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Dilaudid
hydromorphone
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about opioid use and how to mitigate associated risks; reserve opioid analgesics for patients with inadequate tx alternatives; ER form not indicated for prn analgesic use; proper dosing and titration essential to decr. respiratory depression risk
Medication Error Risk
ensure accuracy when prescribing, dispensing, and administering hydromorphone oral solution; dosing errors due to confusion between mg and mL or different concentrations can result in accidental overdose and death; hydromorphone injection high potency formulation (10 mg per mL) for use in opioid-tolerant patients only; do not confuse with standard parenteral hydromorphone forms, overdose and death could result
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance with risk of addiction, abuse, and misuse, which can lead to overdose and death; assess opioid abuse or addiction risk prior to prescribing; regularly reassess all patients for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases may occur even with recommended use, especially during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; instruct patients to swallow ER tabs whole to avoid exposure to potentially fatal hydromorphone dose
Accidental Ingestion
accidental ingestion of even one dose, especially by children, can result in fatal hydromorphone overdose
Risks from Concomitant Use with Benzodiazepines, CNS Depressants
concomitant opioid use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant use for patients with inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
advise pregnant patients with extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts available at delivery
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel patients and/or caregivers with each Rx on serious risks, safe use, and importance of reading medication guide
Adult Dosing .
Dosage forms: TAB: 2 mg, 4 mg, 8 mg; SOLUTION: 1 mg per mL; INJ (pre-filled syringe): 0.5 mg per 0.5 mL, 1 mg per mL, 2 mg per mL, 4 mg per mL
Dosage Form Details
- [SUPPOSITORY form discontinued in US for this brand; see generic]
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, moderate-severe
- [PO route, tablet]
- Dose: individualize dose PO q3-6h prn; Start: 2-4 mg PO q4-6h prn; Info: in patients converting from other opioids, consider starting 1-2 mg PO q4-6h prn; use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PO route, oral solution]
- Dose: individualize dose PO q3-6h prn; Start: 2.5-10 mg PO q3-6h prn; Info: in patients converting from other opioids, consider starting 1.25-5 mg PO q3-6h prn; use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [parenteral route]
- Dose: individualize dose IV/SC/IM q2-3h prn; Start: 0.2-1 mg IV q2-3h prn; 1-2 mg SC/IM q2-3h prn; Info: IV preferred to SC/IM; use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [rectal route]
- Dose: 3 mg PR q6-8h prn; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PCA route (off-label)]
- Dose: 0.05-0.4 mg IV q6-20min prn; Start: 0.1-0.5 mg IV x1; Info: basal rate for opioid-experienced patients is up to 0.5 mg/h; dosing varies, refer to institution protocol; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [PO route]
- CrCl <80: decr. usual start dose by 50-75%
- HD: start 0.5-1 mg q6h prn; no supplement after dialysis; PD: start 0.5-1 mg q6h prn; no supplement
- [parenteral route]
- CrCl <80: decr. usual start dose by 50-75%
- HD: decr. usual start dose, amount not defined; no supplement after dialysis; PD: decr. usual start dose, amount not defined; no supplement
- [rectal route]
- renal impairment: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [PO route]
- Child-Pugh Class B: decr. usual start dose by 50-75%; Child-Pugh Class C: decr. usual start dose, amount not defined, titrate slowly
- [parenteral route]
- Child-Pugh Class B: decr. usual start dose by 50-75%; Child-Pugh Class C: decr. usual start dose, amount not defined, titrate slowly
- [rectal route]
- hepatic impairment: not defined, caution advised
Peds Dosing .
- Dosage forms: TAB: 2 mg, 4 mg, 8 mg; SOLUTION: 1 mg per mL; INJ (pre-filled syringe): 0.5 mg per 0.5 mL, 1 mg per mL, 2 mg per mL, 4 mg per mL
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, moderate-severe (off-label)
- [PO route, 6 mo and older, <50 kg]
- Dose: individualize dose PO q3-4h prn; Start: 30-80 mcg/kg/dose PO q3-4h prn; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PO route, 6 mo and older, >50 kg]
- Dose: individualize dose PO q3-4h prn; Start: 1-2 mg PO q3-4h prn; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [parenteral route, 6 mo and older, <50 kg]
- Dose: individualize dose IV q2-6h prn; Start: 15-20 mcg/kg/dose IV q2-6h prn; Alt: 6 mcg/kg/h IV; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [parenteral route, 6 mo and older, >50 kg]
- Dose: individualize dose IV/SC/IM q2-6h prn; Start: 0.2-0.6 mg IV q2-4h prn; 0.8-1 mg SC/IM q4-6h prn; Alt: 0.3 mg/h IV; Info: IV preferred to SC/IM; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PCA route, <50 kg]
- Dose: 2-5 mcg/kg/dose IV q6-20min prn; Start: 8 mcg/kg/dose IV x1; Max: 20 mcg/kg/h; Info: basal rate for opioid-experienced patients is up to 3 mcg/kg/h; dosing varies, refer to institution protocol; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PCA route, >50 kg]
- Dose: 0.05-0.4 mg IV q6-20min prn; Start: 0.1-0.5 mg IV x1; Info: basal rate for opioid-experienced patients is up to 0.5 mg/h; dosing varies, refer to institution protocol; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [see below]
- renal impairment: decr. usual dose, amount not defined
- HD/PD: not defined, caution advised
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to sulfites
- MAO inhibitor use within 14 days
- breastfeeding (ER form)
- opioid non-tolerant patients (ER or high potency form)
- hepatic impairment, Child-Pugh Class C (ER form)
- respiratory depression, severe
- asthma, acute
- asthma, severe
- GI obstruction, known or suspected
- paralytic ileus
- GI stricture (ER form)
- coma
- consciousness, impaired
- circulatory shock
- abrupt withdrawal (physically opioid-dependent patients)
- caution: hypersensitivity to opioids
- caution: elderly patients
- caution: debilitated patients
- caution: renal impairment
- caution: hepatic impairment
- caution: pulmonary impairment
- caution: sleep apnea (long-term use)
- caution: CNS depression
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: alcohol abuse history
- caution: drug abuse history
- caution: mental illness history
- caution: head injury
- caution: ICP incr.
- caution: seizure disorder
- caution: hypovolemia
- caution: GI motility disorder
- caution: pancreatitis, acute
- caution: biliary disease, acute
- caution: GU obstruction
Drug Interactions .
Overview
hydromorphone
opioid
- UGT2B7 substrate
- antidiuretic hormone effects
- CNS depression
- decreases gastrointestinal motility
- hyponatremia
- hypotensive effects
- lowers seizure threshold
- opioid agonist
- potentiates neuromuscular blockade
- serotonergic effects
- urinary retention
- consider prescribing an opioid overdose reversal agent, especially with concomitant CNS depressant use
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- naltrexone
- potassium chloride
- potassium citrate
- safinamide
- samidorphan
Avoid/Use Alternative
- 5-HTP
- aldesleukin
- alfentanil
- almotriptan
- alprazolam
- amifampridine
- amitriptyline
- amoxapine
- amphetamine
- black cohosh
- bromocriptine
- buprenorphine
- buspirone
- butalbital
- butorphanol
- carbamazepine
- chlordiazepoxide
- citalopram
- clobazam
- clomipramine
- clonazepam
- clonidine
- clopidogrel
- clorazepate
- clozapine
- cocaine
- codeine
- cyclobenzaprine
- desipramine
- desvenlafaxine
- dexmethylphenidate
- dextroamphetamine
- dextromethorphan
- diazepam
- dihydrocodeine
- dihydroergotamine
- doxepin
- doxepin topical
- doxylamine
- duloxetine
- eletriptan
- eluxadoline
- ergotamine
- escitalopram
- esketamine
- estazolam
- ethanol (alcoholic beverage)
- ethanol injection
- etomidate
- fenfluramine
- fentanyl
- fluoxetine
- flurazepam
- fluvoxamine
- frovatriptan
- gabapentin
- gabapentin enacarbil
- gepirone
- granisetron
- haloperidol
- hydrocodone
- hydromorphone
- imipramine
- iohexol
- isocarboxazid
- isoniazid
- kava
- ketamine
- kratom
- levomilnacipran
- levorphanol
- linezolid
- lisdexamfetamine
- lithium
- lofexidine
- lorazepam
- lumateperone
- meperidine
- metaxalone
- methadone
- methamphetamine
- methylene blue injection
- methylene blue oral
- methylergonovine
- methylphenidate
- metoclopramide
- midazolam
- milnacipran
- mirtazapine
- morphine
- nalbuphine
- naratriptan
- nefazodone
- nortriptyline
- olanzapine
- oliceridine
- ondansetron
- opium
- oxazepam
- oxybate
- oxycodone
- oxymorphone
- palonosetron
- paroxetine
- pentazocine
- phenelzine
- phenobarbital
- pramlintide
- prasugrel
- pregabalin
- procarbazine
- prochlorperazine
- promethazine
- protriptyline
- quazepam
- rasagiline
- remimazolam
- revefenacin inhaled
- rizatriptan
- ropeginterferon alfa-2b
- SAMe
- scopolamine
- selegiline
- selegiline transdermal
- sertraline
- St. John's wort
- sumatriptan
- tapentadol
- tedizolid
- temazepam
- thalidomide
- ticagrelor
- tradipitant
- tramadol
- tranylcypromine
- trazodone
- triazolam
- trimipramine
- venlafaxine
- vilazodone
- vortioxetine
- yohimbe
- ziprasidone
- zolmitriptan
- zuranolone
Monitor/Modify Tx
- acebutolol
- alfuzosin
- aliskiren
- allopurinol
- alprostadil intracavernous
- amantadine
- amifostine
- amiloride
- amlodipine
- apomorphine
- apraclonidine ophthalmic
- aprocitentan
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- articaine
- asenapine
- atenolol
- atracurium
- avanafil
- azilsartan medoxomil
- baclofen
- baclofen intrathecal
- benazepril
- berberine
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bexagliflozin
- bisoprolol
- bortezomib
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- brompheniramine
- bumetanide
- bupivacaine
- bupivacaine liposomal
- bupropion
- cabergoline
- canagliflozin
- candesartan cilexetil
- cannabidiol
- cannabis
- captopril
- carbinoxamine
- cariprazine
- carisoprodol
- carteolol ophthalmic
- carvedilol
- cenobamate
- cetirizine
- chamomile, German
- chlophedianol
- chlorcyclizine
- chloroprocaine
- chlorothiazide
- chlorpheniramine
- chlorpromazine
- chlorthalidone
- chlorzoxazone
- cilostazol
- cisatracurium
- clemastine
- clevidipine
- clofarabine
- coenzyme Q-10
- cyproheptadine
- dantrolene
- dapagliflozin
- daridorexant
- darifenacin
- denileukin diftitox
- desflurane
- desmopressin
- deutetrabenazine
- dexbrompheniramine
- dexchlorpheniramine
- dexmedetomidine
- dexmedetomidine injection
- dichlorphenamide
- difelikefalin
- difenoxin
- diltiazem
- dimenhydrinate
- dinutuximab
- diphenhydramine
- diphenoxylate
- dipyridamole
- domperidone
- doxazosin
- dronabinol
- droperidol
- efavirenz
- elinzanetant
- empagliflozin
- enalapril
- enalaprilat
- entacapone
- entrectinib
- eplerenone
- epoprostenol
- ertugliflozin
- eslicarbazepine acetate
- esmolol
- eszopiclone
- ethacrynic acid
- ethanol (in some formulations)
- ethosuximide
- etripamil nasal
- felbamate
- felodipine
- fenoldopam
- ferumoxytol
- fesoterodine
- flaxseed
- flibanserin
- fluphenazine
- fosinopril
- foslevodopa
- fosphenytoin
- furosemide
- ganaxolone
- garlic
- gilteritinib
- glofitamab
- glycopyrrolate
- guanfacine
- hydralazine
- hydrochlorothiazide
- hydroxyzine
- hyoscyamine
- ifosfamide
- iloperidone
- iloprost
- indapamide
- iopamidol
- irbesartan
- iron sucrose
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- labetalol
- lacosamide
- lamotrigine
- landiolol
- lemborexant
- levetiracetam
- levobunolol ophthalmic
- levocetirizine
- levodopa
- lidocaine
- linvoseltamab
- lisinopril
- losartan
- loxapine
- lubiprostone
- lurasidone
- magnesium sulfate
- mannitol
- maraviroc
- meclizine
- melatonin
- mepivacaine
- meprobamate
- methocarbamol
- methohexital
- methsuximide
- methyldopa
- metolazone
- metoprolol
- metyrapone
- metyrosine
- milrinone
- milsaperidone
- minoxidil
- mitotane
- moexipril
- molindone
- mosunetuzumab
- mycophenolate mofetil
- nadolol
- nattokinase
- naxitamab
- nebivolol
- nelarabine
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nimodipine
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- obinutuzumab
- olmesartan medoxomil
- opicapone
- orphenadrine
- oxcarbazepine
- oxybutynin
- paliperidone
- palopegteriparatide
- pamabrom
- passion flower
- pegvisomant
- pentamidine
- pentobarbital
- perampanel
- perindopril
- perphenazine
- pheniramine
- phenoxybenzamine
- phentolamine
- phenytoin
- pimozide
- pindolol
- pramipexole
- prazosin
- primidone
- propafenone
- propofol
- propranolol
- pyrilamine
- quetiapine
- quinapril
- ramelteon
- ramipril
- remifentanil
- repotrectinib
- riociguat
- risperidone
- rocuronium
- ropinirole
- ropivacaine
- rotigotine transdermal
- rufinamide
- sacubitril
- selinexor
- sevoflurane
- sildenafil
- silodosin
- sodium ferric gluconate complex
- solifenacin
- sotagliflozin
- sotalol
- sparsentan
- spironolactone
- stiripentol
- succinylcholine
- sufentanil
- suvorexant
- tadalafil
- tagraxofusp
- tamsulosin
- tasimelteon
- taurine
- telmisartan
- terazosin
- tetrabenazine
- thioridazine
- thiotepa
- thiothixene
- tiagabine
- timolol
- timolol ophthalmic
- tizanidine
- tolcapone
- tolterodine
- topiramate
- torsemide
- trandolapril
- treprostinil
- triamterene
- trifluoperazine
- trihexyphenidyl
- trimethobenzamide
- triprolidine
- trospium
- valbenazine
- valerian
- valproic acid
- valsartan
- vardenafil
- vasopressin
- vecuronium
- verapamil
- vigabatrin
- viloxazine
- vosoritide
- zaleplon
- ziconotide
- zolpidem
- zonisamide
Caution Advised
- acetazolamide
- aclidinium inhaled
- alosetron
- atropine
- barium
- belladonna alkaloids
- benztropine
- botulinum toxin
- busulfan
- chlorambucil
- cisapride
- clidinium
- dicyclomine
- disopyramide
- erenumab
- erythromycin
- fexinidazole
- flavoxate
- glycopyrrolate inhaled
- glycopyrronium topical
- homatropine
- hydroxychloroquine
- ipratropium inhaled
- loperamide
- magnesium citrate
- methscopolamine
- mexiletine
- nelfinavir
- polyethylene glycol
- polyethylene glycol/electrolytes
- potassium acid phosphate
- potassium gluconate
- potassium phosphate
- pyridostigmine
- rifampin
- ritonavir
- sodium picosulfate
- sofpironium topical
- sulfate bowel prep
- tiotropium inhaled
- treosulfan
Adverse Reactions .
Serious Reactions
- respiratory depression
- central sleep apnea
- circulatory depression
- hypotension, severe
- ICP incr.
- seizures
- bradycardia
- paralytic ileus
- biliary spasm
- opioid-induced esophageal dysfunction
- hypersensitivity reaction
- anaphylaxis
- adrenal insufficiency
- opioid-induced androgen deficiency (long-term use)
- dependency
- abuse
- withdrawal symptoms if abrupt D/C (physically opioid-dependent patients)
- opioid-induced hyperalgesia
- allodynia
Common Reactions
- dizziness
- somnolence
- nausea
- vomiting
- hyperhidrosis
- flushing
- dysphoria
- euphoria
- xerostomia
- pruritus
- headache
- constipation
- anorexia
- rash
- insomnia
- anxiety
- agitation
- muscle spasms
- depression
- abdominal cramps
- injection site reaction (INJ form)
Safety/Monitoring .
Monitoring Parameters
Cr at baseline; signs/symptoms of respiratory depression; signs/symptoms of hypotension including BP after tx start if hypotension risk, then after dose incr.
Look/Sound-Alike Drug Names
Dilaudid confused with: Demerol; Dilantin; Dilaudid-HP; Dolophine
HYDROmorphone confused with: buprenorphine; HYDROcodone/acetaminophen; haloperidol; HYDROcodone; morphine sulfate; oxyMORphone
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, especially if prolonged use, or immediately before and during labor; risk of teratogenicity low, though risk of neonatal complications, including respiratory depression and neonatal opioid withdrawal syndrome, based on limited human data and drug's mechanism of action
Lactation
Clinical Summary
avoid use of extended-release forms, otherwise weigh risk/benefit while breastfeeding; monitor infant closely; low risk of infant CNS and respiratory depression based on limited human data and limited drug excretion into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for hydromorphone: liver; CYP450: minimal; UGT: 1A3, 2B7 substrate
Excretion: for hydromorphone: urine primarily, bile; Half-life: 2.3h (IV), 2.5h (PO)
Subclass: Opioids
Mechanism of Action
for hydromorphone: binds to various opioid receptors, producing analgesia and sedation (opioid agonist)
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Rhodes Pharmaceuticals L.P. (PO forms) and Fresenius Kabi USA, LLC (INJ forms)
DEA/FDA: Schedule II
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 2 mg (90 ea): $223.00
- 4 mg (120 ea): $475.00
- 8 mg (75 ea): $539.00
oral liquid:
- 5 mg/5 mL (473 mL): $496.00
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