Cyclobenzaprine 7.5mg Tablets

Cyclobenzaprine acts as a centrally acting skeletal muscle relaxant. It reduces tonic somatic motor activity by influencing both alpha and gamma motor neurons. It does not act directly on the muscle or neuromuscular junction. Its action is primarily at the brain stem, possibly by blocking descending serotonergic and noradrenergic pathways. Structurally similar to tricyclic antidepressants, it may also block norepinephrine and serotonin reuptake.

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, including:
+ 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:

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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Heart block or abnormal heartbeat
+ Heart failure (weak heart)
+ Liver disease
+ Overactive thyroid gland (hyperthyroidism)
A recent heart attack
Use of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
* Concurrent use of certain medications, such as:
+ 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 whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose 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 alertness, as its effects on you are unknown. Wait until you understand how this drug affects you before resuming these 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 maintain adequate hydration.

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 duration for taking this medication. Do not exceed the recommended treatment period.

This medication is often used in conjunction with rest, physical therapy, pain management medications, and other therapeutic interventions as part of a comprehensive treatment plan.

If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects due to age-related factors.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the well-being of both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of discontinuing an MAOI due to risk of serotonin syndrome.

• CNS Depressants (e.g., alcohol, barbiturates, opioids, sedatives, hypnotics, other muscle relaxants) - additive CNS depression (drowsiness, dizziness, impaired coordination).
• Anticholinergic Drugs (e.g., tricyclic antidepressants, antihistamines, atropine, phenothiazines) - additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).
• Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans, tramadol, linezolid, St. John's Wort) - increased risk of serotonin syndrome.

• Guanethidine and similar antihypertensives - cyclobenzaprine may block the antihypertensive effect.
• Tramadol - increased risk of seizures and serotonin syndrome.
• Bupropion - increased risk of seizures.

• Not readily available for specific minor interactions, but caution with any drug affecting CNS or hepatic metabolism.

• Drowsiness
• Dizziness
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention
• Confusion
• Tachycardia
• Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea, incoordination)

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 only if clearly needed and the potential benefits outweigh the potential risks.

Excreted in animal milk; it is unknown whether cyclobenzaprine is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants (e.g., sedation, anticholinergic effects), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use with caution.

Safety and effectiveness in pediatric patients under 15 years of age have not been established. Not recommended for this age group.

Elderly patients are more susceptible to the adverse effects of cyclobenzaprine, particularly drowsiness, dizziness, confusion, and anticholinergic effects (e.g., dry mouth, constipation, urinary retention, blurred vision). Start with a lower dose (e.g., 5 mg once daily at bedtime) and titrate slowly. Avoid use in elderly patients if possible, especially those with pre-existing conditions that may be exacerbated by anticholinergic effects (e.g., glaucoma, prostatic hypertrophy). The American Geriatrics Society Beers Criteria recommends avoiding cyclobenzaprine in older adults due to its anticholinergic properties and risk of sedation.

• Cyclobenzaprine is intended for short-term use (typically 2-3 weeks) for acute muscle spasms, not for long-term management of chronic pain or spasticity due to CNS disease.
• Its efficacy beyond 2-3 weeks has not been established, and prolonged use may increase the risk of adverse effects without additional benefit.
• Patients should be warned about significant drowsiness and dizziness, especially when initiating therapy or increasing dose.
• Has significant anticholinergic properties, which can be problematic in elderly patients or those with conditions like glaucoma or prostatic hypertrophy.
• Avoid concomitant use with MAOIs due to the risk of serotonin syndrome.
• Not effective for muscle spasticity resulting from cerebral or spinal cord disease.

• Other skeletal muscle relaxants (e.g., Tizanidine, Methocarbamol, Metaxalone, Carisoprodol, Baclofen, Diazepam)
• Non-pharmacological treatments (e.g., physical therapy, rest, heat/cold application, massage, acupuncture, chiropractic care)
• Analgesics (e.g., NSAIDs, acetaminophen) for pain relief

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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.