Cyclobenzaprine Hcl (Flexeril)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Cyclobenzaprine Hcl (Flexeril)

FLEXERIL
(cyclobenzaprine hydrochloride) Tablet, Film Coated

DRUG DESCRIPTION

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, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:

FLEXERIL (cyclobenzaprine hydrochloride) Structural Formula Illustration

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 5 mg (Cyclobenzaprine HCl) tablets contain the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, starch, titanium dioxide, Yellow D&C #10 Aluminum Lake HT, and Yellow FD&C #6 Aluminum Lake.

FLEXERIL 10 mg (Cyclobenzaprine HCl) tablets contain the following inactive ingredients: hydroxypropyl cellulose, hypromellose, iron oxide, lactose, magnesium stearate, starch, and titanium dioxide.

What are the possible side effects of cyclobenzaprine (Amrix, Comfort Pac with Cyclobenzaprine, Fexmid, Flexeril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using cyclobenzaprine and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache,...

Read All Potential Side Effects and See Pictures of Flexeril »

What are the precautions when taking cyclobenzaprine hcl (Flexeril)?

Before taking cyclobenzaprine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, overactive thyroid (hyperthyroidism), heart problems (such as irregular heartbeat, heart block, heart failure, recent heart attack), difficulty urinating (such as due to an enlarged prostate), glaucoma.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic...

Read All Potential Precautions of Flexeril »

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

FLEXERIL (cyclobenzaprine hcl) 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 (cyclobenzaprine hcl) 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 (cyclobenzaprine hcl) has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose of FLEXERIL (cyclobenzaprine hcl) 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 FLEXERIL (cyclobenzaprine hcl) for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).

HOW SUPPLIED

FLEXERIL (cyclobenzaprine hcl) tablets are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are yellow-orange, 5-sided D-shaped, film coated tablets, coded FLEX over 5 on one side and without coding on the other. The 10 mg tablets are butterscotch yellow, 5-sided Dshaped, film coated tablets, coded FLEXERIL (cyclobenzaprine hcl) on one side and without coding on the other. The two dosage strengths are supplied as follows:

5 mg NDC
100 count bottle 50580-280-10
10 mg NDC
100 count bottle 50580-874-11

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature].

McNeil Consumer & Specialty Pharmaceuticals, Division Of Mcneil-Ppc, Inc., Fort Washington, PA 19034, Edition: February 2005

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Incidence of most common adverse reactions in the 2 double-blind3, placebo-controlled 5 mg studies (incidence of > 3% on FLEXERIL (cyclobenzaprine hcl) 5 mg):

  FLEXERIL 5 mg
N=464
FLEXERIL 10 mg
N=249
Placebo
N=469
Drowsiness 29% 38% 10%
Dry Mouth 21% 32% 7%
Fatigue 6% 6% 3%
Headache 5% 5% 8%

Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.

The following list of adverse reactions is based on the experience in 473 patients treated with FLEXERIL (cyclobenzaprine hcl) 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.

The adverse reactions reported most frequently with FLEXERIL (cyclobenzaprine hcl) were drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:

  Clinical Studies With FLEXERIL 10 mg Surveillance Program With FLEXERIL 10 mg
Drowsiness 39% 16%
Dry Mouth 27% 7%
Dizziness 11% 3%

Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.

The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet:

Body as a Whole: Syncope; malaise.

Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.

Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.

Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.

Musculoskeletal: Local weakness.

Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia.

Skin: Sweating.

Special Senses: Ageusia; tinnitus.

Urogenital: Urinary frequency and/or retention.

Causal Relationship Unknown

Other reactions, reported rarely for FLEXERIL (cyclobenzaprine hcl) under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:

Body as a whole: Chest pain; edema.

Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.

Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.

Endocrine: Inappropriate ADH syndrome.

Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.

Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss.

Musculoskeletal: Myalgia.

Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell's palsy; alteration in EEG patterns; extrapyramidal symptoms.

Respiratory: Dyspnea.

Skin: Photosensitization; alopecia.

Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.

Drug Abuse And Dependence

Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when FLEXERIL (cyclobenzaprine hcl) 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.

trial. FLEXERIL (cyclobenzaprine hcl) 5 mg and placebo data are from two studies.

Read the Flexeril (cyclobenzaprine hcl) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

FLEXERIL (cyclobenzaprine hcl) may have life-threatening interactions with MAO inhibitors. (See CONTRAINDICATIONS.)

FLEXERIL (cyclobenzaprine hcl) may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.

Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.2

REFERENCES

3Note: FLEXERIL (cyclobenzaprine hcl) 10 mg data are from one clinical

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS, below, and ADVERSE REACTIONS).

Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.

FLEXERIL (cyclobenzaprine hcl) may enhance the effects of alcohol, barbiturates, and other CNS depressants.

PRECAUTIONS

General

Because of its atropine-like action, FLEXERIL (cyclobenzaprine hcl) should be used with caution in patients with a history of urinary retention, angleclosure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.

Impaired Hepatic Function

The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Impairment). These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine. FLEXERIL (cyclobenzaprine hcl) should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward. Due to the lack of data in subjects with more severe hepatic insufficiency, the use of FLEXERIL (cyclobenzaprine hcl) in subjects with moderate to severe impairment is not recommended.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In rats treated with FLEXERIL (cyclobenzaprine hcl) for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis. In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in rats which died prior to 26 weeks; at lower doses, the change was not seen until after 26 weeks.

Cyclobenzaprine did not affect the onset, incidence or distribution of neoplasia in an 81-week study in the mouse or in a 105-week study in the rat.

At oral doses of up to 10 times the human dose, cyclobenzaprine did not adversely affect the reproductive performance or fertility of male or female rats. Cyclobenzaprine did not demonstrate mutagenic activity in the male mouse at dose levels of up to 20 times the human dose.

Pregnancy

Pregnancy Category B: Reproduction studies have been performed in rats, mice and rabbits at doses up to 20 times the human dose, and have revealed no evidence of impaired fertility or harm to the fetus due to FLEXERIL (cyclobenzaprine hcl) . There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when FLEXERIL (cyclobenzaprine hcl) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of FLEXERIL (cyclobenzaprine hcl) in pediatric patients below 15 years of age have not been established.

Use in the Elderly

The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly). The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions. For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed. In such patients FLEXERIL (cyclobenzaprine hcl) should be initiated with a 5 mg dose and titrated slowly upward.

REFERENCES

2ULTRAM® (tramadol HCl tablets, Ortho-McNeil Pharmaceutical)

ULTRACET® (tramadol HCl and acetaminophen tablets, Ortho-McNeil Pharmaceutical)

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Although rare, deaths may occur from overdosage with FLEXERIL (cyclobenzaprine hcl) . 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 FLEXERIL (cyclobenzaprine hcl) is approximately 338 and 425 mg/kg in mice and rats, respectively.

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.

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 FLEXERIL (cyclobenzaprine hcl) 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).

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.

Psychiatric Follow-Up

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

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.

CONTRAINDICATIONS

Hypersensitivity to any component of this product.

Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.

Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.

Hyperthyroidism.

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease.

Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (g) and alpha (a) motor systems.

Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation. Cyclobenzaprine caused slight to moderate increase in heart rate in animals.

Pharmacokinetics

Estimates of mean oral bioavailability of cyclobenzaprine range from 33% to 55%. Cyclobenzaprine exhibits linear pharmacokinetics over the dose range 2.5 mg to 10 mg, and is subject to enterohepatic circulation. It is highly bound to plasma proteins. Drug accumulates when dosed three times a day, reaching steady-state within 3-4 days at plasma concentrations about four-fold higher than after a single dose. At steady state in healthy subjects receiving 10 mg t.i.d. (n=18), peak plasma concentration was 25.9 ng/ mL (range, 12.8-46.1 ng/mL), and area under the concentration-time (AUC) curve over an 8-hour dosing interval was 177 ng.hr/mL (range, 80-319 ng.hr/mL).

Cyclobenzaprine is extensively metabolized, and is excreted primarily as glucuronides via the kidney. Cytochromes P-450 3A4, 1A2, and, to a lesser extent, 2D6, mediate N-demethylation, one of the oxidative pathways for cyclobenzaprine. Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8-37 hours; n=18); plasma clearance is 0.7 L/min. The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment. (See PRECAUTIONS, Use in the Elderly and PRECAUTIONS, Impaired Hepatic Function.)

Elderly

In a pharmacokinetic study in elderly individuals ( ≥ 65yrs old), mean (n=10) steady-state cyclobenzaprine AUC values were approximately 1.7 fold (171.0 ng.hr/mL, range 96.1-255.3) higher than those seen in a group of eighteen younger adults (101.4 ng.hr/ mL, range 36.1-182.9) from another study. Elderly male subjects had the highest observed mean increase, approximately 2.4 fold (198.3 ng.hr/mL, range 155.6-255.3 versus 83.2 ng.hr/mL, range 41.1-142.5 for younger males) while levels in elderly females were increased to a much lesser extent, approximately 1.2 fold (143.8 ng.hr/mL, range 96.1-196.3 versus 115.9 ng.hr/mL, range 36.1-182.9 for younger females).

In light of these findings, therapy with FLEXERIL (cyclobenzaprine hcl) in the elderly should be initiated with a 5 mg dose and titrated slowly upward.

Hepatic Impairment

In a pharmacokinetic study of sixteen subjects with hepatic impairment (15 mild, 1 moderate per Child-Pugh score), both AUC and Cmax were approximately double the values seen in the healthy control group. Based on the findings, FLEXERIL (cyclobenzaprine hcl) should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. Due to the lack of data in subjects with more severe hepatic insufficiency, the use of FLEXERIL (cyclobenzaprine hcl) in subjects with moderate to severe impairment is not recommended.

No significant effect on plasma levels or bioavailability of FLEXERIL (cyclobenzaprine hcl) or aspirin was noted when single or multiple doses of the two drugs were administered concomitantly. Concomitant administration of FLEXERIL (cyclobenzaprine hcl) and naproxen or diflunisal was well tolerated with no reported unexpected adverse effects. However combination therapy of FLEXERIL (cyclobenzaprine hcl) with naproxen was associated with more side effects than therapy with naproxen alone, primarily in the form of drowsiness. No well-controlled studies have been performed to indicate that FLEXERIL (cyclobenzaprine hcl) enhances the clinical effect of aspirin or other analgesics, or whether analgesics enhance the clinical effect of FLEXERIL (cyclobenzaprine hcl) in acute musculoskeletal conditions.

Clinical Studies

Eight double-blind controlled clinical studies were performed in 642 patients comparing FLEXERIL (cyclobenzaprine hcl) 10 mg, diazepam1, and placebo. Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated. In three of these studies there was a significantly greater improvement with FLEXERIL (cyclobenzaprine hcl) than with diazepam, while in the other studies the improvement following both treatments was comparable.

Although the frequency and severity of adverse reactions observed in patients treated with FLEXERIL (cyclobenzaprine hcl) were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with FLEXERIL (cyclobenzaprine hcl) and dizziness more frequently in those treated with diazepam. The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs.

The efficacy of FLEXERIL (cyclobenzaprine hcl) 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1405 patients. One study compared FLEXERIL (cyclobenzaprine hcl) 5 mg and 10 mg t.i.d. to placebo; and a second study compared FLEXERIL (cyclobenzaprine hcl) 5 mg and 2.5 mg t.i.d. to placebo. Primary endpoints for both trials were determined by patient-generated data and included global impression of change, medication helpfulness, and relief from starting backache. Each endpoint consisted of a score on a 5-point rating scale (from 0 or worst outcome to 4 or best outcome). Secondary endpoints included a physician's evaluation of the presence and extent of palpable muscle spasm.

Comparisons of FLEXERIL (cyclobenzaprine hcl) 5 mg and placebo groups in both trials established the statistically significant superiority of the 5 mg dose for all three primary endpoints at day 8 and, in the study comparing 5 and 10 mg, at day 3 or 4 as well. A similar effect was observed with FLEXERIL (cyclobenzaprine hcl) 10 mg (all endpoints). Physician-assessed secondary endpoints also showed that FLEXERIL (cyclobenzaprine hcl) 5 mg was associated with a greater reduction in palpable muscle spasm than placebo.

Analysis of the data from controlled studies shows that FLEXERIL (cyclobenzaprine hcl) produces clinical improvement whether or not sedation occurs.

Surveillance Program

A post-marketing surveillance program was carried out in 7607 patients with acute musculoskeletal disorders, and included 297 patients treated with FLEXERIL (cyclobenzaprine hcl) 10 mg for 30 days or longer. The overall effectiveness of FLEXERIL (cyclobenzaprine hcl) was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less (see ADVERSE REACTIONS).

REFERENCES

1VALIUM® (diazepam, Roche)

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

FLEXERIL (cyclobenzaprine hcl) , especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. In the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased. In elderly patients, FLEXERIL (cyclobenzaprine hcl) should be initiated with a 5 mg dose and titrated slowly upward.

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

FLEXERIL (cyclobenzaprine hcl) , especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. In the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased. In elderly patients, FLEXERIL (cyclobenzaprine hcl) should be initiated with a 5 mg dose and titrated slowly upward.

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Flexeril Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CYCLOBENZAPRINE - ORAL

(sye-klo-BENZ-uh-preen)

COMMON BRAND NAME(S): Flexeril

USES: Cyclobenzaprine is 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.

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 times a day.

The dosage is based on your medical condition and response to treatment. 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.

Tell your doctor if your condition persists after 2 to 3 weeks or if it worsens.

Disclaimer

Flexeril Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Flexeril (cyclobenzaprine hcl) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking cyclobenzaprine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, overactive thyroid (hyperthyroidism), heart problems (such as irregular heartbeat, heart block, heart failure, recent heart attack), difficulty urinating (such as due to an enlarged prostate), glaucoma.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Flexeril Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: tricyclic antidepressants (such as amitriptyline, imipramine).

Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication and for two weeks before treatment. In some cases a serious (possibly fatal) drug interaction may occur.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), other muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, fainting, severe drowsiness, slurred speech, seizures, mental/mood changes (such as confusion, hallucinations).

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised December 2011. Copyright(c) 2011 First Databank, Inc.

Flexeril Patient Information Including Side Effects

Brand Names: Amrix, Comfort Pac with Cyclobenzaprine, Fexmid, Flexeril

Generic Name: cyclobenzaprine (Pronunciation: sye kloe BEN za preen)

What is cyclobenzaprine (Flexeril)?

Cyclobenzaprine is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Cyclobenzaprine is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Cyclobenzaprine may also be used for other purposes not listed in this medication guide.

Cyclobenzaprine 10 mg-GG

round, yellow, imprinted with GG 288

Cyclobenzaprine 10 mg-MUT

round, white, imprinted with MP 577

Cyclobenzaprine 10 mg-MYL

round, orange, imprinted with 751, M

Cyclobenzaprine 10 mg-SCH

round, white, imprinted with DAN, 5658

Cyclobenzaprine 10 mg-TEV

round, yellow, imprinted with PLIVA, 563

Cyclobenzaprine 10 mg-WAT

round, white, imprinted with 5658, DAN

Cyclobenzaprine 5 mg-MYL

round, blue, imprinted with M, 771

Cyclobenzaprine 5 mg-WAT

round, white, imprinted with WATSON, 3256

Flexeril 10 mg

pentagonal, yellow, imprinted with FLEXERIL, MSD 931

Flexeril 5 mg

pentagonal, peach, imprinted with FLEXERIL

What are the possible side effects of cyclobenzaprine (Flexeril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using cyclobenzaprine and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • feeling light-headed, fainting;
  • confusion, weakness, lack of coordination;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • seizure (convulsions);
  • unusual thoughts or behavior, hallucinations (seeing things); or
  • easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

  • dry mouth or throat;
  • blurred vision;
  • drowsiness, dizziness, tired feeling;
  • loss of appetite, stomach pain, nausea;
  • diarrhea, constipation, gas; or
  • muscle weakness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Flexeril (cyclobenzaprine hcl) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about cyclobenzaprine (Flexeril)?

Do not take cyclobenzaprine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take cyclobenzaprine before the MAO inhibitor has cleared from your body.

You should not take cyclobenzaprine if you have recently had a heart attack, or if you have a heart rhythm disorder, congestive heart failure, heart block, or an overactive thyroid.

Cyclobenzaprine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol, which can increase some of the side effects of cyclobenzaprine.

Side Effects Centers

Flexeril Patient Information including How Should I Take

What should I discuss with my doctor before taking cyclobenzaprine (Flexeril)?

Do not take cyclobenzaprine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take cyclobenzaprine before the MAO inhibitor has cleared from your body.

Do not use cyclobenzaprine if you have recently had a heart attack, or if you have:

  • a heart rhythm disorder;
  • congestive heart failure;
  • heart block; or
  • an overactive thyroid.

Before using cyclobenzaprine, tell your doctor if you are allergic to any drugs, or if you have:

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

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cyclobenzaprine.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cyclobenzaprine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of this medication.

How should I take cyclobenzaprine (Flexeril)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Cyclobenzaprine is only part of a complete program of treatment that may also include rest, physical therapy, or other pain relief measures. Follow your doctor's instructions.

Store cyclobenzaprine at room temperature away from moisture, heat, and light.

Side Effects Centers

Flexeril Patient Information including If I Miss a Dose

What happens if I miss a dose (Flexeril)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Flexeril)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of cyclobenzaprine can be fatal.

Overdose symptoms may include drowsiness, fast heartbeat, tremors or shaking, slurred speech, confusion, nausea, vomiting, hallucinations (seeing things), chest pain, or seizure (convulsions).

What should I avoid while taking cyclobenzaprine (Flexeril)?

Cyclobenzaprine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol, which can increase some of the side effects of cyclobenzaprine.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, and medicine for seizures, depression or anxiety can add to sleepiness caused by cyclobenzaprine. Tell your doctor if you regularly use any of these medicines, or any other muscle relaxer.

What other drugs will affect cyclobenzaprine (Flexeril)?

Many drugs can interact with cyclobenzaprine. Below is just a partial list. Tell your doctor if you are using:

  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);
  • glycopyrrolate (Robinul);
  • guanethidine (Ismelin);
  • mepenzolate (Cantil);
  • tramadol (Ultram);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with cyclobenzaprine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about cyclobenzaprine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.12. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com