Drug Uses

Motrin Tablets are used for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Take this medicine for the relief of mild to moderate pain. Your doctor may prescribe Motrin for the treatment of primary dysmenorrhea.

How Taken

Do not exceed 3200 mg total daily dose. If you experience gastrointestinal toxicity, take Motrin Tablets with meals or milk.

Warnings/Precautions

You should not take Motrin if you have previously exhibited hypersensitivity to the drug, or have the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory agents. Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time for the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Possible Side Effects

The most frequent type of adverse reaction you may experience with Motrin Tablets is gastrointestinal. Blurred and/or diminished vision, scotomata, and/or changes in color vision have also been reported.

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Overdose

In case of overdosage, the stomach should be emptied by vomiting. Seek emergency medical attention.

More Information

While on Motrin therapy, you should report to your physician any signs or symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain, or edema.

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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