Cyclobenzaprine 15mg ER Capsules

Cyclobenzaprine acts in the central nervous system (CNS) at the brain stem level to reduce tonic somatic motor activity, influencing both alpha and gamma motor neurons. It is structurally and pharmacologically related to tricyclic antidepressants (TCAs). It does not directly act on the neuromuscular junction or the muscle itself. Its effect is believed to be due to a reduction of tonic somatic motor activity, possibly through an action on the reticular formation and by blocking descending noradrenergic and serotonergic pathways.

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 immediately or seek emergency 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. Watch for:
+ 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:

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, 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.

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 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, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure
* If you are currently taking linezolid or methylene blue, as these medications can 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 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 your full attention, as it may affect your alertness. 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 temperature regulation and fluid balance. To prevent dehydration, drink plenty of fluids to avoid excessive 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 an extended period beyond the recommended timeframe. This medication is often used in conjunction with rest, physical therapy, pain management medications, and other therapeutic interventions.

If you are 65 years or older, do not take this medication without first consulting your doctor to discuss the potential risks and benefits.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
• Hyperthyroidism (due to increased risk of arrhythmias)

• CNS Depressants (e.g., alcohol, barbiturates, benzodiazepines, opioids, other muscle relaxants, antihistamines): Additive CNS depression.
• Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, tramadol, triptans, St. John's Wort): Increased risk of serotonin syndrome.
• Anticholinergic Drugs (e.g., atropine, benztropine, tricyclic antidepressants): Additive anticholinergic effects (e.g., paralytic ileus, urinary retention, blurred vision).
• Guanethidine and similar acting compounds: May block antihypertensive effect.

• CYP1A2, CYP2D6, CYP3A4 Inhibitors: May increase cyclobenzaprine plasma concentrations (e.g., cimetidine, fluoxetine, paroxetine, quinidine, ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice).
• CYP1A2, CYP2D6, CYP3A4 Inducers: May decrease cyclobenzaprine plasma concentrations (e.g., carbamazepine, phenobarbital, phenytoin, rifampin).

• Not specifically identified as minor, but caution with any drug affecting CNS or hepatic metabolism.

• Drowsiness
• Dizziness
• Dry mouth
• Constipation
• Blurred vision
• Fatigue
• Nausea
• Headache
• Confusion
• Urinary retention
• Tachycardia
• Orthostatic hypotension

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.

Excreted into breast milk in animal studies. It is not known if it is excreted in human milk. Due to potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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.

Use with caution due to increased risk of adverse reactions, particularly CNS effects (e.g., confusion, hallucinations, sedation) and anticholinergic effects (e.g., dry mouth, constipation, urinary retention). Start with the lowest effective dose (e.g., 15 mg once daily) and titrate slowly if needed. Avoid in elderly patients with impaired hepatic function.

• Cyclobenzaprine ER is indicated for short-term use (up to 2-3 weeks) as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
• It is not effective for spasticity due to cerebral or spinal cord disease or for chronic pain conditions.
• Patients should be advised about the potential for significant drowsiness and to avoid activities requiring mental alertness.
• Due to its tricyclic antidepressant-like structure, caution is advised in patients with a history of cardiac arrhythmias, heart block, or recent myocardial infarction.
• Risk of serotonin syndrome when co-administered with other serotonergic agents. Educate patients on symptoms.
• Avoid in patients with severe hepatic impairment.

• Other skeletal muscle relaxants (e.g., tizanidine, methocarbamol, carisoprodol, metaxalone, baclofen, orphenadrine)
• Non-pharmacological therapies (e.g., rest, physical therapy, heat/cold therapy, massage, acupuncture)
• NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
• Acetaminophen

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.