Adult Dosing

Muscle spasm

• TABS:
• Initial: 5 mg PO tid
• Titrate: 7.5-10 mg PO tid; Max: 30 mg/day
• Elderly: 5 mg PO qd, titrate slowly upward
• Therapy not recommended for >2-3 wks

• ECAPS:
• Initial: 15 mg PO qd
• Titrate: 30 mg PO qd; [Max: 30 mg/day, 2-3 wks]

Pediatric Dosing

Muscle spasm

• TABS: Child >15 yrs
• Initial: 5 mg PO tid
• Titrate: 7.5-10 mg PO tid; Max: 30 mg/day
• Therapy not recommended for >2-3 wks

• ECAPS:
• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Adjuvant therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions

• Hypersensitivity to any of the ingredients of the product
• Concomitant use or within 14 days of discontinuation of monoamine oxidase (MAO) inhibitors
• Acute recovery phase of myocardial infarction
• Arrhythmias
• Heart block
• Congestive heart failure
• Cardiac conduction disturbances
• Hyperthyroidism
• Hepatic impairment (Amrix)
• Elderly patients (Amrix)

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• ECAPS: Contraindicated
• TABS:
• Mild impairment: Start with 5 mg dose and slowly titrate upward as tolerated
• Moderate or severe impairment: Contraindicated

See Supplemental Patient Information

• Serious central nervous system reactions occur with cyclobenzaprine when used for indications other than muscle spasm at doses greater than those recommended for skeletal muscle spasm
• Cyclobenzaprine causes arrhythmias, sinus tachycardia, prolongation of the conduction time, leading to myocardial infarction and stroke
• In patients with hepatic impairment, plasma concentration of cyclobenzaprine (TABS) is increased, should be used with caution in subjects with mild hepatic impairment starting with lower dose, and should not be used in moderate to severe hepatic impairment
• Cyclobenzaprine enhances the effects of alcohol, barbiturates, and other CNS depressants, and when used with these, impairs mental and/or physical abilities, instruct patients not to perform hazardous work such as operating machinery or driving
• Cyclobenzaprine is not effective for spasticity due to spinal cord or other CNS disease or in children with cerebral palsy
• Life-threatening serotonin syndrome has been reported when coadministered with other drugs that increase serotonin (eg, SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAOIs, discontinue immediately if this occurs

Cautions: Use cautiously in

• History urinary retention
• Angle-closure glaucoma
• Increased IOP
• Anticholinergic use
• CNS depressant use
• Alcohol use
• Mild hepatic impairment (TABS)
• Elderly patients (TABS)

Supplemental Patient Information

• Advise patients to avoid alcohol and other CNS depressant drugs, and also hazardous tasks, such as operating machinery or driving

Amrix, Fexmid, Flexeril interacts with :

	Aricept
	Aricept ODT
	Azilect
	Donepezil
	Eldepryl
	Emsam
	Exelon
	Furazolidone
	Furoxone
	Galantamine
	Isocarboxazid
	Linezolid
	Marplan
	Methblue
	Methylene Blue
	Nardil
	Parnate
	Phenelzine
	Rasagiline
	Razadyne
	Razadyne ER
	Rivastigmine
	Selegiline
	Tranylcypromine
	Urolene Blue
	Zelapar
	Zyvox

Pregnancy Category:B

Breastfeeding: No published data is available evaluating the use of cyclobenzaprine during breastfeeding; other agents may be preferred, especially while nursing a newborn or preterm infant, or when other sedating drugs are used simultaneously. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 29 December 2010). Manufacturer advises caution.

• CNS: Drowsiness, headache, dizziness, irritability, impaired mental acuity, nervousness, confusion, somnolence, tremor, insomia, psychosis, stroke
• CV: Palpitation, arrhythmias, MI, tachycardia, cardiac conduction disturbances
• GI: Dry mouth, abdominal pain, acid regurgitation, constipation, nausea, dyspepsia, unpleasant taste
• EENT: Blurred vision
• RESP: URTI, pharyngitis
• MISC: Fatigue, asthenia, anaphylaxis

• Muscle Relaxants; relieves muscle spasms by acting at the brain stem level. Acts as 5-HT2 receptor antagonist that binds to the serotonin receptor and reduces muscle tone by decreasing the activity of descending serotonergic neurons
• Extensively metabolized by liver; CYP450: 3A4 ,1A2, 2D6 (minor)
• Renally excreted
• Half-life:
• TABS: 18 hrs
• ECAPS: 32 hrs

US Trade Name(s)

• Amrix
• Flexeril[Discontinued]
• Fexmid

US Availability

cyclobenzaprine (generic)

• TABS: 5, 7.5, 10 mg
• ECAPS: 15, 30 mg

Amrix

• ECAPS: 15, 30 mg

Fexmid

• TABS: 7.5 mg

Flexeril (Discontinued)

• TABS: 5, 10 mg

Canadian Trade Name(s)

• Only generic available

Canadian Availability

Cyclobenzaprine (generic)

• TABS: 10 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Neurologic

Skeletal Muscle Relaxants; Centrally Acting

Pricing data from www.DrugStore.com in U.S.A.

• Amrix 15 MG CP24 [Bottle] (CEPHALON)
  60 mg = $649.99
  180 mg = $1930.08
• Flexeril 10 MG TABS [Bottle] (MCNEIL CONSUMER)
  30 mg = $66.48
  90 mg = $176.6
• Cyclobenzaprine HCl 10 MG TABS [Bottle] (CADISTA)
  30 mg = $13.99
  60 mg = $16.98
• Flexeril 5 MG TABS [Bottle] (MCNEIL CONSUMER)
  30 mg = $60.44
  90 mg = $168.38

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• 24 HR Amrix 15 MG Extended Release Capsule (Cephalon, Inc.)
• 24 HR Amrix 30 MG Extended Release Capsule (Cephalon, Inc.)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (4UORTHO LLC)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Actavis Totowa LLC)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (American Health Packaging)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Amneal Pharmaceuticals)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Aurobindo Pharma Limited)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Barr Laboratories, Inc.)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Blenheim Pharmacal, Inc.)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Cadista Pharmaceuticals Inc.)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Contract Pharmacy Services-PA)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (KAISER FOUNDATION HOSPITALS)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Mutual Pharmaceutical)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Mylan Pharmaceuticals Inc.)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (NCS HealthCare of KY, Inc dba Vangard Labs)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Patriot Pharmaceuticals, LLC)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Physicians Total Care, Inc.)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Qualitest Pharmaceuticals)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Rebel Distributors)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Sandoz Inc)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (State of Florida DOH Central Pharmacy)
• Cyclobenzaprine hydrochloride 10 MG Oral Tablet (Watson Laboratories, Inc.)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (4UORTHO LLC)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Actavis Totowa LLC)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Aurobindo Pharma Limited)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Cadista Pharmaceuticals Inc.)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Mutual Pharmaceutical)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Mylan Pharmaceuticals Inc.)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (NCS HealthCare of KY, Inc dba Vangard Labs)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Patriot Pharmaceuticals, LLC)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Physicians Total Care, Inc.)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Qualitest Pharmaceuticals)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Rebel Distributors)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Sandoz Inc)
• Cyclobenzaprine hydrochloride 5 MG Oral Tablet (Watson Laboratories, Inc.)
• Cyclobenzaprine hydrochloride 7.5 MG Oral Tablet (Watson Laboratories, Inc.)
• Flexeril 10 MG Oral Tablet (Keltman Pharmaceuticals Inc)
• Flexeril 10 MG Oral Tablet (McNeil Consumer and Specialty Pharmaceuticals)
• Flexeril 10 MG Oral Tablet (Ortho-McNeil-Janssen Pharmaceuticals, Inc)
• Flexeril 5 MG Oral Tablet (McNeil Consumer and Specialty Pharmaceuticals)
• Flexeril 5 MG Oral Tablet (Ortho-McNeil-Janssen Pharmaceuticals, Inc)