Cyclobenzaprine 10mg Tablets
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
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cyclobenzaprine is a medication used to relax muscles and relieve pain and stiffness caused by muscle spasms. It works by acting on the brain and nervous system to help relax the muscles. It's usually prescribed for short-term use, typically for 2 to 3 weeks.
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.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of 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 have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and 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 extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of 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 have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and 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 extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Avoid alcohol and other medications that can cause drowsiness (e.g., sedatives, tranquilizers, opioids, some antihistamines) while taking cyclobenzaprine, as this can worsen side effects.
- Do not take for longer than prescribed (usually 2-3 weeks) as its effectiveness for long-term use is not established and the risk of side effects increases.
- Take with food if stomach upset occurs.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally three times daily
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
severe_spasm:
May increase to 10 mg orally three times daily, not to exceed 30 mg/day. Use for short periods (up to 2-3 weeks).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for children <15 years)
Adolescent:
Not established (Safety and efficacy not established for children <15 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
No specific adjustment recommended, but use with caution.
Severe:
No specific adjustment recommended, but use with caution.
Dialysis:
Not significantly dialyzable; use with caution.
Hepatic Impairment:
Mild:
Initiate with 5 mg once daily at bedtime, titrate slowly.
Moderate:
Initiate with 5 mg once daily at bedtime, titrate slowly.
Severe:
Not recommended due to increased plasma concentrations and prolonged half-life.
Pharmacology
Mechanism of Action
Cyclobenzaprine acts centrally, primarily at the brain stem, to reduce tonic somatic motor activity influencing both alpha and gamma motor systems. It is structurally related to tricyclic antidepressants and may exert its effect by inhibiting descending serotonergic and noradrenergic pathways. It does not directly act on the muscle or neuromuscular junction.
Pharmacokinetics
Absorption:
Bioavailability:
33-55%
Tmax:
1.5-8 hours (mean 4-6 hours)
FoodEffect:
Food increases bioavailability and peak plasma concentrations, and prolongs Tmax.
Distribution:
Vd:
10-30 L/kg
ProteinBinding:
93%
CnssPenetration:
Yes
Elimination:
HalfLife:
18 hours (range 8-37 hours)
Clearance:
0.7 L/min
ExcretionRoute:
Renal (primarily as metabolites), Fecal (small amount)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
3-8 hours
DurationOfAction:
12-24 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
Fast or abnormal heartbeat
Serotonin syndrome, a severe and potentially deadly condition that may occur when taking this medication with certain other drugs. Symptoms 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, 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
Fast or abnormal heartbeat
Serotonin syndrome, a severe and potentially deadly condition that may occur when taking this medication with certain other drugs. Symptoms 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 drowsiness or dizziness that impairs daily activities
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Fast or irregular heartbeat
- Confusion or hallucinations
- Difficulty urinating
- Severe constipation
- Signs of serotonin syndrome (e.g., agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness/twitching, loss of coordination, 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Heart problems, such as heart block or an abnormal heartbeat, or a history of heart failure (weak 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, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure
* If you are currently taking linezolid or methylene blue, as these medications may interact with this drug
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 change the dose 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Heart problems, such as heart block or an abnormal heartbeat, or a history of heart failure (weak 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, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure
* If you are currently taking linezolid or methylene blue, as these medications may interact with this drug
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 change the dose 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.
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. Drink plenty of fluids to prevent fluid loss.
Before consuming alcohol, marijuana, or other forms of cannabis, 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 often used in conjunction with rest, physical therapy, pain management medications, and other therapies to achieve optimal results.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks 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. Drink plenty of fluids to prevent fluid loss.
Before consuming alcohol, marijuana, or other forms of cannabis, 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 often used in conjunction with rest, physical therapy, pain management medications, and other therapies to achieve optimal results.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Confusion
- Dizziness
- Fast or irregular heartbeat (tachycardia, arrhythmias)
- Low blood pressure (hypotension)
- Dilated pupils
- Blurred vision
- Agitation
- Hallucinations
- Seizures
- Coma
- Respiratory depression
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if ingestion is recent. Monitor cardiac function (ECG) and vital signs.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
Major Interactions
- CNS Depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, other muscle relaxants, sedating antihistamines) - increased CNS depression
- Anticholinergic Agents (e.g., atropine, tricyclic antidepressants, some antihistamines) - increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, St. John's Wort) - increased risk of serotonin syndrome
Moderate Interactions
- Guanethidine and similar antihypertensives - may block antihypertensive effect
- Tramadol - increased risk of seizures
- Bupropion - increased risk of seizures
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function, especially in patients with known or suspected hepatic impairment, as cyclobenzaprine is extensively metabolized by the liver.
Timing: Prior to initiation, particularly in patients with risk factors for hepatic impairment.
Renal function (BUN, creatinine)
Rationale: To assess baseline renal function, as metabolites are renally excreted and caution is advised in severe renal impairment.
Timing: Prior to initiation, particularly in patients with risk factors for renal impairment.
Routine Monitoring
Efficacy (reduction in muscle spasm, pain, improved range of motion)
Frequency: Daily to weekly during initial treatment phase (first 2-3 weeks)
Target: Subjective improvement in symptoms
Action Threshold: Lack of improvement after 1 week, consider alternative therapy or dose adjustment (within recommended limits).
Adverse effects (drowsiness, dizziness, dry mouth, constipation, confusion)
Frequency: Daily, especially during initial treatment and dose adjustments
Target: Absence or mild, tolerable side effects
Action Threshold: Intolerable side effects, severe CNS depression, or signs of anticholinergic toxicity; consider dose reduction or discontinuation.
Mental status/Cognitive function
Frequency: Periodically, especially in elderly patients
Target: Baseline cognitive function maintained
Action Threshold: New onset or worsening confusion, disorientation, or cognitive impairment; consider discontinuation.
Symptom Monitoring
- Drowsiness
- Dizziness
- Dry mouth
- Constipation
- Blurred vision
- Urinary retention
- Confusion
- Nausea
- Fatigue
- Headache
Special Patient Groups
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.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but human data limited.
Second Trimester:
Low risk based on animal data, but human data limited.
Third Trimester:
Low risk based on animal data, but human data limited. Potential for neonatal withdrawal symptoms or CNS depression if used close to delivery, though not well-documented for cyclobenzaprine specifically.
Lactation
L3 (Moderately Safe). Limited human data suggest cyclobenzaprine is excreted into breast milk in small amounts. Monitor infant for drowsiness, poor feeding, or developmental milestones. Use with caution, especially in preterm or neonates.
Infant Risk:
Low to moderate. Potential for drowsiness or sedation in the infant, especially with higher doses or in younger infants. Monitor closely.
Pediatric Use
Not recommended for children under 15 years of age due to lack of established safety and efficacy.
Geriatric Use
Use with caution and at lower doses (e.g., 5 mg once daily at bedtime) due to increased risk of adverse effects such as confusion, hallucinations, anticholinergic effects (dry mouth, constipation, urinary retention), and falls. Elderly patients are more sensitive to CNS depressant and anticholinergic effects.
Clinical Information
Clinical Pearls
- Cyclobenzaprine is intended for short-term use (2-3 weeks) for acute, painful musculoskeletal conditions. It is not effective for chronic pain or spasticity due to cerebral or spinal cord disease.
- Due to its sedative effects, it is often dosed at bedtime, especially the initial dose, to minimize daytime drowsiness.
- Patients should be advised about the potential for additive CNS depression with alcohol and other sedatives.
- Caution is advised in patients with a history of urinary retention, angle-closure glaucoma, or increased intraocular pressure due to its anticholinergic properties.
- Structurally similar to tricyclic antidepressants, it shares some of their side effects and drug interactions, including the risk of serotonin syndrome when combined with other serotonergic agents.
Alternative Therapies
- Other skeletal muscle relaxants (e.g., tizanidine, carisoprodol, methocarbamol, metaxalone, baclofen, diazepam)
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Acetaminophen
- Physical therapy
- Heat/cold therapy
- Massage
- Acupuncture
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (10mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 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, including the amount taken and the time it happened, to ensure you receive the best possible care.