Cyclobenzaprine hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
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Overview
Cyclobenzaprine hydrochloride is an antidepressive agent that is FDA approved for the {{{indicationType}}} of skeletal muscle spasm. Common adverse reactions include constipation, indigestion, nausea, xerostomia, dizziness, somnolence, fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Cyclobenzaprine hydrochloride FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cyclobenzaprine hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cyclobenzaprine hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Cyclobenzaprine hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cyclobenzaprine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cyclobenzaprine hydrochloride in pediatric patients.
Contraindications
There is limited information regarding Cyclobenzaprine hydrochloride Contraindications in the drug label.
Warnings
There is limited information regarding Cyclobenzaprine hydrochloride Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Cyclobenzaprine hydrochloride Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Cyclobenzaprine hydrochloride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Cyclobenzaprine hydrochloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cyclobenzaprine hydrochloride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cyclobenzaprine hydrochloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cyclobenzaprine hydrochloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride in geriatric settings.
Gender
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cyclobenzaprine hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cyclobenzaprine hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Cyclobenzaprine hydrochloride Administration in the drug label.
Monitoring
There is limited information regarding Cyclobenzaprine hydrochloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Cyclobenzaprine hydrochloride and IV administrations.
Overdosage
There is limited information regarding Cyclobenzaprine hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cyclobenzaprine hydrochloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Cyclobenzaprine hydrochloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Cyclobenzaprine hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Cyclobenzaprine hydrochloride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Cyclobenzaprine hydrochloride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Cyclobenzaprine hydrochloride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cyclobenzaprine hydrochloride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cyclobenzaprine hydrochloride How Supplied in the drug label.
Storage
There is limited information regarding Cyclobenzaprine hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cyclobenzaprine hydrochloride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cyclobenzaprine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cyclobenzaprine hydrochloride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cyclobenzaprine hydrochloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.