Applies to levorphanol: oral tablet.
Warning
Oral route (Tablet)
Addiction, Abuse, and Misuse
Levorphanol tartrate tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing levorphanol tartrate tablets, and monitor all patients regularly for the development of these behaviors or conditions.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant eduction programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of levorphanol tartrate tablets. Monitor for respiratory depression, especially during initiation of levorphanol tartrate tablets or following a dose increase.
Accidental Ingestion
Accidental ingestion of even one dose of levorphanol tartrate tablets, especially by children, can result in a fatal overdose of levorphanol tartrate tablets.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of levorphanol tartrate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of levorphanol tartrate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Serious side effects of Levorphanol
Along with its needed effects, levorphanol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking levorphanol:
Incidence not known
- Agitation
- attempts at killing oneself
- bluish lips or skin
- blurred vision
- change in consciousness
- cold, clammy skin
- confusion
- darkening of the skin
- decrease in the frequency of urination
- decreased awareness or responsiveness
- decreased urine output
- depression
- diarrhea
- difficulty in passing urine (dribbling)
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extra heartbeat
- extremely shallow or slow breathing
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- fast, weak pulse
- fever
- hostility
- hives or welts, itching, skin rash
- lightheadedness
- loss of appetite
- loss of consciousness
- muscle twitching
- nausea
- no blood pressure or pulse
- not breathing
- overactive reflexes
- painful urination
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- restlessness
- seizures
- severe sleepiness
- shivering
- stopping of the heart
- sweating
- swelling of the face, ankles, or hands
- talking or acting with excitement you cannot control
- tightness in the chest
- trembling or shaking
- twitching
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur while taking levorphanol:
Symptoms of overdose
- Chest pain or discomfort
- constricted, pinpoint, or small pupils (black part of the eye)
- decreased awareness or responsiveness
- difficult or troubled breathing
- difficulty with sleeping
- dilated neck veins
- disorientation
- drowsiness to profound loss of consciousness
- extreme tiredness or weakness
- headache
- irregular, fast or slow, or shallow breathing
- no muscle tone or movement
- not breathing
- pale or blue lips, fingernails, or skin
- seeing, hearing, or feeling things that are not there
- sleepiness or unusual drowsiness
- swelling of the face, fingers, feet, or lower legs
- weight gain
Other side effects of Levorphanol
Some side effects of levorphanol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Abnormal dreams
- absence of or decrease in body movement
- belching
- change in personality
- changes in vision
- discouragement
- double vision
- dry mouth
- false beliefs that cannot be changed by facts
- feeling sad or empty
- heartburn
- increase in body movements
- indigestion
- irritability
- loss of interest or pleasure
- loss of memory
- nervousness
- poor insight and judgment
- problems with memory or speech
- redness of the skin
- seeing double
- stomach discomfort, upset, or pain
- sweating
- trouble concentrating
- trouble recognizing objects
- trouble sleeping
- trouble thinking and planning
- trouble walking
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- upper abdominal or stomach pain
For Healthcare Professionals
Applies to levorphanol: compounding powder, injectable solution, oral tablet.
General
The adverse effects of this drug are generally similar to the adverse effects observed with other narcotic analgesics including nausea, vomiting, altered mood and mentations, pruritus, flushing, difficulties in urination, constipation, and biliary spasm.[Ref]
Respiratory
Frequency not reported: Apnea, cyanosis, hypoventilation
Nervous system
Cases of serotonin syndrome have been reported with concomitant use of serotonergic drugs.[Ref]
Frequency not reported: Coma, convulsions, dizziness, lethargy, hypokinesia, dyskinesia, hyperkinesia, CNS stimulation
Postmarketing reports: Serotonin syndrome[Ref]
Hypersensitivity
Anaphylaxis has been reported with ingredients contained in the levorphanol tablets.
Postmarketing reports: Anaphylaxis
Cardiovascular
Frequency not reported: Cardiac arrest, shock, hypotension, arrhythmias including bradycardia and tachycardia, palpitations, extra-systoles[Ref]
Gastrointestinal
Frequency not reported: Nausea, vomiting, constipation, dyspepsia, biliary tract spasm, abdominal pain, dry mouth[Ref]
Genitourinary
Frequency not reported: Urinary retention, difficulty urinating[Ref]
Dermatologic
Frequency not reported: Pruritus, urticaria, rash, sweating[Ref]
Psychiatric
Frequency not reported: Suicide attempt, depression, confusion, abnormal dreams, abnormal thinking, nervousness, drug withdrawal, personality disorder, amnesia, insomnia
Renal
Frequency not reported: Kidney failure
Endocrine
Postmarketing reports: Adrenal insufficiency, androgen deficiency
Cases of adrenal insufficiency and androgen deficiency have been reported with opioid use. Adrenal insufficiency has more often been reported following use of greater than 1 month. Androgen deficiency has occurred with chronic opioid use.
Ocular
Frequency not reported: Abnormal vision, pupillary disorder, diplopia
