Palladone
hydromorphone hydrochloride
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
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.