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(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 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.
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.
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.
ADVERSE REACTIONS:
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 by 7,
30 and 90 days for the most frequent reactions (5% or more by 7 days). The
most frequently reported events 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)
| TABLE 2 Cumulative
Incidence of Adverse Reactions for Tramadol HCl In Chronic Trials of
Nonmalignant Pain (N = 427) |
| |
Up to 7 Days |
Up to 30 Days |
Up to 90 Days |
| Dizziness/Vertigo |
26% |
31% |
33% |
| Nausea |
24% |
34% |
40% |
| Constipation |
24% |
38% |
46% |
| Headache |
18% |
26% |
32% |
| Somnolence (Sleepiness) |
16% |
23% |
25% |
| Vomiting |
9% |
13% |
17% |
| Pruritus |
8% |
10% |
11% |
| "CNS Stimulation"1 |
7% |
11% |
14% |
| Asthenia (Weakness) |
6% |
11% |
12% |
| Sweating |
6% |
7% |
9% |
| Dyspepsia (Acid Indigestion) |
5% |
9% |
13% |
| Dry Mouth |
5% |
9% |
10% |
| Diarrhea |
5% |
6% |
10% |
| 1 "CNS
Stimulation" is a composite of nervousness, anxiety, agitation,
tremor, spasticity, euphoria, emotional lability and hallucinations. |
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
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.
OVER DOSAGE:
Serious potential consequences of over dosage of Ultram are
respiratory depression and seizure.
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