Cyclobenzaprine hydrochloride

Description

Each film-coated tablet contains 10 mg of Cyclobenzaprine Hydrochloride, USP. Cyclobenzaprine is a muscle relaxant indicated for the relief of muscle spasms associated with acute, painful musculoskeletal conditions. The formulation is designed to provide effective dosing in a convenient tablet form.

Uses and Indications

Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions.

There are no teratogenic or nonteratogenic effects associated with the use of this medication.

Dosage and Administration

The recommended dose of cyclobenzaprine hydrochloride tablets, USP, is 5 mg administered three times a day.

Healthcare professionals should instruct patients to take the tablets orally, with or without food, as directed. It is important to ensure that patients adhere to the prescribed dosing schedule to achieve optimal therapeutic effects. Adjustments to the dosage should be made based on individual patient response and tolerability, while considering the maximum recommended daily dose.

Contraindications

Use of this product is contraindicated in patients with hypersensitivity to any component of the formulation. Additionally, concomitant use with monoamine oxidase (MAO) inhibitors is contraindicated, as well as use within 14 days following the discontinuation of MAO inhibitors, due to the potential for serious interactions.

Warnings and Precautions

The use of Cyclobenzaprine hydrochloride is associated with significant risks that healthcare professionals must be aware of to ensure patient safety.

Serotonin Syndrome Healthcare professionals should be vigilant for the development of serotonin syndrome, a potentially life-threatening condition. This syndrome has been reported in patients using Cyclobenzaprine hydrochloride in conjunction with other serotonergic agents. Notable drug interactions include selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, and monoamine oxidase (MAO) inhibitors. Symptoms of serotonin syndrome may include confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, shivering, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea. Immediate medical intervention is required if these symptoms occur.

Monitoring Parameters While specific laboratory tests are not detailed in the available information, healthcare providers should consider monitoring patients for signs of serotonin syndrome, especially when initiating or adjusting doses of Cyclobenzaprine hydrochloride in patients who are concurrently taking other serotonergic medications. Regular assessment of the patient's clinical status is recommended to identify any adverse effects promptly.

In summary, the combination of Cyclobenzaprine hydrochloride with other serotonergic drugs poses a serious risk of serotonin syndrome, necessitating careful patient evaluation and monitoring.

Side Effects

The most common adverse reactions observed in clinical trials, specifically in two double-blind, placebo-controlled studies involving cyclobenzaprine hydrochloride at a dosage of 5 mg, occurred in more than 3% of participants. These reactions include drowsiness, dry mouth, fatigue, and dizziness.

Serious adverse reactions include the potential development of serotonin syndrome, which is a life-threatening condition that has been reported when cyclobenzaprine hydrochloride is used in conjunction with other medications such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO) inhibitors.

Patients should be cautioned regarding the use of cyclobenzaprine hydrochloride due to its atropine-like effects. It should be used with caution in individuals with a history of urinary retention, angle-closure glaucoma, or increased intraocular pressure, as well as in those taking anticholinergic medications.

Cyclobenzaprine hydrochloride is contraindicated in patients with hypersensitivity to any component of the product and should not be used concurrently with monoamine oxidase (MAO) inhibitors or within 14 days following their discontinuation.

Although rare, overdosage with cyclobenzaprine hydrochloride can lead to serious outcomes, including death.

Drug Interactions

Concomitant use of monoamine oxidase (MAO) inhibitors is contraindicated, as well as use within 14 days following their discontinuation. The combination of Cyclobenzaprine hydrochloride with other medications that affect serotonin levels may lead to the development of potentially life-threatening serotonin syndrome.

Pharmacodynamic Interactions The following drug classes and specific agents have been associated with an increased risk of serotonin syndrome when used concurrently with Cyclobenzaprine hydrochloride:

• Selective Serotonin Reuptake Inhibitors (SSRIs)

• Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)

• Tricyclic Antidepressants (TCAs)

• Tramadol

• Bupropion

• Meperidine

• Verapamil

Due to the risk of serotonin syndrome, it is advised that patients receiving Cyclobenzaprine hydrochloride be closely monitored for signs and symptoms of this condition when any of the aforementioned agents are prescribed. Adjustments to dosage or therapy may be necessary based on clinical assessment.

Packaging & NDC

The table below lists all NDC Code configurations of Cyclobenzaprine Hydrochloride, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric use of cyclobenzaprine hydrochloride has not been established, and the safety and effectiveness in pediatric patients remain undetermined. The use of cyclobenzaprine hydrochloride is not recommended for children under 15 years of age. Additionally, there are no specific dosing recommendations available for pediatric patients.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of cyclobenzaprine hydrochloride. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy.

Caution is advised when prescribing cyclobenzaprine hydrochloride to geriatric patients, especially those with a history of urinary retention, angle-closure glaucoma, or increased intraocular pressure. Close monitoring of these patients is recommended to mitigate risks associated with the medication.

Pregnancy

Cyclobenzaprine hydrochloride is contraindicated in pregnancy due to potential risks to the fetus associated with its use. The safety of cyclobenzaprine in pregnant women has not been established, and there are concerns regarding its impact on fetal outcomes. Given the lack of adequate studies, caution is advised when considering the use of cyclobenzaprine in pregnant patients. No specific dosage modifications for pregnant patients are provided in the prescribing information. Healthcare professionals should carefully weigh the potential benefits against the risks when treating women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage with cyclobenzaprine hydrochloride, while infrequent, can lead to severe consequences, including fatalities.

Symptoms of Overdosage

Healthcare professionals should be vigilant for potential symptoms associated with cyclobenzaprine hydrochloride overdosage. These may include, but are not limited to, extreme sedation, confusion, hallucinations, and cardiovascular disturbances.

Recommended Actions

In the event of suspected overdosage, immediate medical intervention is crucial. Healthcare providers should initiate supportive care and closely monitor the patient's vital signs. It is essential to assess the severity of symptoms and provide appropriate treatment based on clinical presentation.

Management Procedures

Management of cyclobenzaprine hydrochloride overdosage may involve the use of activated charcoal if the patient presents within a suitable timeframe. Additionally, symptomatic treatment should be administered as necessary, and healthcare professionals should be prepared to manage any complications that arise.

Prompt recognition and intervention are vital to mitigate the risks associated with overdosage of cyclobenzaprine hydrochloride.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies involving cyclobenzaprine hydrochloride. However, adverse developmental outcomes were noted at doses that did not result in teratogenic effects. Additionally, animal studies indicated that cyclobenzaprine hydrochloride did not produce any increase in fetal malformations.

Postmarketing Experience

Reports from postmarketing surveillance have identified the development of potentially life-threatening serotonin syndrome associated with the use of Cyclobenzaprine hydrochloride in combination with other medications, including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, and monoamine oxidase (MAO) inhibitors.

Additionally, it has been noted that abrupt cessation of Cyclobenzaprine hydrochloride after prolonged administration may lead to symptoms such as nausea, headache, and malaise; these symptoms are not indicative of addiction. Furthermore, although rare, fatalities have been reported in cases of overdose involving Cyclobenzaprine hydrochloride.

Patient Counseling

Healthcare providers should advise patients that this medication is not intended for household use and must be dispensed in a child-resistant closure, as required, and in a tight, light-resistant container as defined by the United States Pharmacopeia (USP).

Patients should be instructed to store the medication at a temperature between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit), with permissible excursions between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit), in accordance with USP Controlled Room Temperature guidelines. It is crucial to emphasize the importance of keeping this and all medications out of the reach of children.

Providers should discuss the potential risks associated with cyclobenzaprine hydrochloride, particularly its atropine-like action. Caution should be exercised in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, or those who are taking anticholinergic medications.

Additionally, healthcare providers should inform patients that abrupt cessation of treatment after prolonged use may lead to symptoms such as nausea, headache, and malaise. It is important to clarify that these symptoms are not indicative of addiction.

Storage and Handling

This product is supplied in a container that is not intended for household use. It is essential to dispense the contents using a child-resistant closure, as required, and to store it in a tight, light-resistant container in accordance with the standards defined by the United States Pharmacopeia (USP).

Storage conditions for this product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). Temporary excursions are permissible between 15 to 30°C (59 to 86°F), as outlined by USP Controlled Room Temperature guidelines.

It is crucial to keep this product, along with all medications, out of the reach of children to ensure safety.

Additional Clinical Information

Cyclobenzaprine hydrochloride is administered orally. Clinicians should be aware that while withdrawal symptoms have not been reported with this medication, the pharmacologic similarities among tricyclic drugs necessitate consideration of potential withdrawal effects. Abrupt discontinuation after prolonged use may lead to symptoms such as nausea, headache, and malaise, which are not indicative of addiction.

No additional information is available regarding laboratory tests, patient counseling, or postmarketing experiences.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Cyclobenzaprine Hydrochloride as submitted by Alivio Medical Products, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)