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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Orange, CA, June 12, 2003 - The National Fibromyalgia Association (NFA) announced today that a recent study published in the American Journal of Medicine reports that ULTRACET (tramadol hydrochloride/ acetaminophen) has been found to effectively reduce pain in people with fibromyalgia.
Currently there are no medications approved for the treatment of fibromyalgia in the U.S., so the study's findings provide significant hope for patient's searching for ways to effectively manage the chronic pain of this severe disorder.
Fibromyalgia (FM) is a complex chronic pain illness that can lead to significant patient disability. The fact that there is no known cause or cure for fibromyalgia challenges patients and healthcare professionals alike. It is estimated that FM affects approximately six to eight million Americans and 5% of the world's population. Patients with fibromyalgia suffer from a variety of symptoms ranging from stiffness, muscle spasms and body wide pain, fatigue and severe sleep disturbances.
The study published in the American Journal of Medicine was lead by researcher Robert M. Bennett, M.D., a pain specialist at the Oregon Health and Science University. He compared ULTRACET (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) to placebo in 315 fibromyalgia patients. Patients who used ULTRACET experienced significantly better pain relief, as indicated by statistical analysis, than those who received placebo.
Although Ultracet has received some exposure in the medical industry, not all physicians know about it. "A lot of patients actually have to educate their doctor," notes Bennett, "but they might want to do it diplomatically," he adds.
In the U.S., ULTRACET is approved for the treatment of short-term (five days or less) management of acute pain. The efficacy of ULTRACET in treating pain is based on the value of the drug's two components-tramadol hydrochloride and acetaminophen.
About Fibromyalgia:
Fibromyalgia is a chronic pain disorder that affects people of all genders and ages. The condition is identified by widespread severe musculoskeletal pain, fatigue, and tenderness in localized areas. These areas, called "tender points," can be palpated in the head, neck, shoulder region, arms, hands, lower back, hips, thighs, and knees.
Although physicians have noted the existence of fibromyalgia symptoms in patients for centuries, it was only recognized as a medical disorder during the 1980s. The American College of Rheumatology set up diagnostic for criteria for the condition in 1990. Diagnosis is difficult as it relies on the patient's ability to rate his or her own pain and as of yet, cannot be quantified by laboratory tests. Further complicating diagnosis, fibromyalgia pain can also be accompanied by other conditions including irritable bowel syndrome, restless leg syndrome, Raynaud's syndrome and depression.
Physicians prescribe a variety of medications in an attempt to alleviate the patients' symptoms, as there is no single successful treatment for fibromyalgia. Current treatment options for pain associated with fibromyalgia include physical therapy, nonsteroidal anti-inflammatory drugs and muscle relaxants that may provide temporary relief.
Study Details
This 91-day, multi-center, outpatient, double-blind, randomized, placebo-controlled study compared ULTRACET tablets to placebo. Outcome variables included cumulative time to discontinuation (Kaplan-Meier analysis), final pain visual analog scale scores, final pain relief rating scale scores, total tender points, average myalgic scores, SF-36 Health Survey scores and Fibromyalgia Impact Questionnaire scores.
These scales were used for overall statistical analysis and to evaluate patient responses.
Of 315 patients randomized, 313 (294 women [94%], mean age 50 + 10) completed >1 post-randomization efficacy assessments (n = 156 tramadol/acetaminophen; n = 157 placebo). The Kaplan-Meier analysis of final discontinuation rates for any reason demonstrated significantly better performance with ULTRACET compared with placebo (P = 0.004). ULTRACET patients had significantly better final pain visual analog scale scores, final pain relief rating scale scores, and total Fibromyalgia Impact Questionnaire scores. SF-36 indices of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the ULTRACET patients, indicating statistically significantly higher levels of pain relief in patients taking ULTRACET than placebo.
Adverse event discontinuation occurred in 19% (29/156) of ULTRACET and 12% (18/156) of placebo patients. The most common treatment-emergent adverse events in the ULTRACET vs. placebo groups were nausea (20% vs. 12%), headache (14% vs. 10%), and pruritus (12% vs. 4%). The average dose of ULTRACET was 4.0 tablets/day (+ 1.8). ULTRACET tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen.
About ULTRACET
ULTRACET combines tramadol, a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Single-dose dental pain studies demonstrated that the ULTRACET combination of tramadol and acetaminophen provides faster onset than tramadol alone as well as longer duration and better pain relief over either medication alone.
Tramadol is a non-scheduled, centrally acting synthetic opioid analgesic. Acetaminophen is a non-opiate, non-salicylate analgesic that is often combined with other medications to enhance efficacy. ULTRACET was approved in the U.S. in August 2001.
ULTRACET is indicated for the short-term (five days or less) management of acute pain.
ULTRACET is a centrally acting analgesic that controls pain via different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications.
ULTRACET is not an NSAID, and is not associated with potentially life-threatening gastrointestinal ulcers or bleeding that can occur with NSAIDs and the newer COX-2 NSAIDs. In addition, ULTRACET does not compromise the efficacy of certain antihypertensive agents, while NSAIDs and COX-2 NSAIDs may. ULTRACET can also be prescribed in sulfa-sensitive patients. The most frequently reported side effects with ULTRACET listed in the prescribing information are constipation (6%), somnolence (sleepiness) (6%), and increased sweating (4%).

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