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Alsexolin-injection

INSTRUCTIONS FOR MEDICAL USE

ALSEXOLIN

Trade name of the drug: Alsexoline

Active substance (INN): choline alfoscerate

Pharmaceutical form: solution for injection

Contents:

1 ampoule contains:

Active ingredient: choline alphoscerate 1000 mg/4 ml (in choline alphoscerate hydrate form – 1222.34 mg).

Excipients: Water for injection

Description: colorless or light yellow transparent solution.

Pharmacotherapeutic group: Nootropic medicine.

ATX CODE: N07AX02

Pharmacological properties

Pharmacodynamics

Cholinomimetic of central action with predominant effect on CNS. The drug contains 40.5% metabolically protected choline. Choline alphoscerate is split into choline and alphoscerate in the body under the influence of brain enzymes, which are biotransformed to glycerophosphate. Choline is involved in the synthesis of acetylcholine, improving the transmission of nerve impulses, and glycerophosphate is a precursor of phosphatidylcholine of neuronal membranes, resulting in improved membrane elasticity and receptor function.

The drug improves cerebral blood flow, enhances metabolic processes in the brain, activates brain reticular formation structures and restores consciousness after traumatic brain injury. It has preventive and corrective effect on factors of involutional psychoorganic syndrome, such as changes in phospholipid composition of neuronal membranes and decrease in cholinergic activity.

Pharmacokinetics

The drug penetrates easily through the blood-brain barrier, and accumulates mainly in the brain (45% of concentration in plasma), as well as in liver and lungs. Excretion is mainly via the lungs in the form of carbon dioxide (85%), the remainder being excreted by the kidneys and the intestine.

Indications for use

  • Acute period of craniocerebral injury with predominantly trunk lesions (including in case of impaired consciousness and coma);
  • Cerebral circulation disorders of ischemic type (acute and recovery period) and hemorrhagic type (recovery period);
  • degenerative and involutionary psychoorganic syndromes and consequences of cerebrovascular insufficiency, such as primary and secondary disorders of mnemastic functions, characterized by memory disorders, confusion, disorientation, decreased motivation, initiative and ability to concentrate; changes in the emotional and behavioral sphere: emotional lability, increased irritability, reduced interest; senile pseudomelancholia;
  • multi-infarct dementia.

Administration and dosages

The drug is intended for intramuscular and intravenous administration. In acute conditions, a daily dose of 1 g is administered by injection or intravenously – from 1 g to 3 g per day.

When administered intravenously, 4 ml of the drug are diluted in 50 ml of physiological solution; infusion rate is 60-80 drops/min. The duration of treatment is usually 10 days, but if necessary the treatment can be continued until positive dynamics appear.

Side effects

Nausea (result of dopaminergic stimulation), allergic reactions. Usually, the drug is well tolerated, even with long-term use.

Contraindications

  • Hypersensitivity to the drug components;
  • pregnancy and lactation.

Drug interactions

Drug interactions with other drugs have not been described.

Special indications

Usage during pregnancy and lactation

The drug is contraindicated for use in pregnancy. Breast-feeding should be discontinued during the treatment.

Administration in pediatrics

No experience in application in children.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and to perform potentially dangerous activities.

Overdose

In case of overdose, nausea, restlessness and insomnia are registered, which pass after reduction of the dose or discontinuation of the treatment. Therapy is symptomatic.

Form of production

Solution for injection of 1000 mg/4ml №5, №10 (ampules).

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25oC. Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions for dispensing from pharmacies

Released by doctor’s prescription

Cebrolan – injection

INSTRUCTIONS FOR MEDICAL USE

CEBROLAN

Trade name of drug: CEBROLAN

Active substance (INN): Cerebrolysin

Pharmaceutical form: Solution for injection

Contents:

1 ml of the solution contains:

Active substance: Cerebrolysin concentrate 215.2 mg/ml or 40 mg/ml powder (amino acid peptide complex derived from porcine or bovine brain)

Excipients: Sodium hydroxide, water for injection.

Description: clear amber colored solution.

Pharmacotherapeutic group: Nootropic agent.

ATX code: N06BX

Pharmacological properties

Pharmacodynamics

The drug is a concentrate containing low-molecular-weight biologically active neuropeptides that penetrate through the blood-brain barrier and reach the nerve cells directly.

The drug increases the efficiency of aerobic energy metabolism of the brain, improves intracellular protein synthesis in the developing and aging brain.

It protects neurons from damaging effects.

The drug has neuron-specific neurotrophic activity.

The drug has a positive effect on cognitive impairment, improves concentration, memorization and reproduction of information associated with short-term memory, increases the ability to acquire and retain skills, enhances the process of mental activity, improves mood, promotes positive emotions, thus having a modulating effect on behavior.

Pharmacokinetics

A complex composition of the drug, the active fraction of which consists of a balanced and stable mixture of biologically active oligopeptides with a total multifunctional effect, does not allow the usual pharmacokinetic analysis of the individual components.

Indications for use

Cerebrovascular insufficiency (discirculatory encephalopathy), ischemic stroke (acute phase and rehabilitation phase), conditions after hemorrhagic stroke, traumatic brain injury (brain concussion, craniocerebral injury, conditions after surgical intervention on the brain), mental retardation in children, decreased ability to concentrate in children, dementia syndrome of different genesis (presenile – Alzheimer’s disease, senile Alzheimer’s type, vascular – multi-infarct form, mixed forms), endogenous depression, resistant to antidepressants (in combination therapy).

Dosage and administration

The drug is used parenterally. The dose and duration of administration depend on the nature and severity of the illness, as well as the age of the patient. Single drug administration in dose up to 50 ml is possible, but treatment course is more preferable. Recommended course of treatment is daily injections for 10-20 days.

Acute conditions (ischemic stroke, craniocerebral trauma, complications of neurosurgical operations) – from 10 ml to 50 ml

In the residual period of cerebral stroke and traumatic brain and spinal cord injury – from 5 ml to 50 ml

Psycho-Organic Syndrome and Depression – 5 ml to 30 ml.

Alzheimer’s disease, dementia of vascular and combined Alzheimer’s disease and vascular genesis. 5 ml to 30 ml in neuropedical practice 0.1-0.2 ml/kg body weight.

To increase the effectiveness of treatment, repeated courses may be given as long as improvement of patient’s condition due to treatment is observed. After the first course the frequency of injections may be reduced to 2 or 3 times a week.

The drug is administered parenterally as an intravenous injection (up to 5 ml) and an intravenous injection (up to 10 ml). The drug in dose from 10 ml to 50 ml is recommended to be administered only by slow intravenous infusions after dilution with standard solutions for infusion. The infusion duration is 15 min to 60 min.

Side effects

Digestive system: nausea, vomiting, diarrhea, anorexia, abdominal pain, pseudomembranous enterocolitis, increased liver transaminases activity, hyperbilirubinemia, hepatitis, dysbacteriosis.

Cardiovascular system: decreased BP, vascular collapse, tachycardia.

Metabolism: hypoglycemia (increased appetite, sweating, shivering).

CNS and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesias, anxiety, fear, hallucinations, confusion, depression, motor disorders, seizures.

Sensory organs: disorders of vision, hearing, smell, taste and tactile sensitivity.

Musculoskeletal system: arthralgia, myalgia, tendon rupture, muscle weakness, tendinitis.

Urinary system disorders: hypercreatininemia, interstitial nephritis.

Blood system: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

Dermatological reactions: photosensitization, itching, swelling of the skin and mucous membranes, erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome).

Allergic reactions: urticaria, bronchospasm, choking, anaphylactic shock, allergic pneumonitis, vasculitis. Other: exacerbation of porphyria, rhabdomyolysis, persistent fever, development of superinfection.

Contraindications

Hypersensitivity, acute renal failure, epileptic status.

Caution: pregnancy (I trimester), lactation.

Drug interactions

Increases the effect of antidepressants.

Special indications

After opening the ampoule, the solution should be used immediately.

Administration of the drug during pregnancy (especially during the first trimester) and lactation is possible only after careful analysis of the ratio of the positive effect of the treatment and the risk associated with its use.

The drug has no effect on driving a vehicle and operating potentially dangerous mechanisms.

Precautions

Caution should be exercised in case of allergic diathesis, epilepsy, grand mal seizures.

Overdose

Overdosing caused by use of the drug has not yet been described.

Form of production

In 1 ml, 2 ml, 5 ml or 10 ml ampoules.

Storage conditions

Store in a dry, dark place at a temperature not more than 25ºC. Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Released by a doctor’s prescription.

Encefacolin ® Neo – oral solution

INSTRUCTIONS FOR MEDICAL USE

ENCEFACOLIN® NEO

Trade name of drug: Encefacolin® Neo

Active substance (INN): Citicoline

Pharmaceutical form: oral solution.

Contents:

100 ml of the solution contains:

Active substance: citicoline sodium – 10.45 g;

Excipients: sorbitol 70%, glycerin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium citrate, sodium saccharine, strawberry flavoring, potassium sorbate, citric acid, purified water up to 100 ml.

Description: colorless or yellowish transparent liquid, with a smell of strawberries.

Pharmacotherapeutic group: nootropic agents.

ATX code: N06BX06

Pharmacological properties

Citicoline, being a precursor of the key ultrastructural components of the cell membrane (mainly phospholipids), has a broad spectrum of action: it helps restore the damaged cell membranes, inhibits the action of phospholipases, prevents the excessive formation of free radicals and also prevents cell death by influencing the apoptosis mechanism. In the acute period of stroke citicoline reduces the volume of brain tissue damage, improves cholinergic transmission. In craniocerebral trauma reduces the duration of post-traumatic coma and severity of neurological symptoms, in addition, contributes to reducing the duration of the recovery period. In chronic cerebral hypoxia citicoline is effective in treating cognitive disorders such as memory impairment, lack of initiative, difficulties in performing daily activities and self-care. It increases the level of attention and consciousness and reduces the manifestation of amnesia. Citicoline is effective in treatment of sensory and motor neurological disorders of degenerative and vascular etiology.

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 intestine and liver to form choline and cytidine. After taking the drug, the plasma concentration of choline is significantly increased.

Distribution

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

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% with exhaled CO2.

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

Indications for use

  • Acute period of ischemic stroke (as part of complex therapy).
  • The recovery period of ischemic and hemorrhagic strokes.
  • Craniocerebral trauma (CTS), acute (as part of complex therapy) and recovery period.
  • Cognitive, sensory, motor and neuropsychological disorders associated with cerebral pathology of degenerative or vascular origin.

Directions for use and dosages

The drug is prescribed orally. Before using, the drug may be diluted in a small amount of water (120 ml or 1/2 cup). Taken with a meal or between meals. Recommended dosage regimen

Acute period of ischemic stroke and traumatic brain injury (TBI): 1000 mg (10 ml) every 12 hours. Duration of treatment at least 6 weeks.

Recovery period of ischemic and hemorrhagic strokes, the recovery period of CHT, cognitive and behavioral disorders in degenerative and vascular brain diseases: 500-2000 mg (5-10 ml) 1-2 times a day. Dosage and duration of treatment depending on the severity of the symptoms.

Elderly patients

No dosage adjustment is required when prescribing the drug in elderly patients.

Side effects

Frequency of side effects

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

Allergic reactions (rash, skin itching, anaphylactic shock), headache, dizziness, fever, tremor, nausea, vomiting, diarrhea, hallucinations, edema, dyspnea, insomnia, agitation, decreased appetite, numbness in paralyzed limbs, changes in liver enzyme activity. In some cases, the drug may stimulate the parasympathetic system, as well as have short-term changes in blood pressure.

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

Contraindications

  • Hypersensitivity to any of the ingredients
  • Severe vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system);
  • rare hereditary diseases associated with fructose intolerance;

Drug interactions

Citicoline enhances the effects of levodopa. Should not be administered concomitantly with drugs containing meclofenoxate.

Special Indications

A small amount of crystals may form in the cold due to temporary partial crystallization of the preservative. Upon further storage under the recommended conditions, the crystals will dissolve within several months. The presence of crystals does not affect the quality of the drug. During treatment, caution should be exercised when performing potentially hazardous activities that require special attention and quick reactions (driving a car and other vehicles, working with moving machinery, work of dispatcher and operator, etc.).

Administration during pregnancy and breastfeeding

Sufficient data on the use of citicoline in pregnant women are not available. Although no adverse effects were found in animal studies, during pregnancy the drug is prescribed only in cases when the expected benefits to the mother outweigh the potential risk to the fetus.

When prescribing the drug during lactation women should stop breastfeeding, since there is no data on excretion of citicoline with breast milk. The drug may be used in newborns, if it is necessary for medical indications. The drug contains sorbitol therefore it should not be used in patients with fructose intolerance.

Overdose

Taking into account the low toxicity of the drug, overdosing has not been described.

Form of production

Oral solution 100 mg/ml in 30 ml or 50 ml vials, with measuring spoon or cup.

Storage conditions

In a dry, dark place at a temperature not more than 25ºC. Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies.

Released by a doctor’s prescription.

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