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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 its mode of action
is not completely understood, from animal tests, at
least two complementary mechanisms appear applicable:
the binding of parent 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 and reaches a peak in approximately two
to three hours.
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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 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 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.
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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 dose adjustment is
necessary.
Patients over 75 years old: No more then 300 mg/day
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 on the day of dialysis.
Patients with cirrhosis: Recommended dosage is 50 mg
every 12 hours.
Patients receiving chronic carbamazepine: Doses up to
800 mg daily may be required, this is up to twice the
recommended dose of ULTRAM.
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DRUG
ABUSE AND DEPENDENCE:
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 SEIZURES:
Seizure Risk: Seizures have been reported in patients
receiving ULTRAM within the recommended dosage range.
Concomitant use of ULTRAM increases the seizure risk
in patients taking:
Selective serotonin reuptake inhibitors (SSRI antidepressants
or anoretics -phentermine),
Tricyclic antidepressants and other tricyclic compounds
(e.g., cyclobenzaprine, promethazine, etc.),
Opioids,
MAO inhibitors,
Neuroleptics,
Any drugs that reduce the seizure threshold,
Epilepsy.
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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 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.
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OVERDOSAGE:
Serious potential consequences of 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 or email us at patientcare@health-pharmacy.net.
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insure your safety.
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