Baclofen 5mg 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
Pharmacologic Class
Centrally Acting Skeletal Muscle Relaxant; Gamma-aminobutyric acid (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 acting on the nervous system to reduce the overactivity of nerves that cause muscle tightness.
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.
What to Do If You Miss 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.
What to Do If You Miss 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 alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they can increase drowsiness and dizziness.
- Do not drive or operate heavy machinery until you know how baclofen affects you, as it can cause drowsiness and impair coordination.
- 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:
Initial: 5 mg three times daily; Titrate: Increase by 5 mg per dose every 3 days as needed
Dose Range:
5 - 80 mg
Condition-Specific Dosing:
Spasticity:
Initial: 5 mg 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 (20 mg four times daily).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for oral tablets in general spasticity; however, used off-label for severe spasticity (e.g., cerebral palsy, spinal cord injury) with careful titration. Typical starting dose 0.3 mg/kg/day in 4 divided doses, titrated up to 1.5-2 mg/kg/day (max 40-60 mg/day).
Adolescent:
Not established; generally follow adult dosing with caution.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor for increased adverse effects.
Moderate:
Reduce dose by 50% or extend dosing interval. Monitor closely for adverse effects.
Severe:
Contraindicated or significantly reduced dose (e.g., 5 mg once daily or every other day). Use with extreme caution. Avoid if possible.
Dialysis:
Baclofen is dialyzable. Administer dose after dialysis. Significant dose reduction required (e.g., 5 mg once daily or every other day).
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended; use with caution due to potential for increased CNS effects.
Severe:
No specific adjustment recommended; use with caution due to potential for increased CNS effects.
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 both excitatory and inhibitory neurotransmitter release. This action reduces the release of excitatory amino acids, leading to decreased muscle spasticity.
Pharmacokinetics
Absorption:
Bioavailability:
70-85%
Tmax:
2-3 hours
FoodEffect:
Food does not significantly affect absorption, but may delay Tmax.
Distribution:
Vd:
0.7 L/kg
ProteinBinding:
Approximately 30%
CnssPenetration:
Limited (low lipid solubility), but sufficient to exert therapeutic effects.
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Primarily renal (70-80% unchanged)
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 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 behavior changes
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance or eyesight
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 only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness, drowsiness, tiredness, or weakness
Sleep disturbances
Upset stomach or vomiting
Headache
* Constipation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 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 behavior changes
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance or eyesight
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 only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness, drowsiness, tiredness, or weakness
Sleep disturbances
Upset stomach or vomiting
Headache
* Constipation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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
- Seizures
- Severe muscle weakness
- Rebound spasticity (if abruptly discontinued)
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Be sure to discuss all your medications and health problems with both your doctor and pharmacist to ensure safe and effective treatment.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Be sure to discuss all your medications and health problems with both your doctor and pharmacist to ensure safe and effective treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this medication affects you.
Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may impair your reactions, 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, muscle stiffness, and confusion. In rare cases, this can lead to organ damage and even death. If you need to stop taking this medication, do so gradually under the guidance of your doctor. If you experience 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 experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby. Taking this medication 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 impair your reactions, 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, muscle stiffness, and confusion. In rare cases, this can lead to organ damage and even death. If you need to stop taking this medication, do so gradually under the guidance of your doctor. If you experience 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 experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby. Taking this medication during pregnancy may cause withdrawal symptoms in the newborn.
Overdose Information
Overdose Symptoms:
- Profound drowsiness or coma
- Respiratory depression (slow, shallow breathing)
- Seizures
- Hypotension (low blood pressure)
- Hypothermia
- 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 maintaining airway, breathing, and circulation. There is no specific antidote.
Drug Interactions
Major Interactions
Moderate Interactions
- Tricyclic Antidepressants (TCAs): May potentiate muscle weakness.
- Monoamine Oxidase Inhibitors (MAOIs): Concurrent use may increase CNS depression and hypotensive effects (though less common with baclofen than other muscle relaxants, caution advised).
- Levodopa/Carbidopa: May exacerbate dyskinesia and hallucinations in Parkinson's patients.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: Baclofen is primarily renally excreted; impairment requires dose adjustment.
Timing: Prior to initiation
Spasticity assessment (e.g., Ashworth Scale)
Rationale: To establish baseline severity and monitor treatment efficacy.
Timing: Prior to initiation
Routine Monitoring
Efficacy (reduction in spasticity, improved function)
Frequency: Regularly during titration and periodically thereafter
Target: Individualized
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (drowsiness, dizziness, weakness, confusion, nausea)
Frequency: Regularly, especially during titration
Target: Minimal to none
Action Threshold: Significant or intolerable adverse effects may require dose reduction or discontinuation.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in elderly or those with pre-existing renal impairment
Target: Within normal limits or stable
Action Threshold: Worsening renal function may necessitate dose adjustment.
Symptom Monitoring
- Drowsiness
- Dizziness
- Weakness
- Fatigue
- Nausea
- Confusion
- Headache
- Insomnia
- Hypotension
- Urinary frequency/retention
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for developmental abnormalities based on animal data; human data limited.
Second Trimester:
Limited human data; generally avoid unless clearly needed.
Third Trimester:
Limited human data; potential for neonatal withdrawal symptoms if used close to delivery.
Lactation
Baclofen is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor infant for sedation or poor feeding.
Infant Risk:
Low risk (L3). Monitor for drowsiness, poor feeding, or unusual behavior.
Pediatric Use
Safety and efficacy in children under 12 years have not been established for oral tablets in general spasticity, though it is used off-label for severe spasticity (e.g., cerebral palsy, spinal cord injury) with careful titration and monitoring. Children may be more susceptible to adverse effects.
Geriatric Use
Elderly patients may be more sensitive to the effects of baclofen, particularly CNS adverse effects (drowsiness, confusion, dizziness). Start with lower doses and titrate slowly. Renal function should be carefully monitored as it declines with age.
Clinical Information
Clinical Pearls
- Always titrate baclofen slowly to minimize adverse effects and find the lowest effective dose.
- Never discontinue baclofen abruptly, especially after prolonged use or high doses, due to the risk of severe withdrawal symptoms (e.g., hallucinations, seizures, rebound spasticity). Taper gradually over 1-2 weeks.
- Caution patients about additive CNS depression when combining baclofen with alcohol or other sedating medications.
- Monitor renal function, especially in elderly patients or those with kidney impairment, as baclofen is primarily renally excreted.
- Baclofen is generally more effective for spasticity of spinal origin than for cerebral origin, though it is used for both.
- Consider the patient's functional goals; sometimes a degree of spasticity is necessary for ambulation or posture.
Alternative Therapies
- Tizanidine (Zanaflex)
- Diazepam (Valium)
- Dantrolene (Dantrium)
- Cyclobenzaprine (Flexeril)
- Methocarbamol (Robaxin)
- Botulinum toxin injections (for focal spasticity)
- Physical therapy
- Occupational therapy
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.