ULTRAM® (tramadol hydrochloride tablets) is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax.
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.