Neypilept 100 mg/ml 30 ml No. 1 solution for oral administration
Instructions for medical use of the drug NEIPILEPT Trade name Neipilept International nonproprietary name Citicoline Dosage form Oral solution 100 mg/ml, 30 ml Composition per 1 ml active substance - citicoline sodium (in terms of citicoline) 100.0 mg excipients: sorbitol, glycerin , sodium citrate, potassium sorbate, methyl parahydroxybenzoate, strawberry flavor, propyl parahydroxybenzoate, sodium saccharinate, citric acid monohydrate, purified water. Description Transparent, colorless or slightly yellowish liquid with a characteristic strawberry odor. Pharmacotherapeutic group Nervous system. Psychoanaleptics. Psychostimulants used for attention deficit hyperactivity disorder (ADHD - Attention deficit hyperactivity disorder) and nootropic drugs. Other psychostimulants and nootropics. Citicoline Code ATX N06BX06 Pharmacological properties Pharmacokinetics Absorption: Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, and bioavailability is almost the same as after intravenous administration. Metabolism: Citicoline is metabolized in the intestines and liver to form choline and cytidine. After administration, the concentration of choline in the blood plasma increases significantly. Distribution: Citicoline is widely distributed in brain structures, with rapid incorporation of choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is integrated into 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% by exhaled CO2. There are two phases in the excretion of the drug in the urine: the first phase, around 36 hours, in which the rate of excretion decreases rapidly, and the second phase, in which the rate of elimination decreases much more slowly. The same phasicity is observed during excretion with CO2; the rate of excretion of exhaled CO2 quickly decreases after approximately 15 hours, and then it decreases much more slowly. 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 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 volume of brain tissue damage and improves cholinergic transmission. In case of 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 cerebral hypoxia, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, and difficulties 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. Indications for use - stroke and its consequences - traumatic brain injury and its consequences - cognitive, sensory and motor neurological disorders caused by degenerative and vascular disorders of the brain. Method of administration and dosage Neypilept oral solution is administered orally. Before use, Neypilept can be diluted in a small amount of water (100-120 ml or 1/2 cup). Take with meals or between meals. Recommended dosage regimen Adults: 500–2000 mg (5–20 ml) per day. The dosage and duration of treatment depend on the severity of the symptoms of the disease. Elderly patients When prescribing citicoline to elderly patients, no dose adjustment is required. Side effects Side effects are grouped by frequency of occurrence: very common (> 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 up to <1/1000), very rare (<1/10000), frequency not established. Very rare (< 1/10000 (including individual cases): - allergic reactions (rash, itching, anaphylactic shock) - headache, dizziness, hallucinations, agitation, insomnia, feeling hot, tremor - shortness of breath - nausea, vomiting, diarrhea - swelling - decreased appetite - numbness in paralyzed limbs - changes in liver enzyme activity In some cases, citicoline may stimulate the parasympathetic system and also cause a short-term change in blood pressure If any of the side effects listed in the instructions for use get worse or you notice any other side effects not specified in the instructions, inform your doctor. 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) - patients with rare hereditary fructose intolerance, impaired absorption of glucose-galactose or sucrose - isomaltose due to the presence of sorbitol Drug interactions Citicoline enhances the effects of L-dihydroxyphenylalanine. Should not be used concomitantly with medicinal products containing meclofenoxate. Special instructions Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate in the composition, allergic reactions (including delayed ones) may develop. It contains sorbitol, so patients with rare hereditary problems of fructose intolerance should not take the drug. In the cold, a small amount of crystals may form due to temporary partial crystallization of the preservative. With further storage under recommended conditions, the crystals dissolve within several months. The presence of crystals does not affect the quality of the drug. Use in pediatrics Experience in children is limited: therefore, the drug can be prescribed only in cases where the expected therapeutic benefit outweighs any possible risk. Use during pregnancy and breastfeeding There is 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 consider stopping breastfeeding, since there is no data on the excretion of citicoline into breast milk. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms When using the drug, care should be taken when driving and when engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions. Overdose Given the low toxicity of the drug, cases of overdose have not been described, even if therapeutic doses are exceeded. Release form 30 ml in brown glass bottles, sealed with a plastic screw cap with first opening control. 1 bottle together with a plastic dosing pipette and/or a plastic measuring cup and instructions for medical use in the state and Russian languages in a cardboard pack. Storage conditions At a temperature not higher than 25 oC. Do not freeze. Keep out of the reach of children. Shelf life 2 years. The period of use after opening the bottle is 6 days. Do not use after the expiration date. Dispensing conditions By prescription 141345, Russia, Moscow region, Sergiev Posad municipal district, rural settlement Bereznyakovskoye, pos. Belikovo, d. 10, d. 11, d. 12 Owner of the registration certificate of CJSC “Pharm”, Russia, Moscow region, Sergiev Posad municipal district, rural settlement Bereznyakovskoye, pos. Belikovo, 11. Name, address and contact details (telephone, fax, e-mail) of the organization on the territory of the Republic of Kazakhstan that accepts claims (suggestions) on the quality of medicines from consumers and is responsible for post-registration monitoring of the safety of the medicine: TOO "EL company ( EL company)" 050022, Republic of Kazakhstan, Almaty, st. Masanchi 98 A, office 41 Phone, fax: 292-26-37
Naypilept
Neypilept solution for oral administration 100 mg/ml 100 ml x1, ATX code: N06BX06 (Citicoline) Active substance: citicoline (citicoline) Rec.INN registered by WHO
Dosage form
NAYPYLEPT®
solution for oral administration 100 mg/1 ml: vial. 30 ml, 50 ml or 100 ml per set. with dosage pipette and/or measuring tape. cupreg. No.: LP-003817 dated 08/31/16 - Valid
Release form, composition and packaging
The solution for oral administration is clear, colorless or slightly yellowish, with a characteristic strawberry odor.
1 ml
citicoline sodium (in terms of citicoline) 100 mg
Excipients: sorbitol - 200 mg, glycerol - 50 mg, sodium citrate (sodium citrate dihydrate) - 6 mg, potassium sorbate - 3 mg, methyl parahydroxybenzoate - 1.45 mg, strawberry flavor - 0.408 mg, propyl parahydroxybenzoate - 0.25 mg, sodium saccharinate - 0.2 mg, citric acid monohydrate - up to pH 5.5-6.5, purified water - up to 1 ml.
Clinical-pharmacological group: Nootropic drug Pharmaco-therapeutic group: Nootropic drug
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.
Citicoline 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 volume of brain tissue damage and improves cholinergic transmission. In case of 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 cerebral hypoxia, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, and difficulties 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
Suction
Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, bioavailability is almost the same as after intravenous administration. After taking the drug, the concentration of choline in the blood plasma increases significantly.
Distribution
Citicoline is widely distributed in brain structures, with the rapid introduction of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is integrated into cellular, cytoplasmic and mitochondrial membranes, taking part in the construction of the phospholipid fraction.
Metabolism
Citicoline is metabolized in the intestines and liver to form choline and cytidine.
Removal
Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% by the kidneys and about 12% by exhaled CO2. There are two phases in the excretion of the drug in the urine: the first phase, around 36 hours, in which the rate of excretion decreases rapidly, and the second phase, in which the rate of elimination decreases much more slowly. The same is observed in exhaled CO2, the rate of excretion decreases rapidly after approximately 15 hours, and thereafter it decreases much more slowly.
Indications
- acute period of ischemic stroke (as part of complex therapy),
- 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.
ICD-10 codes
Dosage regimen
The drug is taken orally, during meals or between meals.
Before use, Neupilept® can be diluted in a small amount of water (100-120 ml or 1/2 cup).
Acute period of ischemic stroke and traumatic brain injury: prescribed 1000 mg (10 ml) every 12 hours. Treatment duration is at least 6 weeks.
Recovery period of ischemic and hemorrhagic strokes, recovery period of traumatic brain injury, cognitive and behavioral disorders in degenerative and vascular diseases of the brain: prescribed 500-2000 mg (5-20 ml)/day. The dose and duration of treatment are determined depending on the severity of the symptoms of the disease.
When prescribing citicoline to elderly patients, no dose adjustment is required.
Side effect
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 (≥1/100). 10,000 to <.1/1000), very rare (<.1/10,000), frequency not established.
Very rare (<.1/10,000 (including individual cases)): allergic reactions (rash, itching, anaphylactic shock), headache, dizziness, feeling of heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite, numbness in paralyzed limbs, changes in the activity of liver enzymes. In some cases, citicoline may stimulate the parasympathetic system and also 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 not listed in the instructions are noted, the patient should inform the doctor.
Contraindications for use
- hypersensitivity to any of the components of the drug,
- pronounced vagotonia (high tone of the parasympathetic part of the autonomic nervous system),
- age under 18 years (due to the lack of sufficient clinical data).
Use during pregnancy and breastfeeding
There are insufficient 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 consider stopping breastfeeding, since there is no data on the excretion of citicoline into breast milk.
Use in children The drug is contraindicated in people under 18 years of age (due to the lack of sufficient clinical data).
Use in elderly patients When citicoline is prescribed to elderly patients, no dose adjustment is required.
special instructions
In the cold, a small amount of crystals may form due to temporary partial crystallization of the preservative. With further storage under recommended conditions, the crystals dissolve within several months. The presence of crystals does not affect the quality of the drug.
Impact on the ability to drive vehicles and operate machinery
While using the drug, care should be taken when driving and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
Given the low toxicity of the drug, cases of overdose have not been described, even if therapeutic doses are exceeded.
Drug interactions
Citicoline enhances the effects of levodopa.
Should not be used concomitantly with medicinal products containing meclofenoxate.
Conditions and periods of storage The drug should be stored out of the reach of children at a temperature not exceeding 25°C, and do not freeze. Shelf life: 2 years. Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies The drug is dispensed with a prescription.
