Adult Dosing

Moderate-severe pain

• 2 mg PO q6-8 hrs; may increase up to 3 mg q6-8 hrs; titrate dose q72 hrs
• Dosage should be individualized based on degree of pain and clinical setting

Pediatric Dosing

• Safety and efficacy in pediatric population have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of moderate to severe pain where an opioid analgesic is appropriate

• Hypersensitivity to any of the ingredients of the product, including dextromethorphan
• Respiratory depression
• Increased ICP
• MI
• Hypotension

• N/A

Renal Dose Adjustment

• Severe impairment: Reduction of initial dose recommended, dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Reduction of initial dose recommended, dose adjustments not defined

• It may cause respiratory depression in elderly, debilitated patients. Therefore reduce dose to 50% in patient in any condition affecting respiratory reserve or in conjunction with other drugs affecting the respiratory center
• If used in conjunction with alcohol, other opioids, or illicit drugs, it may result in additive CNS depressive effects, including respiratory depression, hypotension, profound sedation, coma, or death
• Similar to other opioids, it is a Schedule II controlled substance with an abuse liability
• Avoid use in head injury, other intracranial lesions or a pre-existing intracranial hypertension, as it may exaggerate elevation of cerebrospinal fluid pressure
• Avoid administration in patients with gastrointestinal obstruction, especially paralytic ileus because it diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction
• Use with caution in patients with biliary tract disease, including acute pancreatitis, as it may cause spasm of the Sphincter of Oddi and diminish biliary and pancreatic secretions
• Caution must be used with potentially hazardous activities such as driving and operating machinery
• Delirium tremens have been reported

Cautions: Use cautiously in

• Severe renal impairment
• Hepatic impairment
• Elderly or debilitated
• Hypothyroidism
• Addison’s disease
• Toxic psychosis
• Prostatic hypertrophy or urethral stricture
• Acute alcoholism or delirium tremens
• Drug dependency
• Seizure disorder
• Concomitant use with MAOI's

Pregnancy Category:C

Breastfeeding: Safety unknown. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Confusion, sedation, mood disturbances, dysphoria, euphoria, dizziness, floating feeling, hallucinations, headache, unusual dreams
• EENT: Blurred vision, diplopia, miosis
• RESP: Respiratory depression, bronchospasm, apnea, hypoventilation
• CV: Hypotension, bradycardia
• GI: Constipation, dry mouth, nausea, vomiting, biliary spasm
• GU: Urinary retention
• DERM: Flushing, sweating, pruritis, rash
• MISC: Physical dependence, psychological dependence, tolerance, renal failure, risk of suicide, coma, seizure

• Opioid agonist; alters perception and response to pain by binding to opiate receptors in the CNS; produces generalized CNS depression
• Metabolized by liver
• Excreted in urine
• Half-life: 11-16 hrs

US Trade Name(s)

• Only generic available

US Availability

levorphanol (generic)

• TABS: 2 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Opioid Analgesics

Opioid Agonists

Drug Name: L-Dromoran 2 MG Oral Tablet

Ingredient(s): Levorphanol

Imprint: LEVO;3251

Color(s): White

Shape: Round

Size (mm): 6.00

Score: 2

Inactive Ingredient(s): lactose / corn starch / stearic acid / talc

Drug Label Author:
Valeant Pharmaceuticals International

DEA Schedule:
CII

Drug Name: Levorphanol 2 MG Oral Tablet

Ingredient(s): Levorphanol

Imprint: 54;410

Color(s): White

Shape: Round

Size (mm): 6.00

Score: 2

Inactive Ingredient(s): anhydrous lactose / starch, corn / magnesium stearate / stearic acid / talc

Drug Label Author:
Roxane Laboratories, Inc

DEA Schedule:
CII