Oliceridine

Drugs / By

Oliceridine – Description

  • Oliceridine is an intravenous opioid agonist indicated for the treatment of severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.
  • Oliceridine is indicated for use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use.
  • Use of oliceridine beyond 48 hours has not been evaluated in controlled clinical trials.65809 
  • Safety and efficacy were established by comparing oliceridine to both morphine and placebo in randomized, controlled trials of patients undergoing bunionectomy (n = 389) or abdominoplasty (n = 401).
  • Oliceridine demonstrated a statistically greater reduction in pain intensity than placebo and was non-inferior to morphine in both populations. It has a favorable safety and tolerability profile for respiratory and gastrointestinal adverse effects compared to morphine.65817 65818

Indications & Dosage

  •  Severe pain

Maximum Dosage Limits:

•Adults

3 mg/dose IV and 27 mg/day IV.

•Geriatric

3 mg/dose IV and 27 mg/day IV.

•Adolescents

Safety and efficacy have not been established.

•Children

Safety and efficacy have not been established.

•Infants

Safety and efficacy have not been established.

•Neonates

Safety and efficacy have not been established.

indicates a Black Box warning

Contraindications

  •  GI obstruction
  •  ileus
  •  respiratory depression

Precautions

  •  abrupt discontinuation
  •  alcoholism
  •  apheresis
  •  asthma
  •  AV block
  •  biliary tract disease
  •  bradycardia
  •  brain tumor
  •  breast-feeding
  •  cardiomyopathy
  •  celiac disease
  •  chronic obstructive pulmonary disease
  •  CNS depression
  •  coadministration with other CNS depressants
  •  coma
  •  congenital long QT syndrome
  •  cor pulmonale
  •  depression
  •  driving or operating machinery
  •  electrolyte imbalance
  •  females
  •  fever
  •  geriatric
  •  head trauma
  •  heart failure
  •  hepatic disease
  •  human immunodeficiency virus (HIV) infection
  •  hyperparathyroidism
  •  hypocalcemia
  •  hypokalemia
  •  hypomagnesemia
  •  hypothermia
  •  hypothyroidism
  •  hypovolemia
  •  hypoxemia
  •  increased intracranial pressure
  •  infertility
  •  intracranial mass
  •  labor
  •  myocardial infarction
  •  neonatal opioid withdrawal syndrome
  •  obstetric delivery
  •  pancreatitis
  •  pheochromocytoma
  •  poor metabolizers
  •  potential for overdose or poisoning
  •  pregnancy
  •  QT prolongation
  •  reproductive risk
  •  requires an experienced clinician
  •  respiratory insufficiency
  •  rheumatoid arthritis
  •  seizure disorder
  •  seizures
  •  shock
  •  sickle cell disease
  •  sleep apnea
  •  sleep deprivation
  •  stroke
  •  substance abuse
  •  systemic lupus erythematosus

Pregnancy

  • There are no available data on the use of oliceridine during human pregnancy to evaluate for a drug-associated risk of birth defects and miscarriage.
  • Oliceridine is not recommended for use during and immediately before labor when other analgesic techniques are more appropriate.
  • Opioids can prolong labor and obstetric delivery by temporarily reducing the strength, duration, and frequency of uterine contractions.
  • This effect is not consistent and may be offset by an increased rate of cervical dilatation, which may shorten labor. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in the neonate.
  • An opioid antagonist (e.g., naloxone) should be available for reversal of opioid-induced respiratory depression in the neonate.65809 
  • Further, prolonged maternal use of opioids during pregnancy may result in neonatal opioid withdrawal syndrome (NOWS). NOWS may be life-threatening if it is not promptly recognized and treated. Ensure NOWS is managed at the time of delivery according to protocols developed by neonatal experts.
  • Monitor the exposed neonate for withdrawal symptoms, including irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight, and manage accordingly.
  • Onset, duration, and severity of opioid withdrawal may vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination by the newborn.55881 65809 
  • Guidelines recommend early universal screening of pregnant individuals for opioid use and opioid use disorder at the first prenatal visit.
  • Obtain a thorough history of substance use and review the Prescription Drug Monitoring Program to determine if individuals have received prior prescriptions for opioids or other high-risk drugs such as benzodiazepines. Discuss the risks and benefits of opioid use during pregnancy, including the risk of becoming physiologically dependent on opioids, the possibility for NOWS, and how long-term opioid use may affect care during a future pregnancy.64838 64909 
  • In individuals undergoing uncomplicated normal spontaneous vaginal birth, consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks. If opioids are used, use in combination with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.
  • Use immediate-release opioids instead of extended-release or long-acting opioids; order the lowest effective dosage and prescribe no greater quantity of opioids than needed for the expected duration of such pain severe enough to require opioids.64909 
  • For individuals using opioids for chronic pain, consider strategies to avoid or minimize the use of opioids, including alternative pain therapies (i.e., nonpharmacologic) and nonopioid pharmacologic treatments.
  • Opioid agonist pharmacotherapy (e.g., methadone or buprenorphine) is preferable to medically supervised withdrawal in pregnant individuals with opioid use disorder.64838 
  • In animal reproductive studies, oliceridine reduced live litter size at birth and increased postnatal pup mortality between birth and postnatal day 4 when administered intravenously to rats from organogenesis through weaning at doses producing clinically relevant plasma exposure.
  • Oliceridine did not affect embryofetal development in rats and rabbits when administered intravenously during organogenesis at doses producing plasma exposures 7 and 8 times the estimated plasma exposure at the maximum recommended human dose (MRHD) on an AUC basis, respectively.65809

Lactation

  • It is not known whether oliceridine is present in human milk. The effects of oliceridine on a breast-feeding infant and milk production have not been evaluated.
  • Consider the developmental and health benefits of breast-feeding along with the mother’s clinical need for oliceridine and any potential adverse effects on the breast-fed infant from oliceridine or the underlying medical condition.
  • Monitor infants exposed to oliceridine through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breast-fed infants when maternal administration is discontinued or breast-feeding is stopped.65809

Interactions

Adverse Reaction

  •  adrenocortical insufficiency
  •  amenorrhea
  •  anxiety
  •  back pain
  •  constipation
  •  cough
  •  diarrhea
  •  dizziness
  •  drowsiness
  •  dyspepsia
  •  dyspnea
  •  elevated hepatic enzymes
  •  fever
  •  flatulence
  •  flushing
  •  gonadal suppression
  •  headache
  •  hyperalgesia
  •  hyperhidrosis
  •  hypocalcemia
  •  hypoglycemia
  •  hypokalemia
  •  hypomagnesemia
  •  hypophosphatemia
  •  hypotension
  •  hypoventilation
  •  hypoxia
  •  impotence (erectile dysfunction)
  •  infertility
  •  insomnia
  •  libido decrease
  •  muscle cramps
  •  nausea
  •  neonatal opioid withdrawal syndrome
  •  orthostatic hypotension
  •  physiological dependence
  •  pruritus
  •  psychological dependence
  •  rash
  •  respiratory depression
  •  restlessness
  •  seizures
  •  serotonin syndrome
  •  sinus tachycardia
  •  syncope
  •  tolerance
  •  urticaria
  •  vomiting
  •  withdrawal
  •  xerostomia

Administration

  • Injectable Administration
    • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Oliceridine is a clear, colorless solution. Do not use if visibly opaque particles, discoloration, or other foreign particles are observed.
    • Monitor patients closely for respiratory depression, especially within the first 24 to 48 hours after initiation and dose escalation.65809
    • Intravenous Administration
      •  Intermittent IV Injection
        • Administer undiluted.65809
        Patient-Controlled Analgesia (PCA)
        • The 30 mg/30 mL vial is intended for patient-controlled analgesia (PCA) use only.
        • Draw oliceridine directly from the vial into the PCA syringe or bag without diluting.65809

Mechanism of Action

  • Oliceridine is a full opioid agonist and is relatively selective for the mu-opioid receptor. It is a mu-opioid receptor ligand that preferentially engages the G protein pathway, which is thought to be the principal pathway leading to the analgesic effects of opioids.
  • Oliceridine has minimal to no recruitment of beta-arrestin signaling compared to conventional opioids, which is believed to reduce its opioid-related adverse event profile.65809 65818

Pharmacokinetics

  • Oliceridine is administered intravenously. Mean steady-state Vd ranges from 90 to 120 L, indicating extensive tissue distribution. Plasma protein binding is 77%.
  • Oliceridine is primarily metabolized by CYP2D6 and CYP3A4, with minor contributions from CYP2C9 and CYP2C19 into inactive metabolites.
  • Metabolic clearance occurs via oxidation with subsequent glucuronidation. Other biotransformation pathways include N-dealkylation, glucuronidation, and dehydrogenation. The majority of metabolites (70%) and a small amount of parent drug (0.97% to 6.75% of the dose) are excreted in the urine, with the remainder of metabolites eliminated in the feces.
  • The half-life of oliceridine is 1.3 to 3 hours.65809

Affected cytochrome P450 isoenzymes and drug transporters: CYP2C9, CYP2C19, CYP2D6, CYP3A4

  • Oliceridine is primarily metabolized by CYP2D6 and CYP3A4, with minor contributions from CYP2C9 and CYP2C19.
  • Only the inhibition of CYP2D6 and CYP3A4 significantly affects drug metabolism.
  • Oliceridicine does not inhibit any P450 isoenzymes at clinically relevant concentrations. In vitro data indicate oliceridine is not an inhibitor of any of the major drug transporters (e.g., BCRP, MDR1).65809

•Route-Specific Pharmacokinetics

Intravenous Route

  • Onset of analgesia is expected within 2 to 5 minutes after the initial dose.
  • Mean drug clearance decreases slightly with increasing dose, resulting in greater than proportional exposure, especially at doses more than 2 mg.
  • Oliceridine pharmacokinetics were not substantially changed (except for peak concentrations) when administered over different infusion times.65809

•Special Populations

Hepatic Impairment

  • Vd and half-life are increased in patients with moderate or severe hepatic impairment. Estimated Vd in subjects with moderate or severe impairment was 212 and 348 L, respectively, compared to healthy subjects (126 L) or those with mild hepatic impairment (167 L).
  • Half-life was increased to 4.3 and 5.8 hours in subjects with moderate and severe hepatic impairment, respectively, compared to those with no (2.1 hours) or mild (2.6 hours) impairment. Clearance and total exposure were similar between all groups.65809

Renal Impairment

There was no significant difference in oliceridine clearance in subjects with end-stage renal disease compared to healthy subjects.65809

Other

CYP2D6 Poor Metabolizers

  • In CYP2D6 poor metabolizers, plasma clearance is approximately 50% of the plasma clearance in subjects who are nonpoor metabolizers.
  • AUC was approximately 2-fold higher in healthy CYP2D6 poor metabolizers than in subjects who are nonpoor metabolizers.65809

Classifications

  • Central and Peripheral Nervous System
    • Analgesics
      • Opiate Agonists and Related Agents
        •  Opioid Agonists

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39635.Hydromorphone hydrochloride extended-release tablets package insert. Minneapolis, MN: Padagis; 2024 Jan.

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40309.Doral (quazepam) package insert. Atlanta, GA: Galt Pharmaceuticals; 2023 Jan.

40942.Remeron and Remeron SolTabs (mirtazapine tablets and ODT tablets) package insert. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; 2021 Nov.

40943.Onsolis (fentanyl buccal soluble film) package insert. Raleigh, NC: BioDelivery Sciences, International, Inc.; 2021 Mar.

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40951.MS Contin (morphine sulfate extended-release tablets) package insert. Stamford, CT: Purdue Pharma L.P.; 2023 Dec.

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41505.Mirapex ER (pramipexole extended-release tablet) package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2024 July

41533.Ativan (lorazepam) tablets package insert. Bridgewater, NJ: Bausch Health US, LLC; 2023 Jan.

41537.Ativan (lorazepam) injection package insert. Berkeley Heights, NJ: Hikma Pharmaceuticals USA, Inc.; 2023 Jan.

41538.Xanax XR (alprazolam extended-release tablet) package insert. New York, NY: Pharmacia & Upjohn Company; 2023 Jan.

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42227.Latuda (lurasidone) package insert. Marlborough, MA: Sunovion Pharmaceuticals, Inc.; 2025 Jan.

42845.Abilify (aripiprazole) tablets package insert. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2025 Jan.

42938.Haloperidol tablets package insert. Morgantown, WV: Mylan Pharmaceuticals Inc.; 2020 Jul.

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43431.Ketalar (ketamine hydrochloride) package insert. Chestnut Ridge, NY: Par Pharmaceuticals; 2022 Mar.

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43566.Intuniv (guanfacine extended-release tablets) package insert. Lexington, MA: Shire US Inc.; 2020 Aug.

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43931.Diazepam injection package insert. Upper Saddle River NJ: Dash Pharmaceuticals, LLC.; 2021 Mar.

44058.Prozac Weekly (fluoxetine hydrochloride delayed-release capsules) package insert. Indianapolis, IN: Lilly USA, LLC; 2017 Mar.

44156.Zytiga (abiraterone acetate) tablets package insert. Horsham, PA: Janssen Biotech, Inc.; 2021 Aug.

44726.Depakote (divalproex sodium) delayed release tablets package insert. North Chicago, IL: AbbVie Inc.; 2025 May.

44859.Midazolam injection package insert. Lake Forest, IL: Hospira, Inc.; 2023 Feb.

45206.Nitro-Dur (nitroglycerin patch) package insert. Orlando, FL: Ingenus Pharmaceuticals, LLC.; 2017 Sept.

45458.Xalkori (crizotinib) capsules and pellets package insert. New York, NY: Pfizer Labs; 2023 Sept.

45480.Nucynta ER (tapentadol extended-release tablets) package insert. Stoughton, MA: Collegium Pharmaceutical, Inc.; 2023 Dec.

46370.Onfi (clobazam) package insert. Deerfield, IL: Lundbeck Inc.; 2024 Mar.

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46957.Navane (thiothixene capsules) package insert. New York, NY: Pfizer, Inc.; 2017 Mar.

47165.Norvir (ritonavir tablets, solution, and powder) package insert. North Chicago, IL: AbbVie Inc; 2022 Dec.

47184.Fluvoxamine tablets package insert. Baudette, MN: ANI Pharmaceuticals, Inc.; 2023 Aug.

47262.Dimetapp Cold and Allergy Solution (Brompheniramine maleate 2 mg/10 mL oral solution) consumer product label. Pittsburgh PA: Foundation Consumer Healthcare LLC; 2025 Mar.

47268.Clemastine fumarate syrup package insert. Allentown, PA: Genus Lifesciences Inc.; 2024 Sept.

47399.Lithobid extended-release tablets (lithium carbonate, USP) package insert. Baudette, MN: ANI Pharmaceuticals, Inc.; 2022 Oct.

48645.Nefazodone tablet package insert. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2015 Sept.

48650.Dimenhydrinate injection package insert. Schaumburg, IL: APP Pharmaceuticals, LLC; 2019 Dec.

48697.Korlym (mifepristone) tablet package insert. Menlo Park, CA: Corcept Therapeutics; 2019 Nov.

49229.Amytal (amobarbital sodium) package insert. Bridgewater, NJ: Bausch Health US, LLC; 2020 Jul.

49352.Seconal (secobarbital sodium) capsules package insert. Jacksonville, Fl: Ranbaxy Pharmaceuticals, Inc.; 2008 Sept.

49444.Ondansetron hydrochloride (Zofran) tablets and oral solution package insert. Research Triangle Park, NC: GlaxoSmithKline; 2021 April.

49446.Posfrea (palonosetron hydrochloride) injection package insert. E. Parsippany, NJ: Avyxa Pharma, LLC; 2025 Apr.

49500.Amidate (etomidate) package insert. Lake Forest, IL: Hospira, Inc.; 2017 Apr.

49509.Dantrium capsules (dantrolene sodium) package insert. Chestnut Ridge, NY: Par Pharmaceuticals; 2017 May.

49557.Neupro (rotigotine hydrochloride) transdermal system. Smyrna, Georgia: UCB Incorporated; 2021 Jul.

49614.Forane (isoflurane) liquid for inhalation package insert. Deerfield, IL: Baxter Healthcare Corporation; 2024 Dec.

49619.Dilaudid (hydromorphone) injection package insert. Lake Zurich, IL: Fresenius Kabi; 2023 Dec.

49620.Dilaudid (hydromorphone) oral solution and tablet package insert. Stamford, CT: Purdue Pharma L.P.; 2023 Dec.

49815.Sancuso (granisetron) patch package insert. Nashville, TN: Cumberland Pharmaceuticals Inc.; 2024 Sept.

50446.Tenex (guanfacine) package insert. Bridgewater, NJ: Promius Pharma, LLC; 2013 July.

50765.Quinidex Extentabs (quinidine sulfate extended-release tablets) package insert. Richmond, VA: A.H. Robbins Company; 2000 Sept.

51111.Myrbetriq and Myrbetriq Granules (mirabegron extended-release tablets and ER granules for oral suspension) package insert. Northbrook, IL: Astellas Pharma US, Inc.; 2021 March.

51201.Oxymorphone hydrochloride extended-release tablets package insert. Hayward, CA: Amneal Pharmaceuticals LLC; 2024 Jan.

51289.Droperidol injection package insert. Shirley NY: American Regent, Inc. 2023 Mar.

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51369.Chlorzoxazone tablets package insert. Malvern, PA: Endo USA; 2024 Nov.

51440.Conzip (tramadol hydrochloride extended-release capsules) package insert. Alpharetta, GA: Vertical Pharmaceuticals LLC; 2023 Dec.

51727.Xtandi (enzalutamide) capsule and tablet package insert. Northbrook, IL:Astellas Pharma US, Inc.; 2025 Jan.

51740.Maprotiline HCl tablet package insert. Morgantown WV: Mylan Pharmaceuticals Inc; 2014 Dec.

52061.Unisom SleepTabs (doxylamine) product label. Chattanooga, TN: Chattem Inc.; 2022 Dec.

52140.Perampanel (Fycompa) tablets and oral suspension package insert. Woodcliff Lake, NJ: Eisai Inc.; 2019 May.

52387.Sinemet CR (carbidopa; levodopa) sustained-release tablets package insert. Whitehouse Station, NJ: Merck & Co., Inc.; 2018 Apr.

52430.Zanaflex (tizanidine) tablets and capsules package insert. Georgetown, Grand Cayman: Legacy Pharma, Inc.; 2024 Nov.

52650.Methadone oral solution package insert. Eatontown, NJ: West-Ward Pharmaceuticals Corp.: 2019 Apr.

52766.Mytesi (crofelemer) package insert. San Francisco, CA: Napo Pharmaceuticals, Inc.; 2020 Nov.

53440.Marplan (isocarboxazid) package insert. Parsippany, NJ: Validus Pharmaceuticals; 2018 Nov.

54713.VFEND (voriconazole) injection package insert. New York, NY: Pfizer Inc; 2014 Sept.

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55469.Fetzima (levomilnacipran) extended-release capsules package insert. North Chicago, IL: AbbVie, Inc.; 2024 Apr.

55768.Cardizem (diltiazem tablets) package insert. Bridgewater, NJ: Bridgewater, NJ: Bausch Health US, LLC; 2024 Apr.

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56041.Trintellix (vortioxetine tablets) package insert. Lexington, MA: Takeda Pharmaceuticals America, Inc.; 2023 Aug.

56070.Suprane (desflurane) package insert. Deerfield, IL: Baxter Healthcare Corporation; 2022 Nov.

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56303.Hydrocodone bitartrate extended-release capsules package insert. Morristown, NJ: Alvogen, Inc.; 2023 Dec.

56579.U.S. Food and Drug Administration (FDA). For Healthcare Professionals: FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems. Retrieved Aug 2024. Available at: https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-examples-drugs-interact-cyp-enzymes-and-transporter-systems

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56616.Diphenhydramine hydrochloride oral solution 12.5 mg/5 mL package insert (Rx only product). Greenville, SC: Pharmaceutical Associates, Inc.; 2020 Feb.

56665.Hetlioz (tasimelteon) package insert. Washington, D.C.: Vanda Pharmaceuticals, Inc.; 2020 Dec.

57046.Perucca E, Hedges A, Makki KA, et al. A comparative study of the relative enzyme inducing properties of anticonvulsant drugs in epileptic patients. Br J Clin Pharmacol 1984;18:401-10.

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57094.Zykadia (ceritinib) package insert. Indianapolis, IN: Novartis; 2021 Oct.

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57258.Chlordiazepoxide hydrochloride capsules package insert. Cranbury, NJ: Solco Healthcare U.S. LLC; 2023 Jan.

57262.Amytal Sodium [package insert]. Northbrook, IL: Marathon Pharmaceuticals, LLC; 2013.

57272.Baclofen tablet package insert. Philadelphia, PA: Lannett Company, Inc.; 2016 Mar.

57367.Romanelli F, et al. Dextromethorphan abuse: clinical effects and management. J Am Pharm Assoc. 2009; 49:20-27.

57407.Oxycodone hydrochloride and ibuprofen tablet package insert. Elizabeth, NJ: Actavis Elizabeth LLC; 2019 Apr.

57409.Belladonna and Opium rectal suppository package insert. Minneapolis, MN: Padagis; 2023 Apr.

57675.Zydelig (idelalisib) tablet package insert. Foster City, CA:Gilead Sciences, Inc.; 2022 Feb.

57732.Percodan (aspirin; oxycodone) tablet package insert. Malvern, PA: Endo Pharmaceuticals Inc.; 2023 Dec.

57780.Belsomra (suvorexant) tablets package insert. Rahway, NJ: Merck Sharp & Dohme LLC; 2025 Mar.

57789.Ambien (zolpidem immediate-release tablets) package insert. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; 2022 Feb.

57803.Cerdelga (eliglustat) capsules. Waterford, Ireland: Genzyme Ireland, Ltd.;2018 Sept.

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57877.Reglan (metoclopramide) oral tablet package insert. Baudette, MN: ANI Pharmaceuticals; 2020 Jun.

58000.Tybost (cobicistat) package insert. Foster City, CA: Gilead Sciences, Inc; 2021 Sept.

58104.Girennavar B, Jayaprakasha GK, and Patil BS. Potent inhibition of human cytochrome P450 3A4, 2D6, and 2C9 isoenzymes by grapefruit juice and its furocoumarins. Journal of Food Science. 2007;72(8):C417-C421.

58171.Akynzeo (fosnetupitant; palonosetron injection and netupitant; palonosetron capsules) package insert. Lugano, Switzerland: Helsinn Healthcare; 2023 February.

58572.Trezix (acetaminophen 320.5 mg, caffeine 30 mg, dihydrocodeine 16 mg) capsule package insert. Ridgeland, MS: Wraser Pharmaceuticals; 2018 Jul.

58749.Duopa (carbidopa and levodopa) enteral suspension package insert. North Chicago, Il: abbVie, Inc.; 2019 Dec.

58770.Gleevec (imatinib mesylate) tablet package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024 Mar.

58821.Farydak (panobinostat) capsules package insert. Las Vegas, NV: Secura Bio, Inc.; 2021 Sept.

59042.Cresemba (isavuconazonium) package insert. Northbrook, IL: Astellas Pharma US, Inc; 2025 Mar.

59535.Tuzistra XR (chlorpheniramine polistirex; codeine polistirex) extended-release oral suspension package insert. Berwyn, PA: Vernalis Therapeutics Inc.; 2018 Jun.

59577.Cyproheptadine hydrochloride syrup package insert. Philadelphia, PA: Lannett Company, Inc.; 2017 Dec.

59612.Ahist (chlorcyclizine hydrochloride tablet) (OTC) package insert. Louisville, KY: Magna Pharmaceuticals, Inc.; 2013 Jan.

59949.Rexulti (brexpiprazole) tablets package insert. Rockville, MD: Otsuka America Pharmaceutical Inc; 2025 May.

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60079.Thalomid (thalidomide) capsules package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2023 Mar.

60099.Addyi (flibanserin tablets) package insert. Raleigh, NC: Sprout Pharmaceuticals, Inc.; 2021 Sept.

60142.Varubi (rolapitant) package insert. Waltham, MA: Tesaro Inc; 2018 April.

60164.Vraylar (cariprazine capsules) package insert. North Chicago, IL:AbbVie, Inc.; 2024 Nov.

60209.Morphabond ER (morphine sulfate extended-release tablets) package insert. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2019 Oct.

60660.Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes. http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm Retrieved March 23, 2016

60731.Methylene blue injection (Provayblue) package insert. Shirley, NY: American Regent, Inc.; 2024 Feb.

60748.Nuplazid (pimavanserin) tablets and capsules package insert. San Diego, CA: Acadia Pharmaceuticals Inc.; 2025 Jan.

60951.Syndros (dronabinol) oral solution package insert. Chandler, AZ; Insys Therapeutics, Inc. 2024 May.

60958.Levorphanol tablet package insert. Berkeley Heights, NJ: Hikma Pharmaceuticals USA, Inc.; 2024 Jan.

61077.Sustol (granisetron) extended-release injection package insert. San Diego, CA: Heron Therapeutics; 2017 May.

61143.Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm. Retrieved August 31, 2016.

61470.Vistaril (hydroxyzine pamoate) capsules and oral suspension package insert. New York, NY: Pfizer Laboratories; 2023 May.

61691.Vantrela ER (hydrocodone bitartrate) tablets package insert. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2017 Jan.

61797.Ryvent (carbinoxamine maleate) tablet package insert. Hazlet, NJ: Carwin Pharmaceutical Associates, LLC; 2017 Feb.

61816.Kisqali (ribociclib) tablets package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024 Sept.

61825.Xadago (safinamide) package insert. Rockville, MD: MDD US Operations, LLC; 2021 Aug.

61845.Austedo and Austedo XR (deutetrabenazine) tablets and extended-release tablets package insert. Parsippany, NJ: Teva Neuroscience, Inc.; 2025 Feb.

61897.RoxyBond (oxycodone hydrochloride) immediate release tablet package insert. Princeton, NJ: Protega Pharmaceuticals Inc.; 2024 Apr.

62120.Tremfya (guselkumab) injection package insert. Horsham, PA: Janssen Biotech, Inc.; 2025 Mar.

62170.Histex (triprolidine HCl) chewable tablet consumer product label. Canton, MS: Allegis Pharmaceuticals, LLC; 2017 July. (off-market)

62305.Prochlorperazine maleate tablets package insert. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2023 Jan.

62611.Prevymis (letermovir) package insert. Rahway, NJ: Merck Sharp and Dohme, LLC.; 2025 Jan.

62874.Erleada (apalutamide) tablets package insert. Horsham, PA: Janssen Products, LP; 2024 Aug.

62889.Apadaz (benzhydrocodone; acetaminophen) tablets package insert. Celebration, FL: Zevra Therapeutics, Inc.; 2023 Dec.

63074.Semprex- D (acrivastine and pseudoephedrine hcl) capsules package insert. Malvern, PA: Endo Pharmaceuticals Inc.; 2018 April.

63161.Lucemyra (lofexidine) tablets package insert. Louisville, KY: US WorldMeds, LLC; 2018 May.

63228.Atropine sulfate injection package insert. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2018 Mar.

63309.Epidiolex (cannabidiol) oral solution package insert. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; 2024 Mar.

63317.Braftovi (encorafenib) capsules package insert. Boulder, CO: Array BioPharma Inc.; 2025 Mar.

63456.Diacomit (stiripentol) package insert. Beauvais, France: Biocodex; 2022 Jul.

63555.Promethazine hydrochloride tablets package insert. Parsippany, NJ: Actavis Pharma, Inc.; 2016 Dec.

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63571.Copiktra (duvelisib) capsules package insert. Las Vegas, NV: Secura Bio, Inc.; 2024 July.

63584.Vizimpro (dacomitinib) tablet package insert. New York, NY: Pfizer Labs; 2020 Dec.

63616.Clorazepate dipotassium tablet package insert. Morgantown, WV: Mylan Pharmaceuticals, Inc.; 10 Jun.

63638.Pro-Red AC (codeine; dexchlorpheniramine; phenylephrine oral syrup) package insert. Kirksville, MO; Pro Pharma Llc.: 2017 Oct.

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63989.Spravato (esketamine) nasal spray package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2025 Apr.

64021.Zulresso (brexanolone injection for intravenous use) package insert. Cambridge, MA: Sage Therapeutics, Inc.; 2022 Jun.

64568.Inrebic (fedratinib) capsules package insert. Princeton, NJ: Bristol-Meyers Squibb Company; 2025 May.

64576.Xenleta (lefamulin) package insert. Dublin, Ireland: Nabriva Therapeutics US, Inc.; 2021 Mar.

64685.Reyvow (lasmiditan) tablets package insert. Indianapolis, IN: Eli Lilly and Company; 2022 Sep.

64762.Givlaari (givosiran) injection package insert. Cambridge, MA: Alnylam Pharmaceuticals, Inc.; 2024 Apr.

64768.Xcorpi (cenobamate) tablets package insert. Paramus, NJ: SK Life Science, Inc.; 2024 Apr.

64778.Oxbryta (voxelotor) tablets package insert. South San Francisco, CA: Global Blood Therapeutics, Inc.; 2023 Aug.

64838.The American College of Obstetricians and Gynecologists (Joint with the American Society of Addiction Medicine). Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017;130:e81-e94. Reaffirmed 2021.

64848.Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR). https://www.fda.gov/media/133681/download. Retrieved December 19, 2019.

64870.Dayvigo (lemborexant) tablets package insert. Nutley, NJ: Eisai Inc.; 2025 Feb.

64881.Acticon Cold & Allergy (dexbrompheniramine; pseudoephedrine HCl) oral solution package insert. Dorado, PR: ActiPharma, Inc.; 2018 Dec.

64882.RyClora Oral Solution 2mg/5 mL (dexchlorpheniramine maleate) package insert Rx-only. Hazlet, NJ: Carwin Pharmaceutical Associates, LLC.; 2024 Jan

64885.Caplyta (lumateperone) capsules package insert. New York, NY; Intra-Cellular Therapies, Inc.; 2023 Jun.

64906.HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics. Available on the World Wide Web at https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf. Accessed December 27, 2019.

64909.Mills, JR, Huizinga MM, Robinson SB, et al. Opioid-Prescribing Guidelines for Uncomplicated Normal Spontaneous Vaginal Birth. Obstetrics and Gynecology 2019;133:81-90.

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65295.Tukysa (tucatinib) tablets package insert. Bothell, WA: Seattle Genetics, Inc.; 2023 Jan

65634.Fintepla (fenfluramine) oral solution package insert. Smyrna, GA: UCB, Inc.; 2025 Apr.

65685.Dooley KE, Bliven-Sizemore EE, Weiner M, et al. Safety and pharmacokinetics of escalating daily doses of the antituberculosis drug rifapentine in healthy volunteers. Clin Pharmacol Ther 2012; 91:5

65697.Byfavo (remimazolam) injection package insert. Indianapolis, IN: Acacia Pharma, Inc.; 2023 Jan.

65809.Olinvyk (oliceridine) injection package insert. Chesterbrook, PA: Trevana, Inc. 2023 Dec.

65817.Viscusi ER, Skobieranda F, Soergel DG, et al. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the µ-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res 2019;12:927-943.

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66129.Zokinvy (lonafarnib) capsules package insert. Palo Alto, CA: Eiger BioPharmaceuticals, Inc.; 2020 Nov.

66159.Orladeyo (berotralstat) package insert. Durham, NC: BioCryst Pharmaceuticals, Inc.; 2024 Oct.

66501.Azstarys (serdexmethylphenidate and dexmethylphenidate) package insert. Boston, MA: Corium; 2023 Oct.

66704.Lybalvi (olanzapine; samidorphan) package insert. Waltham, MA: Alkermes, Inc.; 2025 Feb.

66926.Korsuva (Difelikefalin) injection package insert. Stamford, CT: Cara Therapeutics, Inc.; 2021 Aug.

67036.Tavneos (avacopan) capsules package insert. Thousand Oaks, CA: ChemoCentryx, Inc.; 2024 Jun.

67248.Quviviq (daridorexant) tablet package insert. Radnor, PA: Idorsia Pharmaceuticals US Inc; 2024 Sept.

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