Flexeril (Cyclobenzaprine Hydrochloride) - Summary

FLEXERIL SUMMARY

FLEXERIL^®
(CYCLOBENZAPRINE HCl) Tablets

Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle function.

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.

See all Flexeril indications & dosage >>

FLEXERIL NEWS HIGHLIGHTS

Media Articles Related to Flexeril (Cyclobenzaprine)

Muscle Spasms
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2009.06.17]
Title: Muscle Spasms
Category: Diseases and Conditions
Created: 6/16/2009
Last Editorial Review: 6/17/2009

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Published Studies Related to Flexeril (Cyclobenzaprine)

Bioequivalence following buccal and sublingual placement of fentanyl buccal tablet 400 microg in healthy subjects. [2008]
BACKGROUND AND OBJECTIVE: The fentanyl buccal tablet (FBT) is formulated to enhance the rate and extent of fentanyl absorption across the buccal mucosa. FBT is indicated for the management of breakthrough pain (a transient flare of pain on a background of chronic pain otherwise controlled by treatment with opioids) in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. This study assessed the bioequivalence of a single 400-microg dose of FBT following buccal (i.e. above a molar tooth between the upper gum and cheek) and sublingual (i.e. placed under the tongue) placement in order to provide an alternative option to patients... CONCLUSION: The results of this study support sublingual FBT placement as a viable alternative to buccal placement in patients who may require an alternate administration site.

Low-dose cyclobenzaprine versus combination therapy with ibuprofen for acute neck or back pain with muscle spasm: a randomized trial. [2005.09]
OBJECTIVE: This prospective, randomized, open-label, multicenter, community-based study was conducted to compare cyclobenzaprine [generic for Flexeril] 5 mg three times daily (TID) orally (CYC5) given for 7 days as monotherapy or in combination with ibuprofen 400 mg TID (CYC5/IBU400) or 800 mg TID (CYC5/IBU800) in adults with acute neck or back pain with muscle spasm... CONCLUSIONS: This randomized, community-based clinical trial demonstrated that combination therapy with cyclobenzaprine 5 mg TID plus ibuprofen was not superior to cyclobenzaprine 5 mg TID alone in adult patients with acute neck and back pain with muscle spasm. All treatments were well tolerated.

Cyclobenzaprine with ibuprofen versus ibuprofen alone in acute myofascial strain: a randomized, double-blind clinical trial. [2003.06]
STUDY OBJECTIVE: We evaluate the analgesic and side effects of adding cyclobenzaprine [generic for Flexeril] to ibuprofen in emergency department patients with acute myofascial strain... CONCLUSION: In ED patients with acute myofascial strain, the addition of cyclobenzaprine to ibuprofen does not improve analgesia but is associated with a greater prevalence of central nervous system side effects.

Efficacy of a low-dose regimen of cyclobenzaprine hydrochloride in acute skeletal muscle spasm: results of two placebo-controlled trials. [2003.04]
BACKGROUND: Cyclobenzaprine [generic for Flexeril] hydrochloride is a muscle relaxant that is effective in improving muscle spasm, reducing local pain and tenderness, and increasing range of motion in acute, painful musculoskeletal conditions. Sedation is the most common adverse event associated with its use at the usual dosage of 10 mg TID. Studies in healthy adults suggest that a lower dose may produce less sedation. Because cyclobenzaprine's duration of action is 4 to 6 hours, reducing the dosing frequency to 10 mg BID would create a potentially painful untreated interval between doses. The alternative is administration of a lower dose (eg, 5 or 2.5 mg) TID. OBJECTIVE: These studies were designed to assess the efficacy and tolerability of cyclobenzaprine 2.5, 5, and 10 mg TID compared with placebo in patients with acute musculoskeletal spasm... CONCLUSIONS: Cyclobenzaprine 2.5 mg TID was not significantly more effective than placebo. The cyclobenzaprine 5- and 10-mg TID regimens were associated with significantly higher mean efficacy scores compared with placebo. Cyclobenzaprine 5 mg TID was as effective as 10 mg TID, and was associated with a lower incidence of sedation.

The effectiveness of adding pharmacologic treatment with clonazepam or cyclobenzaprine to patient education and self-care for the treatment of jaw pain upon awakening: a randomized clinical trial. [2002.01]
AIMS: To compare the relative effectiveness of a benzodiazepine (clonazepam), a muscle relaxant (cyclobenzaprine [generic for Flexeril]), and a placebo for the treatment of jaw pain upon awakening, when each is combined with the recommended nonpharmacological components of initial medical management... CONCLUSION: This study suggests that cyclobenzaprine is statistically superior to either placebo or clonazepam when added to self-care and education for the management of jaw pain upon awakening. Based on the subjects' report of sleep quality, these medications failed to significantly improve sleep in the short term.

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Clinical Trials Related to Flexeril (Cyclobenzaprine)

An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm [Completed]
The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.

Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine [Completed]
CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain. The objective of the present study was to compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone.

DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty patients were divided into two groups: G1 received trigger point injection of 0. 25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients were asked to continue physical exercise. The following parameters were evaluated: pain intensity rated on a numerical and verbal scale, quality of life before and four weeks after treatment, and quality of analgesia.

Evaluation of Stepped Care for Chronic Pain in Iraq and Afghanistan Veterans
The purpose of this study is to determine if a stepped-care intervention makes pain symptoms better and reduces activity limitations because of pain. Our two primary hypotheses are that in OIF/OEF veterans with chronic pain:

1. Stepped care is more effective than usual care in reducing pain-related disability

2. Stepped care is more effective than usual care in reducing psychological distress

Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure [Suspended]
The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to assess the safety and efficacy of the Microwave Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) in the minimally invasive surgical (MIS) procedure in approximately 30 patients at 6 investigational sites in the United States.

Atrial Fibrillation Ablation Device Comparison Study [Recruiting]
Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice of six different devices that he or she can use to treat your atrial fibrillation. It is not known at this point which device is best at treating you, as each device seems to have the same success rate at curing atrial fibrillation. One of the six devices will be selected randomly by card pulled out at the time of enrollment. It is therefore the purpose of this study to compare the devices to each other and to follow up after surgery to determine if any one device is best. This information will be valuable to surgeons and to patients as the treatment for atrial fibrillation develops in the future.

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FLEXERIL PATIENT REVIEWS / RATINGS / COMMENTS

Flexeril review by 21 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		headaches
Dosage & duration:		1x day (dosage frequency: 3 days) for the period of 3 days ago
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Had a lot of headaches all day every day. Doctor said it was tension headaches made by a muscle spasm in my neck. She prescribe this medicine and the headaches are hardly there.
Side effects:		In the mornings I didn't want to get up from school at all. This medicine is strong. I got up at 6 am and reach class at 8 and it was still knocking me out in class. Was soo embarrase. Mind you I took the medicine at 10 30pm the night before.
Comments:		The treatment is going well.

Flexeril review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Muscle spasms
Dosage & duration:		relaxes muscles (dosage frequency: once to twice a day) for the period of 5 years
Other conditions:		Fibromyalgia
Other drugs taken:		none
		Reported Results
Benefits:		I am able to get good restful sleep and that is so important in my pain management.
Side effects:		Sever tiredness, not able to leave the house after taking the medicine.
Comments:		Pain management, I take one to two pills a day as needed.

Flexeril review by 51 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		muscle stiffness
Dosage & duration:		10 mg every 12 hrs. taken i took it everyday for 2 years. for the period of i've been taking it for 2 1/2 years.
Other conditions:		as of 2008 severe rheumatoid arthritis in the joints/muscles. in 2001 it was lupus. they diagnosed.
Other drugs taken:		vicodin 750mg. buspar 5mg. 7.5mg. zantac 150mg. motrin 800mg.elavil 10mg. 25mg. 50mg. flexeril 10mg.
		Reported Results
Benefits:		the benefits aren't that great but i do get some kind of relief. i am in pain everyday all day.
Side effects:		i really could not tell from the many aches and pain i have everyday.
Comments:		there really are no treatments but medications. i also go to the foot doctor, to have callouses removed every two weeks caused from arthritis. three drs. have told me i'm walking on the bones in my feet instead of the soles and to forget about working.