HYDROmorphone (hye-droe-mor-fone) Dilaudid, Dilaudid-HP, Exalgo, Hydromorph Contin, Jurnista

 Indications

Moderate to severe pain (alone and in combination

with nonopioid analgesics). Moderate to severe chronic

pain in opioid-tolerant patients requiring use of daily,

around-the-clock long-term opioid treatment and for

which alternative treatment options are inadequate (extended-

release). Antitussive (lower doses).

Action

Binds to opiate receptors in the CNS. Alters the perception

of and response to painful stimuli while producing

generalized CNS depression. Suppresses the cough reflex

via a direct central action. Therapeutic Effects:

Decrease in moderate to severe pain. Suppression

of cough.

Pharmacokinetics

Absorption: Well absorbed following oral, rectal,

subcut, and IM administration. Extended-release product

results in an initial release of drug, followed by a

second sustained phase of absorption.

Distribution: Widely distributed. Crosses the placenta;

enters breast milk.

Metabolism and Excretion: Mostly metabolized

by the liver.

Half-life: Oral (immediate-release), or injection—

2–4 hr; Oral (extended-release)—8–15 hr.

TIME/ACTION PROFILE (analgesic effect)

ROUTE ONSET PEAK DURATION

PO-IR 30 min 30–90 min 4–5 hr

PO-ER unknown unknown unknown

Subcut 15 min 30–90 min 4–5 hr

IM 15 min 30–60 min 4–5 hr

IV 10–15 min 15–30 min 2–3 hr

Rect 15–30 min 30–90 min 4–5 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Some products

contain bisulfites and should be avoided in patients

with known hypersensitivity; Severe respiratory depression

(in absence of resuscitative equipment) (extended-

release only); Acute or severe bronchial asthma

(extended-release only); Paralytic ileus (extended-release

only); Acute, mild, intermittent, or postoperative

pain (extended-release only); Prior GI surgery or narrowing

of GI tract (extended-release only); Opioid nontolerant

patients (extended-release only); Severe hepatic

impairment (extended-release only).

Use Cautiously in: Head trauma;qintracranial

pressure; Severe pulmonary disease; Moderate or severe

renal disease (extended-release only) (doseprecommended);

Moderate hepatic impairment (extendedrelease

only) (doseprecommended); Hypothyroidism;

Seizure disorder; Adrenal insufficiency; Alcoholism;

Undiagnosed abdominal pain; Prostatic hypertrophy;

Biliary tract disease (including pancreatitis); OB: Labor

and delivery; OB, Lactation: Avoid chronic use; prolonged

use of opioids during pregnancy can result in

neonatal opioid withdrawal syndrome; Geri: Geriatric

or debilitated patients (qrisk of respiratory depression;

dosepsuggested).

Adverse Reactions/Side Effects

CNS: confusion, sedation, dizziness, dysphoria, euphoria,

floating feeling, hallucinations, headache, unusual

dreams. EENT: blurred vision, diplopia, miosis.

Resp: RESPIRATORY DEPRESSION. CV: hypotension,

bradycardia. Endo: adrenal insufficiency. GI: constipation,

dry mouth, nausea, vomiting. GU: urinary retention.

Derm: flushing, sweating. Misc: physical dependence,

psychological dependence, tolerance.

Interactions

Drug-Drug: Exercise extreme caution with MAO inhibitors

(may produce severe, unpredictable reactions—

reduce initial dose of hydromorphone to 25%

of usual dose, discontinue MAO inhibitors 2 wk prior to

hydromorphone). Use with benzodiazepines or

other CNS depressants including other opioids,

non-benzodiazepine sedative/hypnotics, anxiolytics,

general anesthetics, muscle relaxants, antipsychotics,

and alcohol may cause profound sedation,

respiratory depression, coma, and death; reserve

concurrent use for when alternative treatment options

are inadequate. Administration of partial antagonists

(buprenorphine, butorphanol, nalbuphine, or

pentazocine) may precipitate opioid withdrawal in

physically dependent patients. Nalbuphine or pentazocine

maypanalgesia. Drugs that affect serotonergic

neurotransmitter systems, including tricyclic antidepressants,

SSRIs, SNRIs, MAO inhibitors, TCAs,

tramadol, trazodone, mirtazapine, 5–HT3 receptor

antagonists, linezolid, methylene blue, and

triptansqrisk of serotonin syndrome.

Drug-Natural Products: Concomitant use of

kava-kava, valerian, chamomile, or hops canq

CNS depression.

Route/Dosage

Doses depend on level of pain and tolerance. Larger

doses may be required during chronic therapy.

Analgesic

PO (Adults 50 kg): Immediate-release—4–8 mg

every 3–4 hr initially (some patients may respond to doses as small as 2 mg initially); or once 24-hr opioid

requirement is determined, convert to extended-release

by administering total daily oral dose once daily.

PO (Adults and Children 50 kg): 0.06 mg/kg

every 3–4 hr initially, younger children may require

smaller initial doses of 0.03 mg/kg. Maximum dose 5

mg.

IV, IM, Subcut (Adults 50 kg): 1.5 mg every 3–4

hr as needed initially; may beq.

IV, IM, Subcut (Adults and Children 50 kg):

0.015 mg/kg mg every 3–4 hr as needed initially; may

beq.

IV (Adults): Continuous infusion (unlabeled)—

0.2–3 mg/hr depending on previous opioid use. An initial

bolus of twice the hourly rate in mg may be given

with subsequent breakthrough boluses of 50–100% of

the hourly rate in mg.

Rect (Adults): 3 mg every 6–8 hr initially as needed.

Hepatic Impairment

PO (Adults): Moderate hepatic impairment (extended–

release)—pinitial dose by 75%.

Renal Impairment

PO (Adults): Moderate renal impairment (extended–

release)—pinitial dose by 50%; Severe renal

impairment (extended–release)—pinitial dose

by 75%.

Antitussive

PO (Adults and Children 12 yr): 1 mg every 3–4

hr.

PO (Children 6–12 yr): 0.5 mg every 3–4 hr.

Availability (generic available)

Immediate-release tablets: 2 mg, 4 mg, 8 mg. Extended-

release tablets (abuse-deterrent): 4

mg, 8 mg, 12 mg, 16 mg, 32 mg. Controlled-release

capsules: 3 mg, 4.5 mg, 6 mg, 9 mg, 12

mg, 18 mg, 24 mg, 30 mg. Oral solution: 1

mg/mL. Injection: 1 mg/mL, 2 mg/mL, 4 mg/mL, 10

mg/mL. Suppositories: 3 mg.