Cyclobenzaprine Hydrochloride

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.

• 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.

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

  Cyclobenzaprine hydrochloride extended-release capsules are a muscle relaxant 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 2 or 3 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. (1)
  ].

Instruct patients to swallow cyclobenzaprine hydrochloride extended-release capsules intact. Alternatively, the contents of the cyclobenzaprine hydrochloride extended-release capsule 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.

Extended-release capsules in the following strengths:

• 15 mg: Capsules are orange opaque body and orange opaque cap with "B15" in blue ink on cap.
• 30 mg: Capsules are dark blue opaque body and standard red opaque cap with "B30" in white ink on cap.

Because of its atropine-like action, cyclobenzaprine hydrochloride extended-release 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 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)]