Baclofen 25mg/5ml Oral Susp 250ml
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
GABA-B Receptor Agonist
Pregnancy Category
C
FDA Approved
Mar 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 Correctly
To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using household teaspoons or tablespoons, as this can lead to taking too high a dose.
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 it. 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. After opening, discard any unused portion after 2 months. Keep all medications in a safe 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using household teaspoons or tablespoons, as this can lead to taking too high a dose.
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 it. 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. After opening, discard any unused portion after 2 months. Keep all medications in a safe 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid driving or operating heavy machinery until you know how baclofen affects you, as it can cause drowsiness and dizziness.
- Avoid alcohol and other CNS depressants, as they can increase the sedative effects of baclofen.
- 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 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 orally three times daily, titrate slowly
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 (20 mg four times daily).
Pediatric Dosing
Neonatal:
Not established, generally avoided due to lack of safety and efficacy data.
Infant:
Not established, generally avoided due to lack of safety and efficacy data.
Child:
Initial 10-15 mg/day in 3 divided doses. Titrate slowly every 3 days by 5-15 mg/day. Max 40 mg/day for children 2-7 years; Max 60 mg/day for children âĨ8 years.
Adolescent:
Initial 5 mg orally three times daily, titrate slowly as per adult dosing, up to 80 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
Consider dose reduction, monitor for adverse effects.
Moderate:
Reduce initial dose by 50% and titrate cautiously. Monitor closely for CNS effects.
Severe:
Avoid use if possible. If necessary, use very low doses (e.g., 5 mg once daily) and monitor closely. Baclofen is primarily renally excreted.
Dialysis:
Not effectively removed by hemodialysis. Avoid or use with extreme caution at very low doses (e.g., 5 mg every 2-3 days) and monitor for toxicity.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended as baclofen is minimally metabolized by the liver.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Baclofen acts as a gamma-aminobutyric acid (GABA) analogue and is a potent GABA-B receptor agonist. It exerts its effects primarily at the spinal cord level, where it inhibits both monosynaptic and polysynaptic reflexes. This is achieved by hyperpolarization of afferent terminals, leading to presynaptic inhibition of excitatory neurotransmitter release. It may also have some supraspinal effects.
Pharmacokinetics
Absorption:
Bioavailability:
70-85%
Tmax:
2-3 hours
FoodEffect:
Food does not significantly affect the extent of absorption, but may reduce gastrointestinal upset.
Distribution:
Vd:
0.7 L/kg
ProteinBinding:
Approximately 30%
CnssPenetration:
Yes
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (70-80% unchanged)
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
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 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 experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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 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 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 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 experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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 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
- Extreme muscle weakness
- Difficulty breathing
- Confusion or hallucinations
- Seizures (especially if abruptly stopped)
- Changes in heart rate or blood pressure
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 is crucial to avoid 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 vital to verify that it is safe to take this medication with all your current 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 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 is crucial to avoid 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 vital to verify that it is safe to take this medication with all your current 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 operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is 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, 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, your doctor will provide guidance on how to gradually taper off the dosage. If you experience any new or worsening symptoms, consult 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 breastfeeding, inform your doctor. It is necessary 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.
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 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, 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, your doctor will provide guidance on how to gradually taper off the dosage. If you experience any new or worsening symptoms, consult 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 breastfeeding, inform your doctor. It is necessary 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:
- Severe drowsiness or coma
- Respiratory depression (slow, shallow breathing)
- Hypotension (low blood pressure)
- Bradycardia (slow heart rate)
- Hypothermia
- Seizures
- Absent reflexes
- Muscle hypotonia
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
- Antihypertensives: May enhance hypotensive effects.
- Lithium: May exacerbate hyperkinetic movements and symptoms of lithium toxicity.
- Tricyclic antidepressants: May potentiate muscle relaxant effects and cause significant muscle hypotonia.
- MAOIs: Concurrent use may increase CNS depression.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: Baclofen is primarily renally excreted; impairment requires dose adjustment.
Timing: Prior to initiation of therapy.
Spasticity assessment (e.g., Ashworth Scale)
Rationale: To establish baseline severity and monitor treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Spasticity and muscle tone
Frequency: Regularly during dose titration and periodically thereafter.
Target: Reduction in spasticity symptoms without excessive weakness.
Action Threshold: If spasticity is uncontrolled or excessive weakness/sedation occurs, adjust dose.
Adverse effects (e.g., sedation, dizziness, confusion, weakness)
Frequency: Regularly, especially during dose titration.
Target: Minimal to no adverse effects.
Action Threshold: If significant or intolerable adverse effects occur, reduce dose or discontinue.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in elderly patients or those with pre-existing renal impairment.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: If renal function declines, consider dose reduction.
Symptom Monitoring
- Drowsiness
- Dizziness
- Weakness
- Nausea
- Confusion
- Headache
- Insomnia
- Fatigue
- Hypotension
Special Patient Groups
Pregnancy
Use 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, though human data are limited and conflicting.
Second Trimester:
Limited data, monitor for fetal growth and well-being.
Third Trimester:
Potential for neonatal withdrawal symptoms (e.g., seizures, hypertonia, tremors) if used close to term.
Lactation
Baclofen is excreted in breast milk in small amounts. Use with caution. Monitor the infant for signs of sedation (e.g., lethargy, poor feeding).
Infant Risk:
Low risk, but monitor for sedation.
Pediatric Use
Safety and efficacy have not been fully established in children under 2 years of age. Use with caution and careful titration in children over 2 years. Children may be more sensitive to CNS effects.
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to CNS effects (sedation, confusion) and a higher likelihood of impaired renal function. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Abrupt discontinuation of baclofen can lead to severe withdrawal symptoms, including hallucinations, seizures, rebound spasticity, and rhabdomyolysis. Always taper the dose slowly over 1-2 weeks.
- Baclofen is generally more effective for spasticity of spinal origin (e.g., multiple sclerosis, spinal cord injury) than for spasticity of cerebral origin (e.g., stroke, cerebral palsy).
- Patients should be warned about the potential for drowsiness and dizziness, and advised to avoid activities requiring mental alertness until effects are known.
- Oral baclofen is not indicated for the treatment of muscle spasms resulting from rheumatic disorders or for stroke-related spasticity.
Alternative Therapies
- Tizanidine (another alpha-2 adrenergic agonist)
- Cyclobenzaprine (tricyclic antidepressant derivative)
- Dantrolene (direct-acting skeletal muscle relaxant)
- Carisoprodol (metabolized to meprobamate, Schedule IV)
- Methocarbamol
- Metaxalone
- Botulinum toxin injections (for focal spasticity)
- Physical therapy
- Occupational therapy
Cost & Coverage
Average Cost:
Relatively inexpensive per 250ml bottle
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 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'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 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 details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.