Neupilept, 100 mg/ml 100 ml
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Pharmacotherapeutic group: nootropic.
ATX code: N06BX06
Pharmacological properties.
Pharmacodynamics
Citicoline is a natural endogenous compound that is an intermediate meta-
bolyte in the synthesis of phosphatidylcholine, one of the main structural components
of the cell membrane.
It has a broad spectrum of action – helps to restore damaged
cell membranes, inhibits the action of phospholipases, prevents excessive formation
of free radicals, and also prevents cell death, affecting the mechanisms
of apoptosis. In the acute period of stroke citicoline reduces the volume of brain tissue damage, improves cholinergic transmission. In brain injury it reduces the duration of post-traumatic coma and severity of neurological symptoms, besides it contributes to reduction of duration of recovery period.
In chronic cerebral hypoxia cicoline is effective in treating cognitive
disorders such as memory impairment, lack of initiative, difficulties in
performing daily activities and self-care. Increases levels of attention and
consciousness, and reduces the manifestation of amnesia.
Cyticolin is effective in the treatment of sensory and motor neurological disorders of degenerative and vascular
etiology.
Pharmacokinetics
Metabolism: After intravenous administration, citicoline is rapidly hydrolyzed to choline and
cytidine and is delivered to various tissues of the body.
Distribution:After administration, cicoline is widely distributed in brain structures
with rapid incorporation of the choline fraction into structural phospholipids and the
cytidine fraction into citidine nucleotides and nucleic acids. Upon reaching the brain,
citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes,
taking part in the construction of phospholipid fractions.
Elimation:Only a small amount of the dose is excreted by the kidneys and through the intestine (<3%).
About 12% of the dose is excreted with exhaled CO2. Renal excretion is divided into two phases: the first phase, about 36 hours, in which the excretion rate decreases rapidly, and
the second phase, in which the excretion rate decreases much slower. The same phase
is observed in excretion with CO2, the excretion rate of exhaled CO2 decreases rapidly
after about 15 h, it decreases much more slowly thereafter.
Indications
Active ingredient
Composition
Active ingredient:
citicoline sodium (in terms of citicoline) 500 mg
Excipients:
hydrochloric acid concentrated
or
sodium hydroxide to pH 6.5-7.5
water for injection to 4 ml
.
How to take, the dosage
Recommended dosing regimen
Acute period of ischemic stroke and traumatic brain injury (TBI):
1000 mg citicoline every 12 hours from the first day after diagnosis, treatment duration
at least 6 weeks.
Maximum daily dose – 2000 mg.
Restorative period of ischemic and hemorrhagic strokes, restorative
period of CMP, cognitive and behavioral disorders in degenerative and vascular
brain diseases:
Administered v/v or intram 500-2000 mg citicoline daily. Dosage and duration of treatment depend on the severity of the disease symptoms.
Elderly patients
When administering NEIPILEPT® for elderly patients no dose adjustment is required.
The drug should be used immediately after opening the ampoule.
NEUPYLEPT® is given intramuscularly, intravenously by jetting (slowly over 3-5 minutes depending on the dose prescribed) or dropwise (infusion rate – 40-60 drops per
minute).
The intravenous (IV) route of administration is preferable to the intramuscular (IV) route. When administered intravenously, avoid repeated administration to the same site.
NEUPILEPT® is compatible with all types of intravenous isotonic solutions and
dextrose solutions.
Special Instructions
Intravenous NeUPILEPT® is administered slowly (3-5 minutes depending on the dose).
In intravenous drip infusion, 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 NEUPILEPT® 1000 mg per day, the drug is administered intravenously by drop infusion at the rate of 30 drops per minute.
Influence on the ability to drive vehicles, mechanisms
During the use of the drug caution should be exercised while driving a vehicle and engaging in other potentially dangerous activities that require
increased concentration and rapid psychomotor reactions.
Contraindications
– Hypersensitivity to any of the drug components;
– Do not prescribe to patients with severe vagotonia (high tone of parasympathetic nervous system);
– Due to lack of sufficient clinical data it is not recommended to use in children
under 18 years.
Side effects
Side effects are grouped by frequency of occurrence: very frequently (> 1/10), frequently
(⥠1/100 to < 1/10), infrequently (⥠1/1000 to < 1/100), rarely (⥠1/10000 to < 1/1000), very rarely
(< 1/10000), frequency not determined.
Very rare (including individual cases): Allergic reactions (rash, skin itching,
anaphylactic shock), headache, dizziness, fever, tremor, nausea,
vomiting, diarrhea, hallucinations, edema, shortness of breath, insomnia, agitation, decreased appetite,
numbness in paralyzed limbs, changes in liver enzyme activity. In
some cases, citicoline may stimulate the parasympathetic system, and
have short-term changes in blood pressure.
If any of the side effects listed in the instructions are aggravated or you notice
any other side effects not specified in the instructions, tell your doctor.
Overdose
Pregnancy use
There are insufficient data on the use of citicoline in pregnant women. Although no adverse effects were found in
animal studies, during pregnancy
citicoline is prescribed only when the expected benefit to the mother exceeds
the potential risk to the fetus.
When using citicoline during lactation women should stop breast
feeding, since there are no data on the excretion of citicoline with the breast milk.
Similarities
Weight | 0.135 kg |
---|---|
Shelf life | 3 years. Do not use after the expiration date. |
Conditions of storage | At a temperature not exceeding 25 °C. Keep out of reach of children. |
Manufacturer | PharmFirm Sotex, Russia |
Medication form | oral solution |
Brand | PharmFirm Sotex |
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