Tradename:

Baclofen

Composition:

Each tablet contains:

Baclofen 10 mg

Auxiliary components:

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

Properties:

Muscle relaxant of central action; GABAB receptor agonist. 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 skeletal muscle spasticity, relieves painful spasms and clonic seizures. Increases the range of motion in the joints, facilitates passive and active kinesitherapy (exercise, massage, manual therapy).

Indications:

Increased muscle tone: – with multiple sclerosis; -in diseases of the spinal cord of infectious, degenerative and traumatic genesis (for example, tumors, syringomyelia, motor neuron diseases, trauma); – with a stroke; with infantile cerebral palsy; – with meningitis; – with traumatic brain injury; – with alcoholism (affective disorders).

Method of administration and dosage:

For adults, the drug is prescribed in an initial dose of 5 mg 3 times / day; gradually increase the dose every 3 days until the optimal therapeutic effect develops (usually up to 3075 mg / day). For patients who require the use of the drug in higher doses (usually up to 3075 mg / day), Baclofen is prescribed in tablets of 25 mg. The maximum daily dose is 100 mg (assigned for a short time in a hospital setting). The duration of the course of therapy depends on the clinical condition of the patient. You should not suddenly stop using Baclofen due to the possible appearance of hallucinations and exacerbation of spastic conditions. The drug is withdrawn gradually (within 1-2 weeks).

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

In children under the age of 10, the daily dose is determined at the rate of 0.75-2 mg / kg; over the age of 10 years – maximum 2.5 mg / kg / day; those. 2.5 mg 4 times / day. If necessary, the dose is increased with caution every 3 days. The average recommended doses for children from 1 to 2 years old are 1020 mg / day, for children from 2 to 6 years old 20-30 mg / day, for children from 6 to 10 years old – 30-60 mg / day.

Contraindications:

• peptic ulcer of the stomach and duodenum;

-psychoses;

-Parkinson’s disease;

-epilepsy;

• convulsions (in history);

-chronic renal failure;

-pregnancy;

• lactation period (breastfeeding);

-increased sensitivity to the drug.

Precautions:

During treatment with the drug, the manifestations of psychopathic syndromes, schizophrenia, convulsive conditions are aggravated, and confusion may develop. In these patients, Baclofen should be administered with caution, and the patient should be under medical supervision.

After a sudden withdrawal of the drug, a state of fear, confusion, hallucinations, psychopathic, manic, paranoid and convulsive states may occur, and spastic states may also worsen, so the dose of the drug should be reduced gradually over 1-2 weeks.

Baclofen is excreted in the urine, mainly unchanged, so the drug should be used with caution in patients with renal insufficiency. In these patients, the dose of the drug should be reduced accordingly.

Special care should be taken during treatment

with Baclofen in elderly patients (increased risk of undesirable effects).

Caution should be exercised during the use of Baclofen in patients in whom the maintenance of an upright body position and balance or an increase in physical activity depends on an increase in muscle tone.

Side effects:

From the side of the central nervous system and the peripheral nervous system: drowsiness, dizziness, gait disturbance, increased fatigue, confusion, apathy, euphoria, depression, paresthesia, ataxia, tremor, nystagmus, paresis of accommodation, hallucinations, convulsions, lowering of the convulsive threshold.

From the digestive system: nausea, vomiting, dry mouth, constipation, diarrhea.

From the urinary system: urinary retention, dysuria, enuresis;

with prolonged use – impaired renal functio .

From the cardiovascular system: lowering blood pressure, shortness of breath, palpitations, chest pain and loss of consciousness.

Others:

myalgia, muscle weakness, blurred vision, taste disturbance, skin rashes and itching, swelling of the ankle joints, excessive sweating, weight gain, feeling of swelling of the nasal mucosa. In some patients, an increase in the spastic state was observed (a paradoxical reaction to the drug).

Storage method:

At a temperature not higher than 30 degrees. In a dry place.

Packaging:

The cardboard box contains 2 blisters of 10 tablets, paper instructions.