Baklosan
Producer: Polpharma/Medana Pharma S. A. (Polfarm / Medan of Pharm S.A.) Poland
Code of automatic telephone exchange: M03BX01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent - Baclofenum of 10 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-stimulator). 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 – 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 of infectious, degenerative and traumatic genesis (for example, tumors myelosyringosis, diseases of motor neurons, injuries);
- stroke;
- cerebral palsy;
- meningitis;
- craniocereberal injuries.
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 of 5 mg (1/2 tablets on 10 mg) 3 times a day. Gradually each 3 days before therapeutic effect raise a drug dose (usually to 30 - 75 mg a day). At the patients demanding reception of the highest 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. The maximum daily dose makes 100 mg.
Children: an initial dose of 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. The following doses are usually recommended: from 1 to 2 years - 10 – 20 mg a day, from 2 to 6 years - 20 - 30 mg a day, from 6 do10 years - 30 - 60 mg a day. At children over 10 years the maximum dose makes 1,5 - 2,0 mg/kg of body weight.
Features of use:
Side effects often have tranzitorny character, they should be distinguished from symptoms of a disease concerning which treatment is conducted: 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, alkaline phosphotazy, blood glucose. 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:
From a nervous system: drowsiness, dizziness, weakness, increased fatigue, confusion of consciousness, apathy, euphoria, depression, paresthesias, ataxy, tremor, nystagmus, paresis of accommodation, hallucination, spasm, decrease in a convulsive threshold.
From digestive tract: nausea, vomiting, dryness in a mouth, a lock, diarrhea.
From respiratory system: respiratory depression.
From a musculoskeletal system: mialgiya.
From skin and hypodermic cellulose: hyperhidrosis, rash.
From an urinary system: polyuria, ischuria, dysuria, enuresis.
From cardiovascular system: lowering of arterial pressure.
From reproductive system: erectile dysfunction (seldom).
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 influencing the central nervous system, antihypertensives, ethanol. Tricyclic antidepressants strengthen decrease in a muscle tone; the levodopa and a kardidopa increase risk of development of hallucinations, confusion of consciousness, excitement.
Contraindications:
Hypersensitivity, epilepsy, spasms (in the anamnesis), psychoses, Parkinson's disease, a chronic renal failure, pregnancy and the period of a lactation, children's age up to 3 years.
With care at cerebrovascular insufficiency, atherosclerosis of vessels of a brain, a peptic ulcer of a stomach and duodenum, advanced age and children up to 12 years.
Overdose:
Symptoms: a hypomyotonia, oppression of a respiratory center, confusion of consciousness, a 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 dry, protected from light and the place, unavailable to children, at a temperature below 25 °C.
Issue conditions:
According to the recipe
Packaging:
Tablets of 10 mg, 25 mg. On 50 tablets in a polypropylene can with a polyethylene cover without control of the first opening. To bank together with the application instruction in a cardboard pack.