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BACLOFEN is a brand name for Baclofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Baclofen is indicated in patients with severe chronic spasticity of spinal or cerebral origin (associated with injury, multiple sclerosis, cerebral palsy) who are unresponsive to oral baclofen or other orally administered antispastic agents and/or those patients who experience unacceptable side-effects at…
Verbatim from this product's MHRA label. Tap a section to expand.
Intrathecal administration of Baclofen through an implanted delivery system should only be undertaken by physicians with the necessary knowledge and experience. Specific instructions for implantation, programming and/or refilling of the implantable pump are given by the pump manufacturers and must be strictly adhered to.
5 mg/ml or 2 mg/ml into the intrathecal space (EU certified pumps). Establishment of the optimum dose schedule requires that each patient undergoes an initial screening phase with intrathecal bolus, followed by a very careful individual dose titration prior to maintenance therapy.
Respiratory function should be monitored and appropriate resuscitation facilities should be available during the introduction of treatment with Baclofen. Baclofen administration using an implanted delivery system should only be undertaken by physicians with appropriate knowledge and experience.
Specific instructions for using the implantable pump should be obtained from the pump manufacturers. Only pumps constructed of material known to be compatible with the product and incorporating an in-line bacterial retentive filter should be used.
Adult Screening Phase Prior to initiation of a chronic infusion, the patient’s response to intrathecal bolus doses administered via a catheter or lumbar puncture must be assessed. Low concentration ampoules containing 50 micrograms baclofen in 1ml are available for the purpose.
Patients should be infection-free prior to screening, as the presence of a systemic infection may prevent an accurate assessment of the response. The usual initial test dose in adults is 25 or 50 micrograms, increasing step-wise by 25 microgram increments at intervals of not less than 24 hours until a response of approximately 4 to 8 hours duration is observed.
Each dose should be given slowly (over at least one minute). In order to be considered a responder the patient must demonstrate a significant decrease in muscle tone and/or frequency and/or severity of muscle spasms. The variability in sensitivity to intrathecal baclofen between patients is emphasised.
Signs of severe overdose (coma) have been observed in an adult after a single test dose of 25 micrograms. It is recommended that the initial test dose is administered with resuscitative equipment on hand. Patients who do not respond to a 100 micrograms test dose should not be given further dose increments or considered for continuous intrathecal infusion.
Some of the adverse reactions listed below have been reported in patients with spasticity of spinal origin but could also occur in patients with spasticity of cerebral origin. Adverse reactions that are more frequent in either population are indicated below.
Adverse drug reactions (Table 1) are listed according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and Not known (cannot be estimated from available data).
Table 1 Adverse drug reactions Metabolism and nutritional disorders Uncommon:
Dehydration Psychiatric disorders Common: Depression, anxiety, agitation. 4 – Precautions in special patient populations), suicide attempt, hallucinations, paranoia, euphoric mood.
Not known:
Dysphoria Nervous system disorders Very common: Somnolence Common: Convulsion, confusional state, sedation, dizziness, headache, paraesthesia, dysarthria, lethargy, insomnia, disorientation, Uncommon: Ataxia, memory impairment, nystagmus (Convulsion and headache occur more often in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin).
Eye disorders Common:
Accommodation disorder, vision blurred, diplopia.
Intrathecal baclofen therapy is valuable but hazardous. Careful pre-operative assessment is mandatory. The patient must be given adequate information regarding the risks of this mode of treatment and be physically and psychologically able to cope with the pump.
It is essential that the responsible physicians and all those involved in the care of the patient receive adequate instruction on the signs and symptoms of overdose, procedures to be followed in the event of an overdose and the proper home care of the pump and insertion site.
Inflammatory mass at the tip of the implanted catheter:
Cases of inflammatory mass at the tip of the implanted catheter that can result in serious neurological impairment, including paralysis have been reported. Although they have been reported with intrathecal baclofen, they have not been confirmed by contrast MRI or histopathology.
The most frequent symptoms associated with inflammatory mass are: 1) decreased therapeutic response (worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases), 2) pain, 3) neurological deficit/dysfunction.
Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms. Clinicians should use their medical judgement regarding the most appropriate monitoring specific to their patients’ medical needs to identify prodromal signs and symptoms for inflammatory mass especially if using pharmacy compounded drugs or admixtures that include opioids.
In patients with new neurological signs or symptoms suggestive of an inflammatory mass, consider a neurosurgical consultation since many of the symptoms of inflammatory mass are not unlike the symptoms experienced by patients with severe spasticity from their disease.
1). The drug should not be administered by any other route other than intrathecal.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Baclofen in United Kingdom.
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Monitoring of respiratory and cardiac function is essential during this phase, especially in patients with cardiopulmonary disease and respiratory muscle weakness or those being treated with benzodiazepine-type preparations or opiates, who are at higher risk of respiratory depression.
Paediatric population Screening Phase The initial lumbar puncture test dose for patients 4 to <18 years of age should be 25- 50 micrograms/day based upon age and size of the child. Patients who do not experience a response may receive a 25 micrograms/day dose escalation every 24 hours.
The maximum screening dose should not exceed 100 micrograms/day in paediatric patients. Dose-Titration Phase Once the patient's responsiveness to baclofen has been established, an intrathecal infusion may be introduced. Baclofen is most often administered using an infusion pump which is implanted in the chest wall or abdominal wall tissues.
Implantation of pumps should only be performed in experienced centres to minimise risks during the perioperative phase. Infection may increase the risk of surgical complications and complicate attempts to adjust the dose. The initial total daily infused dose is determined by doubling the bolus dose which gave a significant response in the initial screening phase and administering it over a 24 hour period.
e. lasting more than 12 hours) is observed during screening the starting dose should be the unchanged screening dose delivered over 24 hours. No dose increases should be attempted during the first 24 hours. After the initial 24 hour period dosage should be adjusted slowly to achieve the desired clinical effect.
If a programmable pump is used the dose should be increased only once every 24 hours; for non-programmable multi-dose reservoir pumps intervals of 48 hours between dose adjustments are recommended. In either case increments should be limited as follows to avoid possible overdosage: Patients with spasticity of spinal origin: 10-30% of the previous daily dose Patients with spasticity of cerebral origin: 5-15% of the previous daily dose.
If the dose has been significantly increased without apparent clinical effect pump function and catheter patency should be investigated. There is limited clinical experience using doses greater than 1000 micrograms/day. It is important that patients are monitored closely in an appropriately equipped and staffed environment during screening and immediately following pump implantation.
Resuscitative equipment should be available for immediate use in case of life- threatening adverse reactions. Adult Maintenance Therapy The clinical goal is to maintain as normal a muscle tone as possible, and to minimise the frequency and severity of spasms without inducing intolerable side effects.
The lowest dose producing an adequate response should be used. The retention of some spasticity is desirable to avoid a sensation of “paralysis” on the part of the patient. In addition, a degree of muscle tone and occasional spasms may help support circulatory function and possibly prevent the formation of deep vein thrombosis.
In patients with spasticity of spinal origin: maintenance dosing for long-term continuous infusions of intrathecal baclofen has been found to range from 12 to 2003 micrograms/day with most […]
Cardiovascular disorders Uncommon:
Bradycardia Vascular disorders Common: Hypotension Uncommon: Hypertension, deep vein thrombosis, flushing, pallor.
Respiratory, thoracic and mediastinal disorders Common:
Respiratory depression, pneumonia, dyspnoea.
Not known:
Bradypnoea.
Gastrointestinal disorders Common:
Nausea/vomiting, constipation, dry mouth, diarrhoea, decreased appetite, increased salivation.
Uncommon:
Ileus, dysphagia, hypogeusia. (Nausea and vomiting occur more often in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin).
Skin and subcutaneous tissue disorders Common:
Urticaria/pruritus, facial and/or peripheral oedema.
Uncommon:
Alopecia, hyperhydrosis. 4) Renal and urinary disorders Common: Urinary incontinence, urinary retention (Urinary retention occurs more often in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin).
Reproductive system and breast disorders Common:
Sexual dysfunction (Baclofen may compromise erection and ejaculation. ) Not known: Erectile dysfunction General disorders and administration site conditions Common: Asthenia, pyrexia, pain, chills.
Uncommon:
Hypothermia. 4 – Special warnings and precautions for use “Treatment Withdrawal”). Immune system disorders Not known Hypersensitivity Adverse events associated with the delivery system Adverse events associated with the delivery system (inflammatory mass at the tip of the catheter, catheter dislocation with possible complications, pocket infection, meningitis, overdose due to wrong manipulation of the device) have been reported.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
In some cases, performance of an imaging procedure may be appropriate to confirm or rule-out the diagnosis of an inflammatory mass. Pump Implantation Patients should be infection-free prior to pump implantation because the presence of infection may increase the risks of surgical complications.
Moreover, a systemic infection may complicate attempts to adjust the dose. 4 – Special Precautions for Use “Treatment Withdrawal” section). Reservoir Refilling Reservoir refilling must be performed by trained and qualified personnel in accordance with the instructions provided by the pump manufacturer.
4 – Special Precautions for Use “Treatment Withdrawal” section). When refilling the pump care should be taken to avoid discharging the contents of the catheter into the intrathecal space. Strict asepsis is required to avoid microbial contamination and infection.
Extreme caution must be taken when filling a pump equipped with an injection port that allows direct access to the intrathecal catheter as a direct injection into the catheter through the access port could cause a life-threatening overdose.
e. at least one year after the injury). Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion. Use of Baclofen in the paediatric population should be only prescribed by medical specialists with the necessary knowledge and experience.
There is very limited clinical data regarding the safety and efficacy of the use of intrathecal baclofen in children under the age of four years. Precautions in special patient populations In patients with abnormal CSF flow the circulation of drug and hence antispastic activity may be inadequate.
Psychotic disorders, schizophrenia, confusional states or Parkinson’s disease may be exacerbated by treatment with oral baclofen. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.
Close supervision of patients with additional risk factors for suicide should accompany therapy with baclofen. 8 – Psychiatric disorders) Special attention should be given to patients known to suffer from epilepsy as seizures have occasionally been reported during overdose with, and withdrawal from, intrathecal baclofen as well as in patients maintained on therapeutic doses.
Baclofen should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of Baclofen may precipitate an autonomic dysreflexic episode. Baclofen should be used with caution in patients with cerebrovascular or respiratory insufficiency.
An effect of Baclofen on underlying, non-CNS related diseases is unlikely because its systemic availability is substantially lower than after oral administration. Caution should be exercised in patients with history of peptic ulcers and based on observations after oral baclofen therapy, in those with pre-existing sphincter hypertonia.
Renal impairment After oral baclofen dosing, severe neurological outcomes have been reported in patients with renal impairment. Thus, caution should be exercised while administering intrathecal baclofen in patients with renal impairment.
In rare instances elevated SGOT, alkaline phosphatase and glucose levels in the serum have been recorded when using oral Baclofen. Treatment […]