Generic Name and Formulations:
Hydromorphone HCl 8mg, 12mg, 16mg, 32mg; ext-rel tabs; contains sulfites.
Moderate to severe pain in opioid-tolerant patients when continuous opioid analgesia is needed for an extended time period. Not for as-needed use or to treat acute or post-op pain.
Not for initial use. Swallow whole. Take once daily. >17yrs: Individualize based on prior analgesic treatment experience. Monitor closely within first 24–72 hours of starting therapy. See literature for converting from other opioids. Discontinuation of therapy: taper gradually by 25–50% every 2 or 3 days down to a dose of 8mg before discontinuing. Moderate hepatic impairment: start with 25% of normal dose; severe hepatic impairment: consider alternate therapy. Moderate renal impairment: start with 50% of normal dose; severe renal impairment: start with 25% of normal dose or consider alternate therapy.
≤17yrs: not established.
Opioid non-tolerant. Significant respiratory depression. Asthma (acute or severe). Sulfite allergy. Known or suspected paralytic ileus. GI or GU obstruction or stricture.
Increased risk of fatal respiratory depression (esp. when initiating therapy and during dose increases); monitor. Abuse potential (monitor routinely). Accidental exposure may result in fatal overdose (esp. children). Significant COPD or cor pulmonale. Increased intracranial pressure. Head injury. Impaired consciousness or coma: avoid. Renal or hepatic impairment. GI surgery. Biliary tract disease. Acute pancreatitis. Convulsive disorders. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Neonates. Obstetrical analgesia, labor and delivery, nursing mothers: not recommended. Pregnancy (Cat.C).
Not recommended within 14 days of MAOIs. Potentiation with alcohol, CNS depressants (eg, hypnotics, sedatives, anesthetics, antipsychotics); avoid. Mixed agonist/antagonist opioids (eg, buprenorphine, nalbuphine, pentazocine) may reduce effects and precipitate withdrawal symptoms. Additive anticholinergic effects (eg, urinary retention, constipation) with other anticholinergics.
Constipation, GI upset, somnolence, headache, asthenia, dizziness, rash, orthostatic hypotension, urinary retention, respiratory or circulatory depression, syncope.