"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
In approximately 1400 patients treated with Levo-Dromoran (levorphanol) 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 (levorphanol) :
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
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 (levorphanol) 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 (levorphanol) .
Discontinuation of Levo-Dromoran (levorphanol) 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.
Read the Levo Dromoran (levorphanol) Side Effects Center for a complete guide to possible side effects »
Interactions with Other CNS Agents
Concurrent use of Levo-Dromoran (levorphanol) with all central nervous system depressants (eg, alcohol, sedatives, hypnotics, other opioids, general anesthetics, barbitu-rates, 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 (levorphanol) has been observed, it is not recommended for use with MAO inhibitors.
Most cases of serious or fatal adverse events involving Levo-Dromoran (levorphanol) 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 (levorphanol) . In opioid-dependent patients, mixed agonist/antagonist analgesics may precipitate withdrawal symptoms.
Use in Ambulatory Patients
Levo-Dromoran (levorphanol) has been used in both inpatient and outpatient settings, but both physicians and patients must be aware of the risk of orthostatic hypotension, dizziness and syncope in ambulatory patients.
As with other opioids, the use of Levo-Dromoran (levorphanol) may impair mental and/or physical abilities required for the performance of potentially hazardous tasks or for the exercise of normal good judgement and patients and staff should be advised accordingly. Concurrent use of Levo-Dromoran (levorphanol) with central nervous system depressants (eg, alcohol, sedatives, hypnotics, other opioids, barbiturates, tricyclic antidepressants, phenothiazines, tranquilizers, skeletal muscle relaxants and antihistamines) may result in additive central nervous system depressant effects.
Last reviewed on RxList: 6/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Levo Dromoran Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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