Baclofen 25mg/5ml Oral Susp 300ml
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 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 your spinal cord.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely.
When taking a liquid dose, measure it accurately using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool. Avoid using household teaspoons or tablespoons, as this can lead to an incorrect dose and potentially harmful effects.
Before using the medication, shake the container well. If you have a feeding tube, check with your doctor or pharmacist to see if your specific brand of medication can be used with a feeding tube. If it can, take the medication as directed and flush the feeding tube afterwards.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas prone to moisture. Discard any unused portion of the medication 2 months after opening the container. Keep all medications in a safe and secure location, out of the reach of children and pets.
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 adverse effects.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely.
When taking a liquid dose, measure it accurately using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool. Avoid using household teaspoons or tablespoons, as this can lead to an incorrect dose and potentially harmful effects.
Before using the medication, shake the container well. If you have a feeding tube, check with your doctor or pharmacist to see if your specific brand of medication can be used with a feeding tube. If it can, take the medication as directed and flush the feeding tube afterwards.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas prone to moisture. Discard any unused portion of the medication 2 months after opening the container. Keep all medications in a safe and secure location, out of the reach of children and pets.
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 adverse effects.
Lifestyle & Tips
- Avoid driving or operating heavy machinery until you know how baclofen affects you, as it can cause drowsiness or dizziness.
- Avoid alcohol and other medications that cause drowsiness, as this can worsen side effects.
- 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.
- Take baclofen with food or milk if it upsets your stomach.
- Report any new or worsening side effects to 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:
5 mg orally three times daily, titrated slowly
Dose Range:
5 - 80 mg
Condition-Specific Dosing:
spasticity:
Initial dose 5 mg three times daily. May increase by 5 mg increments every 3 days to a maximum of 80 mg/day (20 mg four times daily). Some patients may require 100-120 mg/day, but doses above 80 mg/day should be used with caution.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial dose 0.3 mg/kg/day in 4 divided doses. May increase every 3 days. Max 40 mg/day for children <8 years; Max 60 mg/day for children >8 years (or 2 mg/kg/day, whichever is less).
Adolescent:
Initial dose 5 mg three times daily. May increase by 5 mg increments every 3 days to a maximum of 80 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
Reduce dose by 50% or extend dosing interval.
Moderate:
Reduce dose by 50% or extend dosing interval.
Severe:
Contraindicated or use with extreme caution; significant dose reduction (e.g., 5 mg once daily or every other day) required.
Dialysis:
Baclofen is dialyzable, but clearance is slow. Administer after dialysis. Significant dose reduction required (e.g., 5 mg every 2-3 days).
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Baclofen is a centrally acting skeletal muscle relaxant. It acts as an agonist at GABA-B receptors within the spinal cord, leading to hyperpolarization of afferent terminals and presynaptic inhibition of both monosynaptic and polysynaptic reflexes. This action reduces the release of excitatory neurotransmitters, thereby decreasing muscle spasticity and associated pain.
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 exert therapeutic effects.
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (70-80% unchanged), remainder via feces.
Unchanged:
70-80%
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours
Safety & Warnings
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
Vision changes
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 are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness, drowsiness, fatigue, 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, 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
Vision changes
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 are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness, drowsiness, fatigue, 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, 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 dizziness
- Extreme muscle weakness
- Difficulty breathing
- Confusion or hallucinations
- Seizures
- Fever
- Unusual thoughts or behavior
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All existing health problems, as these may impact the safety and effectiveness of this medication.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All existing health problems, as these may impact the safety and effectiveness of this medication.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to 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 beforehand.
Do not abruptly discontinue this medication, as this may increase your risk of experiencing side effects. These side effects can include hallucinations (perceiving things that are not present), seizures, high fever, muscle stiffness, and confusion. In rare cases, stopping this medication suddenly can lead to organ damage and even death. If you need to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage. Be sure to consult your doctor if you experience any new or worsening symptoms.
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, it is vital to discuss the potential benefits and risks of this medication with your doctor. Taking this medication during pregnancy may cause withdrawal symptoms in the newborn.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to 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 beforehand.
Do not abruptly discontinue this medication, as this may increase your risk of experiencing side effects. These side effects can include hallucinations (perceiving things that are not present), seizures, high fever, muscle stiffness, and confusion. In rare cases, stopping this medication suddenly can lead to organ damage and even death. If you need to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage. Be sure to consult your doctor if you experience any new or worsening symptoms.
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, it is vital to discuss the potential benefits and risks of this medication with your doctor. Taking this medication during pregnancy may cause withdrawal symptoms in the newborn.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or unconsciousness
- Respiratory depression (slow, shallow breathing)
- Coma
- Seizures
- Hypotension (low blood pressure)
- Hypothermia
- Absent reflexes
- Muscle hypotonia (flaccid muscles)
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is supportive, including maintaining airway, breathing, and circulation. There is no specific antidote.
Drug Interactions
Major Interactions
Moderate Interactions
- Tricyclic Antidepressants (TCAs): May potentiate the muscle relaxant effect of baclofen, leading to increased weakness.
- Lithium: May exacerbate hyperkinetic symptoms and dyskinesia.
- Gabapentin: Increased risk of CNS depression and respiratory depression.
Minor Interactions
- NSAIDs: No significant interaction reported, but caution with renal impairment.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: Baclofen is primarily renally excreted; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation of therapy.
Spasticity assessment (e.g., Ashworth Scale)
Rationale: To establish baseline severity and monitor therapeutic response.
Timing: Prior to initiation of therapy.
Neurological assessment (e.g., level of consciousness, motor function)
Rationale: To assess baseline neurological status and identify potential contraindications or risks.
Timing: Prior to initiation of therapy.
Routine Monitoring
Therapeutic response (reduction in spasticity, pain, improved function)
Frequency: Regularly during dose titration and periodically thereafter.
Target: Individualized improvement in symptoms.
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (e.g., sedation, dizziness, weakness, nausea)
Frequency: Regularly, especially during dose titration.
Target: Minimal to tolerable adverse effects.
Action Threshold: Significant or intolerable adverse effects may require dose reduction or discontinuation.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in patients with pre-existing renal impairment or those on long-term therapy.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant decline in renal function requires dose adjustment.
Symptom Monitoring
- Drowsiness
- Dizziness
- Weakness
- Nausea
- Confusion
- Headache
- Insomnia
- Fatigue
- Hypotension
- Urinary frequency/retention
- Constipation
- Withdrawal symptoms (if abruptly discontinued): hallucinations, seizures, rebound spasticity, hyperthermia, rhabdomyolysis
Special Patient Groups
Pregnancy
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; potential for fetal exposure.
Third Trimester:
Limited human data; potential for neonatal withdrawal symptoms if used close to term.
Lactation
Baclofen is excreted into breast milk in small amounts. Use with caution. Monitor breastfed infants for sedation, poor feeding, or unusual behavior.
Infant Risk:
Low risk, but monitor for drowsiness or poor feeding.
Pediatric Use
Safety and efficacy are not fully established for all pediatric age groups, especially infants and neonates. Dosing must be carefully titrated based on weight and response. Increased sensitivity to adverse effects may occur.
Geriatric Use
Elderly patients may be more sensitive to the effects of baclofen, particularly CNS adverse effects (e.g., sedation, confusion, dizziness). Start with lower doses and titrate slowly. Monitor renal function closely.
Clinical Information
Clinical Pearls
- Baclofen should always be tapered slowly over 1-2 weeks to avoid severe withdrawal symptoms, including hallucinations, seizures, rebound spasticity, and hyperthermia.
- It is generally more effective for spasticity of spinal origin (e.g., multiple sclerosis, spinal cord injury) than for cerebral origin (e.g., stroke, cerebral palsy), though it may still be used off-label for the latter.
- Patients with epilepsy should be monitored closely as baclofen may lower the seizure threshold.
- Oral baclofen is not indicated for the treatment of muscle spasms resulting from rheumatic disorders or trauma.
- The oral suspension form is useful for patients who have difficulty swallowing tablets or require precise dose adjustments.
Alternative Therapies
- Tizanidine (Zanaflex)
- Cyclobenzaprine (Flexeril)
- Dantrolene (Dantrium)
- Diazepam (Valium)
- Botulinum toxin injections (e.g., Botox, Myobloc, Dysport)
- Physical therapy
- Occupational therapy
Cost & Coverage
Average Cost:
$50 - $150 per 300ml (25mg/5ml)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.