Baclofen 15mg 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, Antispastic
Pharmacologic Class
GABA-B Receptor Agonist
Pregnancy Category
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.
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 dizziness.
- Take baclofen with food or milk if it causes stomach upset.
- Do not stop taking baclofen suddenly, as this can lead to serious withdrawal symptoms. Your doctor will tell you how to slowly reduce your dose if needed.
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:
10 mg three times daily, titrated
Dose Range:
5 - 80 mg
Condition-Specific Dosing:
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. Further increases may be made cautiously up to a maximum of 80 mg per day (20 mg four times daily).
maintenance:
Typically 30-80 mg/day in 3-4 divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age for spasticity resulting from multiple sclerosis. For other spasticity, careful titration is required, often starting at 0.3 mg/kg/day in 4 divided doses, increasing every 3 days. Max 40 mg/day for children <8 years, 60 mg/day for children >8 years.
Adolescent:
Similar to adult dosing, but with careful titration based on response and tolerability.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor for increased adverse effects.
Moderate:
Reduce initial dose by 50% or more; titrate slowly. Monitor closely for adverse effects.
Severe:
Contraindicated or use with extreme caution at significantly reduced doses (e.g., 5 mg once daily or every other day). Avoid in end-stage renal disease (ESRD) unless benefits clearly outweigh risks and patient can be closely monitored.
Dialysis:
Baclofen is not significantly removed by hemodialysis. Avoid or use with extreme caution at significantly reduced doses. Monitor for signs of toxicity.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, but use with caution due to potential for altered drug metabolism or excretion in severe cases.
Severe:
No specific adjustment recommended, but use with caution due to potential for altered drug metabolism or excretion in severe cases.
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 mono- and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of afferent terminals and inhibition of both excitatory and inhibitory neurotransmission. This action reduces the release of excitatory neurotransmitters, leading to a reduction in muscle spasticity.
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:
Limited, but sufficient to produce therapeutic effects. Higher concentrations are achieved in the spinal cord than in the brain.
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (70-80% unchanged drug), with a small amount excreted in feces.
Unchanged:
70-80%
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
3-4 hours
DurationOfAction:
4-6 hours
Safety & Warnings
Side Effects
Serious 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 output
+ Changes in urination frequency
+ Blood in the urine
Swelling in the arms or legs
Difficulty controlling body movements, twitching, or changes in balance
Trouble 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 are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
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.
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 output
+ Changes in urination frequency
+ Blood in the urine
Swelling in the arms or legs
Difficulty controlling body movements, twitching, or changes in balance
Trouble 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 are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
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 dizziness
- Confusion or hallucinations
- Difficulty breathing
- Seizures
- Unusual muscle weakness or limpness
- Signs of 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 your full attention, such as driving, wait until you understand how this drug affects you.
To ensure your safety, discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor before consumption.
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 cessation can lead to organ problems and even death. If you need to stop taking this drug, your doctor will provide guidance on how to gradually taper off the medication. If you experience any new or worsening symptoms, consult your doctor promptly.
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, planning to become pregnant, or are breastfeeding, inform your doctor, as they 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.
To ensure your safety, discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor before consumption.
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 cessation can lead to organ problems and even death. If you need to stop taking this drug, your doctor will provide guidance on how to gradually taper off the medication. If you experience any new or worsening symptoms, consult your doctor promptly.
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, planning to become pregnant, or are breastfeeding, inform your doctor, as they 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)
- 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
- MAO inhibitors: Caution advised, as severe CNS depression or hypotension may occur.
- Gabapentin: Increased risk of CNS depression and respiratory depression.
- Tricyclic antidepressants: May potentiate muscle weakness.
Monitoring
Baseline Monitoring
Spasticity assessment (e.g., Ashworth Scale)
Rationale: To establish baseline severity and guide dose titration.
Timing: Prior to initiation of therapy.
Renal function (BUN, creatinine)
Rationale: Baclofen is primarily renally excreted; impairment requires dose adjustment.
Timing: Prior to initiation of therapy, especially in elderly or those with suspected renal impairment.
Routine Monitoring
Spasticity symptoms and functional improvement
Frequency: Regularly during dose titration, then periodically (e.g., monthly to quarterly) during maintenance.
Target: Reduction in spasticity, improved function, reduced pain.
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., sedation, dizziness, weakness, nausea)
Frequency: Regularly, especially during dose titration and with any dose change.
Target: Minimal to tolerable side effects.
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in patients with pre-existing renal impairment or those at risk.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant decline in renal function may necessitate dose reduction.
Symptom Monitoring
- Drowsiness
- Dizziness
- Weakness
- Nausea
- Confusion
- Headache
- Insomnia
- Fatigue
- Hypotension
Special Patient Groups
Pregnancy
Baclofen is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential for developmental abnormalities observed in animal studies at high doses. Use only if clearly needed.
Second Trimester:
Risk generally considered similar to first trimester. Monitor for fetal growth.
Third Trimester:
Risk generally considered similar to first trimester. 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 the infant for sedation or poor feeding.
Infant Risk:
Low risk. Monitor for drowsiness, poor feeding, or unusual lethargy in the infant.
Pediatric Use
Not recommended for children under 12 years of age for spasticity resulting from multiple sclerosis. For other spasticity, use with caution and careful titration. Children may be more sensitive to CNS depressant effects.
Geriatric Use
Elderly patients may be more sensitive to the effects of baclofen, particularly CNS depression (drowsiness, dizziness, confusion) and hypotension. Renal function often declines with age, necessitating lower initial doses and slower titration. Start low and go slow.
Clinical Information
Clinical Pearls
- Always taper baclofen slowly over 1-2 weeks (or longer) to avoid severe withdrawal symptoms, which can include hallucinations, seizures, rebound spasticity, and rhabdomyolysis.
- Take with food or milk to minimize gastrointestinal upset.
- Patients should be warned about the potential for drowsiness and dizziness, especially at the start of therapy or with dose increases.
- Monitor for changes in mood or behavior, as baclofen can rarely cause psychiatric disturbances.
- Consider alternative therapies or lower doses in patients with significant renal impairment.
Alternative Therapies
- Tizanidine (Zanaflex)
- Cyclobenzaprine (Flexeril)
- Dantrolene (Dantrium)
- Diazepam (Valium)
- Botulinum toxin injections (e.g., Botox, Myobloc)
- Physical therapy
- Occupational therapy
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (15mg)
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 details. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 information about the medication taken, the amount, and the time it happened.