Amrix
FDA: 2 More NECC Drugs Contaminated »
"Nov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.
The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of th"...
Amrix
Amrix Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Amrix (cyclobenzaprine hcl) is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury. It is a muscle relaxant. This medication is available in generic form. Common side effects include drowsiness, dry mouth, fatigue, dizziness, lightheadedness, constipation, or blurred vision.
The recommended adult dose for most patients is one Amrix 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one 30 mg capsule taken once daily or as two 15 mg capsules taken once daily. Amrix may interact with MAO inhibitors, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bronchodilators, glycopyrrolate, guanethidine, mepenzolate, tramadol, bladder or urinary medications, or irritable bowel medications. Tell your doctor all medications you use. During pregnancy, Amrix should be used only when prescribed. This medication may pass into breast milk. Consult your doctor before breast-feeding. Our Amrix (cyclobenzaprine hcl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Amrix in Detail - Patient Information: Side Effects
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.
Read the entire detailed patient monograph for Amrix (Cyclobenzaprine HCl Extended-Release Capsules) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Amrix Overview - Patient Information: Side Effects
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 right away if you have any serious side effects, including: fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations).
A very serious allergic reaction to this drug is rare. However, get medical help right away 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.
Read the entire patient information overview for Amrix (Cyclobenzaprine HCl Extended-Release Capsules)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Amrix FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The most common adverse reactions in the two 14-day clinical efficacy trials and in the 7-day repeat-dose pharmacokinetic study are presented in Tables 5 and 6, respectively.
Table 5: Incidence of the Most Common Adverse
Reactions Occurring in ≥ 3% of Subjects in Any Treatment Group in the Two
Phase 3, Double-Blind AMRIX Trials
| AMRIX 15 mg N=127 |
AMRIX 30 mg N=126 |
Placebo N=128 |
|
| Dry mouth | 6% | 14% | 2% |
| Dizziness | 3% | 6% | 2% |
| Fatigue | 3% | 3% | 2% |
| Constipation | 1% | 3% | 0% |
| Somnolence | 1% | 2% | 0% |
| Nausea | 3% | 3% | 1% |
| Dyspepsia | 0% | 4% | 1% |
Table 6: Incidence of the
Most Common Adverse Reactions Occurring in ≥ 3% of Subjects in Any
Treatment Group in the Seven-Day Pharmacokinetic Study of AMRIX
| AMRIX 30 mg N = 36 |
|
| Somnolence | 100% |
| Dry mouth | 58% |
| Headache NOS | 17% |
| Dizziness | 19% |
| Vision blurred | 3% |
| Nausea | 8% |
| Dysgeusia | 6% |
| Palpitations | 6% |
| Tremor | 6% |
| Dry throat | 8% |
| Acne NOS | 6% |
| Disturbance in attention | 6% |
| Insomnia | 0 |
In a postmarketing surveillance program (7607 patients treated with cyclobenzaprine 10 mg TID), the adverse reactions reported most frequently were drowsiness, dry mouth, and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:
Table 7: Most Common Adverse
Reactions from Postmarketing Surveillance Program
| Clinical Studies cyclobenzaprine 10 mg TID | Surveillance Program cyclobenzaprine 10 mg TID | |
| Drowsiness | 39% | 16% |
| Dry mouth | 27% | 7% |
| Dizziness | 11% | 3% |
Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion. The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg TID tablet:
Body as a Whole: Syncope; malaise.
Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.
Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice, and cholestasis.
Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.
Musculoskeletal: Local weakness.
Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia; serotonin syndrome.
Skin: Sweating.
Special Senses: Ageusia; tinnitus.
Urogenital: Urinary frequency and/or retention.
Causal Relationship Unknown
Other reactions, reported rarely for cyclobenzaprine under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:
Body as a Whole: Chest pain; edema.
Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.
Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.
Endocrine: Inappropriate ADH syndrome.
Hematologic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.
Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss.
Musculoskeletal: Myalgia.
Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell's palsy; alteration in EEG patterns; extrapyramidal symptoms.
Respiratory: Dyspnea.
Skin: Photosensitization; alopecia.
Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.
Drug Abuse And Dependence
Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when AMRIX is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.
Read the entire FDA prescribing information for Amrix (Cyclobenzaprine HCl Extended-Release Capsules) »
Additional Amrix Information
Amrix - User Reviews
Amrix User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Amrix sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.
Updated & New
