WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, and MISUSE; RISK EVALUATION and MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL and OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
QDOLO is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve QDOLO for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
The most common adverse events (≥15.0%) in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Athena Bioscience, LLC at 1-833-874-2664.
See Full Prescribing Information for all adverse reactions associated with QDOLO.
QDOLO use with Agonist/Antagonist and Partial Agonist Opioid Analgesics should be avoided as it may reduce analgesic effect of QDOLO or precipitate withdrawal symptoms.
See Full Prescribing Information for all drug interactions associated with QDOLO.
Pregnancy and Lactation: May cause fetal harm; breastfeeding is not recommended.
See Full Prescribing Information for use in specific populations associated with QDOLO.
Please see the accompanying Full Prescribing Information
To manage serious risks associated with opioid analgesic products, the Food and Drug Administration (FDA) requires a REMS to ensure the benefits of these products outweigh the risks of addiction, abuse, and misuse. This REMS requires providers of opioid analgesics to offer REMS-compliant education programs for healthcare providers and strongly encourages HCPs to:
For further information and a list of accredited REMS CME/CE, call 1-800-503-0784 or visit www.opioidanalgesicrems.com.
For the FDA Blueprint, visit www.fda.gov/OpioidAnalgesicREMSBlueprint.
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