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 >>

NEWS HIGHLIGHTS

Media Articles Related to Flexeril (Cyclobenzaprine)

Muscle Spasms
Source: MedicineNet Claudication Specialty [2011.12.12]
Title: Muscle Spasms
Category: Diseases and Conditions
Created: 6/16/2009 12:00:00 AM
Last Editorial Review: 12/12/2011 12:00:00 AM

more news >>

Published Studies Related to Flexeril (Cyclobenzaprine)

Evaluation of the muscle relaxant cyclobenzaprine after third-molar extraction. [2011.10]
BACKGROUND: Pain, swelling and trismus are undesirable effects of extraction of impacted mandibular third molars. The authors conducted a study to evaluate the effectiveness of the muscle relaxant cyclobenzaprine when used as a supplement to cryotherapeutic, antibiotic and steroidal anti-inflammatory treatment with the aim of reducing undesirable consequences after third-molar extraction... CONCLUSIONS: The results of this trial indicate that the influence of cyclobenzaprine over pain, swelling and trismus does not justify prescribing additional medication for patients undergoing third-molar extraction. CLINICAL IMPLICATIONS: The muscle relaxant cyclobenzaprine was ineffective in reducing pain, swelling and trismus after third-molar extraction.

Steady-state pharmacokinetics of once-daily cyclobenzaprine extended release: a randomized, double-blind, 2-period crossover study in healthy volunteers. [2011.06]
BACKGROUND: The single-dose pharmacokinetic profile of cyclobenzaprine extended-release (CER) has been previously characterized and compared with the pharmacokinetics of cyclobenzaprine immediate-release (CIR) administered 3 times daily for 3 doses. OBJECTIVE: The objective of this study was to characterize the multiple-dose pharmacokinetic properties of once-daily CER 30 mg and CIR 10 mg TID formulations in healthy volunteers... CONCLUSIONS: Once-daily CER 30 mg delivered sustained plasma cyclobenzaprine levels over 24 hours at steady state. Owing to a protocol violation, steady-state pharmacokinetic properties for CIR could not be assessed. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Evaluation of the muscle relaxant cyclobenzaprine after third-molar extraction. [2011]
aim of reducing undesirable consequences after third-molar extraction... CONCLUSIONS: The results of this trial indicate that the influence of

Steady-state pharmacokinetics of once-daily cyclobenzaprine extended release: a randomized, double-blind, 2-period crossover study in healthy volunteers. [2011]
in healthy volunteers... CONCLUSIONS: Once-daily CER 30 mg delivered sustained plasma cyclobenzaprine

Efficacy and tolerability of cyclobenzaprine extended release for acute muscle spasm: a pooled analysis. [2010.07]
OBJECTIVE: To assess the efficacy and tolerability of once-daily cyclobenzaprine extended release (CER) 15 and 30 mg in relieving acute muscle spasm... CONCLUSION: Once-daily CER was effective in relieving acute muscle spasm based on patient's rating of medication helpfulness at day 4 and was generally well tolerated with a low rate of reported somnolence.

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Clinical Trials Related to Flexeril (Cyclobenzaprine)

Cyclobenzaprine Extended Release (ER) for Fibromyalgia [Recruiting]
Amrix (Cyclobenzaprine hydrochloride Extended release capsules) is approved by the FDA as a muscle relaxant, indicated for the treatment of muscle spasm associated with acute, painful musculoskeletal conditions. Cyclobenzaprine ER (Amrix TM) has a distinct pharmacokinetic profile providing early systemic exposure and consistent plasma concentration over several hours. Overall, a single dose of Amrix 30 mg is similar to that of cyclobenzaprine immediate release 10 mg three times daily. This ER formula should improve compliance, with similar efficacy and possibly less side effects as is often the case with slower release formulations.

There are clinical studies showing that cyclobenzaprine can alleviate pain secondary to Fibromyalgia induced muscle tone. This multi-layered evidence base suggests that cyclobenzaprine may be able to alleviate pain in fibromyalgia. Theoretically in fibromyalgia, pain is interpreted centrally and possibly occurs due to said muscle spasm . Cyclobenzaprine may relieve this pain, thus allowing patients to function better during the day and sleep better at night. Cyclobenzaprine has tricyclic antidepressant structure which may also allow pain signal dampening in the spinal cord as well, similar to amitriptyline which is used off-label for neuropathic pain as well.

Fibromyalgia (FM) is an illness that may involve medical, rheumatologic, autoimmune, sleep, endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger points. Greater than 90% of these patients will report fatigue as a key symptom as well. There are several investigation lines into the treatment of FM induced pain. Exercise, behavioral therapy, amitryptiline, duloxetine, tramadol, sodium oxybate, pregabalin all have randomized trials and almost all focus on pain. There are very few studies evaluating cyclobenzaprine and none studying to Cyclobenzaprine ER formulation. None evaluate pain reduction, sleep and fatigue improvement.

Cyclobenzaprine is a drug with minimal adverse effects (dry mouth, dizziness, fatigue, constipation, somnolence, nausea, and dyspepsia). It may have a safer tolerability profile than some of the FM medications noted above. As cyclobenzaprine is often studied and often added as an augmentation agent to patients' regimens who suffer from acute painful musculoskeletal conditions, the authors feel that cyclobenzaprine would also be effective in this population. The authors wish to conduct a study to determine if cyclobenzaprine ER is safe and tolerable in the treatment of FM induced pain, and secondary fatigue and insomnia. This initial study may allow for continued regulatory studies with this product in FM subjects. The authors propose a double-blind placebo controlled study to determine if cyclobenzaprine ER is safe and effective in reversing FM induced pain, and secondary fatigue and insomnia.

Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine [Recruiting]
The primary objective of the study is to evaluate the effectiveness and safety of cyclobenzaprine hydrochloride extended release (Amrix 15mg/day) for the prophylaxis of chronic migraine compared to a placebo medication. A second objective, is to find out whether there is an improvement in quality of sleep and self-reported depression in patients taking Amrix 15mg daily. The hypothesis is that the number of migraine days per month of patients treated with Amrix 15mg daily will be significantly lower than those patients treated with placebo.

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.

Use of Cyclobenzaprine After Vaginal Surgery [Recruiting]
The management of post-operative pain in patients after vaginal surgery provides many unforeseen challenges. Although vaginal surgery is considered a minimally invasive approach for the repair of pelvic floor prolapse and urinary incontinence, patients may still experience varying degrees of discomfort and post-operative pain. Narcotics, however, can introduce a host of problems in addition to the potential addictive properties of the medication. A vicious cycle ensues as patients seek better pain control at the expense of worsening constipation, but without adequate control of pain after surgery, voiding dysfunctions are often exaggerated.

Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management of acute musculoskeletal injuries, but the practice of prescribing this centrally acting muscle relaxant for post-operative patients has also been successful in the management of pain.

An online search of medical databases revealed that there are currently no published retrospective or prospective studies determining the efficacy of cyclobenzaprine in post surgical patients in conjunction with traditional pain management. The investigators hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic floor muscle attributable to surgery and thereby reduce the use of narcotics. Consequently, the reduction of narcotics and the control of post-surgical pain may also hasten the return of normal urinary and defecatory function.

Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago [Not yet recruiting]
The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.

more trials >>

Reports of Suspected Flexeril (Cyclobenzaprine) Side Effects

Pain (14),  Deafness (12),  Drug Ineffective (11),  Oedema Peripheral (10),  Glaucoma (9),  Hyperbilirubinaemia (9),  Respiratory Disorder (9),  Pierre Robin Syndrome (9),  Somnolence (9),  Cleft Palate (9), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Flexeril review by 23 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Migraine/Tension Headaches/Sleep
Dosage & duration:		10mg taken three times a day as needed for the period of currently taking it, have been on it for
Other conditions:		Mental Illness, Headaches, High Blood Pressure
Other drugs taken:		Ativan, Risperdal, Lexapro, Trazodone, Lamictal, Seroquel, Coreg, Verapamil, Albuterol
		Reported Results
Benefits:		Well, It made me relaxed during the day, and sometimes be able to be calm. It helped my headaches a lot. I would rate it as a 9 or 10. I would recommend this drug definately!
Side effects:		Dry mouth and sometimes restless legs.
Comments:		I was to take 10mg three times a day for headaches as needed. My doctor said if it works, I can stay on it. I recently decided to get off narcotics and this is a good medicine to take.

Flexeril review by 27 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Tension in jaw and Bruxism (grinding of teeth)
Dosage & duration:		5mg - before bedtime taken bedtime (6-8 hours before waking) for the period of 1 week
Other conditions:		None
Other drugs taken:		Adderall 10 1/2mg, Maxalt 5mg (take for migraines) and Albuteral Sulfate (only when needed)
		Reported Results
Benefits:		I woke up with a more relaxed jaw. I have bruxism which is the medical term for the grinding of teeth or the clenching of jaws. So if I have alot of tension in my jaw before I go to bed I will grind my teeth which will lead to migraines. Taking Cyclobenzaprine(Flexeril) before I go to bed helps me avoid waking up in pain due to Bruxism.
Side effects:		I have only had one side effect due to mixing Cyclobenzaprine(Flexeril) with Maxalt which lead to being fatigue and drowsiness.
Comments:		It has been only 1 week of taking Cyclobenzaprine so I may experience different side effects the more I take it. So far this medication has worked for me. I did notice one very positive benefit from taking this medication this 1 week. I started this medication around the same time I start to get PMS symptoms "Mainly very moody and argumentative" and I'm amazed how Cyclobenzaprine effected my PMS symptoms. I have absolutely been the most pleasant person to be around. It feels great to be myself and not angry at everything.

Flexeril review by 47 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		back spasm/pain
Dosage & duration:		10 mg taken once for the period of once
Other conditions:		I was given the medication for back spasms and pain after a pulled muscle.
Other drugs taken:		Toprol xl 50 mg
		Reported Results
Benefits:		It helped with the muscle pain for most of the day.
Side effects:		I was unable to function for the majority of the day it got worse as the day went on. I felt like someone had drugged me. I slept but would feel like I was awake but paralyzed. My speech was slurred and could hardly move. This was all 8 hours into taking the medication. I had not taken a muscle relaxer for about 10 years and now I know why!
Comments:		I was to take the medicine 1 tablet three times a day.