Proneuro - instructions for use, doses, side effects, contraindications

	125 mg / ml	250 mg / ml
Active substance:
Citicolin sodium	522,52	1045,00
in terms of citicoline	500,00	1000,00
Auxiliary substancesa:
The hydrochloric acid solution 0.1 M or sodium hydroxide solution 0.1 M *	to a pH of 6.5 to 7.1
Water for injections	up to 4 ml

Description:Prosaceous, colorless liquid.

Pharmacotherapeutic group:nootropic remedy

ATX: & nbsp

N.06.B.X.06 Citicoline

Pharmacodynamics:

Citicoline, as a precursor of ultrastructural key components of the cell membrane (preferably phospholipids), has a wide spectrum of action - contributes to the restoration of damaged cell membranes, to inhibit phospholipases action, preventing excessive formation of free radicals, as well as preventing cell death by acting on 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 the treatment of cognitive disorders such as memory impairment, lack of initiative, difficulties arising from 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 sensitive and motor neurological disorders of degenerative and vascular etiology.

Pharmacokinetics:

Suction

Citicoline is well absorbed when taken intravenously and intramuscularly.

Metabolism

With intravenous and intramuscular injection citicoline metabolized in the liver with the formation of choline and cytidine. After administration, the concentration of choline in the blood plasma is significantly increased.

Distribution

Citicoline is largely distributed in the structures of the brain, with the rapid introduction of the choline fraction into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates into the brain and actively integrates into cellular, cytoplasmic and mitochondrial membranes, forming part of the fraction of structural phospholipids.

Excretion

Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% - by the kidneys and through the intestine, and about 12% - with the exhaled CO₂.

In excretion of citicoline with urine, two phases can be identified: the first phase, lasting about 36 hours, during which the rate of elimination rapidly decreases, and the second phase, during which the rate of excretion decreases much more slowly. The same is observed in the exhaled CO₂ - the elimination rate decreases rapidly after about 15 hours, and then decreases much more slowly.

Indications:

- Acute period of ischemic stroke (as part of complex therapy).

- atthe restorative period of ischemic and hemorrhagic strokes.

- hCraniocerebral trauma (TBI), acute (as part of complex therapy) and the recovery period.

- toinflammatory and behavioral disorders in degenerative and vascular diseases of the brain.

Contraindications:

Do not prescribe to patients with severe vagotonia (predominance of the parasympathetic part of the autonomic nervous system) and hypersensitivity to any of the components of the drug.

Due to the lack of sufficient clinical data, it is not recommended for use in children under 18 years of age.

Pregnancy and lactation:

Application in pregnancy and during breastfeeding

Sufficient data on the use of citicoline in pregnant women are absent.

Although no adverse effects have been identified in animal studies, Preneuro is prescribed in pregnancy only when the expected benefit to the mother exceeds the potential risk of the fetus.

When appointing Proneuro during lactation, women should stop breastfeeding, as there is no data on the isolation of citicoline with human milk.

Dosing and Administration:

The drug is administered intravenously or intramuscularly.

Intravenous administration is given in the form of a slow intravenous injection (within 3-5 minutes, depending on the prescribed dose) or intravenous drip infusion (40-60 drops per minute).

Intravenous route of administration is preferable to intramuscular. When intramuscular introduction should be avoided repeated administration of the drug in the same place.

Recommended dosing regimen

Acute period of ischemic stroke and craniocerebral trauma):

1000 mg every 12 hours from the first day after diagnosis, duration of treatment is not less than 6 weeks. 3-5 days after the start of treatment (if the swallowing function is not broken), it is possible to switch to oral forms of the Proneiro product.

The recovery period of ischemic and hemorrhagic strokes, the recovery period of TBI, cognitive and behavioral disorders in degenerative and cerebrovascular diseases of the brain:

500-2000 mg per day.Dosage and duration of treatment, depending on the severity of the symptoms of the disease. Perhaps the use of oral forms of the drug Proneuro.

If suspicion of continued intracranial bleeding is recommended not to exceed the dose of Proneuro 1000 mg per day, the drug is injected intravenously at a rate of 30 drops per minute.

Elderly patients

When appointing Proneuro to elderly patients, correction is not required.

The solution in the ampoule is intended for single use. It should be used immediately after opening the ampoule.

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

Side effects:

The incidence of adverse adverse reactions (CPD)

Very rare (<1/10000) (including isolated cases):

Allergic reactions (rash, skin itch, 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, Proneuro can stimulate the parasympathetic system, as well as provide a short-term change in blood pressure.

If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions were noticed, you should inform your doctor about it.

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

In case of an accidental overdose, treatment is symptomatic.

Interaction:

Citicoline increases the effect of levodopa.

Do not administer simultaneously with medicines containing meclophenoxate.

Special instructions:

If there is a suspicion of continued intracranial bleeding, see the section "Dosing and Administration".

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care should be taken when performing potentially hazardous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).

Form release / dosage:Solution for intravenous and intramuscular injection, 125 mg / ml and 250 mg / ml.

Packaging:

To 4 ml in ampoules of colorless transparent neutral glass (type I) with red (pantone 186 C) break ring for a dosage of 250 mg / ml or - with yellow(pantone 116 C) ring break for a dosage of 125 mg / ml. A label is affixed to each ampoule.

By 5 ampoules in a blister of PVC or in a blister of PVC coated with polyethylene film, 2 blister along with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 of the year.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003454

Date of registration:09.02.2016

Expiration Date:09.02.2021

The owner of the registration certificate:GALICHFARM, PAO GALICHFARM, PAO Ukraine

Manufacturer: & nbsp

GALICHFARM, PAO Ukraine

Information update date: & nbsp01.08.2016

Illustrated instructions

Instructions

Prioneiro (Proneuro)