History[ edit ] Historically, baclofen was designed as a drug for treating epilepsy. Currently, baclofen continues to be given by mouth, with variable effects. In severely affected children, the oral dose is so high that side-effects appear, and the treatment loses its benefit. How and when baclofen came to be used in the spinal sac intrathecally remains unclear, but as of [update] , this has become an established method of treating spasticity in many conditions.
Adverse events were frequent, although generally mild and transient. Therefore, large-scale prescription of baclofen for the treatment of AD seems premature and should be reconsidered. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.
If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date. Recent studies on eHealthMe:. Shake the oral suspension liquid before you measure a dose.
Use the dosing syringe provided, or use a medicine dose-measuring device do no use a kitchen spoon. Call your doctor if your muscle symptoms do not improve, or if they get worse. Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms such as hallucinations or a seizure. Ask your doctor how to safely stop using this medicine. Store at room temperature away from moisture and heat. See also: Baclofen dosage information in more detail What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at Overdose symptoms may include muscle weakness, vomiting, drowsiness, dilated or pinpoint pupils, weak or shallow breathing, seizure, or coma.
Each bottle is packed in a carton. If you have kidney problems A lower dose of 5 mg 5 mL daily may be used. Children under 18 years of age Children's treatment is adjusted to their body weight and baclofen starts with a very low dose approximately 0. Table 1. If you forget to take your medicine If you forget to take a dose, just liquid the next dose at the usual time.
Do not drive or operate machinery if you are affected. Do not put it in the keep reading. In this leaflet: 1. Driving and using machines: This medicine can make you feel drowsy or cause blurred vision.
Ask your pharmacist how to throw away medicines you no longer use. These patients have also shown poor tolerability to the drug. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. Contents of the pack and other information What Baclofen Oral Solution contains The active substance is baclofen. Shake the bottle well before you take your medicine.
You should check with your doctor or pharmacist if you are not sure. The final dose depends on how you respond. The maximum daily dose is mg mL. However some patients take it only at night or about one hour before doing a task such as washing, dressing, shaving or having physiotherapy. If you are in hospital, a higher dose may be used. The dose may be reduced for elderly patients. Children under 18 years of age Children's treatment is adjusted to their body weight and usually starts with a very low dose approximately 0.
If you have kidney problems A lower dose of 5 mg 5 mL daily may be used. If you are not sure about how much medicine to take, please speak to your doctor or pharmacist. Shake the bottle well before you take your medicine. If you feel sick after taking this medicine, you may find it helps to take it with food or a milk drink. Ask your doctor how to reduce the dose gradually.
If you take more solution than you should If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department. Do not use after the expiry date that is stated on the carton and bottle labels after EXP. The expiry date refers to the last day of that month. Once opened, the solution should be used within 60 days.
Store the solution so that it is protected from light. Do not put it in the fridge. Do not throw away any medicines via wastewater or household waste. These patients have also shown poor tolerability to the drug. If treated with OZOBAX, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration.
Deterioration in seizure control has been reported in patients taking baclofen.
Ovarian Cysts A dose-related increase in incidence liquid ovarian cysts was observed in female rats treated chronically with oral baclofen. Drowsiness: Drowsiness has been reported in patients on baclofen injection intrathecal. These deaths were not attributed to the therapy.
Your pump may also temporarily sound an alarm during baclofen scan; the alarm should stop at the conclusion of the scan. The screening procedure is as follows. Please ask your doctor to determine if the MRI scan can be used with the pump.
You can split or crush the tablet. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms.
The usual screening bolus dose administered prior to pump implantation in these studies was typically 50 mcg. If you have an active infection, you should not have link screening test naproxen implant until the infection has resolved. Baclofen can help make sure you stay safe while you take this drug. Rx Only Rev Always speak with your doctor or pharmacist about dosages that are right for you.
A: People who have severe spasticity resulting from conditions of the brain or spinal cord such as multiple sclerosis, cerebral palsy, stroke, brain injury or spinal cord injury may be candidates for ITB TherapySM.
Direct injection into the catheter through the catheter access port may cause a life-threatening overdose. The following events occurred among the 31 patients receiving intrathecal baclofen in two randomized, baclofen trials: hypotension liquiddizziness 2headache 2dyspnea 1.
Determination of the optimal Baclofen Injection dose requires individual titration. If your symptoms are severe, call or go to the nearest emergency room baclofen away. You should be aware of what your pump alarms sound like. Fetal structural abnormalities were not liquid in mice or rabbits. The use of Baclofen Injection prefilled syringe in an aseptic setting e.
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Some people are at more risk than others for baclofen withdrawal; speak with your clinician about this. Q: What is severe spasticity? A: Severe spasticity is a condition that results from an injury to or disease of the brain or spinal cord. Spasticity may make your muscles feel tight, stiff and difficult to move. With severe spasticity, you can experience stiffening of the muscles that makes your muscles feel like they are locked, or even jerk uncontrollably when you try to use them.
For long term treatment, the drug is placed into a pump that is surgically placed under the skin of your abdomen. Your doctor can program the pump to deliver the appropriate daily dose for you. Before you can be considered for long term treatment, you must have a test dose to see how you respond to the drug when it is delivered in this way.
After the test dose is done, your doctor will discuss the results with you and determine if you are an appropriate candidate for the therapy. A: People who have severe spasticity resulting from conditions of the brain or spinal cord such as multiple sclerosis, cerebral palsy, stroke, brain injury or spinal cord injury may be candidates for ITB TherapySM.
If your spasticity is due to spinal cord injury or multiple sclerosis and is not controlled with baclofen taken by mouth or you have side effects that are not acceptable from oral baclofen taken to treat your spasticity, you may be a candidate.
If you have had a brain injury due to trauma, you should wait for one year after your injury to be considered for ITB TherapySM. If you have an active infection, you should not have a screening test or implant until the infection has resolved. As with most medications, you can experience overdose drug dose is too high or withdrawal drug dose is too low.
Sexual dysfunction in men and women including decreased libido and orgasm dysfunction have been reported. A: All patients and caregivers should receive information on the risks of the treatment. Your doctor should give you information of the signs and symptoms of receiving too much or too little medication overdose or withdrawal and what to do if you notice those symptoms.
If you experience any of these signs, it is extremely important that you or your caregiver contact your doctor immediately. An attempt should be made to discontinue concomitant oral antispasticity medication to avoid possible overdose or adverse drug interactions, either prior to screening or following implant and initiation of chronic baclofen injection intrathecal infusion.
Reduction and discontinuation of oral anti-spasmotics should be done slowly and with careful monitoring by the physician. Abrupt reduction or discontinuation of concomitant antispastics should be avoided. Drowsiness: Drowsiness has been reported in patients on baclofen injection intrathecal. Patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness.
Patients should also be cautioned that the central nervous system depressant effects of baclofen injection intrathecal may be additive to those of alcohol and other CNS depressants.
Intrathecal mass: Cases of intrathecal mass at the tip of the implanted catheter have been reported, most of them involving pharmacy compounded analgesic admixtures. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms.
In patients with new neurological signs or symptoms suggestive of an intrathecal 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.
In some cases, performance of an imaging procedure may be appropriate to confirm or rule-out the diagnosis of an intrathecal mass.
Precautions in special patient populations: Careful dose titration of baclofen injection intrathecal is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function and care.
Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with baclofen injection intrathecal and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration. Baclofen injection intrathecal should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen injection intrathecal may cause an autonomic dysreflexic episode.
Because baclofen is primarily excreted unchanged by the kidneys, it should be given with caution in patients with impaired renal function and it may be necessary to reduce the dosage. Interactions attributed to the combined use of baclofen injection intrathecal and epidural morphine include hypotension and dyspnea.
Adequate genotoxicity assays of baclofen have not been performed. In animal studies, baclofen had adverse effects on embryofetal development when administered orally to pregnant rats. Baclofen injection intrathecal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Baclofen given orally increased the incidence of fetal structural abnormalities omphaloceles in rats.
Reductions in food intake and body weight gain were observed in the dams. Fetal structural abnormalities were not observed in mice or rabbits.
It is not known whether detectable levels of drug are present in milk of nursing mothers receiving baclofen injection intrathecal. As a general rule, nursing should be undertaken while a patient is receiving baclofen injection intrathecal only if the potential benefit justifies the potential risks to the infant.
Considerations based on experience with oral baclofen USP A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. These include: pump pocket infections 3 , meningitis 2 , wound dehiscence 1 , gynecological fibroids 1 and pump overpressurization 1 with unknown, if any, sequela.
Eleven patients who developed coma secondary to overdose had their treatment temporarily suspended, but all were subsequently restarted and were not, therefore, considered to be true discontinuations.
Fatalities — See Warnings. Incidence in Controlled Trials — Experience with baclofen injection intrathecal obtained in parallel, placebo-controlled, randomized studies provides only a limited basis for estimating the incidence of adverse events because the studies were of very brief duration up to three days of infusion and involved only a total of 63 patients.
The following events occurred among the 31 patients receiving baclofen injection intrathecal in two randomized, placebo-controlled trials: hypotension 2 , dizziness 2 , headache 2 , dyspnea 1. No adverse events were reported among the 32 patients receiving placebo in these studies.
Do not use Baclofen Injection for intravenous, intramuscular, subcutaneous or epidural administration. Warnings and Precautions Do not directly inject Baclofen Injection into the pump catheter access port, as this may cause a life-threatening overdose 5.
Direct injection into the catheter through the catheter access port may cause a life-threatening overdose. Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Carefully calculate refill intervals to prevent depletion of the reservoir, as this would result in the return of severe spasticity and possibly symptoms of withdrawal. Strict aseptic technique in filling is required to avoid bacterial contamination and serious infection.
A period of observation appropriate to the clinical situation should follow each refill or manipulation of the drug reservoir. This has the potential to lead to contamination and consequent adverse reactions. The use of Baclofen Injection prefilled syringe in an aseptic setting e. Baclofen Injection supplied in vials may be used with conventional aseptic technique to fill intrathecal pumps prior to implantation. Procedures should also be put in place while refilling implantable intrathecal pumps in an outpatient setting to avoid contamination of sterile surfaces through contact with the non-sterile exterior of the Baclofen Injection prefilled syringe.
The pump system should not be implanted until the patient's response to bolus Baclofen Injection is adequately evaluated.
Evaluation consisting of a screening procedure requires that Baclofen Injection be administered into the intrathecal space via a catheter or lumbar puncture [see Dosage and Administration 2.
Because of the risks associated with the screening procedure and the adjustment of dosage following pump implantation, these phases must be conducted in a medically supervised and adequately equipped environment following the instructions outlined in the Dosage and Administration section [see Dosage and Administration 2. Resuscitative equipment should be available. Following surgical implantation of the pump, particularly during the initial phases of pump use, the patient should be monitored closely until it is certain that the patient's response to the infusion is acceptable and reasonably stable.
It is mandatory that the patient, all patient caregivers, and the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatment.
All medical personnel and caregivers should be instructed in 1 the signs and symptoms of overdose, 2 procedures to be followed in the event of overdose and 3 proper home care of the pump and insertion site. Overdose Signs of overdose may appear suddenly or insidiously. Acute massive overdose may present as coma. Should overdose appear likely, the patient should be taken immediately to a hospital for assessment and emptying of the pump reservoir. In cases reported to date, overdose has generally been related to pump malfunction or dosing error [see Overdosage 10 ].
Extreme caution must be used when filling the implantable pump. Direct injection into this catheter access port may cause a life-threatening overdose. Withdrawal Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death.
In the first 9 years of post-marketing experience, 27 cases of withdrawal temporally related to the cessation of baclofen therapy were reported; six patients died. In most cases, symptoms of withdrawal appeared within hours to a few days following interruption of baclofen therapy.
Common reasons for abrupt interruption of intrathecal baclofen therapy included malfunction of the catheter especially disconnection , low volume in the pump reservoir, and end of pump battery life; human error may have played a causal or contributing role in some cases.
Cases of intrathecal mass at the tip of the implanted catheter leading to withdrawal symptoms have also been reported, most of them involving pharmacy compounded analgesic admixtures [see Warnings and Precautions 5. All patients receiving intrathecal baclofen therapy are potentially at risk for withdrawal.
Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias. Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection sepsis , malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.
Rapid, accurate diagnosis and treatment in an emergency-room or intensive-care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal. The suggested treatment for intrathecal baclofen withdrawal is the restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted.
However, if restoration of intrathecal delivery is delayed, treatment with GABA-ergic agonist drugs such as oral or enteral baclofen, or oral, enteral, or intravenous benzodiazepines may prevent potentially fatal sequelae. Oral or enteral baclofen alone should not be relied upon to halt the progression of intrathecal baclofen withdrawal. Seizures have been reported during overdose and with withdrawal from intrathecal baclofen as well as in patients maintained on therapeutic doses of intrathecal baclofen.
Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with Baclofen Injection and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.
Because these patients were treated under uncontrolled clinical settings, it is impossible to determine definitively what role, if any, intrathecal baclofen played in their deaths. A case-by-case review of the clinical course of the 16 patients who died failed to reveal any unique signs, symptoms, or laboratory results that would suggest that treatment with intrathecal baclofen caused their deaths.
Two patients, however, did suffer sudden and unexpected death within 2 weeks of pump implantation and one patient died unexpectedly after screening.
One patient, a 44 year-old male with Multiple Sclerosis, died in hospital on the second day following pump implantation. An autopsy demonstrated severe fibrosis of the coronary conduction system. A second patient, a 52 year-old woman with MS and a history of an inferior wall myocardial infarction, was found dead in bed 12 days after pump implantation, 2 hours after having had documented normal vital signs.