• Moderate to severe pain.

Contraindicated in:

• Hypersensitivity
• OB: Lactation: Avoid chronic use during pregnancy or lactation.

Use Cautiously in:

• Head trauma
• Increased intracranial pressure
• Severe renal, hepatic, or pulmonary disease
• Hypothyroidism
• Adrenal insufficiency
• Alcoholism
• Undiagnosed abdominal pain
• Prostatic hyperplasia
• Geri: Older adults (dose ↓ suggested).

CV: hypotension, bradycardia.

Derm: flushing, pruritus, sweating.

EENT: diplopia, blurred vision, miosis.

GI: constipation, vomiting, dry mouth, nausea.

GU: urinary retention.

Neuro: confusion, sedation, dizziness, dysphoria, euphoria, floating feeling, hallucinations, headache, unusual dreams.

Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA).

Misc: psychological dependence, physical dependence, tolerance.

Drug-Drug:

• Use with extreme caution in patients receiving MAO inhibitors (may result in unpredictable, severe reactions—decrease initial dose of levorphanol to 25% of usual dose).
• Additive CNS depression with alcohol, antihistamines, antidepressants, and sedative/hypnotics.
• Administration of partial-antagonist opioid analgesics may precipitate withdrawal in physically dependent patients.
• Nalbuphine may ↓ analgesia.

Drug-Natural Products:

• Concomitant use of kava, valerian, skullcap, chamomile, or hops can increase CNS depression.

(Generic available)

• Tablets: 2 mg; 3 mg;

• PO (Adults ≥50 kg): Initial dosing in opioid-naive patients: 4 mg every 6–8 hr.
• PO (Adults and Children <50 kg): Initial dosing in opioid-naive patients: 0.04 mg/kg every 6–8 hr (unlabeled for use in children).

Levo-Dromoran

• Binds to opiate receptors in the CNS, altering perception of and response to pain.
• Produces generalized CNS depression.

• Decreased pain.

Therapeutic Classification: opioid analgesics

Pharmacologic Classification: opioid agonists

Absorption: Well absorbed following oral administration.

Distribution: Extensive.

Metabolism/Excretion: Mostly metabolized by the liver.

Half-life: 12–16 hr; may be as long as 30 hr with chronic dosing.

Schedule II (C-II)

(analgesic effect)

• Instruct patient on how and when to ask for pain medication.
• REMS: Instruct patient to take levorphanol as directed. If dose is less effective after a few weeks, do not increase dose without consulting health care professional. Discuss safe use, risks, and proper storage and disposal of opioid analgesics with patients and caregivers with each Rx. The Patient Counseling Guide is available at OpioidAnalgesicREMSPCG.
• Advise patient that levorphanol is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
• Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose. Inform patients and caregivers about various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (by prescription, directly from a pharmacist, or as part of a community-based program).
• Medication may cause drowsiness or dizziness. Advise patient to call for assistance when ambulating or smoking. Caution patient to avoid driving or other activities that require alertness until response to the medication is known.
• Advise patient to change positions slowly to minimize orthostatic hypotension.
• Caution patient to avoid concurrent use of alcohol or other CNS depressants.
• Advise ambulatory patients that nausea and vomiting may be decreased by lying down.
• Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
• Rep: Advise patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight); usually occur the first days after birth. Monitor infants exposed to levorphanol through breast milk for excess sedation and respiratory depression. Chronic use may reduce fertility in females and males.

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NDC Code^*

• 42358- Sentynl Therapeutics, Inc.
  • 42358-102- Levorphanol Tartrate
    • 42358-102-10- 100 TABLET in 1 BOTTLE, PLASTIC (42358-102-10)

• 42358- Sentynl Therapeutics, Inc.
  • 42358-103- Levorphanol Tartrate
    • 42358-103-10- 100 TABLET in 1 BOTTLE, PLASTIC (42358-103-10)

• 69543- Virtus Pharmaceuticals, LLC
  • 69543-412- Levorphanol Tartrate
    • 69543-412-10- 100 TABLET in 1 BOTTLE (69543-412-10)