ULTRAM® ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
IMPORTANT SAFETY INFORMATION
Do not take ULTRAM® ER if you have had an allergic reaction to tramadol, codeine, or other opioids in the past. Serious anaphylactic reactions can occur even if you have never taken tramadol. ULTRAM® ER tablets must be swallowed whole. Do not chew, crush or split the tablet before swallowing. This can lead to overdose and possible serious injury including death. Use of alcohol should be avoided when taking ULTRAM® ER.
The maximum daily dose of ULTRAM® ER is 300 mg. Do not change your dose or stop taking ULTRAM® ER without talking with your doctor first.
Talk with your doctor about all the medications you are taking. These may include antidepressants, tranquilizers, hypnotics or other opioid pain medicines. ULTRAM® ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery. Do not take ULTRAM® ER in situations where opioids should not be used, including acute intoxication with alcohol, hypnotics, opioids or narcotics, or psychotropic drugs. ULTRAM® ER may worsen central nervous system and respiratory depression. Before taking ULTRAM® ER, you should inform your doctor if you have been diagnosed with increased intracranial pressure or have had a head injury.
Seizures have been reported in people taking tramadol, the medicine in ULTRAM® ER. The risk of seizures is increased with doses of tramadol above the recommended range. Use of tramadol increases the risk of seizures in people taking antidepressants, other opioids, or other drugs that can cause seizures. Risk of convulsions may also increase in people with epilepsy, a history of seizures, or a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, and central nervous system infections).
ULTRAM® ER may be associated with a potentially life-threatening condition when taken together with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) (classes of drugs for depression or other disorders), triptans, lithium, or St. John's Wort. Some common SSRIs are Paxil® (paroxetine), Prozac®/Sarafem® (fluoxetine), and Zoloft® (sertraline). Some common SNRIs are Cymbalta® (duloxetine) and Effexor® (venlafaxine). Some common triptans are Axert® (almotriptan), Imitrex® (sumatriptan), and Relpax® (eletriptan).
If you experience symptoms such as restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea, contact your doctor immediately.
ULTRAM® ER, like other opioids, can be abused or cause dependence. People who are suicidal or have a history of drug addiction should not take ULTRAM® ER. Do not take more than the recommended dose of ULTRAM® ER. Taking more than the recommended dose of ULTRAM® ER, alone or in combination with alcohol or medications such as tranquilizers, hypnotics, or other opioids, can cause respiratory depression, seizures, overdose and possibly death. These risks exist at all dosage levels. Taking certain medications together can increase the risk of respiratory and central nervous system depression. These medications may include alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics.
Tell your doctor about all your medical conditions and if you are pregnant, think you might be pregnant or are trying to become pregnant.
The most common side effects reported with ULTRAM® ER were dizziness, nausea, constipation, headache, and drowsiness.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Paxil and Imitrex are registered trademarks of GlaxoSmithKline. Prozac/Sarafem and Cymbalta are registered trademarks of Eli Lilly. Zoloft and Relpax are registered trademarks of Pfizer, Inc. Effexor is a registered trademark of Wyeth. Axert is a registered trademark of Almirall Prodesfarma.
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