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.

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NEWS HIGHLIGHTS

Media Articles Related to Flexeril (Cyclobenzaprine)

Muscle Spasms
Source: MedicineNet Hamstring Injury 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)

Cyclobenzaprine ER for muscle spasm associated with low back and neck pain: two randomized, double-blind, placebo-controlled studies of identical design. [2009.05]
OBJECTIVE: To evaluate efficacy and tolerability of once-daily cyclobenzaprine extended release (CER) 15- and 30-mg capsules in patients with muscle spasm associated with acute, painful musculoskeletal conditions... CONCLUSIONS: Once-daily CER 15 mg (study 2) and CER 30 mg (study 1) were effective in treating muscle spasm associated with painful musculoskeletal conditions after 4 days of treatment. Differences between CER and placebo groups did not reach statistical significance on all efficacy measures, and the protocols were not powered to detect differences between active treatment arms. CER was generally safe and well tolerated, with low rates of somnolence.

Bioavailability of a controlled-release cyclobenzaprine tablet and influence of a high fat meal on bioavailability. [2009.04]
CONCLUSIONS: The controlled release tablet showed a relative bioavailability comparable with equal dose of the immediate release product and produced a significantly lower Cmax, as expected in a controlled release formulation. The concomitant administration of the tablet with a high fat meal produced an increase on its bioavailability, mainly in Cmax, with no evidence of dose-dumping.

A pharmacokinetic comparison of single doses of once-daily cyclobenzaprine extended-release 15 mg and 30 mg: a randomized, double-blind, two-period crossover study in healthy volunteers. [2009.01]
OBJECTIVE: The purpose of this study was to compare the pharmacokinetics and tolerability of single oral doses of cyclobenzaprine extended-release (CER) 15- and 30-mg capsules... CONCLUSIONS: Once-daily CER 15 and 30 mg exhibited similarly shaped pharmacokinetic profiles. AUC(0-168), AUC(0-infinity)), and C(max) values for the 30-mg dose were approximately double those for the 15-mg dose, a result consistent with previously reported data on the dose proportionality of cyclobenzaprine immediate release.

Pharmacokinetic profile of armodafinil in healthy subjects : pooled analysis of data from three randomized studies. [2009]
BACKGROUND AND OBJECTIVES: Armodafinil (R-modafinil) is the R- and longer-lasting isomer of the racemic compound modafinil, a wakefulness-promoting medication. Armodafinil is eliminated approximately three times more slowly than the S-isomer of racemic modafinil. Published studies have demonstrated the efficacy of armodafinil for treating excessive sleepiness associated with obstructive sleep apnoea, shift work disorder and narcolepsy. The objectives of this study were to describe the pharmacokinetic profile, tolerability and safety of armodafinil in healthy subjects... CONCLUSIONS: In the present analysis, armodafinil exhibited linear pharmacokinetics over the dose range of 50-400 mg. While food affected the rate but not the extent of absorption, peak plasma concentrations were reached in approximately 2 hours when the drug was taken on an empty stomach. With once-daily dosing, steady state appeared to be reached within 7 days. After reaching peak plasma levels, concentrations of armodafinil declined monophasically, with a mean elimination half-life of around 15 hours. Armodafinil was generally well tolerated.

Comparison of the single-dose pharmacokinetics of once-daily cyclobenzaprine extended-release 30 mg and cyclobenzaprine immediate-release 10 mg three times daily in the elderly: a randomized, open-label, crossover study. [2009]
BACKGROUND AND OBJECTIVE: The clinical utility of cyclobenzaprine for the treatment of muscle spasm associated with acute, painful musculoskeletal conditions is limited by cholinergic adverse effects associated with its use. As expected, these effects may be pronounced in the elderly in whom altered renal and hepatic function may change drug pharmacokinetics. The goal of this study was to characterize the pharmacokinetics of the extended-release formulation of cyclobenzaprine (CER) in elderly volunteers... CONCLUSION: Once-daily CER 30 mg exhibited controlled release of cyclobenzaprine and resulted in systemic exposure similar to that of CIR in subjects aged 65-75 years.

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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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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 39 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Restless Sleep
Dosage & duration:		10mg taken 1 at bedtime for the period of As needed for a Month
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Much more relaxed evenings and better sleep. Was able to sleep through the night. Woke in mornings without back aches and pains. Flexeril was effective as a muscle relaxant.
Side effects:		Very sedated feeling the next morning. Found it very dificult to approach the next day with any vigor. Additionally there was a feeling of nervousness or anxiety associated with taking this medication.
Comments:		One dose nightly as needed for sleep. No other medications or supplements were used.

Flexeril review by 46 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		back pain
Dosage & duration:		1 pill taken every 6-8 hrs for the period of about a week
Other conditions:		nothing else
Other drugs taken:		nothing else
		Reported Results
Benefits:		I had very bad lower back pain with spasms and considerable swelling on my left side, to the extend that when standing, I was leaning to my right. Flexeril took care of most of the pain and much of the swelling.
Side effects:		I felt much less alert -- not tired or sleepy, exactly, but sort of like inebriated, but without the buzz.
Comments:		Once the swelling and discomfort were at a manageable level, I saw a chiropractor. Although his ultrasound treatments weren't particularly effective, I greatly value the information he gave me relating to how I should sit, lie, stand, helpful exercises, etc.