The active ingredient is: Lioresal is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as: Lioresal is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.
Treatment should baclofen and psychiatric be commenced until the spastic state has become stabilised. Lioresal is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, baclofen and psychiatric, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord.
Lioresal is given orally in either tablet or liquid form. These two formulations are bioequivalent. The liquid may be particularly suitable for children or those adults who are unable to take tablets.
Dosage titration can be more precisely managed with the liquid. The lowest dose compatible with an optimal response is recommended.
Before starting treatment with Lioresal it is prudent to realistically assess the overall extent of clinical improvement that the patient may be expected to achieve. Careful titration of dosage is essential particularly in the elderly until the patient is stabilised. If too high a dose baclofen and psychiatric initiated or if the dosage is increased too rapidly side baclofen and psychiatric may occur. This is particularly relevant if the patient is ambulant in order to minimise muscle weakness in the unaffected limbs or where spasticity is necessary for support.
Once the maximum recommended dose has been reached, if the therapeutic effect is not apparent within 6 weeks a decision whether to continue with Lioresal should be taken. Discontinuation of the treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, or where serious adverse effects have occurred see section 4.
Treatment should be started with a dosage of 15 mg daily, preferably in divided doses. The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements. Satisfactory control of symptoms is usually obtained with doses of up to 60mg daily, but a careful adjustment is often necessary to meet the baclofen and psychiatric of each individual patient.
The dose may be increased slowly if required, but a maximum daily dose of more than mg is not advised unless the patient is in hospital under careful medical supervision. Small frequent dosage may prove better in some cases than larger spaced doses. Also some patients benefit from the use of Lioresal only at night to counteract painful flexor spasm.
Similarly a single dose given approximately 1 hour prior to performance of specific tasks such as washing, baclofen and psychiatric, dressing, shaving, physiotherapy, will often improve mobility. Elderly patients may be more susceptible to side effects, particularly in the early stages of introducing Lioresal.
Small doses should therefore be used at the start of treatment, the dose being titrated gradually against the response, under careful supervision.
There is no evidence that the eventual average maximum dose differs from that in younger patients. Treatment should usually be started with a very low dose corresponding to approximately 0. The usual daily dosage for maintenance breast cancer and public health ranges between 0.
In patients with impaired renal function or undergoing chronic haemodialysis, baclofen and psychiatric, a particularly low dosage of Lioresal should be selected i. Lioresal should be administered to end benefits of exercise and diabetes renal failure patients only if the expected benefit outweighs the potential risk.
No studies have been performed in patients with hepatic impairment receiving Lioresal therapy. The liver does not play a significant role in the metabolism of baclofen after oral administration of Lioresal see section 5. However, Lioresal has the potential of elevating liver enzymes. Lioresal should be prescribed with caution in patients with hepatic impairment. Baclofen and psychiatric effects are more likely to occur in these patients. It is therefore recommended that a cautious dosage schedule be adopted and that patients be baclofen and psychiatric under appropriate surveillance.
Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance. Lioresal may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained. Lioresal should be used with extreme care in patients already receiving antihypertensive therapy, see section 4.
Lioresal should be used with caution in patients suffering from cerebrovascular accidents or from respiratory or hepatic impairment. Since unwanted effects are more likely to occur, a cautious dosage schedule should be adopted in elderly and patients with spasticity of cerebral origin see section 4. Baclofen should be used with caution in patients with renal impairement and should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk See section 4.
Neurological signs and symptoms of overdose including clinical manifestations of toxic encephalopathy e. Patients with impaired renal function should be closely monitored for prompt diagnosis of early symptoms of toxicity, baclofen and psychiatric.
Particular caution is required when combining Lioresal to drugs or medicinal products that can significantly affect renal function. Renal function should be closely monitored and Lioresal daily dosage adjusted accordingly to prevent baclofen toxicity.
Cases of baclofen toxicity have been reported in patients with acute renal failure see section 4. 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, baclofen and psychiatric, alleviates clinical symptoms of overdose and shortens the recovery time in these patients. Under treatment with Lioresal neurogenic disturbances affecting emptying of the bladder may show an improvement.
In patients with pre-existing sphincter hypertonia, acute retention of urine may occur; the drug should be used with caution in such cases. In rare instances elevated aspartate aminotransferase, blood alkaline phosphatase and blood glucose levels in serum have been recorded.
Appropriate laboratory tests should be performed in patients with liver diseases or diabetes mellitus in order to ensure that no drug induced changes in these underlying diseases have occurred. Lioresal tablets contain wheat starch. Wheat starch may contain gluten, but only in trace amounts.
Taking Lioesal tablets is therefore considered safe for people with coeliac disease. Treatment should always, unless serious adverse effects occurbe gradually discontinued by successively reducing the dosage over a period of about weeks. Anxiety and confusional state, delirium, hallucination, psychotic disorder, baclofen and psychiatric, mania or paranoia, convulsion status epilepticusbaclofen and psychiatric, dyskinesia, tachycardia, hyperthermia, rhabdomyolysis and temporary aggravation of spasticity have been reported with abrupt withdrawal of Lioresal, especially after long term medication.
Drug withdrawal reactions including postnatal convulsions in neonates have been reported after intrauterine exposure to oral Lioresal see section 4. Treatment should always, unless serious adverse effects occurbaclofen and psychiatric, therefore be gradually discontinued by successively reducing the dosage over a period of about weeks.
There is very limited clinical data on the use of Lioresal in erythromycin and percocet under the age of one year. Lioresal should be used with caution when spasticity is needed to sustain upright posture and balance in locomotion see section 4. Worsening of the symptoms of Parkinsonism has also been reported, baclofen and psychiatric.
Increased baclofen and psychiatric may occur when Lioresal is taken concomitantly with other drugs causing CNS depression including other muscle relaxants such as tizanidinebaclofen and psychiatric, with synthetic opiates or with alcohol see section 4. The risk of respiratory depression is also increased.
In addition, hypotension has been reported with concomitant use of morphine and intrathecal baclofen.
Careful monitoring of respiratory and cardiovascular functions is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness, baclofen and psychiatric.
During concomitant treatment with tricyclic antidepressants, baclofen and psychiatric, the effect of Lioresal may be potentiated, baclofen and psychiatric, resulting in pronounced baclofen and psychiatric hypotonia. Concomitant use of oral Lioresal and lithium resulted in aggravated hyperkinetic symptoms.
Thus, caution should be exercised when Lioresal is used concomitantly with lithium. Since concomitant treatment with Lioresal and anti-hypertensives is likely to increase the fall in blood pressure, baclofen and psychiatric, the dosage of antihypertensive medication should be adjusted accordingly. Drugs or medicinal products that can significantly affect renal function may reduce baclofen excretion leading to toxic effects see section 4.
During pregnancy, especially in the first 3 months, Lioresal should only be employed if its use is of vital necessity. The benefits of the treatment for the mother must be carefully weighed against the possible risks for the child. Baclofen crosses the placental barrier. Drug withdrawal reactions including postnatal convulsions in neonates have been reported after intra-uterine exposure to oral Lioresal see section 4.
In mothers taking Lioresal at therapeutic baclofen and psychiatric, the active substance passes into the breast milk, but in quantities so small that no undesirable effects in the infant are to be expected. Lioresal may be associated with adverse effects such as dizziness, sedation, somnolence and visual impairment See section 4. Patients experiencing these adverse reactions should be advised to refrain from driving or using machines.
Adverse effects occur mainly at the start of treatment e. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication. Should nausea persist following a reduction in dosage, it is recommended that Lioresal be ingested with food or a milk beverage. In patients with a history of psychiatric illness or with cerebrovascular disorders e.
Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients. An undesirable degree of muscular hypotonia - making it more difficult for patients to walk or fend for themselves - may occur and can usually be relieved by re-adjusting the dosage i. Adverse reactions Table 1 are ranked under heading of frequency, the most frequent first, using the following convention: Respiratory depression, confusional state, dizziness, hallucination, depression, fatigue, insomnia, euphoric mood, muscular weakness, ataxia, tremor, nightmare, myalgia, headache, nystagmus, dry mouth.
Reporting suspected adverse reactions after authorization of the medicinal product is important, baclofen and psychiatric. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Baclofen and psychiatric www. Prominent features are signs of central nervous depression: Also liable to occur are: Patients with renal impairment can develop signs of overdose even on low doses of oral Lioresal see section 4.
A deterioration in the condition may occur if various substances or drugs acting on the central nervous system e, baclofen and psychiatric. Supportive measures and symptomatic treatment should be given for complications such as baclofen and psychiatric, hypertension, convulsions, gastrointestinal disorders and respiratory or cardiovascular depression. Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be given, possibly together with a diuretic, baclofen and psychiatric.
Haemodialysis sometimes unscheduled may be useful in severe poisoning associated with renal failure see section 4. Lioresal is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid GABA derivative, Lioresal is chemically unrelated to other antispastic agents. Lioresal depresses monosynaptic and polysynaptic reflex transmission, probably by stimulating the GABA B -receptors, this stimulation in turn inhibiting the release of the excitatory amino acids glutamate and aspartate.