Quinel - instructions for use, dose, side effects, contraindications

Citicoline, being the predecessor of the key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action - it helps to repair damaged cell membranes, inhibits the effect of phospholipases, prevents excessive formation of free radicals, and also prevents cell death by affecting 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 treating cognitive disorders such as memory impairment, lack of initiative, difficulties in performing daily activities and self-service. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia.

Effective in the treatment of sensitive and motor neurologic disorders of degenerative and vascular etiology.

Pharmacokinetics:

Suction

Citicoline is well absorbed by intravenous and intramuscular injection.

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 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. 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 injected citicoline dose is excreted from the human body: less than 3% by the kidneys and about 12% - with exhaled CO2.

Excretion of citicoline with urine can be divided into 2 phases: the first phase, lasting about 36 hours, during which the rate of excretion 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).

- The recovery period of ischemic and hemorrhagic strokes.

- Craniocerebral injury, 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.

Pregnancy and lactation:

Sufficient data on the use during pregnancy are absent. Although there was no evidence of risk to the fetus when the drug was used, during the pregnancy, the Quinel® drug is prescribed only when the expected benefit to the mother exceeds the potential risk to the fetus.

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

Dosing and Administration:

The drug Quinel® 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 the 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), a transition to oral forms of the citicoline preparation is possible.

The recovery period of ischemic and hemorrhagic strokes, the recovery period of craniocerebral trauma, 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.

Elderly patients

When appointing citicoline to elderly patients, dose adjustment 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:

Frequency of adverse reactions: very rare (less than 1/10 000, including individual cases)

Allergic reactions: a rash, skin itching, anaphylactic shock.

Other: a feeling of heat, swelling, shortness of breath.

From the side of the central nervous system and peripheral nervous system: insomnia, headache, dizziness, tremor, numbness in the paralyzed limbs, stimulation of the parasympathetic nervous system.

From the disturbance of the psyche: hallucinations, excitement.

From the side of the cardiovascular system: short-term changes in blood pressure.

From the digestive system: nausea, decreased appetite, vomiting, diarrhea, a change in the activity of hepatic enzymes.

Overdose:

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

Interaction:

Citicoline increases the effects of levodopa.

Do not administer simultaneously with medicines containing meclophenoxate.

Special instructions:

The drug Quinel® is injected intravenously slowly (3-5 minutes depending on the dose). When intravenous drip introduction, the infusion rate should be 40-60 drops per minute.

When persistent intravenous hemorrhage is recommended not to exceed the dose of Quinel ® 1000 mg / day, the drug is administered intravenously drip at a rate of 30 drops per minute.

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

During the treatment period, care should be taken when carrying out potentially hazardous activities requiring special attention and speed of 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 (500 mg / 4 ml) and 250 mg / ml (1000 mg / 4 ml).

Packaging:

To 4 ml in ampoules with a capacity of 5 ml.

3 or 5 ampoules per box or a pack of cardboard with partitions or a liner of paper. By 3 or 5 ampoules per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered or foil-free.

1 circuit cell pack for 3 or 5 ampoules, or 2 contour packs of 5 ampoules are placed in a pack of cardboard.

In each box or pack, the instructions for use and the opener for opening ampoules or the ampoule scarifier are put.

When using ampoules with incisions or a fracture ring, a scarifier ampoule or a knife for opening ampoules is not inserted.

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-003930

Date of registration:01.11.2016

Expiration Date:01.11.2021

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Representation: & nbspVEROPHARM, AO VEROPHARM, AO Russia

Information update date: & nbsp28.12.2017

Illustrated instructions

Instructions

Quinel® (QUINEL®)