AMRIX 15 mg/1

Cyclobenzaprine Hydrochloride · CAPSULE, EXTENDED RELEASE · Cephalon, LLC

No Recall History

Plain English

AMRIX is a capsule, extended release containing cyclobenzaprine hydrochloride at 15 mg/1, taken oral. Manufactured by Cephalon, LLC.

Key Facts

Brand Name: AMRIX
Generic Name: Cyclobenzaprine Hydrochloride
NDC Code (Product): 63459-700
Manufacturer: Cephalon, LLC
Strength: 15 mg/1
Dosage Form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA021777
Marketing Start: 10/02/2007

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain1,332 reports

headache1,017 reports

fatigue1,002 reports

drug ineffective754 reports

off label use700 reports

constipation694 reports

nausea685 reports

back pain619 reports

fall603 reports

rheumatoid arthritis517 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AMRIX ® (cyclobenzaprine hydrochloride extended-release capsules) 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, and limitation of motion. Limitations of Use: AMRIX 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. AMRIX has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. AMRIX is a muscle relaxant 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, and limitation of motion. ( 1 ) Limitations…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended adult dose for most patients is one (1) AMRIX 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) AMRIX 30 mg capsule taken once daily or as two (2) AMRIX 15 mg capsules taken once daily. It is recommended that doses be taken at approximately the same time each day. Use of AMRIX for periods longer than two or three weeks is not recommended [ see Indications and Usage (1) ]. Instruct patients to swallow AMRIX capsules intact. Alternatively, the contents of the AMRIX capsule may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to: Sprinkle the contents of the capsule onto a tablespoon of applesauce and consume immediately without chewing. Rinse the mouth to ensure all of the contents have been swallowed. Discard any unused portion of the AMRIX capsules after the contents have been sprinkled on applesauce. Recommended adult dose for most patients is 15 mg taken once daily. Some patients may require 30 mg…

Contraindications

4 CONTRAINDICATIONS Hypersensitivity to any component of this product. Adverse reactions may include anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue AMRIX if a hypersensitivity reaction is suspected. 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. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Hyperthyroidism. Hypersensitivity to any component of this product (4) Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation (4) During acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure (4) Hyperthyroidism (4)

Drug Interactions

7 DRUG INTERACTIONS Based on its structural similarity to tricyclic antidepressants, AMRIX may have life-threatening interactions with MAO inhibitors [ see Contraindications (4) ] , may enhance the effects of alcohol, barbiturates, and other CNS depressants, may enhance the seizure risk in patients taking tramadol, or may block the antihypertensive action of guanethidine and similarly acting compounds. Postmarketing cases of serotonin syndrome have been reported during combined use of cyclobenzaprine and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors [see Warnings and Precautions (5.1)] . MAO Inhibitors: Life-threatening interactions may occur ( 4 , 7 ) Serotonergic Drugs: Serotonin syndrome has been reported ( 5.1 , 7 ) CNS Depressants: Effects of alcohol, barbiturates, and other CNS depressants may be enhanced ( 5.2 , 7 ) Tramadol: Seizure risk may be enhanced ( 7 ) Guanethidine: Antihypertensive effect may be blocked ( 7 )

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant reactions are described in greater detail, in other sections. Serotonin Syndrome [see Warnings and Precautions ( 5.1 )] Adverse Cardiovascular Effects [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence ≥3% in any treatment group and greater than placebo): dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to AMRIX in 253 patients in 2 clinical trials. AMRIX was studied in two double-blind, parallel-group, placebo-controlled, active-controlled trials of identical design [see Clinical Studies (14)] . The study population was composed of patients with muscle spasms associated with acute painfu…

Frequently Asked Questions

What is AMRIX used for?

AMRIX contains Cyclobenzaprine Hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is AMRIX a controlled substance?

AMRIX is not classified as a controlled substance by the DEA.

What is the generic name for AMRIX?

The generic name for AMRIX is Cyclobenzaprine Hydrochloride. There are 12 other brand versions of Cyclobenzaprine Hydrochloride.

What is the NDC code for AMRIX 15 mg/1?

The NDC (National Drug Code) for AMRIX 15 mg/1 is 63459-700, listed by Cephalon, LLC.

Product NDC

63459-700

Package NDC

63459-700-60

Other Cyclobenzaprine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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