Amrix (Cyclobenzaprine Hydrochloride Extended Release) - Indications and Dosage

INDICATIONS AND USAGE

AMRIX is 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.

AMRIX 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.

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

DOSAGE AND ADMINISTRATION

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

It is recommended that doses be taken at approximately the same time each day.

Use of AMRIX for periods longer than two or three weeks is not recommended (see INDICATIONS AND USAGE).

Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)

HOW SUPPLIED

AMRIX extended-release capsules are available in 15 and 30 mg strengths, packaged in bottles of 60 capsules. AMRIX 15 mg capsules (NDC 63459-700-60) are orange/orange and are embossed  in blue ink with "15 mg" on the body, and Cephalon "Câ€� logo, "Cephalon", and a dashed band on the cap. AMRIX 30 mg capsules (NDC 63459-701-60) are blue/orange and are embossed  in white ink with "30 mg" on the body, and Cephalon "C" logo, “Cephalon", and a dashed band on the cap.

Dispense in a tight, light-resistant container as defined in the USP/NF.
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F); [see USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Distributed by:
Cephalon, Inc.
Frazer, PA 19355

Manufactured by:
Eurand Inc.
Vandalia, Ohio 45377
AMRIX is a trademark of Cephalon, Inc. or its affiliates.

U.S. Patent No. 7,387,793

© 2004, 2006, 2007, 2008 Cephalon, Inc., or its affiliates. All rights reserved.

PI-40018-01
Revised December 2008