Palladone


hydromorphone hydrochloride

Dilaudid, Dilaudid-5, Dilaudid-HP, Hydromorph Contin (CA), Hydromorph-IR (CA), Palladone (UK), Palladone SR, PHL-Hydromorphone (CA), PMS-Hydromorphone (CA)

Pharmacologic class: Opioid agonist

Therapeutic class: Opioid analgesic, antitussive

Controlled substance schedule II

Pregnancy risk category C (with long-term use or at term with high doses: D)

FDA Box Warning

• Drug is a potent Schedule II opioid agonist with highest abuse potential and risk of causing respiratory depression. Alcohol, other opioids, and CNS depressants potentiate respiratory depressant effects, increasing risk of potentially fatal respiratory depression.

Action

Binds to opiate receptors in spinal cord and CNS, altering perception of and response to painful stimuli while producing generalized CNS depression. Also subdues cough reflex and decreases GI motility.

Availability

Injection: 1 mg/ml, 2 mg/ml, 4 mg/ml, 10 mg/ml

Powder for injection (lyophilized): 250-mg vials (high-potency)

Oral solution: 5 mg/5 ml

Rectal suppositories: 3 mg

Tablets: 2 mg, 3 mg, 4 mg, 8 mg

Indications and dosages

Moderate to severe pain

Adults weighing more than 50 kg (110 lb): 2 mg P.O. (tablets) q 4 to 6 hours p.r.n. For more severe pain, 4 mg P.O. (tablets) may be given q 4 to 6 hours. If pain increases in severity, analgesia isn't adequate, or tolerance develops, a gradual increase in dosage may be required. Or 2.5 to 10 mg P.O. (oral solution) q 4 to 6 hours p.r.n. as directed by clinical situation. Or 1 to 2 mg subcutaneously, I.M., or I.V. q 4 to 6 hours p.r.n.; or 3 mg P.R. q 6 to 8 hours p.r.n. Adjust dosage based on pain severity, underlying disease, and patient's age and size.

Contraindications

• Hypersensitivity to narcotics or bisulfites

• Acute or severe bronchial asthma or upper respiratory tract obstruction

Precautions

Use cautiously in:

• increased intracranial pressure; severe renal, hepatic, or pulmonary disease; hypothyroidism; adrenal insufficiency; prostatic hypertrophy; alcoholism

• concurrent use of MAO inhibitors

• elderly patients

• pregnant or breastfeeding patients.

Administration

See Be aware that high-potency hydromorphone (Dilaudid-HP) is a highly concentrated solution and shouldn't be confused with standard parenteral formulations of hydromorphone or other opioids. Overdose and death may result.

• Know that high-potency formulation is recommended for opioid-tolerant patients who require larger than usual doses of opioids to gain adequate pain relief.

• For maximal analgesic effect, give before pain becomes severe.

• For I.V. infusion, mix with dextrose 5% in water, normal saline solution, or lactated Ringer's solution.

• Give single-dose I.V. injection slowly, over 2 to 5 minutes for each 2-mg dose.

• Rotate I.M. and subcutaneous sites to prevent muscle atrophy.

• Give oral form with food to avoid GI upset.

Adverse reactions

CNS: confusion, sedation, dysphoria, euphoria, floating feeling, hallucinations, headache, unusual dreams, anxiety, dizziness, drowsiness

CV: hypotension, hypertension, palpitations, bradycardia, tachycardia

EENT: blurred vision, diplopia, miosis, nystagmus, tinnitus, laryngeal edema, laryngospasm

GI: nausea, vomiting, constipation, abdominal cramps, biliary tract spasm, anorexia

GU: urinary retention, dysuria

Hepatic: hepatotoxicity

Respiratory: dyspnea, wheezing, bronchospasm, respiratory depression

Skin: flushing, diaphoresis

Other: physical or psychological drug dependence; drug tolerance; injection site pain, redness, or swelling

Interactions

Drug-drug. Antidepressants, antihistamines, MAO inhibitors, sedative-hypnotics: additive CNS depression

Antihypertensives, diuretics, guanadrel, guanethidine, mecamylamine: increased risk of hypotension

Atropine, belladonna alkaloids, difenoxin, diphenoxylate, kaolin and pectin, loperamide, paregoric: increased risk of CNS depression, severe constipation

Barbiturates: increased sedation

Buprenorphine, butorphanol, nalbuphine, pentazocine: precipitation of opioid withdrawal in physically dependent patients

Nalbuphine, pentazocine: decreased analgesia

Drug-diagnostic tests. Amylase, lipase: increased levels

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

See With I.V. use, monitor for respiratory depression. Keep resuscitation equipment and naloxone nearby.

• Assess for signs and symptoms of physical or psychological drug dependence.

• Monitor for constipation.

Patient teaching

See Instruct patient to take drug exactly as prescribed before pain becomes severe, but caution him that drug may be habit-forming.

• Tell patient to take oral form with food to avoid GI upset.

• Advise patient to report difficulty breathing, nausea, vomiting, or dizziness.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Tell patient to avoid alcohol while taking drug.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

Palladone

A brand name for HYDROMORPHONE.