Drug Uses

Tramadol 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. Tramadol 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

Tramadol 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 Tramadol exactly as directed. Tramadol 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 Tramadol, 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 Tramadol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Tramadol 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 Tramadol passes into breast milk. Do not take Tramadol 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 Tramadol. The maximum daily dose of Tramadol for people over 75 years of age is 300 mg. Tramadol 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 Tramadol 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 Tramadol overdose include difficulty breathing; shallow, weak breathing; and seizures.

More Information

Do not drink alcohol while taking Tramadol. Alcohol may cause a dangerous decrease in breathing and/ or liver problems when used during treatment with Tramadol. Use caution when driving, operating machinery, or performing other hazardous activities. Tramadol 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 Tramadol.

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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BALTIMORE, MD -- March 18, 2002 --The combination analgesic tramadol/acetaminophen (APAP) can safely provide additional pain relief for osteoarthritis patients who are taking COX-2 non-steroidal anti-inflammatory agents (NSAID).
Dr. Norman Rosenthal and associates at Ortho-McNeil Pharmaceutical in Raritan, New Jersey, United States, described the results of a 91-day, multi-center, randomized double-blind study. Participants were outpatients with symptomatic osteoarthritis and inadequately controlled pain of the knee or hip (pain visual analog (PVA) score greater than or equal to 50 mm) despite COX-2 NSAID therapy for at least two weeks. The study's findings were presented at the 21st Annual Scientific Meeting of the American Pain Society (APS)
Following a wash-out phase of all non-COX-2 NSAID analgesics, patients were randomized to receive add-on tramadol/APAP or placebo, 37.5 mg/375 mg. The medication was titrated by one tablet every three days to a total of four tablets per day on day ten, and then as needed to a maximum of eight tablets per day.
The intent-to-treat population consisted of 306 patients, most of whom had knee pain. The baseline mean PVA scores were 69.0 for tramadol/APAP and 69.5 for placebo.
Tramadol/APAP demonstrated significantly superior efficacy compared to placebo for the primary efficacy variable, the final PVA score; the mean final PVA score was 41.5 mm in the tramadol/APAP group and 48.3 mm in the placebo group. The mean change from baseline PVA score was larger in the tramadol/APAP group (-27.5 mm) than in the placebo group (-21.2 mm).
The mean final pain relief score was significantly higher in the tramadol/APAP group than in the placebo group.
Most adverse events were mild to moderate, and there did not appear to be a specific drug interaction between tramadol/APAP and any COX-2 NSAID.
Overall, the data indicate that the combination analgesic tablet tramadol/APAP is better than placebo for the treatment of pain associated with osteoarthritis in patients for whom COX-2 NSAIDs provide insufficient pain relief.

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