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EXALGO
Narcotic analgesics
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Drug Name:

EXALGO CII

Generic Name and Formulations:
Hydromorphone HCl 8mg, 12mg, 16mg, 32mg; ext-rel tabs; contains sulfites.

Company:
Mallinckrodt, Inc.

Therapeutic Use:

Indications for EXALGO:

Management of pain severe enough to require daily, around-the-clock, long-term analgesia for which alternative opioid therapies are inadequate.

Limitations Of use:

Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.

Adult:

Not for initial use. Swallow whole. Take once daily. >17yrs: Individualize based on prior analgesic treatment experience. Monitor closely within first 24–72hrs of starting therapy. See full labeling 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.

Children:

≤17yrs: not established.

Pharmacological Class:

Opioid.

Contraindications:

Opioid non-tolerant. Significant respiratory depression. Asthma (acute or severe). Sulfite allergy. Known or suspected paralytic ileus. GI obstruction or stricture.

Warnings/Precautions:

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). Risk of neonatal opioid withdrawal syndrome. Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases); consider alternative non-opioid analgesic. Increased intracranial pressure. Head injury. Impaired consciousness or coma: avoid. Brain tumors. Renal or hepatic impairment. GI surgery. Biliary tract disease. Acute pancreatitis. Convulsive disorders. Avoid abrupt cessation. Dispose properly. Elderly. Cachectic. Debilitated. Neonates. Obstetrical analgesia, labor and delivery, nursing mothers: not recommended. Pregnancy (Cat.C).

Interactions:

Not recommended within 14 days of MAOIs. Potentiation with alcohol, CNS depressants (eg, hypnotics, sedatives, anesthetics, antipsychotics); consider dose reduction. Avoid mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Additive anticholinergic effects (eg, urinary retention, constipation) with other anticholinergics.

Adverse Reactions:

Constipation, nausea, vomiting, somnolence, headache, asthenia, dizziness, rash, orthostatic hypotension, urinary retention; respiratory or circulatory depression, syncope, neonatal opioid withdrawal syndrome.

Metabolism:

Hepatic.

Elimination:

Renal.

REMS:

YES

Generic Availability:

NO

How Supplied:

Tabs—100

EXALGO

  • 12mg tablets (Qty:30)
  • appx. price $592.00
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