Contraindicated in:
- Hypersensitivity
- Concurrent alcohol
- Moderate/severe hepatic impairment
- Significant respiratory depression (unless monitoring and resuscitative equipment are readily available)
- Acute or severe bronchial asthma (unless monitoring and resuscitative equipment are readily available)
- Paralytic ileus.
Use Cautiously in:
- Acute alcoholism or delirium tremens or other toxic psychoses
- Mild hepatic impairment
- Head injury/↑ intracranial pressure (may obscure neurologic signs and further ↑ pressure)
- Volume depletion or drugs that may cause hypotension including diuretics and phenothiazines (↑ risk of severe hypotension)
- Circulatory shock (may ↑ risk of severe hypotension)
- Adrenocortical insufficiency
- Seizure disorders
- Hypothyroidism
- Prostatic hypertrophy or ureteral stricture
- Severe pulmonary impairment
- Renal impairment (CCr <50 mL/min)
- Biliary tract disease or pancreatitis
- OB: Lactation: Avoid chronic use; prolonged use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome
- Pedi: Safety and effectiveness not established in children
- Geri: ↑risk of respiratory depression in older adults; dose ↓ suggested.
Exercise Extreme Caution in:
- Conditions association with hypoxia, hypercapnea, ↓ respiratory reserve (including asthma, COPD, cor pulmonale, morbid obesity, sleep apnea, myxedema, kyphoscoliosis, CNS depression and coma).
CNS: confusion, sedation, dizziness, dysphoria, euphoria, floating feeling, hallucinations, headache, unusual dreams.
CV: orthostatic hypotension.
EENT: blurred vision, diplopia, miosis.
Derm: flushing, sweating.
Endo: adrenal insufficiency.
GI: constipation, dry mouth, nausea, vomiting.
GU: urinary retention.
Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA).
Misc: physical dependence, psychological dependence, tolerance.
Larger doses may be required during chronic therapy
- PO (Adults): Opioid-naive patients — 10–20 mg every 4–6 hr as needed, some patients may require initial dose of 5 mg, not to exceed 20 mg. For extended-release, give 5 mg every 12 hr; may titrate in increments of 5–10 mg every 12 hr every 3–7 days.
Therapeutic Classification: opioid analgesics
Pharmacologic Classification: opioid agonists
Absorption: 10% absorbed following oral administration. Food and alcohol significantly ↑absorption (38%).
Distribution: Widely distributed; crosses placenta, enters breast milk.
Metabolism/Excretion: Mostly metabolized by the liver; at least 2 metabolites are pharmacologically active, <1% excreted unchanged in urine.
Half-life: 2.6–4 hr.