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

• Hypersensitivity to any component of this product.

• Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.

• Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.

• Hyperthyroidism.

Warnings

• Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred.

• Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.

• Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.

PRECAUTIONS

• Because of its atropine-like action, cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.

• The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Impairment). These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine. Cyclobenzaprine hydrochloride tablets should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward. Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine hydrochloride in subjects with moderate to severe impairment is not recommended.

• Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. In the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased. In elderly patients, cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward.

• Cyclobenzaprine hydrochloride may have life-threatening interactions with MAO inhibitors. (See CONTRAINDICATIONS.)

• Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.

• Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.

• Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.†

________________________________________

† ULTRAM® (tramadol hydrochloride tablets, Ortho-McNeil Pharmaceutical)

ULTRACET® (tramadol hydrochloride and acetaminophen tablets, Ortho-McNeil Pharmaceutical)

Adverse Reactions

Clinical Trials Experience

• Incidence of most common adverse reactions in the 2 double-blind‡, placebo-controlled 5 mg studies (incidence of > 3% on cyclobenzaprine hydrochloride tablets, 5 mg):

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): B

• Reproduction studies have been performed in rats, mice and rabbits at doses up to 20 times the human dose, and have revealed no evidence of impaired fertility or harm to the fetus due to cyclobenzaprine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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

• It is not known whether this drug is excreted in human milk. Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when cyclobenzaprine hydrochloride is administered to a nursing woman.

Pediatric Use

• Safety and effectiveness of cyclobenzaprine hydrochloride in pediatric patients below 15 years of age have not been established.

Geriatic Use

• The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly). The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions. For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed. In such patients cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward.

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

• In rats treated with cyclobenzaprine hydrochloride for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis. In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in rats which died prior to 26 weeks; at lower doses, the change was not seen until after 26 weeks.

• Cyclobenzaprine did not affect the onset, incidence or distribution of neoplasia in an 81-week study in the mouse or in a 105-week study in the rat.

• At oral doses of up to 10 times the human dose, cyclobenzaprine did not adversely affect the reproductive performance or fertility of male or female rats. Cyclobenzaprine did not demonstrate mutagenic activity in the male mouse at dose levels of up to 20 times the human dose.

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.