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
Levo Dromoran Side Effects, and Drug Interactions - Levorphanol
Levo Dromoran Side Effects, and Drug Interactions - Levorphanol
SIDE EFFECTS
In approximately 1400 patients treated with Levo-Dromoran in controlled clinical
trials, the type and incidence of side effects were those expected of an opioid
analgesic, and no unforeseen or unusual toxicity was reported.
Drugs of this type are expected to produce a cluster of typical opioid effects
in addition to analgesia, consisting of nausea, vomiting, altered mood and mentation,
pruritus, flushing, difficulties in urination, constipation and biliary spasm.
The frequency and intensity of these effects appears to be dose related. Although
listed as adverse events these are expected pharmacologic actions of these drugs
and should be interpreted as such by the clinician.
The following adverse events have been reported with the use of Levo-Dromoran:
Body as a Whole: abdominal pain, dry mouth, sweating
Cardiovascular System: cardiac arrest, shock, hypotension,
arrhythmias including bradycardia and tachycardia, palpitations, extra-systoles
Digestive System: nausea, vomiting, dyspepsia, biliary tract
spasm
Nervous System: coma, suicide attempt, convulsions, depression,
dizziness, confusion, lethargy, abnormal dreams, abnormal thinking, nervousness,
drug withdrawal, hypokinesia, dyskinesia, hyperkinesia, CNS stimulation, personality
disorder, amnesia, insomnia
Respiratory System: apnea, cyanosis, hypoventilation
Skin & Appendages: pruritus, urticaria, rash, injection
site reaction
Special Senses: abnormal vision, pupillary disorder, diplopia
Urogenital System: kidney failure, urinary retention, difficulty
urinating
DRUG ABUSE AND DEPENDENCE
Warning: May be Habit Forming
Levo-Dromoran is a Schedule II Controlled Substance. All drugs of this class
(mu-opioids of the morphine type) are habit forming and should be stored, prescribed,
used and disposed of accordingly. Psychological/physical dependence and tolerance
may develop upon repeated administration of Levo-Dromoran.
Discontinuation of Levo-Dromoran after chronic use has been reported to result
in withdrawal syndromes, and some reports of overuse and self-reported addiction
have been received. Neither withdrawal nor withdrawal symptoms are usually expected
in postoperative patients who used the drug for less than a week or in patients
who are gradually tapered off the drug after longer use.
DRUG INTERACTIONS
Interactions with Other CNS
Agents: Concurrent use of Levo-Dromoran with all central nervous system
depressants (eg, alcohol, sedatives, hypnotics, other opioids, general anesthetics,
barbiturates, tricyclic antidepressants, phenothiazines, tranquilizers, skeletal
muscle relaxants and antihistamines) may result in additive central nervous
system depressant effects. Respiratory depression, hypotension, and profound
sedation or coma may occur. When such combined therapy is contemplated, the
dose of one or both agents should be reduced. Although no interaction between
MAO inhibitors and Levo-Dromoran has been observed, it is not recommended for
use with MAO inhibitors.
Most cases of serious or fatal adverse events involving Levo-Dromoran reported
to the manufacturer or the FDA have involved either the administration of large
initial doses or too frequent doses of the drug to nonopioid tolerant patients,
or the simultaneous administration of levorphanol with other drugs affecting
respiration (see INDIVIDUALIZATION OF DOSAGE and WARNINGS ). The initial dose
of levorphanol should be reduced by approximately 50% or more when it is given
to patients along with another drug affecting respiration.
Interactions with Mixed Agonist/Antagonist Opioid Analgesics:
Agonist/antagonist analgesics (eg, pentazocine, nalbuphine, butorphanol,
dezocine and buprenorphine) should NOT be administered to a patient who has
received or is receiving a course of therapy with a pure agonist opioid analgesic
such as Levo-Dromoran. In opioid-dependent patients, mixed agonist/antagonist
analgesics may precipitate withdrawal symptoms.
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