Baclofen 10mg/20 Inj, 20ml
WARNING: Unsafe side effects have happened when this drug was stopped all of a sudden. Some of these side effects have been high fever, mental changes, more spasms, and muscle stiffness. Rarely, these side effects have led to very bad muscle problems, organ problems, and death. Avoid stopping this drug all of a sudden without talking with your doctor. Be sure you get your pump refilled on time and you know about the pump alarms and what to do if the pump alarm goes off. Tell your doctor if you have ever had signs of withdrawal while getting baclofen tablets or shot. Call your doctor right away if you have signs of withdrawal.Read the package insert for more details. @ COMMON USES: It is used to treat spasms in patients with MS (multiple sclerosis) or spinal cord problems.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antispasticity agent
Pharmacologic Class
GABA-B receptor agonist
Pregnancy Category
Category C
FDA Approved
Mar 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Baclofen is a medicine used to relax muscles and reduce severe muscle stiffness (spasticity) caused by conditions like multiple sclerosis or spinal cord injury. This specific form is given directly into the fluid around your spinal cord using a special pump, which helps it work more effectively with fewer side effects than oral forms.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the guidelines provided to ensure safe and effective use. This medication is administered via injection into the spine.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Carry an identification card stating you have an intrathecal baclofen pump.
- Know your pump refill schedule and do not miss appointments.
- Report any changes in your spasticity or new symptoms immediately to your doctor.
- Avoid abrupt changes in posture to prevent dizziness.
- Do not consume alcohol or other CNS depressants without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
- Baclofen 10mg Tablets
- Baclofen 20mg Tablets
- Baclofen 40mg/20ml Inj, 20ml
- Baclofen 5mg Tablets
- Baclofen 20mg/20ml Inj 20ml
- Baclofen 10mg/20 Inj, 20ml
- Baclofen 5mg/5ml Solution
- Baclofen 50mcg/ml Pf Syr, 1ml
- Baclofen 25mg/5ml Oral Susp 300ml
- Baclofen 25mg/5ml Oral Susp 120ml
- Baclofen 15mg Tablets
- Baclofen 25mg/5ml Oral Susp 250ml
- Baclofen 2000mcg Inj Refill Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized. Initial screening dose (50 mcg, 75 mcg, or 100 mcg) administered intrathecally. If positive response, begin continuous infusion. Initial maintenance dose typically 300-800 mcg/day, titrated based on response.
Dose Range:
12 - 2000 mg
Condition-Specific Dosing:
spasticityOfSpinalOrigin:
Initial screening dose: 50 mcg. Maintenance: 300-800 mcg/day, max 2000 mcg/day.
spasticityOfCerebralOrigin:
Initial screening dose: 25 mcg or 50 mcg. Maintenance: 200-700 mcg/day, max 1200 mcg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For severe spasticity unresponsive to oral baclofen. Initial screening dose: 25-50 mcg. Maintenance: Highly individualized, typically 200-400 mcg/day, range 25-1200 mcg/day.
Adolescent:
Similar to adult dosing, highly individualized based on response and tolerability.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for intrathecal administration, as systemic exposure is minimal. Monitor for increased sensitivity to effects.
Moderate:
No specific adjustment for intrathecal administration, as systemic exposure is minimal. Monitor for increased sensitivity to effects.
Severe:
No specific adjustment for intrathecal administration, as systemic exposure is minimal. Monitor for increased sensitivity to effects.
Dialysis:
Not applicable for intrathecal administration as systemic exposure is minimal and drug is not significantly dialyzable from CSF.
Hepatic Impairment:
Mild:
No specific adjustment for intrathecal administration, as systemic exposure and hepatic metabolism are minimal.
Moderate:
No specific adjustment for intrathecal administration, as systemic exposure and hepatic metabolism are minimal.
Severe:
No specific adjustment for intrathecal administration, as systemic exposure and hepatic metabolism are minimal.
Pharmacology
Mechanism of Action
Baclofen is a gamma-aminobutyric acid (GABA) derivative. It acts as a GABA-B receptor agonist, primarily at the spinal cord level. It inhibits both mono- and polysynaptic reflexes by hyperpolarizing afferent terminals, leading to reduced excitatory neurotransmitter release and decreased muscle spasticity.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intrathecal, directly into CSF)
Tmax:
CSF: 1-2 hours (after bolus)
FoodEffect:
Not applicable (intrathecal administration)
Distribution:
Vd:
CSF: Approximately 22-33 mL (limited to CSF space)
ProteinBinding:
Minimal (approximately 30% in plasma, but systemic exposure is low with intrathecal administration)
CnssPenetration:
Yes (directly administered into CSF)
Elimination:
HalfLife:
CSF: Approximately 4-5 hours (after intrathecal administration)
Clearance:
CSF: Approximately 30 mL/hour
ExcretionRoute:
Primarily renal excretion of unchanged drug from CSF, with minimal systemic elimination.
Unchanged:
Approximately 80% (excreted unchanged in urine after systemic absorption, but intrathecal route minimizes systemic absorption)
Pharmacodynamics
OnsetOfAction:
0.5-1 hour (after intrathecal bolus)
PeakEffect:
4 hours (after intrathecal bolus)
DurationOfAction:
4-8 hours (after intrathecal bolus); continuous infusion provides sustained effect.
Safety & Warnings
BLACK BOX WARNING
Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in severe sequelae including high fever, altered mental status, exaggerated rebound spasticity, muscle rigidity, and rhabdomyolysis, leading in rare cases to organ failure and death. Therefore, abrupt withdrawal of intrathecal baclofen should be avoided. Early symptoms of withdrawal may include increased spasticity, pruritus, and hypotension. Consult the prescribing information for additional details.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Confusion
New or worsening mental, mood, or behavioral changes
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance or coordination
Changes in vision
Chest pain
Muscle pain or weakness
Muscle stiffness
Abnormal burning, numbness, or tingling sensations
Breathing difficulties, slow breathing, or shallow breathing
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine frequency or volume
+ Blood in the urine
Swelling in the arms or legs
Trouble controlling body movements, twitching, or changes in balance
Difficulty swallowing or speaking
Uncontrolled eye movements
Abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Sleep disturbances
Upset stomach or vomiting
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Confusion
New or worsening mental, mood, or behavioral changes
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance or coordination
Changes in vision
Chest pain
Muscle pain or weakness
Muscle stiffness
Abnormal burning, numbness, or tingling sensations
Breathing difficulties, slow breathing, or shallow breathing
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine frequency or volume
+ Blood in the urine
Swelling in the arms or legs
Trouble controlling body movements, twitching, or changes in balance
Difficulty swallowing or speaking
Uncontrolled eye movements
Abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Sleep disturbances
Upset stomach or vomiting
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of overdose: extreme drowsiness, severe muscle weakness, difficulty breathing, feeling very cold, seizures, loss of consciousness.
- Signs of withdrawal: sudden increase in muscle stiffness, itching, fever, confusion, hallucinations, seizures, rapid heart rate, low blood pressure.
- Signs of pump malfunction: return of spasticity, pain at the pump site, swelling, redness.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have an infection, as this may affect the safety or efficacy of the medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.
Before starting, stopping, or modifying the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have an infection, as this may affect the safety or efficacy of the medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.
Before starting, stopping, or modifying the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
When administering this medication to a child, exercise caution, as the risk of certain side effects may be increased in pediatric patients.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby. Taking this drug during pregnancy may cause withdrawal symptoms in the newborn.
Injection Administration
If you notice that this medication is no longer effective, consult with your doctor. Do not exceed the prescribed dose.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
When administering this medication to a child, exercise caution, as the risk of certain side effects may be increased in pediatric patients.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby. Taking this drug during pregnancy may cause withdrawal symptoms in the newborn.
Injection Administration
If you notice that this medication is no longer effective, consult with your doctor. Do not exceed the prescribed dose.
Overdose Information
Overdose Symptoms:
- Profound somnolence
- Hypotonia (severe muscle weakness)
- Respiratory depression (slow, shallow breathing)
- Seizures
- Coma
- Hypothermia
- Bradycardia (slow heart rate)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. Management includes supportive care, maintaining respiration, and potentially withdrawing CSF to reduce baclofen concentration. Naloxone has been reported to reverse some effects in some cases, but its efficacy is not consistently proven. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Other CNS depressants (e.g., opioids, benzodiazepines, tricyclic antidepressants, alcohol): Increased sedation, respiratory depression, hypotension. Monitor closely.
- Antihypertensives: May potentiate hypotensive effects. Monitor blood pressure.
- Tricyclic antidepressants: May potentiate muscle relaxant effects and increase risk of CNS depression.
Moderate Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Concurrent use may increase CNS depression. Use with caution.
- Lithium: May exacerbate hyperkinetic movements in patients with spasticity.
Monitoring
Baseline Monitoring
Spasticity assessment (e.g., Ashworth Scale, Modified Ashworth Scale)
Rationale: To establish baseline severity and guide initial dosing.
Timing: Prior to screening dose and pump implantation.
Neurological examination
Rationale: To assess motor function, reflexes, and sensory status.
Timing: Prior to screening dose.
Cardiovascular status (BP, HR)
Rationale: To assess baseline and monitor for hypotensive effects.
Timing: Prior to screening dose.
Routine Monitoring
Spasticity assessment
Frequency: Daily during titration, then periodically (e.g., monthly to quarterly) during maintenance.
Target: Optimal reduction in spasticity with minimal side effects.
Action Threshold: If spasticity worsens or side effects occur, consider dose adjustment or pump evaluation.
Adverse effects (e.g., sedation, hypotonia, nausea, headache, respiratory depression)
Frequency: Daily during titration, then at each follow-up visit.
Target: Absence or minimal tolerable side effects.
Action Threshold: Significant or intolerable side effects require dose reduction or medical intervention.
Pump reservoir status and refill schedule
Frequency: As per pump manufacturer guidelines and patient's refill schedule (e.g., every 1-3 months).
Target: Adequate drug volume in reservoir.
Action Threshold: Low reservoir volume requires immediate refill to prevent withdrawal.
Neurological status (motor function, reflexes)
Frequency: Periodically during maintenance, especially with dose changes.
Target: Stable or improved neurological function.
Action Threshold: Changes may indicate overdose, underdose, or pump malfunction.
Symptom Monitoring
- Signs of overdose: profound somnolence, hypotonia, respiratory depression, seizures, coma, hypothermia, bradycardia.
- Signs of abrupt withdrawal: increased spasticity, pruritus, hyperthermia, altered mental status, exaggerated rebound spasticity, muscle rigidity, rhabdomyolysis, seizures, hallucinations, cardiovascular instability, death.
Special Patient Groups
Pregnancy
Use only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects at high doses, but human data are limited. Intrathecal administration results in minimal systemic exposure.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of teratogenicity.
Second Trimester:
Limited data.
Third Trimester:
Limited data, potential for neonatal withdrawal if systemic exposure is significant (unlikely with intrathecal).
Lactation
Baclofen is excreted in breast milk after oral administration. However, systemic exposure from intrathecal administration is minimal, making the amount transferred to breast milk likely negligible. Use with caution, monitor infant for sedation.
Infant Risk:
Low (L3 - Moderately Safe)
Pediatric Use
Used for severe spasticity in children unresponsive to oral therapy. Dosing is highly individualized and requires careful titration. Safety and efficacy in children under 4 years of age have not been established.
Geriatric Use
Elderly patients may be more sensitive to the effects of baclofen, particularly sedation and hypotonia. Dosing should be initiated cautiously and titrated slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Intrathecal baclofen is a highly effective treatment for severe, intractable spasticity, but requires specialized management.
- Abrupt withdrawal is a medical emergency and can be fatal. Patients and caregivers must be educated on withdrawal symptoms and the importance of pump refills.
- Dosing is highly individualized and requires careful titration to achieve optimal spasticity reduction with minimal side effects.
- Overdose can lead to severe CNS and respiratory depression. Patients should be monitored for signs of excessive hypotonia or sedation.
- Pump malfunction or infection are serious complications that require immediate medical attention.
Alternative Therapies
- Oral baclofen
- Tizanidine (oral)
- Dantrolene (oral)
- Botulinum toxin injections (e.g., Botox, Myobloc, Dysport)
- Diazepam (oral)
- Clonazepam (oral)
- Surgical interventions (e.g., selective dorsal rhizotomy, tenotomy)
Cost & Coverage
Average Cost:
Highly variable, depends on concentration, volume, and supplier. Typically ranges from hundreds to thousands of dollars per vial/kit. per 20ml vial
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (often requires prior authorization and is covered under medical benefit for pump refills)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.