CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet

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

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Active ingredient:
cyclobenzaprine hydrochloride (UNII: 0VE05JYS2P) (cyclobenzaprine - UNII:69O5WQQ5TI)
Available from:
Contract Pharmacy Services-PA
INN (International Name):
cyclobenzaprine hydrochloride
Composition:
cyclobenzaprine hydrochloride 10 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Cyclobenzaprine HCl 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 HCl 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 HCl 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 discont
Product summary:
Cyclobenzaprine HCl Tablets, USP are available in the following strengths and package sizes: 10 mg (Yellow, round, film-coated, debossed with TL177 on one side and plain on the other side) Blisters of 30’s NDC 67046-119-30 Blisters of 60’s NDC 67046-119-60 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Manufactured by: Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 02/07 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--04/2010--NJW
Authorization status:
Abbreviated New Drug Application
Authorization number:
67046-119-30, 67046-119-60

CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet

Contract Pharmacy Services-PA

----------

CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP

Rx Only

DESCRIPTION

Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula

H NHCI and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at

25º 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

HCI is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-

propanamine hydrochloride, and has the following structural formula:

Cyclobenzaprine HCl Tablets, for oral administration, are available in the following strengths: 5 mg and

10 mg.

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide,

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,

polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow. Cyclobenzaprine HCl tablets 5 mg also

contains FD&C yellow #6.

CLINICAL PHARMACOLOGY

Cyclobenzaprine HCI 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 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 Cyclobenzaprine HCl in the elderly should be initiated with 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 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 Cyclobenzaprine HCl in subjects with

moderate to severe impairment is not recommended.

No significant effect on plasma levels or bioavailability of Cyclobenzaprine HCl or aspirin was noted

when single or multiple doses of the two drugs were administered concomitantly. Concomitant

administration of Cyclobenzaprine HCl and naproxen or diflunisal was well tolerated with no reported

unexpected adverse effects. However combination therapy of 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 Cyclobenzaprine HCl

enhances the clinical effect of aspirin or other analgesics, or whether analgesics enhance the clinical

effect of Cyclobenzaprine HCl in acute musculoskeletal conditions.

Clinical Studies

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

Cyclobenzaprine HCl tablets 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 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

Cyclobenzaprine HCl were comparable to those observed in patients treated with diazepam, dry mouth

was observed more frequently in patients treated with 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 Cyclobenzaprine HCl tablets 5 mg was demonstrated in two seven-day, double-blind,

controlled clinical trials enrolling 1405 patients. One study compared Cyclobenzaprine HCl tablets 5

and 10 mg t.i.d. to placebo; and a second study compared Cyclobenzaprine HCl 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 HCl 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 HCl tablets 10 mg (all endpoints). Physician-assessed secondary endpoints also

showed that Cyclobenzaprine HCl tablets 5 mg was associated with a greater reduction in palpable

muscle spasm than placebo.

Analysis of the data from controlled studies show that 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 Cyclobenzaprine HCl tablets 10 mg for 30 days or

longer. The overall effectiveness of Cyclobenzaprine HCl was similar to that observed in the double-

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

REACTIONS).

INDICATIONS AND USAGE

Cyclobenzaprine HCl 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 HCl 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 HCl tablets have not been found effective in the treatment of spasticity associated with

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

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.

VALIUM® (diazepam, Roche)

Hyperthyroidism.

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.

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

PRECAUTIONS

General

Because of its atropine-like action, Cyclobenzaprine HCl 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 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 Cyclobenzaprine HCl in subjects with moderate to severe

impairment is not recommended.

Information for patients

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,

Cyclobenzaprine HCl should be initiated with a 5 mg dose and titrated slowly upward.

Drug Interactions

Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors. (See

CONTRAINDICATIONS.)

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

ULTRAM® (tramadol HCI tablets, Ortho-McNeil Pharmaceutical)

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

Carcinogenesis, mutagenesis, impairment of fertility

In rats treated with 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 Cyclobenzaprine HCl. 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 HCl is administered to a nursing woman.

Pediatric use

Safety and effectiveness of 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 Cyclobenzaprine HCl should be initiated with a 5 mg dose

and titrated slowly upward.

ADVERSE REACTIONS

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

(incidence of >3% on Cyclobenzaprine HCl tablets 5 mg):

Cyclobenzaprine

HCl tablets 5 mg

Cyclobenzaprine

tablets

Placebo

N=464

N=249

N=469

Drowsiness

Dry Mouth

Fatigue

Headache

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 HCl 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 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

Cyclobenzaprine

tablets 10 mg

Surveillance

Program

With

Cyclobenzaprine

HCl tablets 10 mg

Drowsiness 39%

Dry Mouth 27%

Dizziness

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 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 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.

OVERDOSAGE

Although rare, deaths may occur from overdosage with 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

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

Note: Cyclobenzaprine HCl tablets 10 mg data are from one clinical trial. Cyclobenzaprine HCl tablets 5 mg and

placebo data are from two studies.

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 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 contra-indicated

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.

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose of Cyclobenzaprine HCl 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 HCl 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).

HOW SUPPLIED

Cyclobenzaprine HCl Tablets, USP are available in the following strengths and package sizes:

10 mg (Yellow, round, film-coated, debossed with TL177 on one side and plain on the other side)

Blisters of 30’s NDC 67046-119-30

Blisters of 60’s NDC 67046-119-60

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

Manufactured by:

Cadista Pharmaceuticals Inc.

Salisbury, MD 21801, USA.

Revised 02/07

Repackaged by:

Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--04/2010--NJW

Principal Display Panel

10 mg Blister of 30 Tablets

CYCLOBENZAPRINE HYDROCHLORIDE

cyclobenzaprine hydrochloride tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 70 46 -119 (NDC:59 746 -177)

Route of Administration

ORAL

Contract Pharmacy Services-PA

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

cyclo benza prine hydro chlo ride (UNII: 0 VE0 5JYS2P) (cyclo benzaprine -

UNII:6 9 O5WQQ5TI)

c yc lo be nz a prine

hydro c hlo ride

10 mg

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

TL177

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 70 46 -119 -30

30 in 1 BLISTER PACK

2

NDC:6 70 46 -119 -6 0

6 0 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7756 3

0 4/23/20 10

Labeler -

Contract Pharmacy Services-PA (945429777)

Revised: 4/2010

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