FusePaq Tabradol

Description

Cyclobenzaprine is used to help relax certain 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 take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem.

Cyclobenzaprine is also used to treat a condition called fibromyalgia (muscle pain and stiffness).

Cyclobenzaprine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of this medicine's side effects.

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

This product is available in the following dosage forms:

Capsule, Extended Release

Tablet

Suspension

Before Using

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

Allergies

Tell 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 or sublingual tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cyclobenzaprine sublingual tablet in the elderly.

Because 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.

Breastfeeding

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 before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking 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 medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Cisapride

Dronedarone

Isocarboxazid

Levoketoconazole

Levomethadyl

Linezolid

Mesoridazine

Methylene Blue

Ozanimod

Phenelzine

Pimozide

Piperaquine

Potassium Chloride

Potassium Citrate

Procarbazine

Rasagiline

Safinamide

Saquinavir

Selegiline

Sparfloxacin

Terfenadine

Thioridazine

Tranylcypromine

Ziprasidone

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

Aclidinium

Adagrasib

Alfentanil

Alfuzosin

Almotriptan

Alprazolam

Amantadine

Amineptine

Amiodarone

Amisulpride

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Anagrelide

Anileridine

Apomorphine

Aprobarbital

Aripiprazole

Aripiprazole Lauroxil

Arsenic Trioxide

Artemether

Asenapine

Astemizole

Atazanavir

Atropine

Azithromycin

Baclofen

Barbital

Bedaquiline

Belladonna

Benperidol

Benzhydrocodone

Benzphetamine

Benztropine

Biperiden

Bromazepam

Brompheniramine

Buprenorphine

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Other Interactions

Certain medicines 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 medicines 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 usually 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.

Ethanol

Tobacco

Other Medical Problems

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

Congestive heart failure or

Heart attack, recent or

Heart block or

Heart rhythm problems (eg, arrhythmia) or

Hyperthyroidism (overactive thyroid)—Should not be used in patients with these conditions.

Glaucoma, angle closure, history of or

Increased pressure in the eye, history of or

Seizures, history of or

Trouble urinating, history of—Use with caution. May these conditions worse.

Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body. .

Liver disease, moderate or severe—Use is not recommended in patients with these conditions. .

Proper Use

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 1 tablespoon of applesauce. Swallow the mixture right away without chewing. Rinse the mouth to make sure all of the medicine has been swallowed. Do not save any of the mixture to use later.

If you are using the sublingual tablet:

Drink a few sips of water before taking this medicine to make sure your mouth is moist to lessen numbness of the mouth. Take this medicine after brushing teeth.

Do not cut, crush, chew, or swallow it.

Place the tablet under the tongue until it is dissolved.

Do not eat or drink for at least 15 minutes until the tablets are completely dissolved. Do not drink hot, cold, or acidic drinks until the morning.

Do not talk for at least 5 minutes after taking this medicine.

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.

For fibromyalgia:

For sublingual dosage form (tablets):

Adults—At first, 2.8 milligrams (mg) once a day at bedtime on Days 1 to 14, followed by 5.6 mg once a day at bedtime on Days 15 and onwards. However, the dose is usually not more than 5.6 mg per day.

Children—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.

If you miss a dose of the sublingual tablet, take the next dose at your regular time. 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.

Precautions

It is very important that your doctor check your progress at regular visits for any problems that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

If your condition does not improve within 2 or 3 weeks, or if it becomes worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 2 weeks after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not use the this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

This medicine may cause a serious condition called serotonin syndrome if taken together with some medicines, including some pain or migraine medicines (eg, bupropion, meperidine, tramadol, Wellbutrin®, Demerol®, Zydol®) or medicines for depression (eg, SNRIs, SSRIs, TCAs). Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or 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 the above while you are using this medicine.

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause mouth problems. Check with your doctor right away if you have discomfort, irritation, numbness, pain, or tingling in the mouth.

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, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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:

More common

Dry mouth or throat

excitement or nervousness

numbness, tingling, discomfort, or pain in your mouth, teeth, or tongue

trouble sleeping

unusual muscle weakness

Rare

Agitation

anxiety

black, tarry stools

blurred vision

chest pain, discomfort, or tightness

chills

clumsiness or unsteadiness

confusion

cough

dark urine

difficulty in moving

difficulty swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, pounding, or irregular heartbeat or pulse

fever

headache

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

mental depression

muscle aches, cramps, pains, stiffness, or twitching

nausea

numbness, tingling, pain, or weakness in hands or feet

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pounding in the ears

problems in speaking

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

ringing or buzzing in the ears

seeing, hearing, or feeling things that are not there

seizures

shakiness in the legs, arms, hands, or feet

skin rash, hives, or itching

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swelling

swollen glands

trembling or shaking of the hands or feet

trouble breathing

unusual bleeding or bruising

unusual thoughts or dreams

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

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

seizures

trouble 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:

Less common

Acid or sour stomach

belching

bloated feeling or gas

constipation

diarrhea

frequent urination

general feeling of discomfort or illness

heartburn

indigestion

stomach discomfort, upset, or pain

unpleasant taste or other taste changes

Rare

Inability to have or keep an erection

increased or loss interest in sexual intercourse

increased or loss in sexual ability, desire, drive, or performance

loss or thinning of the hair

swelling of the breasts or breast soreness in both females and males

swelling or inflammation of the mouth

swollen joints

unexpected or excess milk flow from the breasts

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.