A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Flexeril Indications, Dosage, Storage, Stability - Cyclobenzaprine Hcl
Flexeril Indications, Dosage, Storage, Stability - Cyclobenzaprine Hcl
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
FLEXERIL on one side and without coding on the other. The 10 mg tablets are
butterscotch yellow, 5-sided
D-shaped, film coated tablets, coded MSD 931 on one
side and FLEXERIL on the other. The two dosage strengths are supplied as
follows:
|
5 mg 100 count bottle
|
NDC 50580-280-10
|
|
10 mg 100 count bottle
|
NDC 50580-874-11 STORAGE
|
Store at 25°C (77°F);
excursions permitted to 15-30°C (59-86°F).
[see USP Controlled Room Temperature].
For more information call 1-888-440-7903 or visit www.flexeril.info
Manufactured by Merck & Co. Inc., West
Point, PA 19486, USA. Distributed and Marketed by McNeil Consumer & Specialty
Pharmaceuticals Fort Washington, PA 19034, Edition: February 2003, 7629220,
FLEXERIL is a registered trademark of ALZA Corporation Copyright ©ALZA
Corporation, 2001 All rights reserved.
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