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DRUG DESCRIPTION
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 2l7°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:
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AMRIX (cyclobenzaprine hcl extended-release capsules) extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. AMRIX (cyclobenzaprine hcl extended-release capsules) 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 (cyclobenzaprine hcl extended-release capsules) 15 mg capsules also contain red ferric oxide and yellow ferric oxide. AMRIX (cyclobenzaprine hcl extended-release capsules) 30 mg capsules also contain FD&C blue #1, FD&C blue #2, FD&C red #40, and FD&C yellow #6.
What are the possible side effects of cyclobenzaprine (Amrix, Comfort Pac with Cyclobenzaprine, Fexmid, Flexeril)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using cyclobenzaprine and call your doctor at once if you have any of these serious side effects:
- fast, pounding, or uneven heartbeats;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one...
Read All Potential Side Effects and See Pictures of Amrix »
What are the precautions when taking cyclobenzaprine hcl extended-release capsules (Amrix)?
Before taking cyclobenzaprine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an overactive thyroid (hyperthyroidism), certain heart problems (irregular heartbeat, congestive heart failure, heart block/rhythm disorders, recent heart attack).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe difficulty urinating (urinary retention), high pressure inside the eyes (glaucoma), liver...
Read All Potential Precautions of Amrix »
Amrix Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, hallucinations), difficulty urinating, loss of coordination.
Tell your doctor immediately if any of these rare but very serious side effects occur: fast/pounding/irregular heartbeat, fainting, yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting/lack of appetite, dark urine, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking cyclobenzaprine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an overactive thyroid (hyperthyroidism), certain heart problems (irregular heartbeat, congestive heart failure, heart block/rhythm disorders, recent heart attack).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe difficulty urinating (urinary retention), high pressure inside the eyes (glaucoma), liver disease.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
This medication is not recommended for use in the elderly. They may be more sensitive to its side effects, especially drowsiness, dizziness, and confusion, which can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication may pass into breast milk. Consult your doctor before breast-feeding.
Amrix Patient Information Including Side Effects
Brand Names: Amrix, Comfort Pac with Cyclobenzaprine, Fexmid, Flexeril
Generic Name: cyclobenzaprine (Pronunciation: sye kloe BEN za preen)
- What is cyclobenzaprine (Amrix)?
- What are the possible side effects of cyclobenzaprine (Amrix)?
- What is the most important information I should know about cyclobenzaprine (Amrix)?
- What should I discuss with my doctor before taking cyclobenzaprine (Amrix)?
- How should I take cyclobenzaprine (Amrix)?
- What happens if I miss a dose (Amrix)?
- What happens if I overdose (Amrix)?
- What should I avoid while taking cyclobenzaprine (Amrix)?
- What other drugs will affect cyclobenzaprine (Amrix)?
- Where can I get more information?
What is cyclobenzaprine (Amrix)?
Cyclobenzaprine is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.
Cyclobenzaprine is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.
Cyclobenzaprine may also be used for other purposes not listed in this medication guide.
What are the possible side effects of cyclobenzaprine (Amrix)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using cyclobenzaprine and call your doctor at once if you have any of these serious side effects:
- fast, pounding, or uneven heartbeats;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- feeling light-headed, fainting;
- confusion, weakness, lack of coordination;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- seizure (convulsions);
- unusual thoughts or behavior, hallucinations (seeing things); or
- easy bruising or bleeding, unusual weakness.
Less serious side effects may include:
- dry mouth or throat;
- blurred vision;
- drowsiness, dizziness, tired feeling;
- loss of appetite, stomach pain, nausea;
- diarrhea, constipation, gas; or
- muscle weakness.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about cyclobenzaprine (Amrix)?
Do not take cyclobenzaprine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take cyclobenzaprine before the MAO inhibitor has cleared from your body.
You should not take cyclobenzaprine if you have recently had a heart attack, or if you have a heart rhythm disorder, congestive heart failure, heart block, or an overactive thyroid.
Cyclobenzaprine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid drinking alcohol, which can increase some of the side effects of cyclobenzaprine.
- Flexeril
- Amrix