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Uses of Tramadol-ER
Tramadol-ER is a 24-hour prescription pain medication
approved by the FDA for the management of moderate
to moderately severe chronic pain in adults who
need treatment of their pain for an extended period
of time. Tramadol-ER is made with Smartcoat™ technology,
which steadily releases pain medication throughout
your day so that you only have to take it once
every 24 hours to treat your chronic pain.
Tramadol-ER Directions
Adults: Take Tramadol-ER (ULTRAM® ER)
once a day.
Tramadol-ER should be taken at the same time every
day with or without food and should be swallowed
whole and not be chewed, crushed or split, nor
should it be taken with alcohol.
The maximum daily dose of Tramadol-ER (ULTRAM® ER)
is 300mg.
Do not change your dose or stop taking
Tramadol-ER without talking with your doctor first
as you may experience withdrawal symptoms. As with
any prescription medication, be sure to follow
your doctor's instructions.
Tramadol-ER Side Effects
The most common side effects reported
with Tramadol-ER are dizziness, nausea, constipation,
headache, and drowsiness.
Do not take Tramadol-ER if you have had an allergic
reaction to tramadol, codeine, or other opioids
in the past. Do not take Tramadol-ER in any situation
where opioids should not be used, including acute
intoxication with alcohol, hypnotics, narcotics,
centrally acting analgesics, opioids, or psychotropic
drugs. Tramadol-ER may worsen central nervous system
and respiratory depression.
Seizures have been reported in people taking tramadol,
the active ingredient in Tramadol-ER, at recommended
doses. 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).
Tramadol-ER Precautions
Tramadol-ER may impair your ability to perform
potentially hazardous tasks, such as driving a
car or operating machinery. People who are suicidal
or have a history of addiction should not take
Tramadol-ER. Use of alcohol should be avoided when
taking Tramadol-ER. Do not take more than the recommended
dose of Tramadol-ER.
Talk with your doctor about all medications you
are taking. These may include antidepressants,
tranquilizers, hypnotics, or other opioid pain
medicines. 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,
or diarrhea, contact your doctor immediately.
Before taking ULTRAMŽ ER, you should
inform your doctor if you have been diagnosed with
increased intracranial pressure or have had a head
injury.
Tramadol-ER Drug Interactions
Tramadol-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). Symptoms of Serotonin Syndrome
can include mental-state changes such as agitation,
hallucinations, and coma. Symptoms can also include
autonomic instability (e.g. fast heartbeat, fluctuating
blood pressure, increased body temperature), neuromuscular
aberrations (e.g. overactive reflexes, incoordination),
and/or gastrointestinal symptoms (e.g. nausea,
vomiting, diarrhea).
Serious and rarely fatal anaphylactic (allergic)
reactions can occur, even if you have never taken
tramadol.
Taking Tramadol-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.
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.
Tramadol-ER Overdose
If overdose is suspected, contact
your local poison control center or emergency room
immediately. Symptoms of overdose may include cold
and clammy skin, low body temperature, slowed breathing,
slowed heartbeat, drowsiness, dizziness, lightheadedness,
seizures, deep sleep, and loss of consciousness.
Store at room temperature, in sealed container.
Please talk to your healthcare professional for
more information or if you have further questions
about ULTRAM® ER. You can also call the Ortho-McNeil-Janssen
Scientific Affairs, LLC, Customer Communications
Center at 1-800-526-7736 for more information.
In addition, please visit www.ultram-er.com for
full Prescribing Information.
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.
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