Drug Uses

Butalbital/APAP/Caffeine is a barbiturate sedative mixed with a non-aspirin pain medication (acetaminophen) and caffeine. This non-narcotic pain medication and relaxant is often prescribed for tension headaches caused by contractions of the muscles in the neck and shoulder area, and migraine.

How Taken

Butalbital/APAP/Caffeine comes as a capsule and tablet to take by mouth. The usual dosage is one to two tablets every 4-6 hours, but should be taken as directed by your physician. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Warnings/Precautions

Butalbital/APAP/Caffeine may cause you to become drowsy or less alert; therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended until you know your response to this drug. If you are being treated for severe depression or have a history of severe depression or drug abuse, consult with your doctor before taking Butalbital/APAP/Caffeine. Use this drug with caution if you are elderly or in a weakened condition, if you have liver or kidney problems, or if you have severe abdominal trouble. This medication contains acetaminophen (Tylenol), which is toxic to your liver and can be fatal when take above the recommended dosage. The total daily dose of acetaminophen should not exceed 4000mg (4g), or 2000mg (2g) if you are elderly or a chronic user of acetaminophen. Keep in mind that many over the counter products contain acetaminophen, and each tablet of this product contains 325mg. If you are pregnant or plan to become pregnant, inform your doctor immediately. Butalbital/APAP/Caffeine can affect a developing baby. It also appears in breast milk. If this medication is essential to your health, your doctor may advise you to discontinue breastfeeding your baby until your treatment is finished.

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

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Butalbital/APAP/Caffeine. More common side effects may include: Abdominal pain, dizziness, drowsiness, intoxicated feeling, light-headedness, nausea, sedation, shortness of breath, vomiting. Less common or rare side effects may include: Agitation, allergic reactions, constipation, depression, difficulty swallowing, dry mouth, earache, exaggerated feeling of well-being, excessive sweating, excessive urination, excitement, fainting, fatigue, fever, flatulence, headache, heartburn, heavy eyelids, high energy, hot spells, itching, leg pain, mental confusion, muscle fatigue, numbness, rapid heartbeat, ringing in the ears, seizure, shaky feeling, skin redness and/or peeling, sluggishness, stuffy nose, tingling.

Storage

Store below 86 F (30 C); dispense in a tight container and out of reach of children.

Overdose

An overdose of Butalbital/APAP/Caffeine, or combining this medication with alcohol or other central nervous system depressant, may lead to unconsciousness or perhaps death. Butalbital/APAP/Caffeine overdose is indicated by severe drowsiness, confusion, extreme weakness, hallucination, shortness of breath, too slow or troubled breathing, slurred speech, lack of coordination, vomiting with blood, unusually slow heartbeat.

More Information

Do not take Butalbital/APAP/Caffeine if you have taken a monoamine oxidase inhibitor (MAOI) in the last 14 days. Dangerous side effects could result. Butalbital/APAP/Caffeine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

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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