ULTRAM ER is available in once-daily dosage
strengths of 100 mg, 200 mg and 300 mg tablets. The US Food and Drug
Administration (FDA) approved ULTRAM ER in September 2005. Click
here for news about ULTRAM ER.
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INDICATION
ULTRAMŽ ER (tramadol HCl) Extended-Release Tablets are 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
ULTRAM ER is contraindicated in any situation where opioids are
contraindicated, including a history of anaphylactoid reactions to
opioids, and in patients who have previously demonstrated
hypersensitivity to tramadol.
ULTRAM ER must be swallowed whole and must not be chewed, crushed, or
split. Chewing, crushing, or splitting the tablet will result in the
uncontrolled delivery of the opioid and could result in overdose and
death. This risk is increased with concurrent abuse of alcohol and
other substances.
Tramadol, like other opioids used in analgesia, can be abused.
Seizures have been reported in patients receiving tramadol. The risk
of seizure is increased with doses of tramadol above the recommended
range.
Concomitant use of tramadol increases the seizure risk in patients
taking tricyclic antidepressants, selective serotonin reuptake
inhibitors, or other opioids.
Tramadol may enhance the seizure risk in patients taking MAO
inhibitors, neuroleptics, or other drugs that reduce the seizure
threshold.
Risk of convulsions may also increase 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).
Do not prescribe ULTRAM ER for patients who are suicidal or
addiction-prone.
ULTRAM ER should be used with caution and in reduced dosages when
administered to patients receiving CNS depressants such as alcohol,
opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers,
antidepressants or sedative hypnotics. ULTRAM ER increases the risk of
CNS and respiratory depression in these patients.
Administer ULTRAM ER cautiously in patients at risk for respiratory
depression. In these patients nonopioid analgesics should be
considered. When large doses of tramadol are administered with
anesthetic medications or alcohol, respiratory depression may result.
Respiratory depression should be treated as an overdose. If naloxone
is to be administered, use cautiously because it may precipitate
seizures.
Use ULTRAM ER cautiously in patients over 65 years of age due to the
greater frequency of adverse events observed in this population.
ULTRAM ER should not be used in patients with severe renal (CrCl <30
mL/min) or hepatic (Child-Pugh Class C) impairment.
In clinical trials, the most frequently reported side effects in
patients receiving ULTRAM ER and placebo, respectively, were dizziness
(not vertigo, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%),
constipation (12.2%-21.3% vs 4.2%), somnolence (7.3%-11.3% vs 1.7%),
and flushing (7.7%-10.0% vs 4.4%).
ULTRAM ER should not be administered at a dose exceeding 300 mg per
day.
Please see full US Prescribing Information.
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