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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-- Biovail's extended release tramadol formulation demonstrated
highly statistically significant and clinically meaningful
reductions in pain compared to placebo.
-- Incidence of side effects improved versus the immediate
release product.
Biovail Corporation (NYSE:BVF)(TSE:BVF) today announced the Phase III clinical results of its extended release formulation of tramadol (tramadol O.D.). Tramadol is currently dosed 3 to 4 times per day and is prescribed for the treatment of moderate to moderately severe pain. The multi-dose tramadol formulation is currently sold under the brand name Ultram by a division of Johnson and Johnson. Sales of Ultram for the twelve months ended June 2001 grew by approximately 15% and were in excess of $590 million.
In the recently completed study, Biovail's extended release tramadol formulation produced statistically significant and clinically meaningful reductions in pain associated with osteoarthritis compared to placebo following a flexible dosing regimen in which the once-daily formulation was titrated upward or downward over 12 weeks in doses of 200mg, 300mg or 400mg based upon adequacy of pain relief and tolerability of side effects. The primary efficacy variable was pain relief as measured on a Visual Analog Scale (VAS). Secondary measures of efficacy were the pain intensity, stiffness and physical function subscales of WOMAC Osteoarthritis Index, the Patient's and Physician's Global Assessment of Arthritis, patient withdrawal due to inadequate pain relief, and patient assessment of sleep.
As early as Week 1, the first time point evaluated, and throughout the entire twelve week study period, Biovail's extended release tramadol formulation was statistically superior to placebo in reducing pain. The degree of improvement increased throughout the study period was of a magnitude considered to be both highly statistically significant and clinically meaningful. The results for the secondary variables paralleled those of the primary with all results statistically significant in favour of Biovail's once-daily formulation of tramadol.
There was a lower incidence of adverse effects with Biovail's extended release tramadol preparation versus the immediate release product and Biovail's extended release tramadol was well tolerated at all doses.
Dr. Thomas J. Schnitzer, who is Director, Office of Clinical Research at Northwestern University Medical School, commented. "To put these results in perspective, the magnitude of the symptomatic improvement observed with extended release tramadol in this clinical trial of patients with osteoarthritis is similar to that reported with NSAIDS and COX-2 inhibitors in previous studies of comparable patient populations. Furthermore, the lack of renal and serious gastrointestinal side effects of tramadol make this an ideal product for many patients with osteoarthritis who may not be appropriate candidates for many of the other analgesic agents available. This new extended release formulation of tramadol, an agent with proven efficacy in chronic pain, should provide many patients an effective, more convenient means for obtaining pain relief."
Study Rationale
Osteoarthritis is a prevalent chronic painful condition affecting over 30 million Americans. Symptoms of osteoarthritis include pain, joint stiffness and reduced physical function, all of which affect the patient's quality of life. In addition, osteoarthritis represents a useful "surrogate" model to evaluate the efficacy of analgesics for other chronic painful conditions. This model, which is accepted by FDA to document the analgesic potential of drug products, has been used to evaluate the analgesic efficacy of acetaminophen, COX 2 inhibitors and NSAIDS. Osteoarthritis has been used as a model of chronic pain for the evaluation of Ultram and opioid analgesics such as OxyContin(R), and MS Contin(R) that are widely used in patients with chronic non-cancer pain.
Overall Study Design and Plan
The study was a 12-week, multicenter double blind, randomized, dose-titration, parallel-group comparison of the efficacy and safety of extended release tramadol and placebo in the treatment of osteoarthritis of the knee. Approximately 245 patients from 18 to 75 years of age with moderate to severe pain associated with Functional Class I-III osteoarthritis of the knee were planned for study enrolment to ensure that a minimum of 140 patients completed the study. Patients who met the inclusion and exclusion criteria at screening entered a 2 to 7 day washout period during which all analgesic use was discontinued. At the start of the first week of the study (Baseline, Visit 2), eligible patients who reported pain intensity greater than 40 mm on a visual analog scale (VAS) in the index knee joint were randomly assigned to either extended release tramadol or placebo.
Patients assigned to Biovail's extended release tramadol formulation were initiated on 100 mg QD and maintained on their dose for at least 3 days. On Day 4, and for the remainder of the week (until their return to the clinic for Visit 3), patients were permitted to have their dose increased to 200 mg QD, based upon the tolerability of side effects. Beginning at Visit 3, patients must have been maintained on a minimum extended release tramadol dose of 200 mg QD, and the dose titrated upwards if required based upon the adequacy of pain relief and tolerability of side effects. Patients randomized to the placebo group underwent sham dose increases. Further dose escalation and de-escalation was permitted provided that a minimum dose of 200 mg QD was maintained from Week 1 (Visit 3) to Week 12 (Visit 7). In patients with pain unresponsive to appropriate dosage adjustments, or with unacceptable side effects, treatment was discontinued and alternate analgesia therapy initiated, as appropriate. Patients returned for efficacy and safety evaluations at Week 1 (Visit 3), Week 2 (Visit 4), Week 4 (Visit 5), Week 8 (Visit 6) and Week 12 (Visit 7) or at Early Termination.
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.

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