Баклосан®

General characteristics. Structure:

Active ingredient: 10 mg or 25 mg Baclofenum of 10 mg or 25 mg.

Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethyl cellulose.

Pharmacological properties:

Pharmacodynamics. Muscle relaxant of the central action, derivative piperidic acid (GAMKB-stimulyator). Reducing excitability of trailer departments of afferent sensitive fibers and suppressing interneuronels, oppresses mono - and polisinaptichesky transfer of nervous impulses; reduces the preliminary tension of muscle spindles. Has no effect on neuromuscular transmission.

At the neurologic diseases which are followed by spasticity of skeletal muscles weakens cricks and clonic spasms; increases the volume of the movement in joints, facilitates carrying out a passive and active kinesitherapy (physical exercises, massage, manual therapy).

Pharmacokinetics. Absorption – high. The maximum concentration in a blood plasma is reached in 2-3 hours after administration of drug. Communication with proteins of a blood plasma – 30%. Gets through a placental barrier, it is allocated with breast milk. It is metabolized in a liver. It is removed by kidneys (preferential in an invariable look).

Indications to use:

Increase in a muscle tone at multiple sclerosis, diseases of a spinal cord (tumors, a myelosyringosis, diseases of motive motor-neurons, injuries, a myelitis), cerebrovascular diseases, a cerebral palsy, meningitis, a craniocereberal injury.

Route of administration and doses:

Inside, during food. In case of the admission of the next reception it is not necessary to accept a double dose of drug.

Adults. An initial dose – 5 mg (1/2 tablets on 10 mg) 3 times a day, with the subsequent increase in a dose each 3 days on 5 mg before therapeutic effect (usually to 30-75 mg a day). The maximum daily dose makes 100 mg. The final dose is established so that decrease in a muscle tone did not lead to an excessive myasthenia and did not worsen motive functions. At hypersensitivity the initial daily dose makes 5-10 mg, with the subsequent slower increase.

At a chronic renal failure and when carrying out a hemodialysis – a daily dose – 5 mg (1/2 tablets on 10 mg).

At the patients demanding reception of high doses of Baclofenum (from 75 mg to 100 mg a day), it is necessary to use drug in tablets on 25 mg.

At patients 65 years a dose of drug are more senior it is necessary to increase with care, in connection with increase in risk of emergence of side effects.

Children. An initial dose – 5 mg (1/2 tablets on 10 mg) 3 times a day. In case of need it is possible to increase a dose with care each 3 days by 5 mg before therapeutic effect.

The following doses are usually recommended. Children from 3 to 6 years have 20-30 mg a day, from 6 do10 years – 30-60 mg a day. At children 10 years the maximum daily dose are more senior makes 2,5 mg/kg of body weight; an initial dose – 1,5-2,0 mg/kg of body weight.

Drug withdrawal is carried out gradually (within 1-2 weeks).

Features of use:

Side effects often have tranzitorny character, they should be distinguished from symptoms of a disease concerning which treatment is carried out: at the accompanying epilepsy treatment is carried out without cancellation of antiepileptic means.

At patients with diseases of a liver and a diabetes mellitus it is necessary to control periodically activity of "hepatic" transaminases, an alkaline phosphatase, concentration of glucose of blood.

During treatment it is necessary to abstain from potentially dangerous types of activity connected with need of special attention and bystry mental and motor reactions.

Side effects:

Depending on the frequency of emergence allocate the following groups of side effects: very rare – less than 0,01%, rare – more than 0,01% and less than 0,1%, infrequent – more than 0,1% and less than 1%, frequent – more than 1% and less than 10%, very frequent – more than 10%.

From a nervous system: very frequent – drowsiness, sedation; frequent – dizziness, weakness, fatigue, confusion of consciousness, gait disturbance, sleeplessness, euphoria, a depression, an adynamy, an ataxy, a tremor, hallucinations, nightmares, a nystagmus, dryness in a mouth; rare – paresthesias, a dysarthtia.

From cardiovascular system: frequent – decrease in cordial emission, arterial hypotension.

From digestive tract: very frequent – nausea; frequent – vomiting, a lock, diarrhea, the dispepsichesky phenomena; rare – abdominal pains, a dysgeusia, an abnormal liver function.

From respiratory system: frequent – respiratory depression.

From a musculoskeletal system: frequent – a mialgiya.

From sense bodys: frequent – accommodation paresis, visual disturbances.

From skin and hypodermic cellulose: frequent – a hyperhidrosis, rash.

From kidneys and urinary system: frequent – a polyuria, enuresis, a dysuria; rare – an ischuria.

From reproductive system: rare – erectile dysfunction.

General disturbances: very rare – a hypothermia.

In isolated cases increase in spasticity was observed that was regarded as paradoxical reaction to drug.

Interaction with other medicines:

Strengthens effect of the drugs oppressing the central nervous system, hypotensive and antigouty medicines, ethanol.

Tricyclic antidepressants strengthen decrease in a muscle tone; the levodopa, a karbidopa in combination with a levodopa increase risk of development of hallucinations, confusion of consciousness, excitement.

Contraindications:

Hypersensitivity, epilepsy, spasms ( including in the anamnesis), psychoses, Parkinson's disease, a peptic ulcer of a stomach and duodenum, deficit of lactase, a lactose intolerance, glyukozo-galaktozny malabsorption, pregnancy and the period of a lactation, children's age up to 3 years.

With care: cerebrovascular insufficiency, atherosclerosis of vessels of a brain, a chronic renal failure, advanced age, children's age up to 12 years.

Overdose:

Symptoms: hypomyotonia, oppression of a respiratory center, confusion of consciousness, lump; after consciousness return the hypomyotonia can remain within 72 hours.

Treatment: plentiful drink, diuretics; at respiratory depression – artificial ventilation of the lungs. The specific antidote does not exist.

Storage conditions:

List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children. Not to use after the period of validity specified on packaging. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

Tablets of 10 mg, 25 mg. On 50 tablets in the polypropylene can closed by a polyethylene cover without control of the first opening. To bank together with the Application instruction place in a cardboard pack.