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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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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