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ULTRAM® (tramadol hydrochloride)
tablets is a centrally acting analgesic.
name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3
methoxyphenyl) cyclohexanol hydrochloride.
The molecular weight of tramadol hydrochloride is 299.8.
Tramadol hydrochloride is a
white, bitter, crystalline and odorless powder.
It is readily soluble in water and ethanol
and has a pKa of 9.41.
The n-octanol/water log partition coefficient (logP) is 1.35 at pH
7. ULTRAM® tablets contain 50 mg
of tramadol hydrochloride and are white in color.
Inactive ingredients in the tablet are
pregelatinized corn starch, modified starch (corn),
hypromellose, lactose, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, polysorbate 80, sodium starch glycolate,
titanium dioxide and carnauba wax.
ULTRAM® contains tramadol,
a centrally acting synthetic opioid analgesic. Although its
mode of action is not completely
understood, from animal tests, at least two
appear applicable: binding of parent and M1 metabolite to
μ-opioid receptors and weak
inhibition of re-uptake of norepinephrine and serotonin.
Opioid activity is due to both
low affinity binding of the parent compound and higher
affinity binding of the O-demethylated
metabolite M1 to μ-opioid receptors. In animal
models, M1 is up to 6 times more
potent than tramadol in producing analgesia and 200
times more potent in μ-opioid binding.
Tramadol-induced analgesia is only partially.
antagonized by the opiate antagonist
naloxone in several animal tests. The relative
contribution of both tramadol and M1 to
human analgesia is dependent upon the plasma
concentrations of each compound
(see CLINICAL PHARMACOLOGY,
Tramadol has been shown to inhibit
reuptake of norepinephrine and serotonin in vitro, as
have some other opioid analgesics.
These mechanisms may contribute independently to
the overall analgesic profile of ULTRAM®.
Analgesia in humans begins approximately
within one hour after administration
and reaches a peak in approximately two to three
Apart from analgesia, ULTRAM®
administration may produce a constellation of
symptoms (including dizziness,
somnolence, nausea, constipation, sweating and pruritus)
similar to that of other opioids.
In contrast to morphine, tramadol has not been shown to
cause histamine release. At therapeutic doses,
ULTRAM® has no effect on heart rate,
left-ventricular function or cardiac index.