Baclofen 5mg/5ml Solution
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; GABA-B 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 benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription 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 taking too much medication.
Storing and Disposing of Your Medication
Different brands of this medication have varying storage requirements. Some need to be refrigerated, while others can be stored at room temperature. Consult your pharmacist for specific storage instructions. Do not freeze your medication, and protect it from light exposure.
What to Do If You Miss a Dose
If you forget to take 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 to make up for the missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription 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 taking too much medication.
Storing and Disposing of Your Medication
Different brands of this medication have varying storage requirements. Some need to be refrigerated, while others can be stored at room temperature. Consult your pharmacist for specific storage instructions. Do not freeze your medication, and protect it from light exposure.
What to Do If You Miss a Dose
If you forget to take 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 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 or dizziness.
- Avoid alcohol and other medications that cause drowsiness (e.g., sedatives, pain medications) while taking baclofen, as this can increase side effects.
- Take baclofen with food or milk if it upsets your stomach.
- 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:
5 mg orally three times daily, titrated gradually
Dose Range:
5 - 80 mg
Condition-Specific Dosing:
spasticity:
Initial: 5 mg orally 3 times daily for 3 days; increase by 5 mg per dose every 3 days as needed. Max: 20 mg orally 3-4 times daily (total 80 mg/day).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial: 0.3 mg/kg/day orally 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 3 times daily for 3 days; increase by 5 mg per dose every 3 days as needed. Max: 20 mg orally 3-4 times daily (total 80 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor for increased adverse effects.
Moderate:
Reduce initial dose by 50% (e.g., 2.5 mg once daily or every other day); titrate cautiously. Monitor closely for CNS effects.
Severe:
Contraindicated or use with extreme caution at significantly reduced doses (e.g., 2.5 mg once daily or every other day). Monitor closely for CNS effects and accumulation.
Dialysis:
Baclofen is poorly dialyzable. Administer after dialysis. Significant dose reduction required; consider 2.5 mg every 2-3 days or as needed based on response and adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, as hepatic metabolism is minimal. Use with caution due to potential for altered drug sensitivity.
Severe:
No specific adjustment needed, as hepatic metabolism is minimal. Use with caution due to potential for altered drug sensitivity.
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, although the exact mechanism is not fully understood. This action reduces the release of excitatory neurotransmitters, leading to decreased 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:
Yes, but limited (CSF concentrations are about 12% of plasma concentrations)
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (70-80% unchanged drug)
Unchanged:
70-80%
Pharmacodynamics
OnsetOfAction:
0.5-1 hour
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours
Confidence:
Medium
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 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 frequency or volume
+ 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:
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, 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 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 frequency or volume
+ 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:
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, 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
- Extreme muscle weakness
- Difficulty breathing
- Confusion or hallucinations
- Seizures (especially if stopping abruptly)
- 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 information will help your doctor and pharmacist assess 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 dosage of any medication without first consulting 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 and pharmacist assess 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 dosage of any medication without first consulting your doctor.
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 impair your reactions, 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, stiff muscles, and confusion. In rare instances, stopping this medication suddenly can lead to organ problems and even death. If you need to stop taking this medication, it is vital to do so gradually, following the specific instructions provided by your doctor. 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 experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are 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 impair your reactions, 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, stiff muscles, and confusion. In rare instances, stopping this medication suddenly can lead to organ problems and even death. If you need to stop taking this medication, it is vital to do so gradually, following the specific instructions provided by your doctor. 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 experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are 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)
- 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
- CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics): Increased CNS depression (sedation, respiratory depression).
- Tricyclic antidepressants (TCAs): Potentiation of muscle relaxant effect, increased sedation.
- Monoamine Oxidase Inhibitors (MAOIs): Enhanced CNS depression and hypotensive effects (use with caution, avoid concurrent use if possible).
Moderate Interactions
- Antihypertensives: Additive hypotensive effects.
- Lithium: Exacerbation of dyskinesia and other neurological symptoms.
- Gabapentin: Increased risk of CNS depression and respiratory depression.
- Tizanidine: Increased risk of CNS depression and hypotension.
Minor Interactions
- Food: No significant interaction, but taking with food may reduce GI upset.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: Baclofen is primarily renally excreted; impairment can lead to accumulation and toxicity.
Timing: Prior to initiation of therapy.
Neurological assessment (spasticity, muscle tone, reflexes)
Rationale: To establish baseline severity of spasticity and guide dose titration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Effectiveness (reduction in spasticity, improved function)
Frequency: Regularly during dose titration and periodically thereafter.
Target: Individualized based on patient goals.
Action Threshold: If spasticity is not adequately controlled or if adverse effects outweigh benefits, consider dose adjustment or alternative therapy.
Adverse effects (drowsiness, dizziness, weakness, confusion, nausea)
Frequency: Regularly, especially during dose titration and with any dose change.
Target: Minimize occurrence.
Action Threshold: If severe or persistent, consider dose reduction or discontinuation.
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.
Action Threshold: If renal function declines, reduce baclofen dose.
Symptom Monitoring
- Drowsiness
- Dizziness
- Weakness
- Nausea
- Confusion
- Headache
- Insomnia
- Fatigue
- Hypotension
Special Patient Groups
Pregnancy
Category C. Use during pregnancy 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 observed in animal studies at high doses. Human data limited.
Second Trimester:
Limited human data. Risk generally considered low if clinically indicated.
Third Trimester:
Limited human data. Risk generally considered low if clinically indicated. Neonatal withdrawal symptoms (e.g., seizures, hypertonia) have been reported following in utero exposure to baclofen, particularly with high doses or abrupt maternal discontinuation.
Lactation
L3 (Moderately Safe). Baclofen is excreted into breast milk in small amounts. The amount ingested by the infant is generally low and unlikely to cause adverse effects, especially in full-term, healthy infants. Monitor infant for sedation or poor feeding.
Infant Risk:
Low risk of adverse effects in breastfed infants. Monitor for drowsiness, poor feeding, or unusual lethargy.
Pediatric Use
Used for spasticity in children with cerebral palsy or spinal cord injury. Dosing is weight-based and requires careful titration. Children may be more sensitive to CNS depressant effects.
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to CNS effects (drowsiness, dizziness, confusion) and a higher likelihood of age-related renal impairment, which can lead to drug accumulation. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Always taper baclofen slowly over 1-2 weeks to avoid severe withdrawal symptoms, which can include hallucinations, seizures, rebound spasticity, and rhabdomyolysis.
- Patients should be warned about the potential for drowsiness and dizziness, especially at the start of therapy or with dose increases.
- Taking baclofen with food can help minimize gastrointestinal upset.
- Baclofen is not effective for muscle spasms resulting from rheumatic disorders or stroke.
- Monitor renal function, especially in elderly patients or those with kidney disease, as baclofen is primarily renally excreted.
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:
Varies widely, typically low per 100 mL (5mg/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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.