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.
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.
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 or a history of seizures.
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.
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.
Paxil and Imitrex are registered trademarks of GlaxoSmithKline. Prozac
and Cymbalta are registered trademarks of Eli Lilly. Sarafem is a
registered trademark of Warner Chilcott. Zoloft and Relpax are
registered trademarks of Pfizer, Inc. Effexor is a registered trademark
of Wyeth. Axert is a registered trademark of Almirall Prodesfarma.
©Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2007. All rights
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