CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Cyclobenzaprine hydrochloride tablets are 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. Cyclobenzaprine hydrochloride tablets 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. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO) inhibitors or with
Product summary:
Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side. They are supplied as follows: Bottles of 10: Bottles of 100: Bottles of 500: Bottles of 1000: Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side. They are supplied as follows: Bottles of 10: Bottles of 90: Bottles of 100: Bottles of 180: Bottles of 270: Bottles of 500: Bottles of 1000 Bottles of 5000: You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-537-60

CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated

Direct_Rx

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CYCLOBENZAPRINE HYDROCHLORIDE

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:

[structural formula for cyclobenzaprine.]

Cyclobenzaprine Hydrochloride Tablets, USP are supplied as 5 mg and 10 mg tablets for oral

administration.

Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6,

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene

glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C

Yellow #10 and polysorbate.

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 (γ) and alpha (α) 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 nghr/mL (range, 80-319 nghr/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 (≥65 yrs old), mean (n=10) steady state cyclobenzaprine

AUC values were approximately 1.7-fold (171.0 nghr/mL, range 96.1-255.3) higher than those seen in

a group of eighteen younger adults (101.4 nghr/mL, range 36.1-182.9) from another study. Elderly

male subjects had the highest observed mean increase, approximately 2.4-fold (198.3 nghr/mL, range

155.6-255.3 versus 83.2 nghr/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 nghr/mL, range 96.1-196.3

versus 115.9 nghr/mL, range 36.1-182.9 for younger females).

In light of these findings, therapy with cyclobenzaprine hydrochloride tablets 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, cyclobenzaprine hydrochloride tablets 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 cyclobenzaprine

hydrochloride tablets in subjects with moderate to severe impairment is not recommended.

No significant effect on plasma levels or bioavailability of cyclobenzaprine hydrochloride tablets or

aspirin was noted when single or multiple doses of the two drugs were administered concomitantly.

Concomitant administration of cyclobenzaprine hydrochloride tablets and naproxen or diflunisal was

well tolerated with no reported unexpected adverse effects. However combination therapy of

cyclobenzaprine hydrochloride tablets 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 cyclobenzaprine hydrochloride tablets enhance the clinical effect of aspirin

or other analgesics, or whether analgesics enhance the clinical effect of cyclobenzaprine

hydrochloride tablets in acute musculoskeletal conditions.

Clinical Studies

Eight double-blind controlled clinical studies were performed in 642 patients comparing

cyclobenzaprine hydrochloride 10 mg, diazepam, 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 cyclobenzaprine 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

cyclobenzaprine were comparable to those observed in patients treated with diazepam, dry mouth was

observed more frequently in patients treated with cyclobenzaprine 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 cyclobenzaprine hydrochloride tablets 5 mg was demonstrated in two seven-day,

double-blind, controlled clinical trials enrolling 1405 patients. One study compared cyclobenzaprine

hydrochloride tablets 5 and 10 mg t.i.d. to placebo; and a second study compared cyclobenzaprine

hydrochloride tablets 5 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 cyclobenzaprine hydrochloride tablets 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

cyclobenzaprine hydrochloride tablets 10 mg (all endpoints). Physician-assessed secondary endpoints

also showed that cyclobenzaprine hydrochloride tablets 5 mg was associated with a greater reduction in

palpable muscle spasm than placebo.

Analysis of the data from controlled studies shows that cyclobenzaprine 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 cyclobenzaprine hydrochloride tablets 10 mg for 30

days or longer. The overall effectiveness of cyclobenzaprine was similar to that observed in the

double-blind controlled studies; the overall incidence of adverse effects was less (see ADVERSE

REACTIONS).

Cyclobenzaprine hydrochloride tablets are 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.

Cyclobenzaprine hydrochloride tablets 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.

Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity

associated with cerebral or spinal cord disease, or in children with cerebral palsy.

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.

Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with

Cyclobenzaprine Hydrochloride when used in combination with other drugs, such as selective

serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic

antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO)

inhibitors. The concomitant use of Cyclobenzaprine Hydrochloride with MAO inhibitors is

contraindicated (see CONTRAINDICATIONS). Serotonin syndrome symptoms may include mental

status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis,

tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia,

hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting,

diarrhea). Treatment with Cyclobenzaprine Hydrochloride and any concomitant serotonergic agents

should be discontinued immediately if the above reactions occur and supportive symptomatic treatment

should be initiated. If concomitant treatment with Cyclobenzaprine Hydrochloride and other

serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment

initiation or dose increases (see PRECAUTIONS, Drug Interactions).

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.

Cyclobenzaprine may enhance the effects of alcohol, barbiturates, and other CNS depressants.

General

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.

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. Cyclobenzaprine hydrochloride tablets 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 cyclobenzaprine hydrochloride tablets in

subjects with moderate to severe impairment is not recommended.

Information for Patients

Cyclobenzaprine hydrochloride tablets, 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, cyclobenzaprine hydrochloride tablets should be initiated with a 5 mg

dose and titrated slowly upward.

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of

Cyclobenzaprine Hydrochloride and other drugs, such as selective serotonin reuptake inhibitors

(SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs),

tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO) inhibitors. Patients should

be advised of the signs and symptoms of serotonin syndrome, and be instructed to seek medical care

immediately if they experience these symptoms (see WARNINGS, and see PRECAUTIONS, Drug

Interactions).

Drug Interactions

Cyclobenzaprine may have life threatening interactions with MAO inhibitors (see

CONTRAINDICATIONS). Postmarketing cases of serotonin syndrome have been reported during

combined use of Cyclobenzaprine Hydrochloride and other drugs, such as selective serotonin reuptake

inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants

(TCAs), tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO) inhibitors. If

concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically

warranted, careful observation is advised, particularly during treatment initiation or dose increases (see

WARNINGS).

Cyclobenzaprine 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In rats treated with cyclobenzaprine hydrochloride 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 cyclobenzaprine.

There are, however, no adequate and well-controlled 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 cyclobenzaprine hydrochloride is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of cyclobenzaprine hydrochloride 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 cyclobenzaprine should be initiated with a 5 mg dose and

titrated slowly upward.

Incidence of most common adverse reactions in the 2 double-blind‡, placebo-controlled 5 mg studies

(incidence of > 3% on cyclobenzaprine hydrochloride tablets 5 mg):

Cyclobenzaprine

Hydrochloride

Tablets 5 mg

N=464 Cyclobenzaprine

Hydrochloride

Tablets 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

cyclobenzaprine hydrochloride tablets 10 mg in additional controlled clinical studies, 7607 patients in

the post-marketing 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 cyclobenzaprine hydrochloride 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:

‡Note: Cyclobenzaprine hydrochloride tablets 10 mg data are from one clinical trial. Cyclobenzaprine

hydrochloride tablets 5 mg and placebo data are from two studies.

Clinical Studies

with Cyclobenzaprine Hydrochloride

Tablets 10 mg

Surveillance Program

with Cyclobenzaprine Hydrochloride

Tablets 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, serotonin

syndrome.

Skin: Sweating.

Special Senses: Ageusia; tinnitus.

Urogenital: Urinary frequency and/or retention.

Causal Relationship Unknown

Other reactions, reported rarely for cyclobenzaprine hydrochloride 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.

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.

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.

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 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).

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.

For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets 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 tablets 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).

Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631"

on one side and debossed "V" on the reverse side.

They are supplied as follows:

Bottles of 10:

Bottles of 100:

Bottles of 500:

Bottles of 1000:

Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed

"2632" on one side and debossed "V" on the reverse side.

They are supplied as follows:

Bottles of 10:

Bottles of 90:

Bottles of 100:

Bottles of 180:

Bottles of 270:

Bottles of 500:

Bottles of 1000

Bottles of 5000:

You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-

1088 or www.fda.gov/medwatch.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Manufactured for:

Solco Healthcare US, LLC

Cranbury, NJ 08512, USA

8182950-01

Revised: 02/2017

CYCLOBENZAPRINE HYDROCHLORIDE

cyclobenzaprine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 19 19 -537(NDC:43547-40 0 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CYCLO BENZAPRINE HYDRO CHLO RIDE (UNII: 0 VE0 5JYS2P) (CYCLOBENZAPRINE

- UNII:6 9 O5WQQ5TI)

CYCLOBENZAPRINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

Product Characteristics

Color

ye llo w

S core

no sco re

Dire ct_Rx

S hap e

ROUND

S iz e

Flavor

Imprint Code

26 32;V

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -537-6 0

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7779 7

0 8 /14/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -537)

Revised: 8/2019

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