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

Excipients: sorbitol - 100.0 mg, glycerol 50.0 mg, glycerolformal 11.0 mg, sodium citrate 5.0 mg, sodium saccharinate 1.5 mg, methyl parahydroxybenzoate 1.6 mg, potassium sorbate 1.4 mg; acid citric monohydrate 1.0 mg, propyl parahydroxybenzoate 0.4 mg, water 1 ml.

Description:

Colorless or yellow-tinged liquid with a specific odor.

During storage, slight opalescence may appear, disappearing when the preparation is kept at room temperature (about 20 ° C).

Pharmacotherapeutic group:nootropic remedy

ATX: & nbsp

N.06.B.X.06 Citicoline

Pharmacodynamics:

Citicoline, being the predecessor of the key ultrastructure components of the cell membrane (mainly phospholipids), has a wide spectrum of action - it helps to restore damaged cell membranes, inhibits the effect of phospholipases, preventing excessive formation of free radicals, and also preventing cell death by affecting the mechanisms of apoptosis.

In an acute period, strokea citicoline reduces the volume of damaged brain tissue improves cholinergic transmission.

With traumatic brain injury reduces the duration of post-traumatic coma and the severity of neurologic symptoms, In addition, 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,The emergence of daily activities and self-service. Increases the level of attention and consciousness, and also reduces the manifestations of amnesia.

Citicoline is effective in treatment sensitive and motor neurological disorders degenerative and vascular etiology.

Pharmacokinetics:

Suction

Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, and bioavailability is approximately the same as after intravenous administration.

Metabolism

The drug is metabolized in the intestine and in the liver with the formation of choline and cytidine.

After taking 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 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 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 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);

- the recovery period of ischemic and hemorrhagic strokes;

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

- Cognitive 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.

Carefully:

No data.

Pregnancy and lactation:

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 to 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:

Prioneer solution for oral administration is given orally. Before use, the preparation can be diluted in a small amount of water (120 ml or _1/2 glass).

Take with meals or between meals.

Recommended dosing regimen

Acute period of ischemic stroke and craniocerebral trauma (CCT):

1000 mg (10 ml) every 12 hours. Treatment duration is not less than 6 weeks.

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 (5-10 ml 1-2 times a day).Dosage and duration of treatment depends on the severity of the symptoms of the disease.

Elderly patients

When appointing Proneuro to elderly patients, dose adjustment is not required.

Instructions for using the dispenser:

1. Place the dispenser in the vial (the dispensing piston is completely lowered.

2. Carefully pull the plunger of the dispenser until the solution level is equal to the corresponding mark on the dispenser.

3. Before taking the right amount of solution, dilute 1/2 cup water (120 ml). After each use, it is recommended to rinse the dispenser with water.

Side effects:

Frequency of side effects

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 listed in the manual are aggravated,or any other side effects not listed in the instructions have been noticed, you should inform your doctor.

Overdose:

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

Interaction:

Citicoline increases the effect of levodopa.

Do not administer simultaneously with medicines containing meclophenoxate.

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 rapid reactions.

Form release / dosage:

Solution for oral administration, 100 mg / ml.

Packaging:

To 45 ml in bottles of dark glass, ukuporennyh covers Cork-screwed from high density polyethylene with controlthe first autopsy. A label is attached to the vial.

Each vial with the instruction for use and a syringe dispenser made of high-density polyethylene is put in a pack.

Storage conditions:

Store in a dark place in the original packaging, at a temperature of 8 to 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003478

Date of registration:01.03.2016

Expiration Date:01.03.2021

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

Manufacturer: & nbsp

GALICHFARM, PAO Ukraine

Information update date: & nbsp11.08.2016

Illustrated instructions

Instructions

Prioneiro (Proneuro)