Entsetron-SOLOfarm - instructions for use, doses, side effects, contraindications

Citicoline - the natural endogenous compound which is an intermediate metabolite in the synthesis of phosphatidylcholine - one of the basic structural components of the cell membrane.

Citicoline has a broad spectrum of action: it helps to restore damaged cell membranes, inhibit the action of phospholipases, prevents excessive formation of free radicals and prevents 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 effective in the treatment of cognitive disorders such as memory loss, lack of initiative, the difficulties encountered in carrying out 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 orally. Absorption after oral administration is almost complete, and bioavailability is almost the same as after intravenous administration.

Metabolism

Citicoline is metabolized in the intestine and 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 choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is embedded in 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% by the exhaled CCH. In the excretion of the drug with urine, two phases are distinguished: the first phase is about 36 hours, in which the elimination rate decreases rapidly, and the second phase, in which the elimination rate decreases much more slowly. The same phase is observed when deduced from CO2, the rate of excretion of CO2 exhaled rapidly decreases after about 15 hours, later it decreases much more slowly.

Indications:

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

- Reconstructive period of ischemic and hemorrhagic strokes.

- Craniocerebral 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 of the components of the drug.

- Do not prescribe 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 to use in children under 18 years of age.

Pregnancy and lactation:

There is insufficient data on the use of citicoline in pregnant women. During pregnancy citicoline appoint only in cases where the expected benefit for the mother exceeds the potential risk to the fetus.

When using citicoline during lactation, women should decide whether to stop breastfeeding,because there is no data on the excretion of citicoline into breast milk.

Dosing and Administration:

Solution for oral administration, applied orally.

Before use, the preparation can be diluted in a small amount of water (100-120 ml or 1/2 cup). Take with meals or between meals.

Recommended dosing regimen

Acute period of ischemic stroke or craniocerebral trauma (CCI): 1000 mg (10 ml) every 12 hours. The 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 cerebrovascular 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 appointing citicoline to elderly patients, dose adjustment is not required.

Side effects:

Side-effects are grouped according to the frequency of occurrence: very often (≥ 1/10), often (≥ 1/100 to <1/10), infrequently (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to < 1/1000), very rarely (<1/10000), the frequency is not set.

Very rarely (<1/10000 (including individual cases)): allergic reactions (rash, itchy skin, anaphylactic shock), headache, dizziness, a feeling of heat.Tremor, nausea, vomiting, diarrhea, hallucinations, swelling, dyspnea, insomnia, agitation, decreased appetite, numbness in the paralyzed limbs, changes in hepatic enzyme activity. In some cases citicoline can stimulate the parasympathetic system, and also have a short-term change in blood pressure.

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

Interaction:

Citicoline increases the effects of levodopa.

Do not use simultaneously with medicines containing meclophenoxate.

Special instructions:

No data.

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

During the use of the drug, caution should be exercised in managing the transport and in dealing with other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for oral administration 100 mg / ml.

Packaging:

By 5 or 10 ml into ampoules of low-density polyethylene (Polytvist). 3 or 5 ampoules in a bag of foil film or without it. 1 packet of foil film with 3 or 5 ampoules or 2 packages of foil film with 3 or 5 ampoules or 3, 5, 6 or 10 ampoules together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-004825

Date of registration:24.04.2018

Expiration Date:24.04.2023

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp28.05.2018

Illustrated instructions

Instructions

Enzetron-SOLOfarm (Encetron-SOLOpharm)