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Ultram

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About ULTRAM®ULTRAM (tramadol hydrochloride tablets) image shot
(tramadol hydrochloride tablets)

What ULTRAM® is
What ULTRAM® is NOT
Dosage
Warnings
Side Effects

What ULTRAM® is
ULTRAM® (tramadol hydrochloride tablets) is a prescription medication indicated for the management of moderate to moderately severe pain. ULTRAM received U.S. Food and Drug Administration (FDA) approval in March 1995. Tramadol has been prescribed in more than 55 million patients worldwide and ULTRAM has been prescribed in more than 21 million patients in the United States. See What is ULTRAM® and How Does It Work? in the Frequently Asked Question section for more information.
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What ULTRAM® is NOT
ULTRAM is a centrally acting synthetic analgesic, not a non-steroidal anti-inflammatory drug (NSAID). ULTRAM has no anti-inflammatory activity and no potential for prostaglandin-mediated side effects. Unlike NSAIDs, ULTRAM does not have the potential to compromise the efficacy of certain antihypertensive agents (diuretics, beta blockers, and ACE-inhibitors). See What is ULTRAM® and How Does It Work? in the Frequently Asked Question section for more information.
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Dosage and Administration—Adults (17 years of age and over)
For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of ULTRAM can be improved by initiating therapy with the following titration regimen: ULTRAM should be started at 25 mg/day qAM and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, ULTRAM 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.

For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, ULTRAM 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day. See How Should I Take ULTRAM®? in the Frequently Asked Questions section for more information.
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Warnings
Seizures have been reported in-patients receiving ULTRAM. The risk of seizures is increased with doses of ULTRAM above the recommended range. ULTRAM increases the seizure risk in patients taking certain medications (e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors, opioids) and may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or in patients with a medical history that may suggest increased risk of seizure. Please see full U.S. Prescribing Information. See Who Should Not Take ULTRAM®? and Can I Take ULTRAM® Along With Other Medications? in the Frequently Asked Question section for more information.

Patients with a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids may be at risk and therefore should not receive ULTRAM.

Cases of abuse and dependence on ULTRAM have been reported. ULTRAM should not be used in opioid-dependent patients. Since ULTRAM can reinitiate physical dependence, it is not recommended for patients with a tendency to drug abuse, a history of drug dependence, or chronically using opioids.
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Side Effects
The most frequently reported side effects experienced with ULTRAM were constipation, nausea, dizziness, headache, somnolence, and vomiting. See Does ULTRAM® Have Side Effects? in the Frequently Asked Question section for more information.
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Frequently Asked Questions

 

Frequently Asked Questions

What is ULTRAM® and How Does It Work?
Who Should Not Take ULTRAM®?
Why Has My Doctor Prescribed ULTRAM® for Me?
Can I Take ULTRAM® Along With Other Medications?
Can I Take ULTRAM® and Drink Alcohol?
Does ULTRAM® Have Side Effects?
How Should I Take ULTRAM®?
How Should ULTRAM® Be Stored?
Why Is Chronic Pain So Hard to Treat?
What Else Might I Do to Manage My Pain?

What is ULTRAM® and How Does It Work?
ULTRAM is a prescription-only pain medicine intended for people who have moderate to moderately severe chronic pain. ULTRAM helps your body's system relieve pain in two important ways. Laboratory studies suggest that first, ULTRAM acts directly on parts of the brain and spinal cord to reduce the amount of pain. Second, it reduces the size of the pain signal passed from one nerve to another. ULTRAM works differently from an NSAID (which stands for nonsteroidal anti-inflammatory drug and is pronounced "EN-sayd"), such as ibuprofen. ULTRAM is also different from other pain medications, such as codeine or morphine. While the mode of action of ULTRAM is not completely understood, laboratory studies suggest that at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to opioid receptors and weak inhibition of the re-uptake of norephinephrine and serotonin.
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Who Should Not Take ULTRAM®?
Cases of abuse and dependence on ULTRAM have been reported. ULTRAM should not be used in opioid-dependent patients. Since ULTRAM can reinitiate physical dependence, it is not recommended for patients with a tendency to drug abuse, a history of drug dependence, or chronically using opioids.

Additionally, anyone who has had an allergic-type reaction to either ULTRAM or any product containing an opioid medicine (like Tylenol®* with Codeine) should not take ULTRAM.

Talk with your doctor if you may be pregnant, or are trying to become pregnant, before using ULTRAM or any other medicine. Safe use during pregnancy has not been established.

As with all prescription medicines, you should not share your ULTRAM tablets with anyone else. Also, you should not take medicines that have not been prescribed specifically for you.

All prescription medicines should be taken under the medical supervision of your doctor.
*Tylenol® is a registered trademark of McNeil Consumer Products Company.
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Why Has My Doctor Prescribed ULTRAM for Me?
ULTRAM may be a good choice for people who need effective relief of chronic pain. This patient group may include: People at risk of stomach ulcers. ULTRAM has not been associated with ulcers or stomach bleeding in medical studies. People taking certain medicines to control their high blood pressure. ULTRAM does not interfere with the ways in which various blood pressure medicines work. People at risk of kidney problems. ULTRAM does not affect the hormone-like system that helps keep the kidneys working normally; this is a special consideration in older people.
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Can I Take ULTRAM® Along with Other Medications?
There are certain medications that should be used with caution while taking ULTRAM. These other medications include tranquilizers, sleeping pills, antidepressants, and opioid pain medicines. Be sure to talk with your doctor about all other medicines you are taking before starting your prescription for ULTRAM.
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Can I Take ULTRAM® And Drink Alchohol?
ULTRAM should not be taken with alcohol-containing beverages.
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Does ULTRAM® Have Side Effects?
All medicines, including ULTRAM, can cause side effects. People who experienced side effects with ULTRAM in medical studies usually did so at the beginning of treatment. The most frequently reported side effects experienced with ULTRAM were constipation, nausea, dizziness, headache, somnolence, and vomiting. Patients should talk to their doctors about any side effects they experience while taking ULTRAM.

ULTRAM may impair your ability to drive a car or operate machinery.

Seizures have been reported in patients taking ULTRAM. The risk of seizures is increased with doses of ULTRAM above the recommended range. You should not take more than 400 mg of ULTRAM (eight 50 mg tablets) per day.

ULTRAM increases the risk of seizures in patients taking certain medications for other medical conditions (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, or opioids). ULTRAM may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).

Patients with a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRAM.
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How Should I Take ULTRAM®?
You will get the best pain relief by following your doctor's instructions and taking ULTRAM as it was prescribed for you. ULTRAM may be taken with or without food. You may find it easiest to take your ULTRAM tablets at the same times every day. In any case, you should not take more than the dose prescribed, and you should never take more than 2 tablets in a 4-hour period. Talk with your doctor and pharmacist about all of the medicines you are currently taking. Be sure to tell your doctor and pharmacist if you have any allergies, or if you have ever had an allergic reaction to any medicine. And report any unusual developments or problems that may appear.
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How Should ULTRAM® Be Stored?
ULTRAM should be stored at room temperature away from heat and direct light. ULTRAM should be kept in the same container in which you received it from the pharmacy. Remember, ULTRAM and all medications should be kept out of the reach of children.
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Why Is Chronic Pain So Hard to Treat?
Despite all of the remarkable progress in many areas of medicine in the recent past, pain remains one of the most difficult medical conditions to treat. This is especially true of chronic pain, which is prolonged pain caused by disease or pain that persists after an acute injury has healed. There are several reasons why:

  • Precise medical evaluation of pain and its causes is often difficult.
  • The type and intensity of pain can vary from one person to another.
  • Different people respond differently to treatment.

If you are like most people who have a chronic painful condition, your pain just won't go away and may actually make it hard for you to lead your life as you would like to.
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What Else Might I Do to Manage My Pain?
Pain medication is only one way to manage pain effectively. There are some changes you can make in your daily life to help keep your pain under control. Your doctor may also recommend a number of other ways to control pain. Talk with your doctor about a daily plan that can help you.

What You Can Do:

  • Learn more about your condition
  • Take your medicine as recommended by your doctor
  • Get plenty of sleep
  • Use pain-friendly devices, like can openers and doorknob attachments
  • Wear clothing with zippers instead of buttons

Talk with Your Doctor About:

  • A simple exercise program
  • Breathing and relaxation Techniques
  • Body massage
  • Physical therapy
  • Hot or cold packs
  • A diet plan

Be sure to ask your doctor about the types of non-drug pain management techniques that might work for you. You can also ask for referrals to specific providers of these services.
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