Cyclobenzaprine 30mg ER Capsules
It is used to relax muscles.
Drug Class
Skeletal Muscle Relaxant
Pharmacologic Class
Centrally Acting Skeletal Muscle Relaxant; Tricyclic Antidepressant Derivative
Pregnancy Category
Category B
FDA Approved
Feb 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cyclobenzaprine extended-release capsules are a medicine used for short-term relief of muscle spasms, often along with rest and physical therapy. It works by acting on the brain to help relax muscles and reduce pain.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and try to take it at the same time every day. Swallow the capsule whole - do not chew or crush it. If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but be sure to swallow the mixture immediately without chewing. After taking your dose, rinse your mouth to ensure you've swallowed all of the medication. If you've opened a capsule and don't use the entire contents, discard the leftover portion.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, away from the bathroom. Store all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about how to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and try to take it at the same time every day. Swallow the capsule whole - do not chew or crush it. If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but be sure to swallow the mixture immediately without chewing. After taking your dose, rinse your mouth to ensure you've swallowed all of the medication. If you've opened a capsule and don't use the entire contents, discard the leftover portion.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, away from the bathroom. Store all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about how to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Avoid alcohol and other medications that cause drowsiness (e.g., sedatives, tranquilizers, opioids) while taking this medication, as it can increase drowsiness and dizziness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can impair your ability to perform these tasks safely.
- Take the capsule whole; do not crush, chew, or open the extended-release capsule, as this can lead to rapid release of the drug and increased side effects.
- This medication is typically used for short periods (usually 2-3 weeks) for acute muscle spasms, not for long-term use.
- To help with dry mouth, chew sugarless gum, suck on hard candy, or use saliva substitutes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
15 mg or 30 mg once daily
Dose Range:
15 - 30 mg
Condition-Specific Dosing:
acute_muscle_spasm:
15 mg once daily, may increase to 30 mg once daily based on individual patient response. Maximum recommended dose is 30 mg once daily. Use for short periods (up to 2-3 weeks).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in patients under 18 years of age for ER formulation)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, use with caution
Moderate:
No specific adjustment, use with caution
Severe:
No specific adjustment, use with caution (potential for accumulation of renally excreted metabolites, though parent drug is primarily hepatic metabolism)
Dialysis:
Not available (Cyclobenzaprine is highly protein bound and extensively metabolized, unlikely to be significantly removed by dialysis)
Hepatic Impairment:
Mild:
Use with caution, consider lower dose (e.g., 15 mg once daily)
Moderate:
Contraindicated
Severe:
Contraindicated
Pharmacology
Mechanism of Action
Cyclobenzaprine acts in the central nervous system at the brain stem level to reduce tonic somatic motor activity, influencing both alpha and gamma motor systems. It is structurally and pharmacologically related to tricyclic antidepressants. It does not directly act on the neuromuscular junction or directly on skeletal muscles.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50% (for IR, ER formulation designed for sustained release)
Tmax:
7-8 hours (for ER)
FoodEffect:
Food increases bioavailability and Tmax slightly, but not clinically significant; can be taken with or without food.
Distribution:
Vd:
Approximately 1000 L
ProteinBinding:
>90%
CnssPenetration:
Yes
Elimination:
HalfLife:
32-33 hours (range 25-40 hours for ER)
Clearance:
Not available (primarily hepatic metabolism)
ExcretionRoute:
Primarily renal (as metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour (for IR, ER onset is slower due to sustained release)
PeakEffect:
3-8 hours (for ER)
DurationOfAction:
12-24 hours (for ER)
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, which may include:
+ 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
Fast or abnormal heartbeat
Serotonin syndrome, a severe and potentially deadly condition that may occur when taking this medication with certain other drugs. Warning signs include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach
+ Vomiting
+ Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
* Upset stomach
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.
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, which may include:
+ 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
Fast or abnormal heartbeat
Serotonin syndrome, a severe and potentially deadly condition that may occur when taking this medication with certain other drugs. Warning signs include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach
+ Vomiting
+ Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
* Upset stomach
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 dizziness or fainting
- Confusion, hallucinations, or unusual thoughts/behavior
- Fast, pounding, or irregular heartbeat
- Chest pain or shortness of breath
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Signs of serotonin syndrome (e.g., agitation, restlessness, rapid heart rate, sweating, muscle stiffness, twitching, fever, nausea, vomiting, diarrhea)
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.
Certain health conditions, including:
+ Abnormal heart rhythms or heart block
+ Heart failure (a weakened heart)
+ Liver disease
+ An overactive thyroid gland
If you have recently had a heart attack
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
* If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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.
Certain health conditions, including:
+ Abnormal heart rhythms or heart block
+ Heart failure (a weakened heart)
+ Liver disease
+ An overactive thyroid gland
If you have recently had a heart attack
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
* If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you.
To minimize the risk of dehydration, be mindful of your fluid intake, especially in hot weather or during physical activity. Drinking plenty of fluids can help prevent fluid loss.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
Adhere to your doctor's prescribed treatment duration and do not take this medication for longer than recommended.
This medication is typically used in conjunction with rest, physical therapy, pain management medications, and other therapies to achieve optimal results.
If you are 65 years or older, do not take this medication without first consulting your doctor to discuss potential risks and benefits.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you.
To minimize the risk of dehydration, be mindful of your fluid intake, especially in hot weather or during physical activity. Drinking plenty of fluids can help prevent fluid loss.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
Adhere to your doctor's prescribed treatment duration and do not take this medication for longer than recommended.
This medication is typically used in conjunction with rest, physical therapy, pain management medications, and other therapies to achieve optimal results.
If you are 65 years or older, do not take this medication without first consulting your doctor to discuss potential risks and benefits.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Rapid heartbeat (tachycardia)
- Low blood pressure (hypotension)
- Confusion
- Agitation
- Hallucinations
- Seizures
- Coma
- Cardiac arrest
What to Do:
In case of overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose management is symptomatic and supportive. An ECG should be performed and cardiac monitoring initiated. Gastric lavage and activated charcoal may be considered.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOIs due to risk of hyperpyretic crisis, convulsions, and death)
Major Interactions
- CNS Depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, other muscle relaxants): Additive CNS depressant effects (drowsiness, dizziness, impaired coordination).
- Anticholinergic Drugs (e.g., atropine, tricyclic antidepressants, some antihistamines): Additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, tramadol, triptans, St. John's Wort): Increased risk of serotonin syndrome.
- Tricyclic Antidepressants (TCAs): Additive anticholinergic and CNS depressant effects; potential for increased risk of arrhythmias.
Moderate Interactions
- CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase cyclobenzaprine plasma concentrations.
- CYP1A2 Inhibitors (e.g., cimetidine, fluvoxamine): May increase cyclobenzaprine plasma concentrations.
- CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine): May increase cyclobenzaprine plasma concentrations.
- CYP Inducers (e.g., carbamazepine, rifampin, phenytoin, phenobarbital): May decrease cyclobenzaprine plasma concentrations.
Minor Interactions
- Not specifically categorized as minor, but general caution with any drug that may cause drowsiness or anticholinergic effects.
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: Cyclobenzaprine is extensively metabolized by the liver; LFTs are important, especially in patients with suspected hepatic impairment or before initiating therapy in such patients.
Timing: Prior to initiation, if clinically indicated (e.g., history of liver disease).
Renal Function (CrCl)
Rationale: Although primarily hepatic metabolism, metabolites are renally excreted. Caution in severe renal impairment.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Effectiveness (muscle spasm relief)
Frequency: Daily/as needed
Target: Reduction in pain and muscle stiffness
Action Threshold: Lack of improvement after 2-3 weeks, consider discontinuing or alternative therapy.
CNS Depression (drowsiness, dizziness, confusion)
Frequency: Daily
Target: Minimal to no impairment
Action Threshold: Significant impairment, consider dose reduction or discontinuation.
Anticholinergic Effects (dry mouth, constipation, blurred vision, urinary retention)
Frequency: Daily
Target: Tolerable or absent
Action Threshold: Severe or intolerable symptoms, consider dose reduction or discontinuation.
Cardiovascular Effects (tachycardia, arrhythmias)
Frequency: As needed, if symptoms arise
Target: Normal heart rate and rhythm
Action Threshold: Persistent tachycardia, palpitations, or other arrhythmias, investigate and consider discontinuation.
Symptom Monitoring
- Drowsiness
- Dizziness
- Dry mouth
- Constipation
- Blurred vision
- Urinary retention
- Fatigue
- Nausea
- Headache
- Confusion
- Tachycardia
- Palpitations
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, shivering, twitching, muscle rigidity, loss of coordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies; human data limited.
Second Trimester:
No specific increased risk identified in animal studies; human data limited.
Third Trimester:
No specific increased risk identified in animal studies; human data limited. Consider potential for neonatal withdrawal symptoms if used close to delivery, though not well-documented for cyclobenzaprine.
Lactation
Cyclobenzaprine is excreted into breast milk. Caution is advised when administered to a nursing woman. The American Academy of Pediatrics considers it to be of unknown effect on the nursing infant but may be of concern. Infant risk is generally low for single doses, but prolonged use or high doses may cause sedation in the infant.
Infant Risk:
L3 (Moderately Safe - some evidence of risk, but benefits may outweigh)
Pediatric Use
Safety and efficacy of cyclobenzaprine extended-release capsules have not been established in pediatric patients under 18 years of age. Not recommended for this population.
Geriatric Use
Elderly patients (65 years and older) are more susceptible to adverse reactions, particularly CNS effects (drowsiness, dizziness, confusion) and anticholinergic effects (dry mouth, constipation, urinary retention, blurred vision). Increased risk of falls. Use with caution and consider starting with lower doses (e.g., 5 mg IR) if immediate release is used, or avoid ER formulation due to prolonged half-life. Cyclobenzaprine is on the Beers List as a potentially inappropriate medication in older adults due to its anticholinergic properties and risk of sedation.
Clinical Information
Clinical Pearls
- Cyclobenzaprine is intended for short-term use (typically 2-3 weeks) for acute, painful musculoskeletal conditions, not for chronic pain or spasticity due to cerebral or spinal cord disease.
- Due to its anticholinergic properties, it should be used with extreme caution or avoided in patients with narrow-angle glaucoma, urinary retention, or prostatic hypertrophy.
- Avoid in elderly patients due to increased risk of CNS depression, anticholinergic effects, and falls.
- Patients should be warned about the potential for additive CNS depression when used with alcohol or other CNS depressants.
- Educate patients on the signs and symptoms of serotonin syndrome, especially if they are taking other serotonergic medications.
Alternative Therapies
- Other skeletal muscle relaxants (e.g., tizanidine, carisoprodol, methocarbamol, metaxalone, baclofen, diazepam)
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
- Acetaminophen
- Physical therapy
- Heat/cold therapy
- Massage therapy
- Acupuncture
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
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 this 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 occurred.