Prescription drugs info

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.

Stop taking cyclobenzaprine and get emergency help immediately if any of the following effects occur:

Cyclobenzaprine Rare Side Effects
* Changes in the skin color of the face
* fast or irregular breathing
* large swellings that look like hives on the face, eyelids, mouth, lips, and/or tongue
* puffiness or swelling of the eyelids or the area around the eyes
* shortness of breath, troubled breathing, tightness in chest, and/or wheezing
* skin rash, hives, or itching

Check with your doctor immediately if any of the following side effects occur:

Cyclobenzaprine Rare Side Effects
* Fainting

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)

Check with your doctor as soon as possible if any of the following side effects occur:

Cyclobenzaprine Rare Side Effects
* Clumsiness or unsteadiness
* confusion
* mental depression or other mood or mental changes
* 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

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:

Cyclobenzaprine More common Side Effects
* Blurred vision
* dizziness or lightheadedness
* drowsiness
* dryness of mouth

Cyclobenzaprine Less common or rare Side Effects
* 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 in 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.

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It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

cyclobenzaprine 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; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using cyclobenzaprine.

You should NOT use the extended-release capsules if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days .

cyclobenzaprine may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to cyclobenzaprine before you drive, use machines, or do anything else that could be dangerous if you are 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, 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.

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

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Take cyclobenzaprine 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.

Cyclobenzaprine dosing
The dose of cyclobenzaprine 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 cyclobenzaprine. 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:

o For the oral dosage form (tablets):
+ Adults and teenagers 15 years of age and older—The usual dose is 10 milligrams (mg) three times a day. The largest amount should be no more than 60 mg (six 10-mg tablets) a day.
+ Children and teenagers up to 15 years of age—Dose must be determined by your doctor.

o For the oral dosage form (extended-release capsules):
+ Adults—The usual dose is 15 mg once a day. Some patients may require up to 30 mg (one 30 mg capsule or two 15 mg capsules) per day.
+ Children—Use and dose must be determined by your doctor .

Cyclobenzaprine missed dose
If you miss a dose of cyclobenzaprine, 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.

Cyclobenzaprine storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.

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Cyclobenzaprine is used to help relax certain muscles in your body. It helps relieve the pain, stiffness, and discomfort caused by strains, sprains, or injuries to your muscles. However, cyclobenzaprine does not take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem. Cyclobenzaprine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of cyclobenzaprine’s side effects.

Cyclobenzaprine may also be used for other conditions as determined by your doctor.

Cyclobenzaprine is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cyclobenzaprine is used in certain patients with fibromyalgia syndrome (also called fibrositis or fibrositis syndrome).

Cyclobenzaprine commonly used brand name(s):

In the U.S.
* Amrix
* Fexmid
* Flexeril

Cyclobenzaprine available dosage forms:
* Capsule, Extended Release
* Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F). [See USP Controlled Room Temperature]. This is a bulk package. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.

KEEP CYCLOBENZAPRINE AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Manufactured by
Amneal Pharmaceuticals
Paterson, New Jersey 07504

Distributed by
Amneal Pharmaceuticals
Glasgow, Kentucky 42141
MF# 306
Rev.: 01-2008

Repackaged by
Rebel Distributors Corp.
Thousand Oaks, CA 91320

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The tablets are supplied as follows:

10 count bottle NDC 21695-037-10
12 count bottle NDC 21695-037-12
14 count bottle NDC 21695-037-14
15 count bottle NDC 21695-037-15
20 count bottle NDC 21695-037-20
21 count bottle NDC 21695-037-21
30 count bottle NDC 21695-037-30
45 count bottle NDC 21695-037-45
60 count bottle NDC 21695-037-60
90 count bottle NDC 21695-037-90
100 count bottle NDC 21695-037-00

Cyclobenzaprine hydrochloride 10 mg tablets are supplied as butterscotch yellow, round, film-coated convex tablets, debossed with “AN41″ on one side and plain on the other side.

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For most patients, the recommended dose of Cyclobenzaprine hydrochloride is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of Cyclobenzaprine hydrochloride for periods longer than two or three weeks is not recommended.

Less frequent dosing should be considered for hepatically impaired or elderly patients.

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Although rare, deaths may occur from overdosage with Cyclobenzaprine hydrochloride.

Multiple drug ingestion (including alcohol) is common in deliberate Cyclobenzaprine overdose. As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity may develop rapidly after Cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible. The acute oral LD50 of Cyclobenzaprine hydrochloride is approximately 338 and 425 mg/kg in mice and rats, respectively.

CYCLOBENZAPRINE OVERDOSAGE MANIFESTATIONS
The most common effects associated with Cyclobenzaprine overdose are drowsiness and tachycardia. Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations. Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.

Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of Cyclobenzaprine toxicity.

Other potential effects of overdosage include any of the symptoms listed under ADVERSE REACTIONS.

CYCLOBENZAPRINE OVERDOSAGE MANAGEMENT

General
As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.

In order to protect against the rare but potentially critical manifestations described above, obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. Monitoring of plasma drug levels should not guide management of the patient. Dialysis is probably of no value because of low plasma concentrations of the drug.

Gastrointestinal Decontamination
All patients suspected of an overdose with Cyclobenzaprine hydrochloride should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated.

Cardiovascular
A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose. Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation (as needed), should be instituted for patients with dysrhythmias and/or QRS widening. A pH >7.60 or a pCO2 <20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

CYCLOBENZAPRINE OVERDOSAGE AND CNS
In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines or, if these are ineffective, other anticonvulsants (e.g. phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center.

CYCLOBENZAPRINE OVERDOSAGE PSYCHIATRIC FOLLOW-UP
Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

CYCLOBENZAPRINE OVERDOSAGE PEDIATRIC MANAGEMENT
The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

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Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when Cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.

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Because of its atropine-like action, Cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.

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