Drug Uses

Ultram is used to relieve moderate to moderately severe pain. It also may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. Ultram works by decreasing the brain's perception and response to pain. It also reduces the size or magnitude of the pain signal passed from one nerve to another. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How Taken

Ultram comes as a tablet to take it orally. It usually is taken every 4-6 hours as needed. It may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Ultram exactly as directed. Ultram can be habit-forming. Do not take a larger dose take it more often, or for a longer period than your doctor tells you to.

Warnings/Precautions

Before taking Ultram, tell your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Ultram, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Ultram is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether Ultram passes into breast milk. Do not take Ultram without first talking to your doctor if you are breast-feeding a baby. If you are over 75 years of age, you may be more likely to experience side effects from Ultram. The maximum daily dose of Ultram for people over 75 years of age is 300 mg. Ultram is not approved by the FDA for use by children younger than 16 years of age.

Missed Dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Possible Side Effects

Although side effects from Ultram are not common, they can occur. The most frequently reported events were in the central nervous system (Migraine, Speech disorders) and gastrointestinal system (Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure). Tell your doctor if any of these symptoms are severe or do not go away: dizziness, headache, drowsiness, blurred vision, upset stomach, vomiting, and diarrhea. If you experience any of the following symptoms, call your doctor immediately: fast heartbeat, redness, swelling, and itching of the face, numbness or tingling of the hands and feet, difficulty breathing, changes in urination, seizures.

Storage

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).

Overdose

Seek emergency medical attention. Symptoms of a Ultram overdose include difficulty breathing; shallow, weak breathing; and seizures.

More Information

Do not drink alcohol while taking Ultram. Alcohol may cause a dangerous decrease in breathing and/ or liver problems when used during treatment with Ultram. Use caution when driving, operating machinery, or performing other hazardous activities. Ultram may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid sleeping pills, tranquilizers, sedatives, and antihistamines except under the supervision of your doctor. These drugs may increase drowsiness caused by Ultram.

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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