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LEVORPHANOL TARTRATE
At a glance
| Generic name | LEVORPHANOL TARTRATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
Boxed warnings
- WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS Addiction, Abuse, and Misuse Because the use of Levorphanol Tartrate Tablets exposes 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 and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Levorphanol Tartrate Tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Levorphanol Tartrate Tablets are essential [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of Levorphanol Tartrate Tablets, especially by children, can result in a fatal overdose of levorphanol [see WARNINGS ]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (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 [see WARNINGS ] . Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS ] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ].
Common side effects
- Nausea
- Vomiting
- Constipation
- Pruritus
- Altered mood and mentation
- Flushing
- Difficulties in urination
- Biliary spasm
- Dizziness
- Abdominal pain
- Dry mouth
- Sweating
Serious adverse events
- Respiratory depression/Apnea
- Cardiac arrest
- Coma
- Serotonin syndrome
- Anaphylaxis
- Adrenal insufficiency
- Convulsions
- Shock
- Kidney failure
- Hyperalgesia and Allodynia
Primary sources
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| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LEVORPHANOL TARTRATE CI brief — competitive landscape report
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