Cyclobenzaprine hydrochloride

Cyclobenzaprine hydrochloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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 treatment 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)

skeletal muscle spasm

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

• Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.

• Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

• Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

• Dosing information:

• Immediate release tablets, 5 mg ORALLY 3 times/day; based on response, may increase to 10 mg ORALLY 3 times/day for up to 2 to 3 weeks.
• Extended-release capsules, 15 mg ORALLY once daily; based on response, may increase to 30 mg ORALLY once daily for up to 2 to 3 weeks.

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)

skeletal muscle spasm

• Cyclobenzaprine hydrochloride immediate-release tabletS are indicated for pediatric patients of age 15 years or older.

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

Flexeril, Amrix, Fexmid, FusePaq Tabradol.

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.