Universal reference book for medicines
Product name: BACLOSAN ® (BACLOSAN)

Active substance: baclofen

Type: Miorelaxant of central action

Manufacturer: Pharmaceutical Works POLPHARMA (Poland) manufactured by MEDANA PHARMA (Poland)
Composition, form of production and packaging
Tablets are
white, round, biconvex, with a dividing risk.

1 tab.

baclofen 10 mg

Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethylcellulose.

50 pcs.
- polypropylene cans (1) - cardboard packs.
Tablets are white, round, biconvex.

1 tab.

baclofen 25 mg

Excipients: lactose, potato starch, gelatin, talc, magnesium stearate, ethylcellulose.

50 pcs.
- polypropylene cans (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Miorelaxant of central action;
agonist of GABA B receptors. Reducing the excitability of the end sections of the afferent sensitive fibers and suppressing the intermediate neurons, inhibits the mono- and polysynaptic transmission of nerve impulses; reduces the preliminary stress of the muscle spindles. Does not affect the transfer of impulses in neuromuscular synapses. With neurological diseases accompanied by spasticity of skeletal muscles, it alleviates painful spasms and clonic convulsions. Increases the volume of movement in the joints, facilitates the conduct of passive and active kinesitherapy (physical exercises, massage, manual therapy).
PHARMACOKINETICS

Suction

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

Binding to plasma proteins is about 30%.
Baclofen penetrates the placental barrier, excreted in breast milk.
Metabolism

Metabolised in the liver.

Excretion

It is excreted in the urine, mostly unchanged.

INDICATIONS

Increased muscle tone with:

- Multiple sclerosis;

- diseases of the spinal cord (tumors, syringomyelia, motor neuron diseases, trauma, myelitis);

- cerebrovascular diseases;

- cerebral palsy;

- Meningitis;

- craniocerebral trauma.

DOSING MODE

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 3 times / day, followed by a 5-mg dose increase every 3 days until the therapeutic effect (usually up to 30-75 mg / 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, the daily dose is 5 mg.

In patients requiring high doses of baclofen (from 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, due to an 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 before the onset of therapeutic effect.
Usually the following doses are recommended: in children from 3 to 6 years - 20-30 mg / day, from 6 to 10 years - 30-60 mg / day, in children over 10 years, themaximum daily dose is 2.5 mg / kg body weight;
the initial dose is 1.5-2 mg / kg body weight.
Abolition of the drug is carried out gradually (within 1-2 weeks).

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, 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 senses: frequent - paresis of accommodation, visual disturbances.

From the skin and subcutaneous tissue: frequent - hyperhidrosis, rash.

From the kidneys and urinary system: frequent - polyuria, enuresis, dysuria;
rare - urinary retention.
From the side of the reproductive system: rare - erectile dysfunction.

Common disorders: very rare - hypothermia.

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

CONTRAINDICATIONS

- psychoses;

- Parkinson's disease;

- epilepsy;

- convulsions (including anamnesis);

- Stomach ulcer and duodenal ulcer;

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

- Pregnancy;

- lactation (breastfeeding);

- Hypersensitivity to baclofen.

With caution appoint the drug for cerebrovascular insufficiency, cerebral arteriosclerosis, chronic renal failure, in elderly patients, children under 3 years.

PREGNANCY AND LACTATION

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

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in chronic renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with liver disease should periodically monitor the activity of hepatic transaminases.

APPLICATION FOR CHILDREN

With caution appoint the drug to children under the age of 12 years.

APPLICATION IN ELDERLY PATIENTS

With caution appoint the drug to elderly patients.

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

Impact on the ability to drive vehicles and manage mechanisms

Patients taking Baclosan ® should refrain from potentially dangerous activities associated with the need for increased attention and rapid psychomotor reactions.

OVERDOSE

Symptoms: muscle hypotension, oppression of the respiratory center, confusion, coma (after the return of consciousness, muscle hypotension may persist for 72 hours).

Treatment: plentiful drink, reception of diuretics, at oppression of breath - IVL.
There is no specific antidote.
DRUG INTERACTION

With simultaneous application of Baclosan ® enhances the effect of drugs that affect the central nervous system, antihypertensive, antidotal drugs, ethanol.

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

With the simultaneous administration of Baklosan with levodopa and carbidopa, hallucinations, confusion, and arousal can occur.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry, protected from light and out of reach of children a
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