Prescription Drug Information: Cyclobenzaprine Hydrochloride

CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride capsule, extended release
Quality Care Products, LLC

1 INDICATIONS AND USAGE

Cyclobenzaprine hydrochloride extended-release capsules 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, and limitation of motion.

Limitations of Use:

  • Cyclobenzaprine hydrochloride extended-release capsules 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 extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.

2 DOSAGE AND ADMINISTRATION

The recommended adult dose for most patients is one (1) cyclobenzaprine hydrochloride extended-release capsule, 15 mg taken once daily. Some patients may require up to 30 mg/day, given as one (1) cyclobenzaprine hydrochloride extended-release capsule, 30 mg taken once daily or as two (2) cyclobenzaprine hydrochloride extended-release capsules, 15 mg taken once daily.

  • It is recommended that doses be taken at approximately the same time each day.
  • Use of cyclobenzaprine hydrochloride extended-release capsules for periods longer than two or three weeks is not recommended [ see Indications and Usage (1)].

Instruct patients to swallow cyclobenzaprine hydrochloride extended-release capsules intact. Alternatively, the contents of the cyclobenzaprine hydrochloride extended-release capsules may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:

  • Sprinkle the contents of the capsule onto a tablespoon of applesauce and consume immediately without chewing.
  • Rinse the mouth to ensure all of the contents have been swallowed.
  • Discard any unused portion of the cyclobenzaprine hydrochloride extended-release capsules after the contents have been sprinkled on applesauce.

3 DOSAGE FORMS AND STRENGTHS

Extended-release capsules USP in the following strengths:

  • 15 mg: Capsules are dark orange cap/red opaque body and are imprinted with black ink with “T035” on the body and cap.
  • 30 mg: Capsules are orange opaque cap/white opaque body and are imprinted with black ink with “T036” on the body and cap.

4 CONTRAINDICATIONS

  • Hypersensitivity to any component of this product. These adverse reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue cyclobenzaprine hydrochloride extended-release capsules if a hypersensitivity reaction is suspected.
  • 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.
  • During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
  • Hyperthyroidism.

5 WARNINGS AND PRECAUTIONS

5.1 Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of cyclobenzaprine hydrochloride extended-release capsules with MAO inhibitors is contraindicated [see Contraindications (4)]. Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Treatment with cyclobenzaprine hydrochloride extended-release capsules and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated. If concomitant treatment with cyclobenzaprine hydrochloride extended-release capsules and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases.

5.2 Tricyclic Antidepressant-like Effects

Cyclobenzaprine is structurally related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke [see Contraindications (4)]. Cyclobenzaprine hydrochloride extended-release capsules may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Some of the more serious central nervous system (CNS) reactions noted with the tricyclic antidepressants have occurred in short-term studies of cyclobenzaprine for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm. If clinically significant CNS symptoms develop, consider discontinuation of cyclobenzaprine hydrochloride extended-release capsules.

5.3 Use in the Elderly

As a result of a 40% increase in cyclobenzaprine plasma levels and a 56% increase in plasma half-life following administration of cyclobenzaprine hydrochloride extended-release capsules in elderly subjects as compared to young adults, use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in the elderly [see Clinical Pharmacology (12.3)].

5.4 Use in Patients with Hepatic Impairment

As a result of two-fold higher cyclobenzaprine plasma levels in subjects with mild hepatic impairment, as compared to healthy subjects, following administration of immediate-release cyclobenzaprine and because there is limited dosing flexibility with cyclobenzaprine hydrochloride extended-release capsules, use of cyclobenzaprine hydrochloride extended-release capsules is not recommended in patients with mild, moderate, or severe hepatic impairment [see Clinical Pharmacology (12.3)].

5.5 Atropine-like Action

Because of its atropine-like action, cyclobenzaprine hydrochloride extended-release capsules 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.

6 ADVERSE REACTIONS

The following clinically significant reactions are described in greater detail, in other sections.

  • Serotonin Syndrome [see Warnings and Precautions (5.1)]
  • Adverse Cardiovascular Effects [see Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to cyclobenzaprine hydrochloride extended-release capsules in 253 patients in 2 clinical trials. Cyclobenzaprine hydrochloride extended-release capsules were studied in two double-blind, parallel-group, placebo-controlled, active-controlled trials of identical design [see Clinical Studies (14)]. The study population was composed of patients with muscle spasms associated with acute painful musculoskeletal conditions. Patients received 15 mg or 30 mg of cyclobenzaprine hydrochloride extended-release capsules taken orally once daily, cyclobenzaprine immediate-release (IR) 10 mg three times a day, or placebo for 14 days.

The most common adverse reactions (incidence ≥3% in any treatment group and greater than placebo) were dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence (see Table 1).

Table 1: Incidence of the Most Common Adverse Reactions Occurring in ≥ 3% of Patients in any Treatment Group* and Greater Than Placebo in the Two Phase 3, Double-Blind Cyclobenzaprine Hydrochloride Extended-Release Capsules Trials

Placebo

Cyclobenzaprine Hydrochloride Extended-Release Capsules 15 mg

Cyclobenzaprine Hydrochloride Extended-Release Capsules 30 mg

N=128

N=127

N=126

Dry mouth

2%

6%

14%

Dizziness

2%

3%

6%

Fatigue

2%

3%

3%

Constipation

0%

1%

3%

Somnolence

0%

1%

2%

Nausea

1%

3%

3%

Dyspepsia

1%

0%

4%

*Cyclobenzaprine Hydrochloride Extended-Release Capsules 15 mg QD, Cyclobenzaprine Hydrochloride Extended-Release Capsules 30 mg QD, or cyclobenzaprine IR tablets TID

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