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LIORESAL (BACLOFEN) TABLETS PRECAUTIONS

Psychiatric and nervous system disorders

Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously with Lioresal and kept under careful surveillance, because exacerbations of these conditions may occur.

Epilepsy or other potential convulsive conditions

Caution is needed in patients with epilepsy or other convulsive conditions, cortical or subcortical brain damage or significant EEG a bnormalities, since ingestion of baclofen may cause deterioration of seizure control and EEG changes and may precipitate convulsions. In patients with epilepsy and muscle spasticity, Lioresal can be employed under appropriate supervision, provided adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported occasionally after cessation of Lioresal or with overdosage.

Others

Lioresal should be used with caution in patients with:
  • peptic ulcers or with a history of peptic ulcers
  • cerebrovascular diseases or from respiratory or hepatic insufficiency.
  • porphyria
  • a history of alcoholism
  • diabetes mellitus (baclofen may increase blood glucose concentrations)
  • hypertension
    Since unwanted effects are more likely to occur, a cautious dosage schedule should be adopted in elderly and patients with spasticity. Lioresal is not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders.

    Changes in muscle tone

    Lioresal should be used with caution in patients who use spasticity to maintain upright posture and balance in moving. If an undesirable degree of muscular hypotonia occurs, making it more difficult for patients to walk or fend for themselves, this can usually be relieved by adjusting the dosage (i.e. by reducing the doses given during the day and possibly increasing the evening dose).

    During treatment with Lioresal, neurogenic disturbances affecting emptying of the bladder may improve, whereas in patients with pre-existing sphincter hypertonia, acute retention of urine may occur. The drug should, therefore, be used with caution in such cases.

    Hepatic impairment

    Because baclofen is partially metabolised in the liver, patients with impaired liver function should be periodically monitored with laboratory tests.

    Renal impairment

    Since baclofen is largely eliminated by the kidneys, a dosage reduction is advised to avoid drug accumulation. Lioresal should be used with caution in patients with renal impairment and should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk.

    Particular caution is required when combining Lioresal to drugs or medicinal products thatcan significantly impact renal function. Renal function shall be closely monitored and Lioresal daily dosage adjusted accordingly to prevent baclofen toxicity.

    Besides discontinuing treatment, unscheduled haemodialysis might be considered as a treatment alternative in patients with severe baclofen toxicity. Haemodialysis effectively removes baclofen from the body, alleviates clinical symptoms of overdose and shortens the recovery time in these patients.

    Abrupt discontinuation

    Anxiety and confusional states, delirium, hallucinations, psychotic disorders, mania, orparanoia, convulsion (status epilepticus), dyskinesia, tachycardia, hyperthermia and - as a rebound phenomenon - temporary aggravation of spasticity have been reported upon the abrupt withdrawal of Lioresal, especially after long-term medication.

    Postnatal convulsions have been reported after intrauterine exposure to oral Lioresal.

    For the intrathecal formulation of Lioresal, it has been reported that clinical characteristics of withdrawal may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.

    Except in overdose-related emergencies or where serious adverse effects have occurred, treatment should, therefore, always be gradually withdrawn by successive dosage reduction over a period of approx. 1 to 2 weeks.

    If withdrawal symptoms occur, restarting baclofen therapy and withdrawing over a longer period may help to resolve withdrawal problems.

    Switching from oral to intrathecal baclofen and vice versa

    An attempt should be made to discontinue concomitant antispastic medication to avoid possible overdose or adverse drug interactions. This should preferably be done before switching from oral to intrathecal baclofen or vice versa and requires careful monitoring by the physician. Abrupt reduction or discontinuation of concomitant antispastics during chronic therapy with baclofen should be avoided.

    Effect on ability to drive or use machinery

    Lioresal may be associated with adverse effects such as dizziness, sedation, somnolence and visual impairment which may impair the patientís reaction. Patients experiencing these adverse reactions should be advised to refrain from driving or using machines.

    The patient's ability to react may be adversely affected by sedation and decreased alertness caused by Lioresal. Patients should, therefore, exercise due caution when driving a vehicle or operating machinery.

    Posture and balance

    Lioresal should be used with caution when spasticity is needed to sustain upright posture and balance in locomotion.

    Wheat starch

    Lioresal tablets contain wheat starch. Wheat starch may contain gluten, but only in trace amounts.

    Effects on Fertility

    There are no data available on the effect of baclofen on fertility in humans.

    Use in Pregnancy (Category B3)

    In two teratogenic studies in pregnant rats, baclofen has been shown to increase the incidence of omphalocoeles (ventral hernias) in fetuses at a dose of 20 mg/kg/day, which is maternotoxic. The relevance of this finding to humans is unknown. At the same dose there was also an increased incidence of incomplete sternebral ossification in the fetuses.

    In mice, no teratogenic effects were observed at a dose of 81.5 mg/kg/day given via the diet or up to 40 mg/kg/day given by gavage. At 40 mg/kg/day by gavage, a delay in fetal growth was associated with maternal anorexia. The lack of maternotoxicity seen in the dietary study suggests that the dose used was inadequate.

    In pregnant rabbits, oral doses up to 10 mg/kg/day were manifested as a sedative effect. Skeletal examination of fetuses revealed a marked increase in the absence of ossification of the phalangeal nuclei of fore-limbs and hind-limbs.

    There are no adequate and well-controlled studies in pregnant women. Baclofen crosses the placental barrier and should be used during pregnancy only if the expected benefit outweighs the potential risk to the foetus.

    One case of suspected withdrawal reaction (generalised convulsions) has been reported in a week-old infant whose mother had taken baclofen during pregnancy. The convulsions, which were refractory to different anticonvulsants, ceased within 30 minutes ofgiving baclofen to the infant.

    Use in Lactation

    Studies in lactating women are limited to one (1) patient. In this particular case, availableevidence suggests that baclofen is found in quan tities so small that undesirable effects in the infant would have been unlikely.

    Genotoxicity

    Baclofen did not induce mutations in bacterial or mammalian cells in vitro, lacked DNA damaging activity in the sister chromatid exchange assay and had no clastogenic activity in the nuclear anomaly test.

    Carcinogenicity

    A two year carcinogenicity study in rats found no evidence that baclofen had carcinogenic potential at oral doses up to 100 mg/kg/day. An apparently dose-related increase in the incidence of ovarian cysts and enlarged and/or haemorrhagic adrenals at the highest two doses (50 and 100 mg/kg/day) was observed in female rats. The clinical relevance of these findings is not known.

    Ovarian cysts have been found by palpation in about 5% of the multiple sclerosis patients who were treated with oral Lioresal for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are known to occur spontaneously in a proportion of the normal female population.



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