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Flexeril (Cyclobenzaprine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FLEXERIL 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, limitation of motion, and restriction in activities of daily living.

FLEXERIL 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.

FLEXERIL 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

For most patients, the recommended dose of FLEXERIL is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of FLEXERIL for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).

HOW SUPPLIED

FLEXERIL tablets are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are yellow-orange, 5-sided D-shaped, film coated tablets, coded FLEX over 5 on one side and without coding on the other. The 10 mg tablets are butterscotch yellow, 5-sided D-shaped, film coated tablets, coded FLEXERIL on one side and without coding on the other. The two dosage strengths are supplied as follows:

  5 mg 100 count bottleNDC 50580-280-10
10 mg 100 count bottleNDC 50580-874-11

STORAGE

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature].

Rx Only

For more information call 1-888-440-7903
or visit www.flexeril.info

McNeil Consumer & Specialty Pharmaceuticals
DIVISION OF MCNEIL-PPC, INC.
Fort Washington, PA 19034

Edition: February 2005
7629222

FLEXERIL is a registered trademark of ALZA Corporation
Copyright ©ALZA Corporation, 2001
All rights reserved.

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