Cyclobenzaprine 5mg Tablets
It is used to relax muscles.
Drug Class
Skeletal Muscle Relaxant
Pharmacologic Class
Centrally Acting Skeletal Muscle Relaxant
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 is usually used for short periods, 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 place, avoiding the bathroom. Keep 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 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, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal 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 place, avoiding the bathroom. Keep 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 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, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal 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 alcohol and other CNS depressants (e.g., sedatives, tranquilizers, opioids) as they can increase drowsiness and dizziness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Take exactly as prescribed; do not take more or less than directed.
- This medication is for short-term use; prolonged use is not recommended.
- To relieve dry mouth, suck on sugarless candy or ice chips, or use saliva substitutes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg three times daily
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
initial_dose:
5 mg three times daily, may be increased to 10 mg three times daily based on response and tolerability.
maximum_dose:
30 mg/day (10 mg three times daily)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for patients under 15 years of age)
Adolescent:
Not established (Safety and efficacy not established for patients under 15 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution, as cyclobenzaprine is primarily metabolized by the liver and excreted renally. Accumulation of metabolites may occur.
Dialysis:
Not available (Not significantly dialyzable)
Hepatic Impairment:
Mild:
Use with caution, consider lower doses (e.g., 5 mg once daily initially).
Moderate:
Use with caution, consider lower doses (e.g., 5 mg once daily initially).
Severe:
Contraindicated due to significantly increased plasma concentrations.
Pharmacology
Mechanism of Action
Cyclobenzaprine acts in the central nervous system (CNS) at the brain stem level to reduce tonic somatic motor activity, influencing both gamma and alpha motor systems. It is structurally and pharmacologically related to tricyclic antidepressants. It does not directly act on the muscle or neuromuscular junction.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (Extensive first-pass metabolism)
Tmax:
1.5 to 8 hours (mean 4-6 hours)
FoodEffect:
Food increases the extent of absorption and delays the rate of absorption.
Distribution:
Vd:
Not available (Extensive tissue distribution)
ProteinBinding:
Approximately 93%
CnssPenetration:
Yes
Elimination:
HalfLife:
18 hours (range 8-37 hours)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as glucuronide conjugates of metabolites)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
3-8 hours
DurationOfAction:
12-24 hours (though typically dosed TID due to shorter perceived effect)
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. Warning signs include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Sweating a lot
+ Severe diarrhea
+ Upset stomach
+ Throwing up
+ 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. Warning signs include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Sweating a lot
+ Severe diarrhea
+ Upset stomach
+ Throwing up
+ 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
- Confusion or hallucinations
- Fast or irregular heartbeat
- Difficulty urinating
- Severe constipation
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Symptoms of serotonin syndrome (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 symptoms you experienced.
Certain health conditions, including:
+ Heart problems, such as heart block, abnormal heartbeat, or heart failure (a weakened heart)
+ Liver disease
+ An overactive thyroid gland
A recent heart attack
Use of specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure
* Concurrent use of linezolid or methylene blue
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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:
+ Heart problems, such as heart block, abnormal heartbeat, or heart failure (a weakened heart)
+ Liver disease
+ An overactive thyroid gland
A recent heart attack
Use of specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure
* Concurrent use of linezolid or methylene blue
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm 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.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. Wait until you understand how this drug affects you before engaging in such activities.
In hot weather or during physical activity, be mindful of your body's need for fluids to prevent dehydration. Drink plenty of fluids to avoid 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.
Adhere to your doctor's instructions regarding the duration of treatment with this medication. Do not exceed the recommended treatment period.
This medication is typically used in conjunction with rest, physical therapy, pain management medications, and other therapeutic interventions.
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 are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. Wait until you understand how this drug affects you before engaging in such activities.
In hot weather or during physical activity, be mindful of your body's need for fluids to prevent dehydration. Drink plenty of fluids to avoid 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.
Adhere to your doctor's instructions regarding the duration of treatment with this medication. Do not exceed the recommended treatment period.
This medication is typically used in conjunction with rest, physical therapy, pain management medications, and other therapeutic interventions.
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 are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Dizziness
- Fainting
- Fast or irregular heartbeat
- Low blood pressure
- Confusion
- Hallucinations
- Agitation
- Vomiting
- Coma
- Respiratory depression
- Seizures
What to Do:
Call 911 or your local poison control center immediately (e.g., 1-800-222-1222). Seek emergency medical attention. Treatment is symptomatic and supportive. An ECG should be performed and cardiac monitoring initiated.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
- Hyperthyroidism (due to increased risk of arrhythmias)
Major Interactions
- CNS Depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, other muscle relaxants, antihistamines with sedative properties) - increased CNS depression
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort) - increased risk of serotonin syndrome
- Anticholinergic Drugs (e.g., atropine, scopolamine, some antihistamines, TCAs) - increased anticholinergic effects (e.g., paralytic ileus, urinary retention, blurred vision)
- Guanethidine and similar acting compounds - may block antihypertensive effect
Moderate Interactions
- CYP1A2, CYP2D6, CYP3A4 Inhibitors (e.g., cimetidine, fluoxetine, paroxetine, quinidine, ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice) - may increase cyclobenzaprine plasma concentrations
- CYP1A2, CYP2D6, CYP3A4 Inducers (e.g., carbamazepine, rifampin, phenytoin, phenobarbital) - may decrease cyclobenzaprine plasma concentrations
Minor Interactions
- Not specifically identified as minor, but general caution with drugs affecting hepatic metabolism.
Monitoring
Baseline Monitoring
Patient history (cardiac, thyroid, glaucoma, urinary retention)
Rationale: To identify contraindications or conditions requiring caution.
Timing: Prior to initiation
Baseline vital signs (BP, HR)
Rationale: To establish baseline and monitor for potential cardiovascular effects.
Timing: Prior to initiation
Routine Monitoring
Efficacy (reduction in muscle spasm, pain)
Frequency: Daily during acute treatment, then as needed
Target: Subjective improvement
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Adverse effects (drowsiness, dizziness, dry mouth, constipation, confusion)
Frequency: Daily during acute treatment, then as needed
Target: Absence or mild, tolerable side effects
Action Threshold: Severe or intolerable side effects may require dose reduction or discontinuation.
Mental status/Cognitive function (especially in elderly)
Frequency: Periodically, or if changes observed
Target: Stable cognitive function
Action Threshold: New or worsening confusion, disorientation, or cognitive impairment.
Symptom Monitoring
- Drowsiness
- Dizziness
- Dry mouth
- Constipation
- Blurred vision
- Urinary retention
- Confusion
- Nausea
- Fatigue
- Headache
- Tachycardia
- Arrhythmias (rare)
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 if used close to delivery, though not well-documented for cyclobenzaprine specifically.
Lactation
It is not known if cyclobenzaprine is excreted in human milk. Due to its structural similarity to TCAs, which are excreted in milk, caution should be exercised. The American Academy of Pediatrics considers it a drug for which the effect on nursing infants is unknown but may be of concern. Consider potential infant exposure vs. maternal benefit.
Infant Risk:
L3 (Moderately Safe - Limited data, potential for adverse effects, but not contraindicated. Monitor infant for sedation, poor feeding, or other signs of drug exposure.)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients below 15 years of age. Generally not recommended due to lack of data and potential for increased side effects.
Geriatric Use
Use with caution in elderly patients (65 years and older) due to increased risk of adverse reactions, particularly CNS effects (drowsiness, dizziness, confusion, falls) and anticholinergic effects (dry mouth, constipation, urinary retention). Start with lower doses (e.g., 5 mg once daily at bedtime) and titrate slowly. Avoid in elderly patients with impaired hepatic function.
Clinical Information
Clinical Pearls
- Cyclobenzaprine is intended for short-term use (2-3 weeks) for acute, painful musculoskeletal conditions, not for chronic pain.
- Its mechanism of action is more akin to a tricyclic antidepressant than a direct muscle relaxant, which explains its sedative and anticholinergic side effects.
- Often prescribed at bedtime due to its sedative properties, which can help with sleep and reduce daytime drowsiness.
- Patients should be warned about the additive CNS depressant effects with alcohol and other sedatives.
- Due to its anticholinergic properties, use with caution in patients with glaucoma, urinary retention, or prostatic hypertrophy.
- Contraindicated with MAOIs due to risk of hyperpyretic crisis and seizures.
Alternative Therapies
- Other skeletal muscle relaxants (e.g., tizanidine, carisoprodol, methocarbamol, metaxalone, baclofen, diazepam)
- NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
- Acetaminophen
- Physical therapy
- Heat/cold therapy
- Rest
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 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.