Baclosan® (Baclosan®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceBaclofenBaclofen
Dosage form: & nbsppills
Composition:
1 tablet contains:
Active substance: baclofen 10 mg or 25 mg.
Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethyl cellulose.
Description:
Tablets are white, round, biconvex. Tablets of 10 mg have
dividing risk.
Pharmacotherapeutic group:Miorelaxant of central action
ATX: & nbsp

M.03.B.X   Other muscle relaxants of central action

Pharmacodynamics:
Miorelaxant of central action, a derivative of gamma-aminobutyric acid (GABA-stimulant). Reducing the excitability of the terminal parts of the afferent
sensitive fibers and suppressing intermediate neurons, inhibits mono- and polysynaptic transmission of nerve impulses; reduces the
tension of muscle spindles. Has no effect on the neuromuscular transmission.
With neurological diseases accompanied by spasticity of skeletal muscles, it alleviates painful spasms and clonic convulsions; increases the amount of movement in the joints, facilitates the conduct of passive and active kinesitherapy (physical exercises, massage, manual therapy).
Pharmacokinetics:
Absorption is high.The maximum concentration in the blood plasma is achieved 2-3 hours after taking the drug. Connection with blood plasma proteins - 30%. Penetrates through the placental barrier, excreted in breast milk. Metabolised in the liver.
It is excreted by the kidneys (mostly unchanged).
Indications:
Increased muscle tone with multiple sclerosis, diseases of the spinal cord (tumors, syringomyelia, motor neuroneal diseases, trauma, myelitis), cerebrovascular diseases, cerebral palsy, meningitis, craniocerebral trauma.
Contraindications:
Hypersensitivity, epilepsy, convulsions (including in the anamnesis), psychosis, Parkinson's disease, gastric and duodenal ulcer, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, pregnancy and lactation, children under 3 years.
Carefully:
Cerebrovascular insufficiency, cerebral arteriosclerosis, chronic renal failure, elderly age, children under 12 years.
Pregnancy and lactation:The drug is contraindicated in pregnancy and lactation.
Dosing and Administration:
Inside, with food.If you miss a regular dose, you should not take a double dose of the drug.
Adults:
The initial dose is 5 mg (1/2 tablet of 10 mg) 3 times a day, followed by a 5-mg dose increase every 3 days until the therapeutic effect (usually up to 30-75 mg per day).
The maximum daily dose is 100 mg.
The final dose is set in such a way that a decrease in muscle tone does not lead to excessive myasthenia and does not impair motor functions.
With increased sensitivity, the initial daily dose is 5-10 mg, followed by a slower increase.
In chronic renal failure and hemodialysis, a daily dose of 5 mg (1/2 tablets of 10 mg).
In patients requiring high doses of baclofen (75 mg to 100 mg per day), a drug in tablets of 25 mg should be used.
In patients older than 65 years, the dose should be increased with caution, in conjunction. with an increased risk of side effects.
Children:
The initial dose is 5 mg (1/2 tablet of 10 mg) 3 times a day. If necessary, the dose can be increased with caution every 3 days by 5 mg before the onset of therapeutic effect.
Usually the following doses are recommended:
In children from 3 to 6 years - 20-30 mg per day, from 6 to 10 years - 30-60 mg per day. In children older than 10 years, the maximum daily dose is 2.5 mg / kg body weight; the initial dose is 1.5-2.0 mg / kg body weight.
Abolition of the drug is carried out gradually (within 1-2 weeks).
Side effects:
Depending on the frequency of occurrence, 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 the nervous system: very frequent - drowsiness, sedation; frequent - dizziness, weakness, fatigue, confusion, gait disturbance, insomnia, euphoria, depression, asthenia, ataxia, tremor, hallucinations, nightmares, nystagmus, dry mouth; rare - paresthesia, dysarthria.
From the cardiovascular system: frequent - reduction of cardiac output, arterial hypotension.
From the gastrointestinal tract: very frequent - nausea; frequent - vomiting, constipation, diarrhea, dyspeptic phenomena; rare - abdominal pain, dysgeusia, impaired liver function.
From the respiratory system: frequent - respiratory depression.
From the musculoskeletal system: frequent - myalgia.
From the sense organs: frequent - paresis of accommodation, visual disturbances.
From the skin and subcutaneous tissue: frequent - a hyperhidrosis, an eruption.
From the side of the kidneys and the urinary system: frequent - polyuria, enuresis, dysuria; rare - urinary retention.
On the part of the reproductive system: rare - erectile dysfunction.
Common violations: very rare - hypothermia.
In isolated cases, there was an increase in spasticity, which was regarded as a paradoxical reaction to the drug.
Overdose:
Symptoms: muscle hypotension, depression of the respiratory center, confusion, coma; after the return of consciousness, muscle hypotension can persist for 72 hours.
Treatment: plentiful drink, diuretics; with respiratory depression - artificial
ventilation of lungs. There is no specific antidote.
Interaction:
Strengthens the effect of drugs that depress the central nervous system, antihypertensive and anti-gout drugs, ethanol.
Tricyclic antidepressants increase the decrease in muscle tone; levodopa, carbidopa in combination with levodopa increase the risk of hallucinations, confusion, agitation.
Special instructions:
Side effects are often transient, they should be distinguished from the symptoms of the disease, for which treatment is performed: with concomitant epilepsy, treatment is carried out without the abolition of antiepileptic drugs.
In patients with liver diseases and diabetes mellitus, it is necessary to periodically monitor the activity of "liver" transaminases, alkaline phosphatase, blood glucose concentration.
Effect on the ability to drive transp. cf. and fur:During treatment should refrain from potentially dangerous activities associated with the need for increased attention and rapid mental and motor reactions.
Form release / dosage:
Tablets 10 mg, 25 mg.
Packaging:
For 50 tablets in a polypropylene jar covered with a polyethylene lid without first opening control.
The bank, together with the instruction for use, is placed in a cardboard box.
Storage conditions:
In a dry, the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life:
3 years. Do not use the drug after the expiration date.
Terms of leave from pharmacies:On prescription
Registration number:P N 014785/01
Date of registration:06.11.2009 / 15.02.2016
Expiration Date:Unlimited
The owner of the registration certificate:Pharmaceutical factory "POLFARMA" JSCPharmaceutical factory "POLFARMA" JSC Poland
Manufacturer: & nbsp
Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
Information update date: & nbsp14.01.17
Illustrated instructions
    Instructions
    Up