Tramadol Drug Uses

Tramadol is used to relieve moderate to moderately severe pain. It also may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. Tramadol works by decreasing the brain's perception and response to pain. It also reduces the size or magnitude of the pain signal passed from one nerve to another. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How Taken

Tramadol comes as a tablet to take it orally. It usually is taken every 4-6 hours as needed. It may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Tramadol exactly as directed. Tramadol can be habit-forming. Do not take a larger dose take it more often, or for a longer period than your doctor tells you to.

Tramadol Warnings/Precautions

Before taking Tramadol, tell your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Tramadol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Tramadol is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether Tramadol passes into breast milk. Do not take Tramadol without first talking to your doctor if you are breast-feeding a baby. If you are over 75 years of age, you may be more likely to experience side effects from Tramadol. The maximum daily dose of Tramadol for people over 75 years of age is 300 mg. Tramadol is not approved by the FDA for use by children younger than 16 years of age.

Tramadol 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.

Tramadol Possible Side Effects

Although side effects from Tramadol are not common, they can occur. The most frequently reported events were in the central nervous system (Migraine, Speech disorders) and gastrointestinal system (Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure). Tell your doctor if any of these symptoms are severe or do not go away: dizziness, headache, drowsiness, blurred vision, upset stomach, vomiting, and diarrhea. If you experience any of the following symptoms, call your doctor immediately: fast heartbeat, redness, swelling, and itching of the face, numbness or tingling of the hands and feet, difficulty breathing, changes in urination, seizures.

Tramadol Storage

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).

Tramadol Overdose

Seek emergency medical attention. Symptoms of a Tramadol overdose include difficulty breathing; shallow, weak breathing; and seizures.

More Information

Do not drink alcohol while taking Tramadol. Alcohol may cause a dangerous decrease in breathing and/ or liver problems when used during treatment with Tramadol. Use caution when driving, operating machinery, or performing other hazardous activities. Tramadol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid sleeping pills, tranquilizers, sedatives, and antihistamines except under the supervision of your doctor. These drugs may increase drowsiness caused by Tramadol.

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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We also recommend regular "drug checks" with your doctors. You may be able to switch to lower–cost generics, or to one of our Medspharmacy-online.com. Even if you have coverage, you may be able to save hundreds of dollars by switching to less expensive generics or by buying from Medspharmacy-online.com. Drug stores even in a single town or city can charge prices for the same drugs that vary by 50% or more. Shopping wisely for Tramadol can also save you money. This may mean buying drugs online or through mail order, checking prices at local pharmacies and discount stores, and getting a 90–day supply of any medicines you take on a regular basis.

Q: Do you deliver Tramadol to my state?
A: Due to regulations we cannot ship medicines to all states, please check the order form for the current list of states that we can ship to.


-- 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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