Release form, composition and packing Baclosan
Pill white, round, biconvex, with a separating mark. 1 tab. baclofen 10 mg. Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethylcellulose.
Pill white, round, biconvex. 1 tab. baclofen 25 mg. Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethylcellulose.
Clinico-pharmacological group: Relaxant central action.
Pharmacological action
Centrally acting muscle relaxant; GABAB-receptor agonist. Reducing the excitability of the terminal divisions of the afferent sensory fibers and suppressing the intermediate neurons, depresses mono-and polysynaptic transmission of nerve impulses, reduces the prestressing muscle spindles. Does not affect the transmission of impulses in the nerve-muscle synapses.
In neurological diseases involving skeletal muscle spasticity, reduces the painful spasms and clonic convulsions. Increases the amount of movement in joints, facilitates active and passive kinesitherapy (exercise, massage, chiropractic).
Pharmacokinetics
Suction
After oral administration, baclofen is rapidly and completely absorbed from the gastrointestinal tract. Cmax in blood plasma is reached 2-3 h after dosing.
Distribution
Plasma protein binding is about 30%. Baclofen crosses the placental barrier, excreted in breast milk.
Metabolism
Metabolized in the liver.
Breeding
Excreted in the urine, mainly unchanged.
Statement
Increased muscle tone:
multiple sclerosis;
in diseases of the spinal cord of an infectious, degenerative and traumatic origin (eg, tumors, syringomyelia, motor neuron disease, injury);
stroke;
with Cerebral Palsy;
of meningitis;
with traumatic brain injuries;
in alcoholism (affective disorders).
Dosing regimen
Set individually. Adult prescribe medication in an initial dose of 5 mg 3 times / day every 3 days gradually increase the dose to the development of optimal therapeutic effect (usually up to 30-75 mg / day). Patients who need to use the drug in higher doses (usually up to 30-75 mg / day), Baklosan prescribed in tablets of 25 mg. The maximum daily dose - 100 mg.
Patients older than 65 years the drug dose should be increased with caution due to an increased risk of side effects. Initial single dose for children is 5 mg, the multiplicity of reception 3 times a day.
If necessary, carefully increase the dose every 3 days. The average recommended doses are for children aged 1 to 2 years - 10-20 mg / day, from 2 to 6 years - 20-30 mg / day, from 6 to 10 years - 30-60 mg / day.
In children older than 10 years, the maximum daily dose is determined by the rate of 1.5-2 mg / kg body weight. The drug is taken with meals. When Missed not take a double dose.
Side effect
CNS and peripheral nervous system: drowsiness, dizziness, gait disturbance, fatigue, confusion, apathy, euphoria, depression, paresthesias, ataxia, tremor, nystagmus, paresis of accommodation, hallucinations, convulsions, decreased seizure threshold.
From the digestive system: nausea, vomiting, dry mouth, constipation, diarrhea.
With the urinary system: urinary retention, dysuria, enuresis, with prolonged use - renal dysfunction.
Cardio-vascular system: blood pressure reduction.
Other: myalgia, muscular weakness.
Contraindications
psychosis;
Parkinson's disease;
epilepsy;
convulsions (history);
chronic renal failure;
pregnancy;
Lactation (breastfeeding), increased sensitivity to baklofenu.
With carefully administered medication in cerebrovascular disease, atherosclerosis of cerebral vessels in patients with gastric ulcer and duodenal ulcer, elderly patients, children under the age of 12 years.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding).
Use in hepatic dysfunction
In patients with liver disease should periodically monitor the activity of hepatic transaminases.
Use in renal impairment
Contraindicated in chronic renal failure.
Cautions
In patients with liver disease and diabetes should regularly monitor the activity of hepatic transaminases and alkaline phosphatase, and blood glucose.
Effects on ability to drive vehicles and management mechanisms
Patients taking Baklosan should refrain from potentially dangerous activities associated with the necessity of increased attention and rapid psychomotor reactions.
Overdose
Symptoms: muscular hypotonia, respiratory center depression, confusion, coma (after the return of consciousness muscular hypotonia may persist for 72 h).
Treatment: excessive drinking, taking diuretics, and respiratory depression - AV. A specific antidote does not exist.
Drug Interactions
While the application Baklosan enhances the action of drugs affecting the central nervous system, hypotensive drugs, ethanol.
While the application Baklosana with tricyclic antidepressants can significantly decrease muscle tone. Patients with Parkinson's disease while receiving Baklosana with levodopa and carbidopa may have hallucinations, confusion, agitation.
Conditions and terms of
List B. The drug should be stored in a dry place, protected from light and away from children at or above 25 ° C. Shelf life - 5 years.
Pill white, round, biconvex, with a separating mark. 1 tab. baclofen 10 mg. Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethylcellulose.
Pill white, round, biconvex. 1 tab. baclofen 25 mg. Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethylcellulose.
Clinico-pharmacological group: Relaxant central action.
Pharmacological action
Centrally acting muscle relaxant; GABAB-receptor agonist. Reducing the excitability of the terminal divisions of the afferent sensory fibers and suppressing the intermediate neurons, depresses mono-and polysynaptic transmission of nerve impulses, reduces the prestressing muscle spindles. Does not affect the transmission of impulses in the nerve-muscle synapses.
In neurological diseases involving skeletal muscle spasticity, reduces the painful spasms and clonic convulsions. Increases the amount of movement in joints, facilitates active and passive kinesitherapy (exercise, massage, chiropractic).
Pharmacokinetics
Suction
After oral administration, baclofen is rapidly and completely absorbed from the gastrointestinal tract. Cmax in blood plasma is reached 2-3 h after dosing.
Distribution
Plasma protein binding is about 30%. Baclofen crosses the placental barrier, excreted in breast milk.
Metabolism
Metabolized in the liver.
Breeding
Excreted in the urine, mainly unchanged.
Statement
Increased muscle tone:
multiple sclerosis;
in diseases of the spinal cord of an infectious, degenerative and traumatic origin (eg, tumors, syringomyelia, motor neuron disease, injury);
stroke;
with Cerebral Palsy;
of meningitis;
with traumatic brain injuries;
in alcoholism (affective disorders).
Dosing regimen
Set individually. Adult prescribe medication in an initial dose of 5 mg 3 times / day every 3 days gradually increase the dose to the development of optimal therapeutic effect (usually up to 30-75 mg / day). Patients who need to use the drug in higher doses (usually up to 30-75 mg / day), Baklosan prescribed in tablets of 25 mg. The maximum daily dose - 100 mg.
Patients older than 65 years the drug dose should be increased with caution due to an increased risk of side effects. Initial single dose for children is 5 mg, the multiplicity of reception 3 times a day.
If necessary, carefully increase the dose every 3 days. The average recommended doses are for children aged 1 to 2 years - 10-20 mg / day, from 2 to 6 years - 20-30 mg / day, from 6 to 10 years - 30-60 mg / day.
In children older than 10 years, the maximum daily dose is determined by the rate of 1.5-2 mg / kg body weight. The drug is taken with meals. When Missed not take a double dose.
Side effect
CNS and peripheral nervous system: drowsiness, dizziness, gait disturbance, fatigue, confusion, apathy, euphoria, depression, paresthesias, ataxia, tremor, nystagmus, paresis of accommodation, hallucinations, convulsions, decreased seizure threshold.
From the digestive system: nausea, vomiting, dry mouth, constipation, diarrhea.
With the urinary system: urinary retention, dysuria, enuresis, with prolonged use - renal dysfunction.
Cardio-vascular system: blood pressure reduction.
Other: myalgia, muscular weakness.
Contraindications
psychosis;
Parkinson's disease;
epilepsy;
convulsions (history);
chronic renal failure;
pregnancy;
Lactation (breastfeeding), increased sensitivity to baklofenu.
With carefully administered medication in cerebrovascular disease, atherosclerosis of cerebral vessels in patients with gastric ulcer and duodenal ulcer, elderly patients, children under the age of 12 years.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding).
Use in hepatic dysfunction
In patients with liver disease should periodically monitor the activity of hepatic transaminases.
Use in renal impairment
Contraindicated in chronic renal failure.
Cautions
In patients with liver disease and diabetes should regularly monitor the activity of hepatic transaminases and alkaline phosphatase, and blood glucose.
Effects on ability to drive vehicles and management mechanisms
Patients taking Baklosan should refrain from potentially dangerous activities associated with the necessity of increased attention and rapid psychomotor reactions.
Overdose
Symptoms: muscular hypotonia, respiratory center depression, confusion, coma (after the return of consciousness muscular hypotonia may persist for 72 h).
Treatment: excessive drinking, taking diuretics, and respiratory depression - AV. A specific antidote does not exist.
Drug Interactions
While the application Baklosan enhances the action of drugs affecting the central nervous system, hypotensive drugs, ethanol.
While the application Baklosana with tricyclic antidepressants can significantly decrease muscle tone. Patients with Parkinson's disease while receiving Baklosana with levodopa and carbidopa may have hallucinations, confusion, agitation.
Conditions and terms of
List B. The drug should be stored in a dry place, protected from light and away from children at or above 25 ° C. Shelf life - 5 years.
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