Flexeril 10mg Tablets

Cyclobenzaprine acts as a centrally acting skeletal muscle relaxant. It reduces tonic somatic motor activity by influencing both alpha and gamma motor systems. It does not act directly on the muscle or neuromuscular junction. Its action is primarily at the brain stem, with no direct effect on muscle function. It is structurally related to tricyclic antidepressants and may block norepinephrine and serotonin reuptake, contributing to its effects.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when 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.

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.
Certain health conditions, including:
+ Heart problems, such as heart block, 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 whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dosage of any medication without consulting your doctor first.

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 engaging in activities that require your full attention, as it may affect your alertness. Wait until you understand how this drug affects you before performing such tasks.

In hot weather or during physical activity, be mindful of your body's temperature regulation and hydration status. Drink plenty of fluids to prevent dehydration and potential 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 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 are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOIs due to risk of hyperpyretic crisis, convulsions, and death)
• Tramadol (increased risk of serotonin syndrome)
• Other centrally acting muscle relaxants (additive CNS depression)

• Alcohol (additive CNS depression)
• Other CNS depressants (e.g., barbiturates, benzodiazepines, opioids, sedating antihistamines, other muscle relaxants) (additive CNS depression)
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, St. John's Wort) (increased risk of serotonin syndrome)
• Anticholinergic agents (e.g., atropine, benztropine, some antihistamines) (additive anticholinergic effects, increased risk of paralytic ileus)
• Guanethidine (may block antihypertensive effect)

• Antihypertensives (may reduce efficacy of some antihypertensives)
• CYP450 inhibitors (e.g., cimetidine, fluoxetine, fluvoxamine, quinidine) (potential for increased cyclobenzaprine levels, though not consistently clinically significant)
• CYP450 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin) (potential for decreased cyclobenzaprine levels)

• Not many specific minor interactions; most are covered by additive effects.

• Muscle spasm severity
• Pain level
• Range of motion
• Level of sedation/drowsiness
• Dizziness/lightheadedness
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention
• Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, sweating, tremor, muscle rigidity, nausea, vomiting, diarrhea)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks to the fetus.

L3 (Moderately safe). Cyclobenzaprine is excreted into breast milk in animals, and it is likely excreted in human milk. Due to its long half-life and potential for sedation in the infant, caution is advised. Monitor the infant for drowsiness, poor feeding, and developmental milestones. Consider alternative agents or temporary discontinuation of breastfeeding.

Safety and effectiveness have not been established in pediatric patients below 15 years of age. Use is generally not recommended in this population.

Elderly patients are more susceptible to the adverse effects of cyclobenzaprine, particularly CNS effects (e.g., drowsiness, dizziness, confusion) and anticholinergic effects (e.g., dry mouth, constipation, urinary retention, blurred vision). Due to its anticholinergic properties and potential for sedation, cyclobenzaprine is listed on the Beers Criteria as a medication to avoid in older adults. If used, initiate with lower doses (e.g., 5 mg at bedtime) and titrate slowly, monitoring closely for adverse effects.

• Cyclobenzaprine is structurally and pharmacologically similar to tricyclic antidepressants (TCAs), sharing some of their side effects (e.g., anticholinergic effects, sedation, cardiac effects at high doses).
• It is intended for short-term use (2-3 weeks) for acute, painful musculoskeletal conditions, not for chronic pain or long-term muscle spasticity.
• High potential for CNS depression; patients should be warned about driving and operating machinery.
• Avoid concomitant use with alcohol or other CNS depressants.
• Caution is advised in patients with a history of urinary retention, narrow-angle glaucoma, or increased intraocular pressure due to its anticholinergic effects.
• Contraindicated in patients recovering from acute myocardial infarction, with heart block, conduction disturbances, or congestive heart failure due to TCA-like effects.

• Other centrally acting skeletal muscle relaxants (e.g., methocarbamol, tizanidine, metaxalone, carisoprodol, orphenadrine)
• Benzodiazepines (e.g., diazepam - generally not preferred for muscle spasm due to abuse potential and broader CNS effects)
• Non-pharmacologic therapies (e.g., physical therapy, heat/cold therapy, massage, rest, exercise)

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.