailability is practically the same as after intravenous administration.
Metabolism: Citicoline is metabolized in the intestine and liver to form choline and cytidine. After administration, 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 phospholiiides 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.
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 CO :. In the excretion of the drug in the urine, 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 removal with CO2, the rate of excretion of exhaled CO2 quickly decreases after about 15 hours, and then it decreases much more slowly.

Indications for use

• 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.

Contraindications

• 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 during breastfeeding
There are no sufficient data on the use of citicoline in pregnant women. During pregnancy, citicoline is prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
When using citicoline during lactation, women should decide on the termination of breastfeeding, since there is no data on the excretion of citicoline in breast milk.

Method of administration and dosage
NEYPILEPTЃ oral solution is administered orally. Before use, NEUPILEPT Ѓ can be diluted in a small amount of water (100-120 ml or 1/2 cup). It is taken with meals or between meals.

Recommended dosage regimen
Acute period of ischemic stroke and traumatic brain injury (TBI): 1000 mg (10 ml) every 12 hours. Duration of treatment is at least 6 weeks.
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: 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 citicoline is prescribed to elderly patients, dose adjustment is not required.

Side effects
Side effects are grouped by frequency of occurrence: very often (> 1/10), often (> 1/100 to <1/10), infrequently (? 1/1000 to <1/100), rarely (? 1/10000 up to <1/1000), very rarely (? 1/10000), the frequency has not been established.
Very rare (<1/10000 (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 have a short-term change in blood pressure.

If any of the side effects indicated in the instructions 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, cases of overdose are not described, even if the therapeutic doses are exceeded.

Interaction with other medicinal products
Citicoline enhances the effects of levodopa.
Should not be used concomitantly with medicinal products containing meclofenoxate.

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

Influence on the ability to drive vehicles and mechanisms
During the use of the drug, care should be taken when driving and when engaging in other potentially hazardous activities.
requiring increased concentration of attention and speed of psychomotor reactions.

Release form
Oral solution, 100 mg / ml.
30 ml, 50 ml or 100 ml in brown glass vials, sealed with a plastic screw cap with first opening control.
1 bottle with a plastic dosing pipette and / or a plastic measuring cup and instructions for use in a cardboard box.

Storage conditions
At a temperature not exceeding 25 ? —. Do not freeze. Keep out of the reach of children.

Shelf life is
2 years. Do not use after the expiration date printed on the package.

Terms of dispensing
By prescription.