Neyrobion
Producer: Nycomed Austria GmbH (Nikomed Austria Gmbh) Austria
Code of automatic telephone exchange: A11DB
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
1 tablet coated contains:
Kernel:
Active agents:
Excipients: magnesium stearate of 2,14 mg, methyl cellulose of 4,00 mg, starch of corn 20,00 mg, gelatin of 23,76 mg, lactoses monohydrate of 40,00 mg, talc of 49,86 mg.
Cover:
wax of 300 mkg, gelatin of 920 mkg, methyl cellulose of 1,08 mg, acacia of 1,96 mg, глицерол 85% 4,32 mg, povidone 25 4,32 of mg, calcium carbonate of 8,64 mg, silicon dioxide of colloid 8,64 mg, kaolin of 21,50 mg, titanium dioxide of 28,00 mg, talc of 47,10 mg, sucrose of 133,22 mg.
Thiamin disulfide (B1 vitamin) of 100,00 mg
Pyridoxine hydrochloride (B6 vitamin) of 200,00 mg
Cyanocobalamine (B12 vitamin) of 240,00 mkg (including 20% surplus)
Description. Biconvex round tablets, coated, brilliant, almost white color.
Pharmacological properties:
Pharmacodynamics. Drug contains a combination of neurotropic active agents of a complex of vitamins of group B. The contained vitamins: thiamin (B1), a pyridoxine (B6) and cyanocobalamine (B12) play a special role as coenzymes in the intermediate metabolism proceeding in the central and peripheral nervous system.
Like other vitamins, they are irreplaceable food components which the organism is not capable to synthesize independently.
Therapeutic introduction to an organism of B1, V6 and V12 vitamins fills often existing insufficient intake of vitamins C with food that provides existence in an organism of necessary quantities of coenzymes.
The combined use of vitamins of group B increases their therapeutic effectiveness as efficiency of a combination surpasses efficiency of separate components.
Therapeutic use of these vitamins at various diseases of a nervous system is directed to, on the one hand, to compensate the existing deficit (perhaps because of the increased requirement of an organism caused directly by a disease) and, on the other hand, to stimulate the natural mechanisms directed to recovery.
At the same time, the favorable effect has indirect analgeziruyushchy effect of a complex of vitamins of group B on therapeutic result.
Pharmacokinetics. Thiamin
After intake thiamin is exposed to dozozavisimy transport which mechanism carries the dual nature: active absorption at concentration to 2 µmol/l and passive diffusion at concentration over 2 ¼¬¼«½Û/l. In a liver there is a thiamin phosphorylation. The elimination half-life makes about 4 hours.
The human body contains about 30 mg of thiamin. Taking into account bystry metabolism he is brought in 4-10 days.
Pyridoxine
The pyridoxine is soaked up very quickly, generally in an upper part of intestines, and the maximum in 2-5 hours is removed. Performance of function of a coenzyme demands phosphorylation of a pyridoxine. The pyridoxine in a fosforilirovayiy form (pyridoxal phosphate) almost for 80% contacts proteins of a blood plasma. The human body contains about 40-150 mg of a pyridoxine. In days kidneys remove 1,7-3,6 mg.
Cyanocobalamine
Cyanocobalamine is soaked up from digestive tract by means of 2 mechanisms:
- release under the influence of a gastric juice and bystry linkng with an internal factor,
- passive diffusion through an intestines epithelium irrespective of an internal factor. At doses over 1,5 mkg the last mechanism plays a significant role.
At patients with B12-scarce anemia the reabsorption after intake makes about 1% from 100 mkg and more.
Excess of cyanocobalamine generally collects in a liver.
He is brought from a liver with bile in intestines and reabsorbirutsya substantially at enterohepatic circulation. Speed of metabolism of cyanocobalamine in days makes 2,5 mkg.
Indications to use:
In complex therapy of the following neurologic diseases:
Neuritis and neuralgia:
- epileptiform neuralgia,
- neuritis of a facial nerve,
- intercostal neuralgia,
- the pain syndrome caused by backbone diseases (a lumbar ishialgia, a plexopathy, the radicular syndrome caused by degenerative changes of a backbone).
Route of administration and doses:
Pill is taken inside, without chewing, washing down with a small amount of water, in time or after food.
On 1 tablet 3 times a day or on doctor's orders.
Duration of treatment is defined by the doctor and averages 1-1,5 months. Dose adjustment of drug at therapy is recommended more than 4 weeks.
Features of use:
At prolonged use (more than 6-12 months) of B6 vitamin in a daily dose of 50 mg there can be peripheral touch neuropathy. Therefore at long therapy it is recommended to control a condition of the patient regularly.
At emergence of symptoms of peripheral touch neuropathy (paresthesia) it is necessary to correct a dose and, if necessary, to stop administration of drug. At B12 vitamin reception the clinical picture, and also laboratory indicators at a funicular myelosis or pernicious anemia can lose the specificity.
Influence on ability to drive the car and to work with mechanisms
Neyrobion does not exert impact on ability to driving of motor transport and to control of mechanisms.
Side effects:
Frequency of side effects of drug is regarded as follows:
Very frequent:> 1/10
Frequent:> 1/100, <1/10
Infrequent:> 1/1000, <1/100
Rare:> 1/10 000, <1/1000
Very rare: <1/10 000, including separate messages
Frequency is not established: cannot be estimated at the available data.
From immune system:
Very rare: Hypersensitivity reactions, such as perspiration, tachycardia and skin reactions - an itch, urticaria.
From the alimentary system:
Frequency is not established: nausea, vomiting, diarrhea, abdominal pain.
Interaction with other medicines:
At simultaneous use with a levodopa the pyridoxine can reduce protivoparkinsonichesky action of a levodopa.
Simultaneous use of antagonists of a pyridoxine (for example, an isoniazid, гидралазин, Penicillaminum or Cycloserinum) can increase the need for a pyridoxine.
Thiamin is inactivated ftoruratsily. Ftoruratsil competitively inhibits phosphorylation of thiamin to thiamine pyrophosphate. Antacids reduce thiamin absorption.
"Loopback" diuretics, for example, furosemide, can block a canalicular resorption, thus, strengthening thiamin excretion at prolonged use that leads to decrease in content of thiamin in blood.
Alcohol intake and black tea leads to decrease in absorption of thiamin.
The drinks containing sulfites (for example, wine), strengthen thiamin degradation.
Contraindications:
Hypersensitivity to any component of drug.
Age up to 18 years (in connection with the high content of active ingredients).
Drug contains lactose and sucrose therefore its use is contraindicated to patients with hereditary intolerance of a galactose or fructose, deficit of lactase, glyukozo-galactoses ache malabsorption or sakharazno-izomaltazny insufficiency.
Use at pregnancy and during breastfeeding
At pregnancy and in the period of a lactation drug use Neyrobion is not recommended in connection with the high content of vitamins.
B1, V6 and V12 vitamins are removed with breast milk, however, the risk of emergence of overdose at the newborn is not established. In some cases, reception of high doses of B6 vitamin (> 600 mg a day), can suppress secretion of breast milk.
In need of administration of drug in the period of a lactation, breastfeeding should be stopped.
Overdose:
B1 vitamin
Thiamin has broad therapeutic range. Very high doses (> 10 g) have ganglioblokiruyushchy effect and suppress transfer of nervous impulses, i.e. have myorelaxation effect.
B6 vitamin
The pyridoxine will bark very small toxicity.
Use of a pyridoxine within 2 months and more in a dose over 1 g a day, can cause neurotoxic effects.
At overdose after intake more than 2 g a day were noted the following effects: neuropathies with an ataxy, sensitivity disturbance, cerebral spasms with changes on an ECG, and also, in some cases, hypochromia anemia and seborrheal dermatitis.
B12 vitamin
After parenteral administration of a high dose (and also in rare instances after intake) eczematic changes of skin and a high-quality form of an acne were observed.
Therapeutic measures at overdose consist in washing of digestive tract, reception of absorbent carbon, purpose of symptomatic therapy.
Storage conditions:
At a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to apply after the expiry date specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Tablets are coated.
On 10 tablets in the blister from PVC / it is SCARLET.
On 2 blisters with the application instruction place in a cardboard pack.