A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ultram Side Effects, and Drug Interactions - Tramadol Hcl
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SIDE EFFECTS
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, TYLENOL® with Codeine #3 (acetaminophen
300 mg with codeine phosphate 30 mg),and aspirin 325 mg with codeine phosphate
30 mg, however, the rates of withdrawals due to adverse events appeared to be
higher in the ULTRAM groups.
|
Table 2:Cumulative Incidence of Adverse Reactions for
ULTRAM 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
|
16%
|
23%
|
25%
|
|
Vomiting
|
9%
|
13%
|
17%
|
|
Pruritus
|
8%
|
10%
|
11%
|
|
"CNS Stimulation"1
|
7%
|
11%
|
14%
|
|
Asthenia
|
6%
|
11%
|
12%
|
|
Sweating
|
6%
|
7%
|
9%
|
|
Dyspepsia
|
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.
|
Incidence 1% to less than 5%,possibly causally related:
the following lists adverse reactions that occurred with an incidence of
1% to less than 5% in clinical trials, and for which the possibility of a causal
relationship with ULTRAM exists.
Body as a Whole: Malaise.
Cardiovascular: Vasodilation.
Central Nervous System: Anxiety, Confusion, Coordination
disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.
Gastrointestinal: Abdominal pain, Anorexia, Flatulence.
Musculoskeletal: Hypertonia.
Skin: Rash.
Special Senses: Visual disturbance.
Urogenital: Menopausal symptoms, Urinary frequency,
Urinary retention.
Incidence less than 1%,possibly causally related: the
following lists adverse reactions that occurred with an incidence of less than
1% in clinical trials and/or reported in post-marketing experience.
Body as a Whole: Accidental injury, Allergic reaction,
Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental
status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis,
seizures and coma).
Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.
Central Nervous System: Abnormal gait, Amnesia, Cognitive
dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia,
Seizure (see WARNINGS),Tremor.
Respiratory: Dyspnea.
Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis,
Urticaria, Vesicles.
Special Senses: Dysgeusia.
Urogenital: Dysuria, Menstrual disorder.
Other adverse experiences, causal relationship unknown:
A variety of other adverse events were reported infrequently in patients
taking ULTRAM during clinical trials and/or reported in post-marketing experience.
A causal relationship between ULTRAM and these events has not been determined.
However, the most significant events are listed below as alerting information
to the physician.
Cardiovascular: Abnormal ECG, Hypertension, Hypotension,
Myocardial is chemia, Palpitations, Pulmonary edema, Pulmonary embolism.
Central Nervous System: Migraine, Speech disorders.
Gastrointestinal: Gastrointestinal bleeding, Hepatitis,
Stomatitis, Liver failure.
Laboratory Abnormalities: Creatinine increase, Elevated
liver enzymes, Hemoglobin decrease, Proteinuria.
Sensory: Cataracts, Deafness, Tinnitus.
DRUG ABUSE AND DEPENDENCE
ULTRAM may induce psychic and physical dependence of the morphine-type
(µ-opioid).(See WARNINGS.) Dependence and
abuse, including drug-seeking behavior and taking illicit actions to obtain
the drug are not limited to those patients with prior history of opioid dependence.
The risk in patients with substance abuse has been observed to be higher. ULTRAM
is associated with craving and tolerance development. Withdrawal symptoms may
occur if ULTRAM is discontinued abruptly. These symptoms may include:anxiety,sweating,insomnia,rigors,pain,nausea,tremors,diarrhea,upper
respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience
suggests that withdrawal symptoms may be relieved by reinstitution of opioid
therapy followed by a gradual, tapered dose reduction of the medication combined
with symptomatic support.
DRUG INTERACTIONS
In vitro studies indicate that tramadol is unlikely to inhibit
the CYP3A4-mediated metabolism of other drugs when tramadol is administered
concomitantly at therapeutic doses. Tramadol does not appear to induce its own
metabolism in humans, since observed maximal plasma concentrations after multiple
oral doses are higher than expected based on single-dose data. Tramadol is a
mild inducer of selected drug metabolism pathways measured in animals.
Use With Carbamazepine
Patients taking carbamazepine may have a significantly
reduced analgesic effect of ULTRAM. Because carbamazepine increases tramadol
metabolism and because of the seizure risk associated with tramadol, concomitant
administration of ULTRAM and carbamazepine is not recommended.
Use With Quinidine
Tramadol is metabolized to M1 by CYP2D6. Quinidine is
a selective inhibitor of that isoenzyme, so that concomitant administration
of quinidine and ULTRAM results in increased concentrations of tramadol and
reduced concentrations of M1.The clinical consequences of these findings are
unknown. In vitro drug interaction studies in human liver microsomes indicate
that tramadol has no effect on quinidine metabolism.
Use With Inhibitors of CYP2D6
In vitro drug interaction studies in human liver microsomes
indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine,
paroxetine, and amitriptyline could result in some inhibition of the metabolism
of tramadol.
Use With Cimetidine
Concomitant administration of ULTRAM with cimetidine does
not result in clinically significant changes in tramadol pharmacokinetics. Therefore,
no alteration of the ULTRAM dosage regimen is recommended.
Use With MAO Inhibitors
Interactions with MAO Inhibitors, due to interference
with detoxification mechanisms, have been reported for some centrally acting
drugs (see WARNINGS, Use With MAO Inhibitors).
Use With Digoxin and Warfarin
Post-marketing surveillance has revealed rare reports of digoxin
toxicity and alteration of warfarin effect, including elevation of prothrombin
times.
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