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Fda approves flexeril 5 mg for less-sedating management of low back pain - drugs.com mednews

Until now, cyclobenzaprine HCl, the component in
Flexeril 5 mg, has become available only in 10 mg tablets. Flexeril
10 mg may be known as highly efficacious. Within a clinical study
versus placebo, each dosage strength of Flexeril demonstrated an
ability to relieve muscle spasm pain, but patients taking Flexeril
5 mg reported significantly less drowsiness than patients taking
the 10 mg tablet.

"Musculoskeletal pain, particularly lower back pain with muscle
spasms, is a leading source of physician visits," explained Bill
McCarberg, M. D. , Director, Chronic Pain Management Program, Kaiser
Permanente, North park, Calif. "Because Flexeril 5 mg relieves
muscle spasm pain with a lower incidence of unwanted effects versus the
10 mg tablet, physicians now take over greater dosing flexibility for
your initial management of sprains, strains, along with painful
musculoskeletal injuries. "

The effectiveness of Flexeril 5 mg was demonstrated in 2
seven-day, double-blind, placebo-controlled, randomized,
multi-center numerous studies enrolling 1,405 patients with acute
(<14 days), physician-rated moderate or moderately severe
painful muscle spasm in the lower back or neck. Concomitant use of
analgesics, psychotropic agents and drugs with the potential to
cause sedation were prohibited.

Over a one-week procedure, patients reported that
Flexeril 5 mg provided relief of musculoskeletal spasm symptoms
significantly greater than placebo. Typically, patients
experienced some, a lot, or complete relief of symptoms within A couple of days
of starting treatment with both strengths of Flexeril.

The incidence of sedation was significantly reduced patients
taking Flexeril 5 mg compared to those taking Flexeril 10 mg (29%
vs. 38%, respectively; 10% for placebo). Most people who reported
sedation developed it within the first or second day of dosing. Most
episodes were mild and would not result in discontinuation of
therapy. Only two percent of patients reported severe sedation. "In
clinical practice it is found out that a person who does not
experience sedation as a result of stages of treatment, will
likely not experience drowsiness later in the course of treatment,"
noted Dr. McCarberg.

Dry mouth, another side effects connected with most muscle
relaxants, have also been significantly lacking in the Flexeril 5 mg
patient group weighed against the Flexeril 10 mg group (21% vs. 32%,
respectively; 7% for placebo). Other adverse events reported in
in excess of three percent of patients include fatigue and
headache.

Analysis in the data from controlled research has shown that Flexeril
produces clinical improvement whether or not sedation occurs. "The
data demonstrate which the efficacy of Flexeril is not due to
sedation," said Dr. McCarberg.

Flexeril really should not be taken by patients during acute recovery
phase of myocardial infarction or by patients with arrhythmias,
heart block, conduction disturbances, congestive heart failure,
allergies to cyclobenzaprine or any other ingredients in Flexeril,
hyperthyroidism, current or recent use (within A fortnight after
discontinuation) of monoamine oxidase inhibitors (MAOIs). Flexeril
may improve the link between alcohol, barbiturates, along with CNS
depressants. Flexeril may impair mental and/or physical abilities
needed for performance of hazardous tasks, such as operating
machinery or driving a vehicle.

Visit www. Flexeril. buy celexa without a prescription info
to find out more. To learn more about Flexeril 5 mg,
call 1-888-440-7903.

Source: McNeil Consumer & Specialty Pharmaceuticals

Posted: February 2003