Baclofen 10mg Tablets
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
Skeletal Muscle Relaxant, Antispasticity Agent
Pharmacologic Class
GABA-B Receptor Agonist
Pregnancy Category
C
FDA Approved
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Baclofen is a medication used to relax muscles and relieve muscle spasms, stiffness, and pain caused by conditions like multiple sclerosis or spinal cord injury. It works by calming overactive nerves in the spinal cord.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. It's essential to follow the dosage instructions carefully to ensure you get the most benefit from your treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. If you split your tablets, be aware that they may have a limited storage time. Check with your pharmacist to determine how long you can safely store the split tablets. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. It's essential to follow the dosage instructions carefully to ensure you get the most benefit from your treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. If you split your tablets, be aware that they may have a limited storage time. Check with your pharmacist to determine how long you can safely store the split tablets. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
Lifestyle & Tips
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness or dizziness.
- Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) while taking baclofen, as this can increase drowsiness and other side effects.
- Do not stop taking baclofen suddenly, especially if you have been on it for a long time or at high doses. Abrupt discontinuation can lead to severe withdrawal symptoms (e.g., hallucinations, seizures, rebound spasticity). Your doctor will guide you on how to slowly reduce the dose.
- Take baclofen with food or milk if it causes stomach upset.
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:
Initially 5 mg three times daily, titrated every 3 days
Dose Range:
5 - 80 mg
Condition-Specific Dosing:
spasticity:
Initial: 5 mg orally three times daily for 3 days, then 10 mg three times daily for 3 days, then 15 mg three times daily for 3 days, then 20 mg three times daily. Max: 80 mg/day in divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial: 0.3 mg/kg/day in 4 divided doses. Titrate slowly based on response and tolerability. Max: 40 mg/day for children <8 years; 60 mg/day for children >8 years (or 2 mg/kg/day, whichever is less).
Adolescent:
Initial: 5 mg orally three times daily, titrate slowly. Max: 80 mg/day in divided doses.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for mild impairment, but monitor for increased adverse effects.
Moderate:
Reduce initial dose to 5 mg once daily, titrate cautiously. Monitor closely for adverse effects.
Severe:
Contraindicated in end-stage renal disease unless benefits outweigh risks and close monitoring is possible. If used, reduce dose significantly (e.g., 5 mg every 2-3 days) and monitor for toxicity.
Dialysis:
Baclofen is poorly dialyzable. Avoid use or use with extreme caution and significant dose reduction (e.g., 5 mg every 2-3 days) with close monitoring for toxicity. Consider alternative agents.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, as hepatic metabolism is minimal.
Severe:
No specific adjustment needed, as hepatic metabolism is minimal.
Pharmacology
Mechanism of Action
Baclofen is a gamma-aminobutyric acid (GABA) derivative that acts as a GABA-B receptor agonist. It is thought to exert its effects by inhibiting both monosynaptic and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of afferent terminals and inhibition of excitatory neurotransmitter release. This leads to a reduction in spasticity and associated muscle spasms.
Pharmacokinetics
Absorption:
Bioavailability:
70-85%
Tmax:
2-3 hours
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.7 L/kg
ProteinBinding:
Approximately 30%
CnssPenetration:
Yes, crosses the blood-brain barrier, but CNS concentrations are lower than plasma concentrations.
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (70-80% as unchanged drug)
Unchanged:
70-80%
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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 behavior 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 output
+ Changes in urination frequency
+ 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. Many people may not experience any side effects or may only have mild ones. 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 is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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 behavior 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 output
+ Changes in urination frequency
+ 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. Many people may not experience any side effects or may only have mild ones. 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 is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:
- Severe drowsiness or sedation
- Confusion or hallucinations
- Difficulty breathing
- Unusual muscle weakness
- Seizures (especially if abruptly stopped)
- Severe allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Do not abruptly discontinue this medication, as this may increase your risk of experiencing side effects, including hallucinations (perceiving things that are not present), seizures, high fever, stiff muscles, and confusion. In rare cases, sudden discontinuation can lead to organ problems and even death. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the medication. If you experience any new or worsening symptoms, discuss them with your doctor.
When administering this medication to children, exercise caution, as they may be at a higher risk of developing certain side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform 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.
Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Do not abruptly discontinue this medication, as this may increase your risk of experiencing side effects, including hallucinations (perceiving things that are not present), seizures, high fever, stiff muscles, and confusion. In rare cases, sudden discontinuation can lead to organ problems and even death. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the medication. If you experience any new or worsening symptoms, discuss them with your doctor.
When administering this medication to children, exercise caution, as they may be at a higher risk of developing certain side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform 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.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or coma
- Respiratory depression (slow, shallow breathing)
- Hypotension (low blood pressure)
- Bradycardia (slow heart rate)
- Hypothermia
- Seizures
- Muscle hypotonia (flaccid muscles)
- Absent reflexes
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including airway management, respiratory support, and maintaining cardiovascular function. There is no specific antidote.
Drug Interactions
Major Interactions
Moderate Interactions
- Tricyclic antidepressants: May potentiate muscle relaxant effects and increase risk of CNS depression.
- Lithium: May exacerbate hyperkinetic movements and increase risk of neurotoxicity.
- Gabapentin: Increased risk of CNS depression and respiratory depression.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: Baclofen is primarily renally excreted; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation
Spasticity assessment (e.g., Ashworth Scale)
Rationale: To establish baseline severity and monitor therapeutic response.
Timing: Prior to initiation
Routine Monitoring
Therapeutic response (reduction in spasticity, improved function)
Frequency: Regularly during dose titration and periodically thereafter
Target: Individualized
Action Threshold: Lack of efficacy or excessive adverse effects warrant dose adjustment or discontinuation.
Adverse effects (e.g., drowsiness, dizziness, weakness, nausea)
Frequency: Regularly, especially during dose titration
Target: Minimal to none
Action Threshold: Persistent or severe adverse effects warrant dose reduction or discontinuation.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in patients with pre-existing renal impairment or elderly patients.
Target: Within normal limits or stable for patient
Action Threshold: Significant decline in renal function may necessitate dose adjustment.
Symptom Monitoring
- Drowsiness
- Dizziness
- Weakness
- Nausea
- Confusion
- Fatigue
- Headache
- Insomnia
- Withdrawal symptoms (e.g., hallucinations, seizures, rebound spasticity) if abruptly discontinued.
Special Patient Groups
Pregnancy
Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show increased incidence of omphaloceles (ventral hernias) and incomplete sternal ossification.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data; potential for neonatal withdrawal symptoms if used near term.
Lactation
Considered generally safe. Baclofen is excreted into breast milk in small amounts. Monitor infant for sedation or poor feeding.
Infant Risk:
Low
Pediatric Use
Use with caution and careful dose titration. Safety and efficacy in children under 12 years have not been fully established, but it is commonly used off-label for spasticity in cerebral palsy and other conditions. Start with low doses and titrate slowly.
Geriatric Use
Elderly patients may be more sensitive to the effects of baclofen and may experience increased drowsiness, dizziness, and confusion. Start with lower doses and titrate slowly. Monitor renal function closely.
Clinical Information
Clinical Pearls
- Baclofen should be tapered slowly over 1-2 weeks to avoid withdrawal symptoms (e.g., hallucinations, seizures, rebound spasticity).
- Patients should be warned about the potential for CNS depression (drowsiness, dizziness) and advised to avoid activities requiring mental alertness.
- Renal impairment significantly impacts baclofen clearance; dose adjustments are crucial.
- Often used in combination with physical therapy and other modalities for spasticity management.
- Oral baclofen is not effective for spasticity of cerebral origin in all patients.
Alternative Therapies
- Tizanidine (Zanaflex)
- Dantrolene (Dantrium)
- Diazepam (Valium)
- Botulinum toxin injections (e.g., Botox, Myobloc, Dysport)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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.