Baklosan tablets 25mg, No. 50

Increased muscle tone with:

• multiple sclerosis;

• spinal cord diseases (tumors, syringomyelia, motor neuron diseases, trauma, myelitis);

• cerebrovascular diseases;

• cerebral palsy;

• meningitis;

• traumatic brain injury.

Inside, during meals. If you miss the next dose, you should not take a double dose of the drug.

Adults

The initial dose is 5 mg 3 times / day, with a subsequent increase in the dose every 3 days by 5 mg until the onset of a therapeutic effect (usually up to 30-75 mg / day). The maximum daily dose is 100 mg.

The final dose is set so that the decrease in muscle tone does not lead to excessive myasthenia gravis and does not impair motor function. With hypersensitivity, the initial daily dose is 5-10 mg, followed by a slower increase.

In chronic renal failure and during hemodialysis, the daily dose is 5 mg.

In patients requiring high doses of baclofen (from 75 mg to 100 mg per day), the drug should be used in tablets of 25 mg.

In patients over 65 years of age, the dose of the drug should be increased with caution, due to the increased risk of side effects.

Children

The initial dose is 5 mg 3 times / day. If necessary, the dose can be increased with caution every 3 days by 5 mg until the onset of a therapeutic effect.

The following doses are usually recommended: in children from 3 to 6 years old - 20-30 mg / day, from 6 to 10 years old - 30-60 mg / day, in children over 10 years old the maximum daily dose is 2.5 mg / kg of body weight; the initial dose is 1.5-2 mg / kg of body weight.

Cancellation of the drug is carried out gradually (within 1-2 weeks).

White tablets, round, biconvex

1 tab.

baclofen 10 mg or 25 mg

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

• Psychoses;

• Parkinson's disease;

• epilepsy;

• convulsions (including history);

• peptic ulcer of the stomach and duodenum;

• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

• pregnancy;

• lactation (breastfeeding);

• hypersensitivity to baclofen.

  The drug is prescribed with caution for cerebrovascular insufficiency, atherosclerosis of the cerebral vessels, chronic renal failure, in elderly patients, in children under 3 years of age.

pharmachologic effect

Muscle relaxant of central action; agonist of GABAB receptors. Reducing the excitability of the terminal sections of afferent sensory fibers and suppressing intermediate neurons, it inhibits mono- and polysynaptic transmission of nerve impulses; reduces the pre-tension of muscle spindles. Does not affect the transmission of impulses in the neuromuscular synapses. In neurological diseases, accompanied by spasticity of skeletal muscles, relieves painful spasms and clonic seizures. Increases the range of motion in the joints, facilitates passive and active kinesitherapy (exercise, massage, manual therapy).

Pharmacokinetics

Suction

Absorption is high. Cmax in blood plasma is achieved 2-3 hours after taking the drug.

Distribution

Plasma protein binding is about 30%. Baclofen crosses the placental barrier and is excreted in breast milk.

Metabolism

It is metabolized in the liver.

Withdrawal

It is excreted in the urine, mainly unchanged.

Side effect

Depending on the frequency of occurrence, the following groups of side effects are distinguished: 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, tremors, hallucinations, nightmares, nystagmus, dry mouth; rare - paresthesias, dysarthria.

From the side of the cardiovascular system: frequent - decreased cardiac output, arterial hypotension.

From the gastrointestinal tract: very frequent - nausea; frequent - vomiting, constipation, diarrhea, dyspeptic symptoms; rare - abdominal pain, dysgeusia, abnormal liver function.

From the respiratory system: frequent - respiratory depression.

From the musculoskeletal system: frequent - myalgia.

From the senses: frequent - accommodation paresis, visual disturbances.

Skin and subcutaneous tissue disorders: frequent - hyperhidrosis, rash.

On the part of the kidneys and urinary system: frequent - polyuria, enuresis, dysuria; rare - urinary retention.

Reproductive system disorders: rare - erectile dysfunction.

General disorders: very rare - hypothermia.

In isolated cases, an increase in spasticity was observed, which was regarded as a paradoxical reaction to the drug.

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Application for violations of liver function

In patients with liver disease, it is necessary to periodically monitor the activity of hepatic transaminases.

Application for impaired renal function

Contraindicated in chronic renal failure.

Application in children

The drug is prescribed with caution to children under 12 years of age.

Use in elderly patients

The drug is prescribed with caution to elderly patients.

special instructions

Side effects are often transient in nature, they should be distinguished from the symptoms of the disease for which treatment is being carried out: with concomitant epilepsy, treatment is carried out without canceling antiepileptic drugs.

In patients with liver disease and diabetes mellitus, it is necessary to periodically monitor the activity of hepatic transaminases and alkaline phosphatase, as well as blood glucose.

Influence on the ability to drive vehicles and mechanisms

Patients taking BaklosanЃ should refrain from potentially hazardous activities associated with the need for increased attention and rapid psychomotor reactions.

Overdose

Symptoms: muscle hypotonia, depression of the respiratory center, confusion, coma (after the return of consciousness, muscle hypotonia can persist for 72 hours).

Treatment: drinking plenty of fluids, taking diuretics, with respiratory depression - mechanical ventilation. There is no specific antidote.

Drug interactions

With the simultaneous use of BaklosanЃ enhances the effect of drugs that affect the central nervous system, antihypertensive, anti-gout drugs, ethanol.

With the simultaneous use of Baklosan with tricyclic antidepressants, a significant decrease in muscle tone is possible.

With the simultaneous administration of Baklosan with levodopa and carbidopa, hallucinations, confusion, and agitation may occur.