Ultram
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FORM OF THE DRUG ULTRAM:
Ultram ( tramadol
hydrochloride ) is a white, bitter, crystalline and odorless powder.
Each Ultram tablet tablet tablet contains 50 mg of tramadol
hydrochloride and is white in color.
Ultram is supplied as a 50 mg (white, film-coated capsule-shaped
tablet) which is engraved with "McNeil" on one side and on one side
and "659" on the other side.
HOW DOES ULTRAM WORK?
Ultram acts
on the central nervous system and unlike codeine and its derivative medications
is a totally synthetic analgesic compound. Although Ultram's mode of
action is not completely understood, from animal tests, at least two complementary
mechanisms appear applicable: the binding of the parent Ultram compound
and its metabolite to opioid receptors and weak inhibition of reuptake of norepinephrine
and serotonin by nerves located within the central nervous system. Ultram -induced
analgesia is only partially reversed by the opiate antagonist naloxone in several
animal tests.
Ultram has been shown to inhibit reuptake of norepinephrine
and serotonin in vitro. These mechanisms may contribute independently to the
overall analgesic profile of Ultram . Analgesia in humans
begins approximately within one hour after administration of Ultram and
reaches a peak in approximately two to three hours.
HOW EFFECTIVE IS ULTRAM?
Ultram has
been given in single oral doses of 50, 75, 100, 150 and 200 mg to patients
with pain following surgical procedures and pain following oral surgery (extraction
of impacted molars). In single-dose models of pain following oral surgery,
pain relief with Ultram was
demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg
of Ultram tended to provide analgesia superior to codeine
sulfate 60 mg, but it was not effective as the combination of aspirin 650 mg
with codeine phosphate 60 mg. In single-dose models of pain following surgical
procedures, 150 mg of Ultram provided
analgesia generally comparable to the combination of acetaminophen 650 mg with
propoxyphene napsylate 100 mg, with a tendency toward later peak effect.
Ultram has been studied in three long-term controlled trials
involving a total of 820 patients, with 530 patients receiving Ultram .
Patients with a variety of chronic painful conditions were studied in double-blind
trials of one to three months duration. Average daily doses of approximately
250 mg of Ultram in divided doses were generally comparable
with five doses of acetaminophen 300 mg with codeine phosphate 30 mg (Tylenol
with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate
30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride
5 mg (Tylox) daily.
HOW DO I USE ULTRAM?
For the treatment of painful conditions Ultram 50
mg to 100 mg can be administered as needed for relief every four to six hours,
not to exceed 400 mg per day. For moderate pain Ultram 50
mg may be adequate as the initial dose, and for more severe pain, Ultram 100
mg is usually more effective as the initial dose.
Individualization of Dose:
- Patients 65 to 75 years of age: No Ultram dose
adjustment is necessary.
- Patients over 75 years old: No more then 300 mg/day of Ultram in
divided doses.
- Patients with kidney impairment: The dosing interval of Ultram should
be increased to 12 hours with a maximum daily dose of 200 mg.
- Dialysis patients: These patients can receive their regular dose of Ultram on
the day of dialysis.
- Patients with cirrhosis: Recommended dosage of Ultram 50
mg every 12 hours.
- Patients receiving chronic carbamazepine: Doses up to 800 mg daily of Ultram may
be required, this is up to twice the recommended dose of Ultram .
ADVERSE REACTIONS WITH ULTRAM:
Ultram was
administered to 550 patients during the double-blind or open-label extension
periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375
were 65 years old or older. TABLE 2 reports the cumulative incidence rate of
adverse reactions with Ultram by
7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The
most frequently reported events on Ultram were
in the central nervous system and gastrointestinal system. Although the reactions
listed in the table are felt to be probably related to Ultram administration,
the reported rates also include some events that may have been due to underlying
disease or concomitant medication. The overall incidence rates of adverse experiences
in these trials were similar for Ultram and the active control
groups, acetaminophen 300 mg with codeine phosphate 30 mg, and aspirin 325
mg with codeine phosphate 30 mg. (TABLE 2)
DRUG ABUSE AND DEPENDENCE WITH ULTRAM:
Ultram has
a potential to cause psychic and physical dependence of the morphone-type.
The drug has been associated with craving, drug-seeking behavior and tolerance
development. Cases of abuse and dependence on Ultram have
been reported.
Ultram should not be used in opioid-dependent patients. Ultram can
reinitiate physical dependence in patients that have been previously dependent
or chronically using other opioids. In patients with a tendency to drug abuse,
a history of drug dependence, or are chronically using opioids, treatment with Ultram is
not recommended.
ULTRAM AND DROWZINESS:
- Ultram may
impair mental or physical abilities required for the performance of potentially
hazardous tasks such as driving a car or operating machinery.
- Ultram should not be taken with alcohol containing beverages.
- Ultram should be used with caution when taking medications
such as tranquilizers, hypnotics or other opiate containing analgesics.
ULTRAM AND PREGNANCY:
- Ultram should
not be used in pregnant women or nursing mothers, safe use in pregnancy has
not been established.
- Chronic use of Ultram during
pregnancy may lead to physical dependence and post-pregnancy withdrawal symptoms
in the newborn.
- Ultram has been shown to cross the placenta. Nonetheless,
the effect of Ultram , if any, on the later growth, development,
and functional maturation of the child is unknown.
OVERDOSAGE:
Serious potential consequences of Ultram over
dosage are respiratory depression and seizure.
ADDITIONAL QUESTIONS:
Not every question can be addressed in this FAQ page. If any additional questions
remain we suggest you contact your local physician.
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