Drug Uses

Ultracet is a unique pain medication. It is used to relieve moderate, acute pain such as pain following surgical procedures, including dental surgery. Ultracet may be used for other types of pain as determined by your health care provider.

How Taken

Take Ultracet tablets orally. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If Ultracet upsets your stomach, take it with food or milk. Do not take more than 2 tablets at a time or more than 8 tablets per day. Higher doses may cause severe side effects, do not take more medication than your prescriber has instructed.

Warnings/Precautions

DO NOT TAKE Ultracet IF YOU HAVE HAD SEVERE ALLERGIC REACTION to codeine. A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. IF YOU EXPERIENCE difficulty breathing, tightness of chest, swelling of eyelids, face or lips or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of Ultracet unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take Ultracet for longer than prescribed. Ultracet MAY BE HABIT FORMING. Use caution driving or operating machinery. DO NOT DRINK ALCOHOL while taking Ultracet. DO NOT TAKE other products containing acetaminophen (check labels closely) while you are taking Ultracet. IF DIZZINESS OCCURS, sit or stand up slowly. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor that you are taking Ultracet. IF YOU EXPERIENCE WITHDRAWAL SYMPTOMS (nervousness, sweating, nausea, diarrhea, tremor, trouble sleeping), check with your doctor. Discuss with your doctor is you are planning on getting pregnant. Ultracet IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking Ultracet.

Missed Dose

If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Possible Side Effects

Side effects that you should report to your prescriber or health care professional as soon as possible:
Rare or uncommon: changes in vision; difficulty breathing, shortness of breath; fast or irregular heartbeat; hallucinations (seeing and hearing things that are not really there); not passing urine as often as usual; redness, blistering, peeling or loosening of the skin, including inside the mouth; skin rash, itching; seizures (convulsions); yellow tint to your skin or whites of your eyes.
More common: anxiety, agitation; vomiting.
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome); constipation or diarrhea; difficulty sleeping; dizziness, drowsiness; dry mouth; false sense of well being, feeling of unreality, mood changes; headache; indigestion; itching; nausea; sweating or flushing.

Storage

Keep out of reach of children in a container that small children cannot open. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Overdose

Seek emergency medical attention. Symptoms of a Ultracet overdose include nausea; vomiting; sweating; difficulty breathing; shallow, weak breathing; and seizures.

More Information

Use caution when driving, operating machinery, or performing other hazardous activities. Ultracet may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Do not take other prescription or over-the-counter medicines that contain acetaminophen (Tylenol, pain relievers, cold and flu medicines, others) during treatment with Ultracet. Taking too much acetaminophen may be harmful. Avoid sleeping pills, tranquilizers, sedatives and antihistamines except under the supervision of your doctor. Ultracet may cause drowsiness and these agents may worsen this effect.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Orange, CA, June 12, 2003 - The National Fibromyalgia Association (NFA) announced today that a recent study published in the American Journal of Medicine reports that ULTRACET (tramadol hydrochloride/ acetaminophen) has been found to effectively reduce pain in people with fibromyalgia.
Currently there are no medications approved for the treatment of fibromyalgia in the U.S., so the study's findings provide significant hope for patient's searching for ways to effectively manage the chronic pain of this severe disorder.
Fibromyalgia (FM) is a complex chronic pain illness that can lead to significant patient disability. The fact that there is no known cause or cure for fibromyalgia challenges patients and healthcare professionals alike. It is estimated that FM affects approximately six to eight million Americans and 5% of the world's population. Patients with fibromyalgia suffer from a variety of symptoms ranging from stiffness, muscle spasms and body wide pain, fatigue and severe sleep disturbances.
The study published in the American Journal of Medicine was lead by researcher Robert M. Bennett, M.D., a pain specialist at the Oregon Health and Science University. He compared ULTRACET (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) to placebo in 315 fibromyalgia patients. Patients who used ULTRACET experienced significantly better pain relief, as indicated by statistical analysis, than those who received placebo.
Although Ultracet has received some exposure in the medical industry, not all physicians know about it. "A lot of patients actually have to educate their doctor," notes Bennett, "but they might want to do it diplomatically," he adds.
In the U.S., ULTRACET is approved for the treatment of short-term (five days or less) management of acute pain. The efficacy of ULTRACET in treating pain is based on the value of the drug's two components-tramadol hydrochloride and acetaminophen.
About Fibromyalgia:
Fibromyalgia is a chronic pain disorder that affects people of all genders and ages. The condition is identified by widespread severe musculoskeletal pain, fatigue, and tenderness in localized areas. These areas, called "tender points," can be palpated in the head, neck, shoulder region, arms, hands, lower back, hips, thighs, and knees.
Although physicians have noted the existence of fibromyalgia symptoms in patients for centuries, it was only recognized as a medical disorder during the 1980s. The American College of Rheumatology set up diagnostic for criteria for the condition in 1990. Diagnosis is difficult as it relies on the patient's ability to rate his or her own pain and as of yet, cannot be quantified by laboratory tests. Further complicating diagnosis, fibromyalgia pain can also be accompanied by other conditions including irritable bowel syndrome, restless leg syndrome, Raynaud's syndrome and depression.
Physicians prescribe a variety of medications in an attempt to alleviate the patients' symptoms, as there is no single successful treatment for fibromyalgia. Current treatment options for pain associated with fibromyalgia include physical therapy, nonsteroidal anti-inflammatory drugs and muscle relaxants that may provide temporary relief.
Study Details
This 91-day, multi-center, outpatient, double-blind, randomized, placebo-controlled study compared ULTRACET tablets to placebo. Outcome variables included cumulative time to discontinuation (Kaplan-Meier analysis), final pain visual analog scale scores, final pain relief rating scale scores, total tender points, average myalgic scores, SF-36 Health Survey scores and Fibromyalgia Impact Questionnaire scores.
These scales were used for overall statistical analysis and to evaluate patient responses.
Of 315 patients randomized, 313 (294 women [94%], mean age 50 + 10) completed >1 post-randomization efficacy assessments (n = 156 tramadol/acetaminophen; n = 157 placebo). The Kaplan-Meier analysis of final discontinuation rates for any reason demonstrated significantly better performance with ULTRACET compared with placebo (P = 0.004). ULTRACET patients had significantly better final pain visual analog scale scores, final pain relief rating scale scores, and total Fibromyalgia Impact Questionnaire scores. SF-36 indices of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the ULTRACET patients, indicating statistically significantly higher levels of pain relief in patients taking ULTRACET than placebo.
Adverse event discontinuation occurred in 19% (29/156) of ULTRACET and 12% (18/156) of placebo patients. The most common treatment-emergent adverse events in the ULTRACET vs. placebo groups were nausea (20% vs. 12%), headache (14% vs. 10%), and pruritus (12% vs. 4%). The average dose of ULTRACET was 4.0 tablets/day (+ 1.8). ULTRACET tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen.
About ULTRACET
ULTRACET combines tramadol, a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Single-dose dental pain studies demonstrated that the ULTRACET combination of tramadol and acetaminophen provides faster onset than tramadol alone as well as longer duration and better pain relief over either medication alone.
Tramadol is a non-scheduled, centrally acting synthetic opioid analgesic. Acetaminophen is a non-opiate, non-salicylate analgesic that is often combined with other medications to enhance efficacy. ULTRACET was approved in the U.S. in August 2001.
ULTRACET is indicated for the short-term (five days or less) management of acute pain.
ULTRACET is a centrally acting analgesic that controls pain via different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications.
ULTRACET is not an NSAID, and is not associated with potentially life-threatening gastrointestinal ulcers or bleeding that can occur with NSAIDs and the newer COX-2 NSAIDs. In addition, ULTRACET does not compromise the efficacy of certain antihypertensive agents, while NSAIDs and COX-2 NSAIDs may. ULTRACET can also be prescribed in sulfa-sensitive patients. The most frequently reported side effects with ULTRACET listed in the prescribing information are constipation (6%), somnolence (sleepiness) (6%), and increased sweating (4%).

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