Amrix
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Questions & Answers
Side Effects & Adverse Reactions
AMRIX 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. AMRIX may enhance the effects of alcohol, barbiturates, and other CNS depressants.
As a result of a two-fold higher cyclobenzaprine plasma levels in subjects with mild hepatic impairment, as compared to healthy subjects, following administration of immediate-release cyclobenzaprine and because there is limited dosing flexibility with AMRIX, use of AMRIX is not recommended in subjects with mild, moderate or severe hepatic impairment.
As a result of a 40% increase in cyclobenzaprine plasma levels and a 56% increase in plasma half-life following administration of AMRIX in elderly subjects as compared to young adults, use of AMRIX is not recommended in elderly.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AMRIX 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.
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.
History
There is currently no drug history available for this drug.
Other Information
AMRIX® (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in AMRIX extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) 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:
AMRIX extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. AMRIX capsules contain the following inactive ingredients: diethyl phthalate NF, ethylcellulose NF (Ethocel Standard 10 Premium), gelatin, Opadry® Clear YS-1-7006, sugar spheres NF (20-25 mesh), and titanium dioxide. AMRIX 15 mg capsules also contain D&C yellow #10, FD&C green #3, and FD&C red #40. AMRIX 30 mg capsules also contain FD&C blue #1, FD&C blue #2, FD&C red #40, and FD&C yellow #6.
Sources
Amrix Manufacturers
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Rebel Distributors Corp.
![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Rebel Distributors Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amrix | Rebel Distributors Corp.
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).
Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)
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Stat Rx Usa Llc
Amrix | Stat Rx Usa Llc
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).
Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)
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Rebel Distributors Corp
Amrix | Rebel Distributors Corp
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).
Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Amrix | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
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).
Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Amrix | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
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).
Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)
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Physicians Total Care, Inc.
Amrix | Physicians Total Care, Inc.
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).
Dosage Considerations for Special Patient Populations: AMRIX should not be used in the elderly or in patients with impaired hepatic function. (see WARNINGS)
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Cephalon, Inc.
Amrix | Cephalon, Incorporated
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) ]
![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b8ca1d80-6ea9-4a3f-ab06-beedf845de8f&name=AMRIXER15MGLABEL.jpg)
![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=087ae128-1a5d-406e-8bd3-15cb640f6922&name=087ae128-1a5d-406e-8bd3-15cb640f6922-02.jpg)
![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=67c46f2e-59fe-4c20-a07d-79935d496d1f&name=amrix15mgeurand.jpg)
![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e7915254-838d-4382-8d4f-ca74398a8622&name=Amrix30mgEurnad.jpg)
![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c18058a0-9c69-49cf-8454-db3b98427808&name=6022.jpg)
![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Cephalon, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3902123b-1365-ac3c-0934-afff9eeeb1bd&name=image-02.jpg)
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