Medicinal Products

BACLOFENE SUN 10 mg / 5 ml 2 mg / mL

Generic drug of Lioresal 10 MG / 5 ML
Therapeutic class: Rheumatology
active ingredients: Baclofen
laboratory: Sun Pharma Indus Eur BV

Injectable solution for intrathecal infusion
Box of 1 ampoule of 5 ml
All forms

Indication

Treatment of severe chronic spasticity associated with multiple sclerosis, lesions of medullary or cerebral origin that can not be successfully treated with standard treatment.

Pediatric patients

Intrathecal baclofen is indicated in patients aged 4 to 18 years with severe chronic spasticity of medullary or cerebral origin (associated with trauma, multiple sclerosis or other medullary pathology) not responding to others. orally administered antispastic drugs (including oral baclofen) and / or in patients with intolerable adverse effects at effective oral doses.

Dosage BACLOFENE SUN 10 mg / 5 ml 2 mg / mL Solution for injection for intrathecal infusion Box of 1 ampoule of 5 ml

For single bolus test injections, BACLOFENE SUN is administered by lumbar puncture or via a catheter inserted into the subarachnoid space. During chronic treatment, the baclofen solution is administered intrathecally by means of an implantable pump that delivers the solution continuously into the subarachnoid space (EU-certified pumps).

In order to determine the optimal dosage, each patient should undergo a test phase with an intrathecal bolus of baclofen, followed by an individual dose-setting period that will be performed with extreme caution before initiation of treatment. interview.

Intrathecal administration of baclofen using an implantable system should only be performed by an experienced physician with the required skills. It is extremely important to strictly follow the manufacturer's specific instructions regarding implantation, pump programming and / or tank filling.

This procedure is necessary because of the differences in the therapeutic dose of baclofen needed for each patient. The long-term administration of BACLOFENE SUN 10 mg / 20 ml and BACLOFENE SUN 10 mg / 5 ml is achieved by means of an implantable pump allowing the release of baclofen solution in the cerebrospinal fluid.

The efficacy of BACLOFENE SUN administered by the SyncroMed infusion system has been demonstrated in clinical studies. This subcutaneous delivery system, generally implanted at the level of the abdominal wall, has a refillable reservoir. This system is connected to a subcutaneous intrathecal catheter to the subarachnoid space. There is no confirmed experience with other implantable pump systems.

Before administering BACLOFENE SUN, myelography of the subarachnoid space should be performed in patients with post-traumatic spasticity. In case of radiological signs of arachnoiditis, treatment with BACLOFENE SUN should not be initiated.

Before administering BACLOFENE SUN, the clarity and absence of coloring of the solution should be checked. Only solutions free of particles should be used. A cloudy or discolored solution should not be used and should be removed. The solution contained in the ampoule is stable, isotonic, pyrogen-free and antioxidant-free and has a pH between 5 and 7.

Each bulb is for single use.

Implementation Phase / Dose Phase (Inpatient)

Once the baclofen response has been confirmed in the test phase, intrathecal perfusion is initiated using one of the implantable pumps mentioned above. The antispastic activity of baclofen begins within 6 to 8 hours after the start of continuous infusion and peaks within 24 to 48 hours.

The initial daily dose of BACLOFENE SUN is calculated as follows:

If the test dose has been effective for more than 12 hours, the initial daily dose is the test dose. If the test dose has been effective for less than 12 hours, the initial daily dose should be twice the test dose. The dosage should not be increased in the first 24 hours.

After the first day of treatment, the daily dosage may be gradually increased daily to achieve the desired clinical effect. The increase in daily dose should not exceed 10 to 30% of the previous dose in patients with spasticity of spinal origin and 5 to 15% in patients with cerebral spasticity. When using a programmable pump, it is advisable to adjust the dosage once in a 24-hour period. For non-programmable pumps with a 76 cm catheter, delivering 1 ml / day, the response to treatment is to be evaluated over a 48 hour interval. If, after a significant increase in the daily dose, no clinical effect is obtained within this time, it is necessary to check the operation of the pump and the permeability of the catheter.

In general, the dosage is increased to a maintenance dose of 300 to 800 μg / day in patients with spasticity of spinal origin. Patients with cerebral spasticity usually require lower doses (see below).

Maintenance treatment

The goal is to use the minimal dose that can control spasticity without causing intolerable side effects. Due to a decrease in the clinical effect of the treatment or the course of the disease, a gradual increase in the dose, in a hospital setting, is usually necessary. Similarly, the daily dosage may be increased by 10 to 30% in patients with spasticity of medullary origin and 5 to 20% in patients with cerebral spasticity, by adjusting either the flow rate of the pump or the concentration of baclofen in the tank. In case of adverse effects, the daily dosage should, conversely, be reduced by 10 to 20%.

The need for a substantial increase in the dose, in order to achieve a sufficient clinical effect, should make it look for malfunction of the pump or kinking, rupture (tearing) or displacement of the catheter.

In patients with spasticity of medullary origin, the long-term maintenance dose of BACLOFENE SUN as a continuous intrathecal infusion is usually 300 to 800 μg baclofen per day. The lowest and highest daily dose administered during the dose-setting phase is 12 μg and 2003 μg, respectively (US studies). Experience is limited for daily doses above 1000 μg / day. During the first months of treatment, the dosage should be checked and adjusted very regularly.

In patients with cerebral spasticity, the long-term continuous maintenance dose of BACLOFENE SUN in intrathecal infusion ranges from 22 to 1400 μg baclofen per day, with an average dose of 276 μg / day at 1 year and 307 μg / day at 2 years of treatment. Children under 12 usually require lower doses (range: 24 to 1199 μg / day, mean: 274 μg / day).

If this is technically possible with the pump used, once a constant daily dosage is reached and the antispastic activity is stabilized, it may be possible to try to adapt the administration according to daily fluctuations in spasticity. . For example, if spasms occur more frequently at night, this may require a 20% increase in the hourly infusion rate. The infusion rate changes should be programmed so that they begin 2 hours before the desired clinical effect.

For the duration of the treatment, at least once a month, it is necessary to check the tolerance of BACLOFENE SUN in the hospital and to look for signs of infection. The operation of the infusion system should be checked regularly. Local infection or catheter malfunction may lead to interruption of baclofen delivery leading to life-threatening conditions (see Warnings and Precautions section ).

The concentration of baclofen needed when filling the pump depends on the total daily dose and pump flow. If concentrations other than 0.05 mg / ml, 0.5 mg / ml or 2 mg / ml are required, BACLOFENE SUN should be diluted in Sodium Chloride Injection without preservative under aseptic conditions.

During long-term treatment, in approximately 5% of patients, it may be necessary to increase the dosage, due to a loss of efficacy (development of a tolerance to treatment). As described in the literature, making a therapeutic window over a period of 10 to 14 days, during which morphine sulfate without preservative is administered intrathecally, may prevent the development of tolerance. After this period, it is possible that the baclofen sensitivity is restored. The intrathecal treatment can then be resumed, starting at the initial infusion dose and the dosage should be readjusted to avoid overdose accidents. This must be done in a hospital setting.

Special populations

In patients with abnormal CSF circulation due to, for example, blockage due to inflammation or trauma, delayed diffusion of BACLOFENE SUN may decrease its antispastic activity and increase the occurrence of adverse effects (see section 4.3). ).

Due to decreased renal clearance, it may be necessary to reduce the dosage in patients with renal impairment.

Pediatric patients:

Maintenance treatment

The clinical objective is to maintain a muscle tone as close as possible to normal and to limit the frequency and severity of spasms without causing intolerable side effects. The lowest dose required to obtain a satisfactory response should be used. Maintaining a certain degree of spasticity is desirable in order to avoid a feeling of "paralysis" in the patient. In addition, it may be important to maintain a certain level of muscle tone and to tolerate occasional spasms to promote circulatory function and prevent the eventual formation of deep vein thromboses.

In patients aged 4 to 18 years, with spasticity of cerebral and medullary origin, the initial maintenance dose is between 50 and 200 μg / day (mean dose: 100 μg / day). The total daily intake tends to increase during the first year of treatment. Also, it is necessary to individually adjust the maintenance dose according to the clinical response. The experiment is limited for doses higher than 1000 μg / day.

The safety and efficacy of intrathecal baclofen in the treatment of cerebral and medullary spasticity in children under 4 years of age have not been established (see Warnings and Precautions ). .

Elderly patients

In clinical studies, patients older than 65 were treated with BACLOFENE SUN without any specific problems being observed. The experience with baclofen tablets, however, shows that the frequency of occurrence of adverse effects may be greater in this category of patients. The occurrence of adverse effects should be carefully monitored in elderly patients.

Treatment stop

There is no specific limit to the duration of treatment.

With the exception of emergency situations related to overdose or the occurrence of serious adverse effects, treatment should always be stopped by gradually reducing the dose. BACLOFENE SUN must not be stopped abruptly. Abrupt discontinuation of intrathecal administration of baclofen, whatever the cause, may manifest as severe fever, impaired consciousness, rebound exacerbation of spasticity and muscle rigidity. in rare cases this has led to epileptic seizures / status epilepticus, rhabdomyolysis, multi-visceral failure and death (see Warnings and Precautions section ).

Sudden discontinuation of BACLOFENE SUN, particularly at doses above those recommended, may result in a significant increase in spasticity. Sudden discontinuation of baclofen tablets treatment was also followed by confusion, sensory disturbances, impaired consciousness with hallucinations, epileptic seizures / status epilepticus, and sometimes Exacerbation of spasticity, especially after long-term treatment.

Withdrawal syndrome

Abrupt discontinuation of intrathecal administration of baclofen, whatever the cause, may manifest as severe fever, impaired consciousness, rebound exacerbation of spasticity and muscle rigidity. in rare cases this has led to epileptic seizures / status epilepticus, rhabdomyolysis, multi-visceral failure and death (see Warnings and Precautions section ).

Symptoms due to discontinuation of treatment may be confused with those of intoxication. This also requires hospitalization of the patient.

Treatment of withdrawal syndrome

Rapid diagnosis and admission to an emergency or intensive care unit are important to prevent life-threatening prognosis and the systemic effects of stopping intrathecal administration of baclofen.

Against indications

Baclofen SUN should not be administered in the following cases:

Hypersensitivity to the active substance or to any of the excipients (see section Composition ),

· Drug-resistant epilepsy.

Baclofen SUN should be administered only in the subarachnoid space. Baclofen SUN should not be administered intravenously, intramuscularly, subcutaneously or epidurally.

Adverse effects Baclofene Sun 10 MG / 5 ML

Adverse reactions (Table 1) are ranked in order of decreasing frequency according to the following convention: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and <1/1000) and very rare (<1/10000), including isolated cases, unknown (can not be estimated based on available data). Within each frequency category, adverse effects are presented in order of decreasing severity.

Table 1

Metabolism and nutrition disorders

· Frequent:

decreased appetite.

· Rare :

dehydration.

Psychiatric disorders

· Frequent:

depression, confusion, disorientation, agitation, anxiety.

· Rare :

suicidal thoughts, paranoia, hallucinations, dysphoria.

Nervous system disorders

· Very common :

drowsiness.

· Frequent:

respiratory depression, epileptic seizures, lethargy, dysarthria, headache, paresthesia, insomnia, sedation, vertigo.

Epileptic seizures and headache are more common in patients with cerebral spasticity.

· Rare :

ataxia, hypothermia, dysphagia, memory problems, nystagmus.

Eye disorders

· Frequent:

accommodation disorders with blurred vision and diplopia.

Heart conditions

· Rare :

bradycardia.

Vascular disorders

· Frequent:

orthostatic hypotension.

· Rare :

deep vein thrombosis, hypertension, skin flush, paleness.

Respiratory, thoracic and mediastinal disorders

· Frequent:

aspiration pneumonia, dyspnoea, bradypnea.

Gastrointestinal disorders

· Frequent:

vomiting, constipation, diarrhea, nausea, dry mouth, salivary hypersecretion.

Nausea and vomiting are more common in patients with cerebral spasticity.

· Rare :

ileus, hypogeusia

Skin and subcutaneous tissue disorders

· Frequent:

urticaria, pruritus.

· Rare :

alopecia, hyperhidrosis.

Musculoskeletal and systemic disorders

· Very common :

hypotonia.

· Frequent:

hypertonia, muscle weakness.

Renal and urinary disorders

· Frequent:

urinary retention, urinary incontinence.

Urinary retention is more common in patients with cerebral spasticity.

Disorders of reproductive organs and breast

· Frequent:

sexual dysfunction.

General disorders and administration site conditions

· Frequent:

facial or peripheral edema, pain, fever, chills.

Ovarian cysts were observed by palpation in approximately 5% of the female population with multiple sclerosis treated with baclofen tablets for at least 1 year. In most cases, these cysts disappeared spontaneously despite continued treatment. Part of the healthy female population is known to develop ovarian cysts spontaneously.

A reliable causal relationship between the observed adverse events and the administration of Baclofen SUN is not always possible because some of the observed adverse events may also be symptoms of the underlying disease to be treated. Particularly common side effects, such as dizziness, dizziness, drowsiness, headache, nausea, low blood pressure, and muscle weakness are usually due to the medication.

Adverse reactions related to the infusion system

It may be a displacement / twisting / tearing (tearing) of the catheter, infection of the implantation site, meningitis, sepsis, serous effusion of the "pump bag" and a hematoma associated with a possible risk of inflammation, pump malfunction and CSF leakage, as well as long-term skin perforation, overdose or underdosing due to improper handling.

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