EXALGO CII

Indications for EXALGO:

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.

Adult Dose for EXALGO:

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.

Children's Dose for EXALGO:

≤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 or GU 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). 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).

Interactions:

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.

Adverse Reactions:

Constipation, GI upset, somnolence, headache, asthenia, dizziness, rash, orthostatic hypotension, urinary retention, respiratory or circulatory depression, syncope.

Metabolism:

Hepatic.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Tabs—100