Ultram Online Information
Tramadol
HCl (Ultram, Ortho-McNeil Pharmaceutical), a
new centrally acting analgesic indicated for
the management of moderate to moderately severe
pain, has gained FDA approval.
Tramadol has a dual mechanism of action: blocking
incoming pain signals and prolonging the body's
natural pain-modifying mechanisms, according
to the manufacturer. The company states that
because the drug does not inhibit prostaglandin
production, as do nonsteroidal anti-inflammatory
drugs, it is less likely to cause ulcers and
gastrointestinal bleeding than other drugs of
its class.
The recommended dosage is 50 to 100 mg administered
as needed for pain relief every 4 to 6 hours,
up to a maximum daily dose of 400 mg. Labeling
states that the 50-mg dose might be adequate
for controlling moderate pain, while the 100-mg
dose is usually more effective as the initial
dose for more severe pain. Dosage adjustments
and increased dosing intervals are recommended
for certain patient populations, especially
those with hepatic or renal impairment.
The most commonly reported adverse reactions
during clinical trials were dizziness/vertigo
(26% of patients taking the drug for up to 7
days; 31% for up to 30 days; and 33% for up
to 90 days); nausea (24%, 34%, and 40%, respectively);
and constipation (24%, 38%, and 46%, respectively).
Labeling warns that "a few" seizures
have been reported in patients receiving excessive
(700 mg), single oral doses or large (300 mg)
IV doses of tramadol and that it might increase
seizure risk in patients taking monoamine oxidase
(MAO) inhibitors, neuroleptics, other drugs
that reduce the seizure threshold, patients
with epilepsy, or those otherwise at increased
risk for seizure. It should be used with caution
and with reduced dosages in patients receiving
central nervous system depressants and with
"great caution" in those taking MAO
inhibitors.
This drug is contraindicated in patients hypersensitive
to it or in cases of acute intoxication with
alcohol, hypnotics, centrally acting analgesics,
opioids, or psychotropic drugs. |
