Fda approves flexeril 5 mg for less-sedating therapy for lower back pain - drugs.com mednews
Until now, cyclobenzaprine HCl, the active component in
Flexeril 5 mg, has been available only in 10 mg tablets. Flexeril
10 mg is regarded as highly efficacious. Inside a clinical study
versus placebo, each dosage strength of Flexeril demonstrated an
capacity to relieve muscle spasm pain, but patients taking Flexeril
5 mg reported a lot less drowsiness than patients taking
the ten mg tablet.
"Musculoskeletal pain, particularly back pain with muscle
spasms, can be a leading reason behind physician visits," explained Bill
McCarberg, M. D. , Director, Chronic Pain Management Program, Kaiser
Permanente, Los angeles, Calif. "Because Flexeril 5 mg relieves
muscle spasm pain with a lower incidence of negative effects as opposed to
10 mg tablet, physicians now take over greater dosing flexibility for
the initial treating sprains, strains, along with other painful
musculoskeletal injuries. "
The effectiveness of Flexeril 5 mg was demonstrated by 50 percent
seven-day, double-blind, placebo-controlled, randomized,
multi-center clinical 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 treatment, patients reported that
Flexeril 5 mg provided relief of musculoskeletal spasm symptoms
significantly over placebo. Usually, patients
experienced some, a good deal, or complete relief of symptoms within Two days
of starting treatment with both strengths of Flexeril.
The incidence of sedation was significantly short of patients
taking Flexeril 5 mg in comparison with those taking Flexeril 10 mg (29%
vs. 38%, respectively; 10% for placebo). Most sufferers who reported
sedation developed it about the 1st or 2nd day of dosing. Most
episodes were mild and would not bring about discontinuation of
therapy. Only two percent of patients reported severe sedation. wellbutrin online without a prescription "In
clinical practice it's been found out that a person who'd not
experience sedation during the early stages of treatment, may
likely not experience drowsiness later throughout treatment,"
noted Dr. McCarberg.
Dry mouth, another side effect associated with most muscle
relaxants, seemed to be significantly reduced the Flexeril 5 mg
patient group compared to the Flexeril 10 mg group (21% vs. 32%,
respectively; 7% for placebo). Other adverse events reported in
more than three percent of patients include fatigue and
headache.
Analysis on the data from controlled research has revealed that Flexeril
produces clinical improvement if sedation occurs. "The
data demonstrate how the efficacy of Flexeril just isn't because of
sedation," said Dr. McCarberg.
Flexeril must 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 some other ingredients in Flexeril,
hyperthyroidism, current or recent use (within 2 weeks after
discontinuation) of monoamine oxidase inhibitors (MAOIs). Flexeril
may improve the results of alcohol, barbiturates, along with CNS
depressants. Flexeril may impair mental and/or physical abilities
essential for performance of hazardous tasks, for instance operating
machinery or driving a motor vehicle. amoxicillin online no prescription
Visit www. Flexeril. info
for additional information. To learn more about Flexeril 5 mg,
call 1-888-440-7903.
Source: McNeil Consumer
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