RECOGNAN solution for oral administration 100 mg/ml 10 ml No. 10
Clinical-pharmacological group: Nootropic drug Pharmaco-therapeutic group: Nootropic drug Pharmacological action Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action: promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, preventing the excessive formation of free radicals , as well as preventing cell death by affecting the mechanisms of apoptosis. In the acute period of stroke, it reduces the volume of damaged tissue and improves cholinergic transmission. In case of traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, in addition, it helps to reduce the duration of the recovery period. Citicoline is effective in the treatment of cognitive, sensory and motor neurological disorders of degenerative and vascular etiology. In chronic cerebral ischemia, citicoline is effective in treating disorders such as memory impairment, lack of initiative, and difficulties in performing daily activities and self-care. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia. Pharmacokinetics Absorption Citicoline is well absorbed when taken orally. Absorption after oral administration is almost complete, and bioavailability is approximately the same as after intravenous administration. After oral and parenteral administration, the concentration of choline in the blood plasma increases significantly. Distribution Citicoline is widely distributed in brain structures, with rapid incorporation of choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and is actively incorporated into cellular, cytoplasmic and mitochondrial membranes, forming part of the fraction of structural phospholipids. Metabolism When administered intravenously and intramuscularly, citicoline is metabolized in the liver to form choline and cytidine. Excretion Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% by the kidneys and intestines and about 12% by exhaled air. The excretion of citicoline in urine can be divided into 2 phases: a first phase, lasting about 36 hours, during which the rate of excretion decreases rapidly, and a second phase, during which the rate of excretion decreases much more slowly. The same is observed in exhaled air - the rate of elimination decreases rapidly after approximately 15 hours and then decreases much more slowly.
Recognan solution for internal use 100 mg/ml 10 ml No. 10
Compound
Active substance: citicoline sodium - 10 g. Excipients: sorbitol - 20 g, glycerol - 5 g, methyl parahydroxybenzoate - 0.145 mg, propyl parahydroxybenzoate - 0.025 mg, potassium sorbate - 0.3 g, sodium citrate dihydrate - 0.6 g, sodium saccharinate - 0.02 g , strawberry flavor FRESA S.1487S - 0.04 g, citric acid - up to pH 6.0, purified water - up to 100 ml.
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 intestines and liver with the formation of choline and cytidine. After administration, the concentration of choline in the blood plasma increases significantly.
Distribution
Citicoline is widely distributed in brain structures, with rapid incorporation of choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and is actively incorporated into cellular, cytoplasmic and mitochondrial membranes, forming part of the fraction of structural phospholipids.
Removal
Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% by the kidneys and through the intestines and about 12% by exhaled air.
The excretion of citicoline in urine can be divided into 2 phases: a first phase, lasting about 36 hours, during which the rate of excretion decreases rapidly, and a second phase, during which the rate of excretion decreases much more slowly. The same is observed in exhaled air - the rate of elimination decreases rapidly after approximately 15 hours. And then it decreases much more slowly.
Indications for use
- ischemic stroke (acute period);
- ischemic and hemorrhagic stroke (recovery period);
- traumatic brain injury (acute and recovery period);
- cognitive impairment in degenerative and vascular diseases of the brain.
Contraindications
- vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
- children and adolescents up to 18 years of age;
- hypersensitivity to citicoline.
Directions for use and doses
Recognan®, oral solution, is administered orally. Before use, the drug can be diluted in a small amount of water (120 ml or 1/2 cup).
Take with meals or between meals.
Recommended dosage regimen
- Acute period of ischemic stroke and traumatic brain injury (TBI):
1000 mg (10 ml or 1 sachet) every 12 hours. Duration of treatment for at least 6 weeks.
- Recovery period of ischemic and hemorrhagic strokes, recovery period of TBI, cognitive and behavioral disorders in degenerative and vascular diseases of the brain:
500-2000 mg per day (5-10 ml 1-2 times a day or 1 sachet (1000 mg) 1-2 times a day). Dosage and duration of treatment depending on the severity of the symptoms of the disease.
Elderly patients
When prescribing Recognan® to elderly patients, no dose adjustment is required.
Recommendations for the use of Recognan® in sachets:
1. Take the Recognan® 1000 mg sachet by the edge and shake.
2. Tear off the edge of the bag in the area indicated by the dotted line.
3. Drink the contents of the sachet immediately after opening.
4. Or dissolve in half a glass of drinking water (120 ml) and drink.
Storage conditions
Store out of the reach of children at a temperature of 15°C to 25°C.
Best before date
2 years. Do not use after the expiration date indicated on the package.
special instructions
Citicoline should not be used concomitantly with medicinal products containing meclofenoxate.
Description
Nootropic drug.
Dosage form
The solution for oral administration is clear, colorless, with a characteristic strawberry odor.
Use in children
Contraindicated in children and adolescents under 18 years of age.
Pharmacodynamics
Nootropic drug. Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action: it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, preventing the excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis.
In the acute period of stroke, it reduces the volume of damaged tissue and improves cholinergic transmission.
In case of traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms.
Citicoline improves the symptoms observed during hypoxia: memory impairment, emotional lability, lack of initiative, difficulties in performing daily activities and self-care. Effective in the treatment of cognitive, sensory and motor neurological disorders of degenerative and vascular etiology.
Side effects
From the nervous system: insomnia, headache, dizziness, agitation, tremor, numbness in paralyzed limbs.
From the digestive system: nausea, loss of appetite, changes in the activity of liver enzymes.
Allergic reactions: rash, itchy skin, anaphylactic shock.
Other: fever; in some cases - short-term hypotensive effect, stimulation of the parasympathetic nervous system.
Use during pregnancy and breastfeeding
There are no sufficient data on the use of citicoline in pregnant women. Although animal studies have not revealed any negative effects, during pregnancy the drug Recognan® is prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
When prescribing Recognan® during lactation, women should stop breastfeeding, since there is no data on the excretion of citicoline in human milk.
Interaction
Citicoline enhances the effects of levodopa.
Should not be administered concomitantly with medicinal products containing meclofenoxate.
Overdose
Given the low toxicity of the drug, cases of overdose have not been described.
Release form
Oral solution 100 mg/ml 10 ml No. 10.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, care must be taken when performing potentially hazardous activities that require increased attention and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, working as a dispatcher, operator, etc.).
Recognan instructions for use
Instructions for medical use of the drug Recognan
Release form: Recognan - oral solution 100 ml. 30 ml of the drug in bottles. A bottle with a dosing pipette is placed in a box made of cardboard. Bags. 10 ml of the drug in bags made of multilayer combined material (PET-LDPE-aluminum-PE). Sachets in quantities of 5 or 10 pcs. placed in a box of cardboard.
Composition: Recognan contains: active substance: citicoline monosodium salt 10.45 g (equivalent to 10 g of citicoline). Excipients: sorbitol - 20 g; glycerol - 5 g; propylene glycol - 1.04 g; methyl parahydroxybenzoate - 0.16 g; propyl parahydroxybenzoate - 0.04 g; potassium sorbate - 0.14 g; sodium citrate dihydrate - 0.6 g; sodium saccharinate - 0.02 g; Azorubine dye (E122) - 0.002 g; strawberry flavor FRESA S. 1487S – 0.04 g; citric acid - up to pH 6; purified water - up to 100 ml
Recognan is a modern neuroprotective drug (INN: citicoline), which has a wide range of therapeutic possibilities: it is used in the treatment of diseases such as ischemic stroke, both in the acute and recovery periods, acute and recovery periods of traumatic brain injury, cognitive and behavioral disorders for degenerative and vascular diseases of the brain. Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action - it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, prevents the excessive formation of free radicals, and also prevents cell death by affecting the mechanisms of apoptosis. In the acute period of stroke, it reduces the volume of damage to brain tissue and improves cholinergic transmission. In case of TBI, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, in addition, it helps to reduce the duration of the recovery period. Citicoline is effective in the treatment of cognitive, sensory and motor neurological disorders of degenerative and vascular etiology. In chronic cerebral ischemia, citicoline is effective in treating disorders such as memory impairment, lack of initiative, and difficulties arising in performing daily self-care activities. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia. Pharmacokinetics Absorption. 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 intestines and liver with the formation of choline and cytidine. After administration, the concentration of choline in the blood plasma increases significantly. Distribution. Citicoline is widely distributed in brain structures, with rapid incorporation of choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and is actively incorporated 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 intestines and about 12% by exhaled air. The excretion of citicoline in urine can be divided into 2 phases: the 1st phase, lasting about 36 hours, during which the rate of excretion decreases rapidly, and the 2nd, during which the rate of excretion decreases much more slowly. The same thing is observed in exhaled air - the rate of excretion decreases rapidly after about 15 hours. And then decreases much more slowly.
Indications for use: Indications for use of the drug Recognan are: acute period of ischemic stroke (as part of complex therapy); recovery period of ischemic and hemorrhagic strokes; traumatic brain injury, acute (as part of complex therapy) and recovery periods; cognitive and behavioral disorders in degenerative and vascular diseases of the brain.
Directions for use: Take Recognan orally, during meals or between meals. Before use, the drug can be diluted in a small amount of water (120 ml or 1/2 cup). Recommended dosage regimen. 500–2000 mg per day (5–10 ml 1–2 times a day or 1 pack (1000 mg) 1–2 times a day). The dosage and duration of treatment depend on the severity of the symptoms of the disease. Special groups of patients Elderly. When prescribing Recognan to elderly patients, no dose adjustment is required. Instructions for using the dosing pipette included with the bottle Place the dosing pipette in the bottle (the pipette piston is completely lowered). Carefully pull the plunger of the dosing pipette until the solution level is equal to the corresponding mark on the pipette. Before use, the required amount of solution can be diluted in 1/2 glass of water (120 ml). After each use, it is recommended to rinse the dosing pipette with water. Recommendations for the use of Recognan in sachets Take a sachet of Recognan®, 1000 mg, by the edge and shake. Tear off the edge of the bag in the place indicated by the dotted line. Drink the contents of the sachet immediately after opening or dissolve in 1/2 glass of drinking water (120 ml) and drink.
Side effects: Allergic reactions (rash, skin itching, anaphylactic shock), headache, dizziness, feeling of heat, tremor, nausea, vomiting, diarrhea, hallucinations, swelling, shortness of breath, insomnia, agitation, loss of appetite, numbness in paralyzed limbs, changes liver enzyme activity. In some cases, Recognan can stimulate the parasympathetic system and also have a short-term effect on blood pressure. If any of the side effects listed in the description get worse or any other side effects not listed in the description are noticed, you should tell your doctor.
Contraindications: Contraindications to the use of the drug Recognan are: hypersensitivity to any of the components of the drug; patients with severe vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system); rare hereditary diseases associated with fructose intolerance; children under 18 years of age (due to the lack of sufficient clinical data). With caution: there is no information on relative contraindications when using the drug.
Pregnancy: There are no sufficient data on the use of Recognan in pregnant women. Although animal studies have not revealed a negative effect, during pregnancy the drug Recognan is prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. When prescribing Recognan during lactation, women should stop breastfeeding, since there is no data on the excretion of citicoline in human milk.
Interaction with other drugs: Recognan enhances the effects of levodopa. Should not be prescribed concomitantly with drugs containing meclofenoxate.
Overdose : Cases of overdose of Recognan have not been described.
Storage conditions: At a temperature of 15–25 °C. Keep out of the reach of children.
Additionally: In the cold, a small amount of crystals may form due to temporary partial crystallization of the preservative. With further storage under recommended conditions, the crystals dissolve within several months. The presence of crystals does not affect the quality of the drug. Influence on the ability to drive vehicles and machinery. During the treatment period, care must be taken when performing potentially hazardous activities that require increased attention and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, working as a dispatcher, operator, etc.).
Conditions for dispensing from pharmacies: By prescription.
Shelf life: 2 years. Do not use after the expiration date stated on the package.
Manufacturer Farmasierra Manufacturing S.L., Spain (bottle). Highway Irun, km 26200, San Sebastian de dos Reis, 28700, Madrid, Spain. SAG Manufacturing S.U., Spain (bag) Highway NI. 36 km, San Agustin de Guadalix, 28750. Madrid, Spain.
