Brand Name: Flexeril, Amrix and Fexmid
Generic Name: Cyclobenzaprine
Drug Class: Skeletal Muscle Relaxants

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Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N•HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates.

Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, Ndimethyl- 1-propanamine hydrochloride, and has the following structural formula:

FLEXERIL 5 mg (Cyclobenzaprine HCl) is supplied as a 5 mg tablet for oral administration. FLEXERIL 10 mg (Cyclobenzaprine HCl) is supplied as a 10 mg tablet for oral administration.

FLEXERIL tablets contain the following inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide, lactose, magnesium stearate, starch, and titanium dioxide. FLEXERIL 5 mg tablets also contain Yellow D&C #10 Aluminum Lake HT, and Yellow FD&C #6 Aluminum Lake.

What Health Conditions Does Flexeril Treat ?

Flexeril can treat Muscle Spasm, Sciatica, Fibromyalgia, migraine, Chronic Myofascial Pain, and Joint Disorder.

How Flexeril works

- Flexeril is a brand (trade) name for cyclobenzaprine. Cyclobenzaprine relaxes muscles by reducing muscle hyperactivity through an action on both gamma and alpha motor systems (these are nerve fibers that directly connect with skeletal muscle and are responsible for muscle contraction). Cyclobenzaprine acts primarily through the brain stem rather than the spinal cord and does not act directly on skeletal muscle.
- Flexeril will not reduce muscle spasm due to central nervous system (CNS) disease, such as cerebral palsy.
- Flexeril belongs to a class of drugs known as muscle relaxants.

What is Flexeril

Flexeril (cyclobenzaprine) is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain. Flexeril is used together with rest and physical therapy to treat skeletal muscle conditions such as pain, injury, or spasms. Flexeril may also be used for purposes not listed in this medication guide.

Warnings

You should not use Flexeril if you have a thyroid disorder, heart block, congestive heart failure, a heart rhythm disorder, or you have recently had a heart attack. Do not use cyclobenzaprine if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine.

Before taking this medicine

You should not use Flexeril if you are allergic to cyclobenzaprine, or if you have:

a thyroid disorder;
heart block, heart rhythm disorder, congestive heart failure; or
if you have recently had a heart attack.

Flexeril is not approved for use by anyone younger than 15 years old. Do not use Flexeril if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. Some medicines can interact with cyclobenzaprine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications. To make sure Flexeril is safe for you, tell your doctor if you have ever had:

liver disease;
glaucoma;
enlarged prostate; or
problems with urination.

It is not known whether cyclobenzaprine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk. Older adults may be more sensitive to the effects of this medicine.

WHAT IS CYCLOBENZAPRINE AND HOW DOES IT WORK?

Cyclobenzaprine is a prescription drug used short-term to treat muscle spasms. It is usually used along with rest and physical therapy. It works by helping to relax the muscles. Cyclobenzaprine is available under the following different brand names: Flexeril, Amrix and Fexmid. Dosages of Cyclobenzaprine: Tablet (adult and pediatric)

5 mg
7.5 mg
10 mg

Capsule, extended-release (adult only)

15 mg
30 mg

Dosage Considerations – Should be Given as Follows: Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. This medication is not recommended for use in older adults because they may be at greater risk for side effects while using this drug. This medication should only be used short-term (for 3 weeks or less) unless directed by your doctor. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Muscle Spasm Immediate-release tablet

Adult: 5 mg orally every 8 hours, may increase dose to 7.5-10 mg orally every 8 hours as needed
Under 15 years of age: Safety and efficacy not established
Over 15 years of age: 5 mg orally every 8 hours, may increase dose to 7.5 mg orally every 8 hours as needed
Geriatric: Immediate-release tablet: 5 mg/day orally initially; dose slowly upward and consider less frequent dosing

Extended-release capsule

Adult 15 mg orally once per day; some patients may require up to 30 mg orally once per day
Under 18 years of age: Safety and efficacy not established
Geriatric: Extended-release capsule not recommended in elderly, because of increased plasma levels (40%) and prolonged half-life (56%) compared with young adults

Dosing Modifications Hepatic impairment

Immediate-release tablet: 5 mg/day orally initially; dose slowly and consider less frequent dosing
Extended-release capsule: Not recommended in mild-to-severe hepatic impairment

Renal impairment

Not studied

For the Consumer

Applies to cyclobenzaprine: oral capsule extended release, oral suspension, oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, cyclobenzaprine (the active ingredient contained in Flexeril) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur while taking cyclobenzaprine: Rare

Clumsiness or unsteadiness
confusion
fainting
mental depression
problems in urinating
ringing or buzzing in the ears
skin rash, hives, or itching occurring without other symptoms of an allergic reaction listed above
unusual thoughts or dreams
yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking cyclobenzaprine: Symptoms of overdose

Convulsions (seizures)
drowsiness (severe)
dry, hot, flushed skin
fast or irregular heartbeat
hallucinations (seeing, hearing, or feeling things that are not there)
increase or decrease in body temperature
troubled breathing
unexplained muscle stiffness
unusual nervousness or restlessness (severe)
vomiting (occurring together with other symptoms of overdose)

Side effects not requiring immediate medical attention

Some side effects of cyclobenzaprine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred vision
dizziness, drowsiness, or lightheadedness
dryness of the mouth

Less common or rare

Bloated feeling or gas, indigestion, nausea or vomiting, or stomach cramps or pain
constipation
diarrhea
excitement or nervousness
frequent urination
general feeling of discomfort or illness
headache
muscle twitching
numbness, tingling, pain, or weakness in hands or feet
pounding heartbeat
problems in speaking
trembling
trouble sleeping
unpleasant taste or other taste changes
unusual muscle weakness
unusual tiredness

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first. Severe Interactions of Cyclobenzaprine include:

isocarboxazid
phenelzine
tranylcypromine

Cyclobenzaprine has moderate interactions with at least 43 different drugs. Cyclobenzaprine has mild interactions with at least 221 different drugs. Minor interactions of Cyclobenzaprine include:

desipramine
dimenhydrinate
donepezil
eucalyptus
galantamine
sage
tacrine
trazodone

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

WHAT ARE WARNINGS AND PRECAUTIONS FOR CYCLOBENZAPRINE?

Warnings

This medication contains cyclobenzaprine. Do not take Flexeril, Amrix or Fexmid if you are allergic to cyclobenzaprine or any ingredients contained in this drug
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

Avoid use if hypersensitivity to cyclobenzaprine or if you have hyperthyroidism
During the acute recovery phase of myocardial infarction and in patients with irregular heartbeat, heart block or conduction disturbances, or congestive heart failure
Do not use simultaneously or within 14 days of discontinuing antidepressants
Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or similar tricyclic antidepressants) simultaneously with antidepressants

Effects of Drug Abuse

May cause drowsiness/dizziness; do not ingest alcohol or other central nervous system depressants as it may impair ability to operate heavy machinery

Short-Term Effects

May cause drowsiness/dizziness; do not ingest alcohol or other central nervous system depressants as it may impair ability to operate heavy machinery
See "What Are Side Effects Associated with Using Cyclobenzaprine?"

Long-Term Effects

Cyclobenzaprine use is only recommended for short periods, 2-3 weeks
See "What Are Side Effects Associated with Using Cyclobenzaprine?"

Cautions

Use only for short periods, 2-3 weeks
Use caution in urinary retention, narrow-angle glaucoma or intensive outpatient program, or simultaneous use of other anticholinergic drugs
May cause drowsiness/dizziness; do not ingest alcohol or other central nervous system depressants as it may impair ability to operate heavy machinery
May take with food to avoid stomach upset
Serotonin syndrome reported when co-administered with other drugs that increase serotonin (for example selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or anti-depressants [see also Contraindications])
Not effective for treatment of spasticity associated with cerebral/spinal cord disease or for pediatric cerebral palsy
Elderly patients may be more prone to adverse effects and require dose/frequency reduction
Use immediate release with caution in hepatic impairment; avoid extended-release form as it is not recommended with hepatic impairment

Pregnancy and Lactation

Cyclobenzaprine use in pregnancy may be acceptable
Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk
Consult with your physician prior to use
Cyclobenzaprine excretion in breast milk is unknown
Use with caution
Consult with your physician prior to use

Cyclobenzaprine is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Cyclobenzaprine is in a class of medications called skeletal muscle relaxants. It works by acting in the brain and nervous system to allow the muscles to relax.

How should this medicine be used?

Cyclobenzaprine comes as a tablet and an extended-release capsule to take by mouth. The tablet is usually taken with or without food three times a day. The extended-release capsule is usually taken with or without food once a day. Do not take this drug for more than 3 weeks without talking to your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cyclobenzaprine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release capsules whole; do not chew or crush them.

If you are not able to swallow the extended-release capsule whole, mix the contents of the capsule with applesauce. Eat the mixture right away and swallow without chewing. After you eat the mixture, take a drink, and swish and swallow to make sure that you have received all the medication.

What special precautions should I follow?

Before taking cyclobenzaprine,

tell your doctor and pharmacist if you are allergic to cyclobenzaprine, any other medications, or any of the ingredients in cyclobenzaprine tablets or capsules. Ask your pharmacist for a list of the ingredients.
tell your doctor if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor will probably tell you not to take cyclobenzaprine if you are taking one of these medications.
tell your doctor and pharmacist what other prescription and nonprescription drugs, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: medications for allergies, coughs, or colds; barbiturates such as butabarbital (Butisol), phenobarbital, and secobarbital (Seconal); bupropion (Aplenzin, Forfivo XL, Wellbutrin, Zyban); meperidine (Demerol); sedatives; sleeping pills; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); selective serotonin and norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), milnacipran (Savella) and venlafaxine (Effexor); tranquilizers; tricyclic antidepressants (TCAs) such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); tramadol (Conzip, Ultram, in Ultracet); verapamil (Calan, Covera HS, Verelan, in Tarka); or any other medication for depression, mood, anxiety, or thought disorder. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with cyclobenzaprine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. ;
tell your doctor if you are recovering from a recent heart attack, or if you have an overactive thyroid gland. heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body), or an irregular heartbeat, heart block, or other problems with the electrical impulses of your heart. Your doctor will probably tell you not to take cyclobenzaprine.
tell your doctor if you have increased pressure in the eye or glaucoma, difficulty urinating, or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking cyclobenzaprine, call your doctor immediately.
talk to your doctor about the risks and benefits of taking cyclobenzaprine if you are 65 years of age or older. Older adults should not usually take cyclobenzaprine because it is not as safe or effective as other medications that can be used to treat the same condition.
you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how cyclobenzaprine affects you.
ask your doctor about the safe use of alcoholic beverages while you are taking cyclobenzaprine. Cyclobenzaprine can make the effects of alcohol worse.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for the missed one.

What side effects can this medication cause?

Cyclobenzaprine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

dry mouth
dizziness
nausea
constipation
heartburn
extreme tiredness

If you experience any of the following symptoms, call your doctor immediately:

skin rash
hives
swelling of the face or tongue
difficulty breathing or swallowing
irregular or fast heart rate
chest pain

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store the extended-release capsule away from light.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

drowsiness
fast or irregular heartbeat
feeling agitated
confusion
trouble speaking or moving
dizziness
nausea
vomiting
hallucination (seeing things or hearing voices that do not exist)
tremor
loss of consciousness

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

Amrix^®
Flexeril^®^¶