Prescribed by U.S. doctors and dispensed by U.S. pharmacists.
Ultram (Tramadol) is a white,
bitter, crystalline and odorless powder. Each Tramadol tablet tablet tablet contains
50 mg of tramadol hydrochloride and is white in color.
HOW DOES Tramadol WORK? Tramadol 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. Tramadol-induced
analgesia is only partially reversed by the opiate antagonist naloxone in several
animal tests. Tramadol has been shown to inhibit reuptake of norepinephrine and
serotonin in vitro. These mechanisms may contribute independently to the
overall analgesic profile of Tramadol. Analgesia in humans begins approximately
within one hour after administration and reaches a peak in approximately two to
three hours.
HOW EFFECTIVE IS Tramadol? Tramadol 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 Tramadol 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. Tramadol has been studied in three long-term
controlled trials involving a total of 820 patients, with 530 patients receiving
Tramadol. 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 Tramadol 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 Tramadol?
For the treatment of painful conditions Tramadol 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 Tramadol 50 mg may be adequate as the initial dose, and for more
severe pain, Tramadol 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 Tramadol 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 Tramadol.
ADVERSE REACTIONS:
Tramadol 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 Tramadol 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 Tramadol 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:
Tramadol 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 Tramadol have been reported.
Tramadol should not be used in opioid-dependent patients. Tramadol 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 Tramadol is not recommended.
Tramadol AND SEIZURES:
Seizure Risk:Seizures have been reported in patients receiving Tramadol within
the recommended dosage range. Concomitant use of Tramadol 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
Tramadol AND DROWZINESS:
Tramadol may impair mental or physical abilities required for the performance
of potentially hazardous tasks such as driving a car or operating machinery.
Tramadol should not be taken with alcohol containing beverages.
Tramadol should be used with caution when taking medications such as tranquilizers,
hypnotics or other opiate containing analgesics.
Tramadol AND PREGNANCY:
Tramadol 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.
Tramadol has been shown to cross the placenta. Nonetheless, the effect of Tramadol,
if any, on the later growth, development, and functional maturation of the child
is unknown.
OVERDOSAGE:
Serious potential consequences of over dosage are respiratory depression and
seizure.
