What is AMRIX?
AMRIX ® (cyclobenzaprine hydrochloride extended-release capsules) is a prescription medicine used along with rest and physical therapy to help treat muscle spasm due to acute, painful musculoskeletal problems. AMRIX should only be used for up to 2 or 3 weeks. It is not known if AMRIX is effective when used for longer periods. It is not known if AMRIX is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Who should not take AMRIX?
Do not take AMRIX if you:
- are allergic to cyclobenzaprine or any of the ingredients of AMRIX. Talk to your healthcare provider or get medical help right away if you have symptoms of an allergic reaction such as difficulty breathing, hives, swelling of your face or tongue, or itching
- are taking certain antidepressants known as monoamine oxidase (MAO) inhibitors, or it has been 14 days or less since you stopped taking a MAO inhibitor. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure
- have had a recent heart attack
- have heart rhythm problems (arrhythmias)
- have heart failure
- have an overactive thyroid (hyperthyroidism)
Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.
What should I avoid while taking AMRIX?
You should not drink alcohol until you know how AMRIX affects you. Taking AMRIX with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times.
Do not drive, operate machinery, or do other dangerous activities until you know how AMRIX affects you.
What are possible side effects of AMRIX?
AMRIX may cause serious side effects that may lead to heart attack or stroke. Call your healthcare provider immediately or go to the nearest hospital emergency room if you have:
- irregular or abnormal heartbeats (arrhythmias)
- fast heartbeat (tachycardia)
Serotonin syndrome is a serious medical condition that may happen when AMRIX is taken with certain other medicines. Call your healthcare provider right away or go to the nearest hospital emergency room if you become severely ill and have some or all of these symptoms:
- agitation, hallucinations, coma, or other changes in mental status
- coordination problems or muscle twitching (overactive reflexes)
- fast heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle stiffness or tightness
The most common side effects of AMRIX include dry mouth, dizziness, fatigue, constipation, nausea, upset stomach, and drowsiness.
Tell your healthcare provider if you get any side effect that bothers you or that does not go away. These are not all the possible side effects of AMRIX. For more information, talk to your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088