FusePaq Tabradol (Oral)

Cyclobenzaprine is used to help relax specific muscles in your body. It helps relieve pain, stiffness, and discomfort caused by strains, sprains, or injuries to your muscles. However, this medicine does not replace the need for rest, exercise, physical therapy, or other treatments that your doctor may suggest for your medical issue. Cyclobenzaprine works on the central nervous system (CNS) to produce its muscle relaxant effects. Its effects on the CNS may also lead to some side effects of this medicine.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking it.

If your condition does not improve within 2 or 3 weeks, or if it gets worse, contact your doctor.

Do not use the extended-release capsules if you have taken an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the last 14 days.

Contact your doctor right away if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or if you see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants include antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, other muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these while using this medicine.

This medicine may cause some people to have blurred vision or become drowsy, dizzy, or less alert than usual. Make sure you know how you react to this medicine before driving, using machines, or doing anything else that could be dangerous if you feel dizzy or are not alert and able to see well.

Cyclobenzaprine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, contact your medical doctor or dentist. Ongoing dryness of the mouth may increase the risk of dental issues, including tooth decay, gum disease, and fungal infections.

In deciding to use a medicine, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cyclobenzaprine extended-release capsules in the pediatric population. Safety and efficacy have not been established.

Geriatric

Since of the possibility of higher blood levels in the elderly as compared to younger adults, use of cyclobenzaprine extended-release capsules is not recommended in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks prior to using this medication while breastfeeding.

Interactions with Drugs

Although certain medications should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially critical that your healthcare professional know if you are using any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medicines is not advised. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Furazolidone
• Iproniazid
• Isocarboxazid
• Levoketoconazole
• Levomethadyl
• Linezolid
• Mesoridazine
• Methylene Blue
• Moclobemide
• Pargyline
• Phenelzine
• Pimozide
• Piperaquine
• Potassium Citrate
• Procarbazine
• Rasagiline
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tranylcypromine
• Ziprasidone

Using this medicine with any of the following drugs is typically not advised, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

• Adagrasib
• Alfentanil
• Almotriptan
• Alprazolam
• Amantadine
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Atazanavir
• Balofloxacin
• Bedaquiline
• Benzhydrocodone
• Benzphetamine
• Besifloxacin
• Bromazepam
• Buprenorphine
• Buserelin
• Butriptyline
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Ceritinib
• Cetirizine
• Chloroquine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clothiapine
• Clozapine
• Codeine
• Crizotinib
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Dothiepin
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Efavirenz
• Encorafenib
• Enoxacin
• Entrectinib
• Erythromycin
• Escitalopram
• Esketamine
• Etrasimod
• Fenfluramine
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Fluconazole
• Flumequine
• Fluoxetine
• Fluvoxamine
• Formoterol
• Foscarnet
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Iprindole
• Ivabradine
• Ivosidenib
• Ketamine
• Ketoconazole
• Lacosamide
• Lapatinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomefloxacin
• Lorcaserin
• Loxapine
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Melitracen
• Meperidine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Metoclopramide
• Metronidazole
• Midazolam
• Milnacipran
• Mirtazapine
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nadifloxacin
• Nafarelin
• Nefazodone
• Nilotinib
• Norfloxacin
• Nortriptyline
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pazufloxacin
• Pefloxacin
• Periciazine
• Phenobarbital
• Pimavanserin
• Pitolisant
• Pixantrone
• Ponesimod
• Posaconazole
• Potassium Oxybate
• Pregabalin
• Primidone
• Propizepine
• Protriptyline
• Prulifloxacin
• Quetiapine
• Quinidine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Revefenacin
• Ribociclib
• Ropeginterferon Alfa-2b-njft
• Rufloxacin
• Scopolamine
• Secretin Human
• Selpercatinib
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Solifenacin
• Sotalol
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tapentadol
• Telithromycin
• Tetrabenazine
• Tianeptine
• Tiotropium
• Topiramate
• Tramadol
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vortioxetine
• Zolpidem
• Zuclopenthixol
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is normally not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you tell your doctor if you have any other medical issues, especially:

• Congestive heart failure or
• Heart attack, recent or
• Heart block or
• Heart rhythm issues (eg, arrhythmia) or
• Hyperthyroidism (overactive thyroid)—Should not be used in patients with these conditions.

• Glaucoma, angle closure, history of or
• Trouble urinating, history of—Use with caution. May these conditions worse.

• Liver disease—Use with caution. The effects may be increased since of slower removal of the drug from the body..

Along with its needed effects, a medicine 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:

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:

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)

Some side effects 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Amrix
• Fexmid
• Flexeril
• FusePaq Tabradol

Available Dosage Forms:

• Capsule, Extended Release
• Tablet
• Suspension

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. To do so may increase the chance of serious side effects.

Swallow the extended-release capsule whole. If you cannot swallow the capsule whole, you may open the capsule and sprinkle the contents over one tablespoon of applesauce. Swallow the mixture right away without chewing. Rinse the mouth to make sure all of the medicine have been swallowed. Do not save any of the mixture to use later.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For relaxing stiff muscles: For oral dosage form (extended-release capsules): Adults—15 milligrams (mg) once a day. Some patients may need 30 mg (one 30 mg capsule or two 15 mg capsules) per day. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults and children 15 years of age and older—10 milligrams (mg) 3 times a day. The largest amount should be no more than 60 mg (six 10-mg tablets) a day. Children younger than 15 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• How much cyclobenzaprine can I take?
• How long does it take for Flexeril to work?
• Is cyclobenzaprine a controlled substance or addictive?
• How long does Flexeril (cyclobenzaprine) stay in your system?
• Can I take cyclobenzaprine and Tylenol together?