Baclofen

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Generic Name: Baclofen Brand Name(s): Generics only. No brands available.

Uses

What is Baclofen used for?

Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles.

How should I take Baclofen?

Take this medication by mouth with or without food as directed by your doctor, usually 3 times a day. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience withdrawal symptoms such as hallucinations and seizures. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

How do I store Baclofen?

Baclofen is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Baclofen in the bathroom or the freezer. There may be different brands of Baclofen that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Baclofen down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Baclofen?

Before taking baclofen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood disorders (such as schizophrenia), brain disorders (such as seizures, stroke).

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes (such as confusion).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Baclofen during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Baclofen. Baclofen is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Baclofen?

Drowsiness, dizziness, weakness, tiredness, headache, trouble sleeping, nausea, increased urination, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, hallucinations).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Baclofen?

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), other muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Baclofen may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Baclofen?

Baclofen may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Baclofen?

Baclofen may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Baclofen.

What is the dose of Baclofen for an adult?

Usual Adult Dose for Spasticity

Oral:

-Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days

-Maintenance dose: Should be individualized.

-Maximum dose: 80 mg/day (20 mg orally 4 times a day)

Comments:

-The lowest dose compatible with an optimal response is recommended.

-Slowly withdraw therapy if benefits are not evident after a reasonable period.

Uses:

-For spasticity of multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity; patients should have reversible spasticity so therapy will aid in restoring residual function

-For spinal cord injuries and other spinal cord diseases

Usual Adult Dose for Cerebral Spasticity

INTRATHECAL SCREENING PHASE: Prior to pump implantation for chronic infusion, patients must show a positive response to an intrathecal bolus dose in a screening trial.

-First Screening Dose: 50 mcg (in a volume of 1 mL) administered into the intrathecal space by barbotage over at least 1 minute; observe patient for 4 to 8 hours for a positive response

-Second Screening Dose: (if no positive response to first screening dose): 75 mcg (in a volume of 1.5 mL) bolus dose administered 24 hours after the first screening dose; observe patient for 4 to 8 hours for a positive response

-Third Screening Dose: (if no positive response to second screening dose): 100 mcg (in a volume of 2 mL) bolus dose administered 24 hours after the second screening dose; observe patient for 4 to 8 hours for a positive response; if no positive response to third screening dose, the patient should not be considered for chronic intrathecal therapy

INTRATHECAL POST-IMPLANT DOSE TITRATION PERIOD:

-The screening dose that received a positive response should be doubled and administered over 24 hours, unless the efficacy of the bolus dose was maintained for more than 8 hours, in which case the starting daily dose should be the screening dose delivered over 24 hours.

-No dose increases should be given in the first 24 hours (i.e., until steady state is achieved).

-ADULT PATIENTS WITH SPASTICITY OF SPINAL CORD ORIGIN: After the first 24 hours, the daily dosage should be increased slowly by 10% to 30% increments and only once every 24 hours, until the desired effect is achieved.

-ADULT PATIENTS WITH SPASTICITY OF CEREBRAL ORIGIN: After the first 24 hours, the daily dose should be increased slowly by 5% to 15% only once every 24 hours, until the desired effect is achieved.

INTRATHECAL MAINTENANCE DOSING FOR SPASTICITY OF SPINAL CORD ORIGIN:

-During periodic refills of the pump, the daily dose may be increased by 10% to 40%, but no more than 40%, to maintain adequate symptom control.

-The daily dose may be reduced by 10% to 20% if patients experience side effects; most patients require gradual increases in dose to maintain optimal response during chronic therapy

-Maintenance dosage for long term continuous infusion: 12 to 2003 mcg/day, with most patients adequately maintained on 300 to 800 mcg/day; there is limited experience with daily doses greater than 1000 mcg/day.

MAINTENANCE DOSING FOR SPASTICITY OF CEREBRAL ORIGIN PATIENTS:

-During periodic refills of the pump, the daily dose may be increased by 5% to 20%, but no more than 20%, to maintain adequate symptom control.

-The daily dose may be reduced by 10% to 20% if patients experience side effects; most patients require gradual increases in dose to maintain optimal response during chronic therapy.

-Maintenance dosage for long term continuous infusion: 22 to 1400 mcg/day, with most patients adequately maintained on 90 to 703 mcg/day; there is limited experience with daily doses greater than 1000 mcg/day.

POTENTIAL NEED FOR DOSE ADJUSTMENTS IN CHRONIC USE:

-During long term treatment, approximately 5% of patients become refractory to increasing doses. There is not sufficient experience to make recommendations for tolerance treatment; however, tolerance has been treated on occasion, in hospital, by a “drug holiday” consisting of the gradual reduction of intrathecal dosing over a 2 to 4-week period and switching to alternative methods of spasticity management.

-After the “drug holiday,” intrathecal dosing may be restarted at the initial continuous infusion dose.

Comments:

-Patients should first respond to a screening dose prior to consideration for long term infusion via an implantable pump.

-For spasticity of spinal cord origin, chronic infusion via an implantable pump should be reserved for patients unresponsive to oral therapy, or those who experience intolerable CNS side effects at effective doses.

-Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal therapy.

-Determination of the optimal dose requires individual titration. The lowest dose with an optimal response should be used.

-A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms.

-Many patients require gradual increases in dose over time to maintain optimal response during chronic therapy.

-A sudden large requirement for dose escalation suggests a catheter complication (i.e., catheter kink or dislodgement).

-Careful dose titration is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function. Allowing occasional spasms may help support circulatory function, possibly prevent the formation of deep vein thrombosis, and optimize activities of daily living.

-Except in overdose related emergencies, dosing should be reduced slowly if the drug is discontinued for any reason.

-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 infusion.

-Monitor patients in a fully equipped environment during the screening phase and dose-titration period immediately following implant. Resuscitative equipment should be available for use in case of life-threatening or intolerable side effects.

Use: For the management of severe spasticity of cerebral or spinal origin

Usual Adult Dose for Spinal Spasticity

INTRATHECAL SCREENING PHASE: Prior to pump implantation for chronic infusion, patients must show a positive response to an intrathecal bolus dose in a screening trial.

-First Screening Dose: 50 mcg (in a volume of 1 mL) administered into the intrathecal space by barbotage over at least 1 minute; observe patient for 4 to 8 hours for a positive response

-Second Screening Dose: (if no positive response to first screening dose): 75 mcg (in a volume of 1.5 mL) bolus dose administered 24 hours after the first screening dose; observe patient for 4 to 8 hours for a positive response

-Third Screening Dose: (if no positive response to second screening dose): 100 mcg (in a volume of 2 mL) bolus dose administered 24 hours after the second screening dose; observe patient for 4 to 8 hours for a positive response; if no positive response to third screening dose, the patient should not be considered for chronic intrathecal therapy

INTRATHECAL POST-IMPLANT DOSE TITRATION PERIOD:

-The screening dose that received a positive response should be doubled and administered over 24 hours, unless the efficacy of the bolus dose was maintained for more than 8 hours, in which case the starting daily dose should be the screening dose delivered over 24 hours.

-No dose increases should be given in the first 24 hours (i.e., until steady state is achieved).

-ADULT PATIENTS WITH SPASTICITY OF SPINAL CORD ORIGIN: After the first 24 hours, the daily dosage should be increased slowly by 10% to 30% increments and only once every 24 hours, until the desired effect is achieved.

-ADULT PATIENTS WITH SPASTICITY OF CEREBRAL ORIGIN: After the first 24 hours, the daily dose should be increased slowly by 5% to 15% only once every 24 hours, until the desired effect is achieved.

INTRATHECAL MAINTENANCE DOSING FOR SPASTICITY OF SPINAL CORD ORIGIN:

-During periodic refills of the pump, the daily dose may be increased by 10% to 40%, but no more than 40%, to maintain adequate symptom control.

-The daily dose may be reduced by 10% to 20% if patients experience side effects; most patients require gradual increases in dose to maintain optimal response during chronic therapy

-Maintenance dosage for long term continuous infusion: 12 to 2003 mcg/day, with most patients adequately maintained on 300 to 800 mcg/day; there is limited experience with daily doses greater than 1000 mcg/day.

MAINTENANCE DOSING FOR SPASTICITY OF CEREBRAL ORIGIN PATIENTS:

-During periodic refills of the pump, the daily dose may be increased by 5% to 20%, but no more than 20%, to maintain adequate symptom control.

-The daily dose may be reduced by 10% to 20% if patients experience side effects; most patients require gradual increases in dose to maintain optimal response during chronic therapy.

-Maintenance dosage for long term continuous infusion: 22 to 1400 mcg/day, with most patients adequately maintained on 90 to 703 mcg/day; there is limited experience with daily doses greater than 1000 mcg/day.

POTENTIAL NEED FOR DOSE ADJUSTMENTS IN CHRONIC USE:

-During long term treatment, approximately 5% of patients become refractory to increasing doses. There is not sufficient experience to make recommendations for tolerance treatment; however, tolerance has been treated on occasion, in hospital, by a “drug holiday” consisting of the gradual reduction of intrathecal dosing over a 2 to 4-week period and switching to alternative methods of spasticity management.

-After the “drug holiday,” intrathecal dosing may be restarted at the initial continuous infusion dose.

Comments:

-Patients should first respond to a screening dose prior to consideration for long term infusion via an implantable pump.

-For spasticity of spinal cord origin, chronic infusion via an implantable pump should be reserved for patients unresponsive to oral therapy, or those who experience intolerable CNS side effects at effective doses.

-Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal therapy.

-Determination of the optimal dose requires individual titration. The lowest dose with an optimal response should be used.

-A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms.

-Many patients require gradual increases in dose over time to maintain optimal response during chronic therapy.

-A sudden large requirement for dose escalation suggests a catheter complication (i.e., catheter kink or dislodgement).

-Careful dose titration is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function. Allowing occasional spasms may help support circulatory function, possibly prevent the formation of deep vein thrombosis, and optimize activities of daily living.

-Except in overdose related emergencies, dosing should be reduced slowly if the drug is discontinued for any reason.

-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 infusion.

-Monitor patients in a fully equipped environment during the screening phase and dose-titration period immediately following implant. Resuscitative equipment should be available for use in case of life-threatening or intolerable side effects.

Use: For the management of severe spasticity of cerebral or spinal origin

Renal Dose Adjustments

Use with caution. Dosage may need to be reduced.

Dose Adjustments

Except in emergency cases associated with an overdose, treatment should be discontinued gradually with successive dose reductions. This drug should not be abruptly discontinued.

Dialysis

Hemodialysis removes this drug from the body, alleviates clinical symptoms of overdose and shortens the recovery time in these patients.

Other Comments

Administration advice:

-The oral formulation of this drug should be taken with food.

-The specific concentration of this drug that should be used for intrathecal infusion depends on the total daily dose required as well as the delivery rate of the pump.

-Patients who do not respond (i.e., demonstrate a significant decrease in muscle tone and/or frequency and/or severity of spasms) following a 100 mcg intrathecal test dose should not be administered additional increases in dose or be considered for continuous intrathecal infusion.

-Over time during maintenance intrathecal therapy, many patients will require gradual dose increases to maintain the desired clinical effect. However, a sudden requirement for a significant increase in dose may signify a catheter complication or pump malfunction. Some patients may require a more complicated dose delivery which coincides with increased or decreased spasticity at different times of the day (e.g., increased infusion rate at night). Some patients may become refractory and develop tolerance to increasing doses. Cessation of intrathecal therapy for a few days may restore sensitivity. Treatment may be restarted at the initial continuous infusion rate and titrated accordingly.

General:

-The oral tablets and liquid are considered bioequivalent.

-In patients who do not exhibit an improvement in symptoms within 6 to 8 weeks of achieving the maximum dosage of the oral formulation, continuation of therapy should be reconsidered.

-The intrathecal formulation of this drug should be reserved for patients unresponsive to oral therapy, or those who experience intolerable central nervous system side effects at effective doses.

-The intrathecal injection is intended for administration in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, in implantable pumps suitable for continuous administration into the intrathecal space.

-Children should be of sufficient body mass to accommodate the intrathecal implantable pump for chronic infusion.

-The pump system should not be implanted until the patient response to bolus intrathecal injection and/or dose titration is adequately evaluated and found to be clinically safe and effective.

-The use of the intrathecal route of administration should only be undertaken by physicians adequately trained in chronic intrathecal infusion therapy, in a medically supervised and adequately equipped environment.

-Specific instructions for implanting, programming, and/or refilling of the implantable pump for intrathecal administration recommended by its manufacturer should be strictly adhered to.

-Do not administer the intrathecal formulation of this drug by any route apart from the intrathecal route.

-During the intrathecal dose titration phase, dose increases should occur once every 24 hours in patients with programmable pumps and every 48 hours in patients with nonprogrammable pumps.

-All patients on intrathecal therapy are at risk for withdrawal. Common reasons for abrupt interruption include malfunction of the catheter, low volume in the pump reservoir, and end of pump battery life; human error may play a causal or contributing role. Prevention of abrupt discontinuation requires careful attention to proper programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled visits for pump refilling and be educated on early symptoms of withdrawal.

-For patients with spasticity due to traumatic brain injury, intrathecal therapy should be delayed until the symptoms of spasticity are stable (i.e., at least one year after the injury).

-No specific dose adjustment guidelines have been suggested for elderly patients; however, caution is recommended in dose selection.

-A suggested treatment of intrathecal baclofen withdrawal is restoration of treatment at or near the same dosage as before therapy was interrupted. If restoration of intrathecal therapy is delayed, treatment with GABA-ergic agonist drugs should be considered. Oral or enteral baclofen alone should not be relied upon to stop intrathecal baclofen withdrawal.

Storage requirements:

-Refer to the manufacturer product information.

Reconstitution/preparation techniques:

-Refer to the manufacturer product information.

Patient advice:

-This drug should be taken during meals with a glass of water.

What is the dose of Baclofen for a child?

Usual Pediatric Dose for Spasticity

12 years and older:

Oral:

-Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days

-Maintenance dose: Should be individualized.

-Maximum dose: 80 mg/day (20 mg orally 4 times a day)

Comments:

-The lowest dose compatible with an optimal response is recommended.

-Slowly withdraw therapy if benefits are not evident after a reasonable period.

Uses:

-For spasticity of multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity; patients should have reversible spasticity so therapy will aid in restoring residual function

-For spinal cord injuries and other spinal cord diseases

Usual Pediatric Dose for Cerebral Spasticity

4 years and older:

-The starting screening dose for pediatric patients is the same as in adult patients, (50 mcg); however, for very small patients, a screening dose of 25 mcg may be tried first:

INTRATHECAL SCREENING PHASE: Prior to pump implantation for chronic infusion, patients must show a positive response to an intrathecal bolus dose in a screening trial.

-First Screening Dose: 25 to 50 mcg (in a volume of 1 mL) administered into the intrathecal space by barbotage over at least 1 minute; observe patient for 4 to 8 hours for a positive response

-Second Screening Dose: (if no positive response to first screening dose): 75 mcg (in a volume of 1.5 mL) bolus dose administered 24 hours after the first screening dose; observe patient for 4 to 8 hours for a positive response

-Third Screening Dose: (if no positive response to second screening dose): 100 mcg (in a volume of 2 mL) bolus dose administered 24 hours after the second screening dose; observe patient for 4 to 8 hours for a positive response; if no positive response to third screening dose, the patient should not be considered for chronic intrathecal therapy

INTRATHECAL POST-IMPLANT DOSE TITRATION PERIOD:

-The screening dose that received a positive response should be doubled and administered over 24 hours, unless the efficacy of the bolus dose was maintained for more than 8 hours, in which case the starting daily dose should be the screening dose delivered over 24 hours.

-No dose increases should be given in the first 24 hours (i.e., until steady state is achieved).

-After the first 24 hours in pediatric patients, the daily dose should be increased slowly by 5% to 15% increments and only once every 24 hours, until the desired effect is achieved.

MAINTENANCE DOSING:

The same dosing recommendations for adults with spasticity of cerebral origin are used in pediatric patients 4 years and older:

-During periodic refills of the pump, the daily dose may be increased by 5% to 20%, but no more than 20%, to maintain adequate symptom control.

-The daily dose may be reduced by 10% to 20% if patients experience side effects.

MAINTENANCE DOSAGE FOR LONG TERM CONTINUOUS INFUSION:

-Pediatric patients 4 to under 12 years may require a lower daily dose: 274 mcg/day, with a range of 24 to 1199 mcg/day

-Age 12 years and older: 22 to 1400 mcg/day, with most patients adequately maintained on 90 to 703 mcg/day; there is limited experience with daily doses greater than 1000 mcg/day

POTENTIAL NEED FOR DOSE ADJUSTMENTS IN CHRONIC USE:

-During long term treatment, approximately 5% of patients become refractory to increasing doses. There is not sufficient experience to make recommendations for tolerance treatment; however, tolerance has been treated on occasion, in hospital, by a “drug holiday” consisting of the gradual reduction of intrathecal dosing over a 2 to 4-week period and switching to alternative methods of spasticity management.

-After the “drug holiday,” intrathecal dosing may be restarted at the initial continuous infusion dose.

Comments:

-Patients should first respond to a screening dose prior to consideration for long term infusion via an implantable pump.

-For spasticity of spinal cord origin, chronic infusion via an implantable pump should be reserved for patients unresponsive to oral therapy, or those who experience intolerable CNS side effects at effective doses.

-Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal therapy.

-Determination of the optimal dose requires individual titration. The lowest dose with an optimal response should be used.

-A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms.

-Many patients require gradual increases in dose over time to maintain optimal response during chronic therapy.

-A sudden large requirement for dose escalation suggests a catheter complication (i.e., catheter kink or dislodgement).

-Careful dose titration is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function. Allowing occasional spasms may help support circulatory function, possibly prevent the formation of deep vein thrombosis, and optimize activities of daily living.

-Except in overdose related emergencies, dosing should be reduced slowly if the drug is discontinued for any reason.

-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 infusion.

-Monitor patients in a fully equipped environment during the screening phase and dose-titration period immediately following implant. Resuscitative equipment should be available for use in case of life-threatening or intolerable side effects.

Use: For the management of severe spasticity of cerebral or spinal origin in pediatric patients 4 years and older

Usual Pediatric Dose for Spinal Spasticity

4 years and older:

-The starting screening dose for pediatric patients is the same as in adult patients, (50 mcg); however, for very small patients, a screening dose of 25 mcg may be tried first:

INTRATHECAL SCREENING PHASE: Prior to pump implantation for chronic infusion, patients must show a positive response to an intrathecal bolus dose in a screening trial.

-First Screening Dose: 25 to 50 mcg (in a volume of 1 mL) administered into the intrathecal space by barbotage over at least 1 minute; observe patient for 4 to 8 hours for a positive response

-Second Screening Dose: (if no positive response to first screening dose): 75 mcg (in a volume of 1.5 mL) bolus dose administered 24 hours after the first screening dose; observe patient for 4 to 8 hours for a positive response

-Third Screening Dose: (if no positive response to second screening dose): 100 mcg (in a volume of 2 mL) bolus dose administered 24 hours after the second screening dose; observe patient for 4 to 8 hours for a positive response; if no positive response to third screening dose, the patient should not be considered for chronic intrathecal therapy

INTRATHECAL POST-IMPLANT DOSE TITRATION PERIOD:

-The screening dose that received a positive response should be doubled and administered over 24 hours, unless the efficacy of the bolus dose was maintained for more than 8 hours, in which case the starting daily dose should be the screening dose delivered over 24 hours.

-No dose increases should be given in the first 24 hours (i.e., until steady state is achieved).

-After the first 24 hours in pediatric patients, the daily dose should be increased slowly by 5% to 15% increments and only once every 24 hours, until the desired effect is achieved.

MAINTENANCE DOSING:

The same dosing recommendations for adults with spasticity of cerebral origin are used in pediatric patients 4 years and older:

-During periodic refills of the pump, the daily dose may be increased by 5% to 20%, but no more than 20%, to maintain adequate symptom control.

-The daily dose may be reduced by 10% to 20% if patients experience side effects.

MAINTENANCE DOSAGE FOR LONG TERM CONTINUOUS INFUSION:

-Pediatric patients 4 to under 12 years may require a lower daily dose: 274 mcg/day, with a range of 24 to 1199 mcg/day

-Age 12 years and older: 22 to 1400 mcg/day, with most patients adequately maintained on 90 to 703 mcg/day; there is limited experience with daily doses greater than 1000 mcg/day

POTENTIAL NEED FOR DOSE ADJUSTMENTS IN CHRONIC USE:

-During long term treatment, approximately 5% of patients become refractory to increasing doses. There is not sufficient experience to make recommendations for tolerance treatment; however, tolerance has been treated on occasion, in hospital, by a “drug holiday” consisting of the gradual reduction of intrathecal dosing over a 2 to 4-week period and switching to alternative methods of spasticity management.

-After the “drug holiday,” intrathecal dosing may be restarted at the initial continuous infusion dose.

Comments:

-Patients should first respond to a screening dose prior to consideration for long term infusion via an implantable pump.

-For spasticity of spinal cord origin, chronic infusion via an implantable pump should be reserved for patients unresponsive to oral therapy, or those who experience intolerable CNS side effects at effective doses.

-Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal therapy.

-Determination of the optimal dose requires individual titration. The lowest dose with an optimal response should be used.

-A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms.

-Many patients require gradual increases in dose over time to maintain optimal response during chronic therapy.

-A sudden large requirement for dose escalation suggests a catheter complication (i.e., catheter kink or dislodgement).

-Careful dose titration is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function. Allowing occasional spasms may help support circulatory function, possibly prevent the formation of deep vein thrombosis, and optimize activities of daily living.

-Except in overdose related emergencies, dosing should be reduced slowly if the drug is discontinued for any reason.

-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 infusion.

-Monitor patients in a fully equipped environment during the screening phase and dose-titration period immediately following implant. Resuscitative equipment should be available for use in case of life-threatening or intolerable side effects.

Use: For the management of severe spasticity of cerebral or spinal origin in pediatric patients 4 years and older

-ORAL: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

-INTRATHECAL: Safety and effectiveness in pediatric patients below the age of 4 years have not been established.

How is Baclofen available?

Baclofen is available in the following dosage forms and strengths:

  • Oral tablet,
  • Compounding powder,
  • Intrathecal solution,
  • Oral suspension.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Baclofen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: June 4, 2018 | Last Modified: June 4, 2018

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