Adult Dosing

Moderate to severe pain

• IM
• Start 2 mg IM q3-4 hr prn
• Usual dose: 1 mg-4mg IM q3-4 hr prn

• IV
• Start 1 mg IV q3-4 hr prn
• Usual dose: 0.5 mg-2 mg IV q3-4 hr prn

Preoperative/preanesthetic medication

• 2 mg IM 60-90 mins before surgery

Balanced anesthesia

• 2 mg IV before induction; then 0.5 mg-1 mg IV in increments

Note:

• Depending on previously administered sedative, analgesic, and hypnotic drugs increment may be higher up to 0.06 mg/kg (4 mg/70 kg)
• Patients may rarely require <4 mg or >12.5 mg (approximately 0.06 mg/kg-0.18 mg/kg)

Labor

• 1-2 mg IV or IM; repeat after 4 hrs

Pediatric Dosing

• Safety and effectiveness in pediatrics have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of pain when the use of an opioid analgesic is appropriate
• Preoperative or preanesthetic medication
• As a supplement to balanced anesthesia
• Relief of pain during labor

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to benzethonium chloride

• N/A

Renal Dose Adjustment

• Renal impairment: Start 0.5 mg IV or 1 mg IM then q6 hr
• Hemodialysis: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Start 0.5 mg IV or 1 mg IM then q6 hr

See Supplemental Patient Information

• Avoid using in patients depending on narcotics. Use butorphanol therapy in such patients only after sufficient time has elapsed after withdrawal from opioid drugs
• This drug is associated with precipitation of withdrawal symptoms in patients taking opioid analgesics chronically
• Difficulties exist in assessing opioid tolerance in patients who have recently received repeated doses of narcotic analgesic
• This drug exhibits potential for drug abuse
• Physical dependence or tolerance is associated with long term continuous use of butorphanol
• For minimizing the risk of abuse and physical dependence carefully select patients dose, use as appropriate and frequently monitor patients
• Carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, drug-induced miosis, and alterations in mental state have occurred in patients with head injury. Interpretation of the clinical course of patients with head injuries is difficult in such patients. Use therapy in such patients only if the benefits of use outweigh the potential risks
• Patients receiving other CNS active agents, or suffering from CNS diseases or respiratory impairment are more prone to respiratory depression
• Dose modification is essential in patients with hepatic and renal disease
• This drug is associated with increasing work load of the heart, especially the pulmonary circuit. Limit the use of butorphanol in patients with acute myocardial infarction, ventricular dysfunction, or coronary insufficiency in such situations where the benefits clearly outweigh the risk.
• Rare occasions of severe hypertension is associated with butorphanol therapy; discontinue therapy and provide therapy with antihypertensive drugs
• Taper dose gradually to discontinue

Cautions: Use cautiously in:

• Renal impairment
• Hepatic impairment
• Cardiac disease
• Acute MI
• Pulmonary impairment
• Geriatrics
• Substance abuse
• Head injury
• CNS depression
• Biliary surgery

Supplemental Patient Information

• Advise patients to avoid engaging in activities requiring mental alertness for at least 1 hr and until the effects of the drug are no longer present
• Advise patients to avoid concomitant use with alcohol

Pregnancy Category:C

Breastfeeding: Small amounts of butorphanol are excreted into breastmilk. Literatures on use with repeated, high, intravenous or intranasal doses of butorphanol during breastfeeding are unavailable; prefer alternative agents especially while nursing a newborn or preterm infant. If essential limit maternal intake and supplement analgesia with a non narcotic analgesic. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 February 2011). Manufacturer suggests using this drug during pregnancy only if the potential benefit justifies the potential risk to the infant.

• RESP: Respiratory depression
• CNS: Dependency, abuse, sedation, dizziness, headache, asthenia, euphoria, confusion, nervousness, lightheadedness
• CV: Severe bradycardia, severe hypotension
• GI: Nausea vomiting, anorexia, constipation
• DERM: Sweating

• Opioid mixed agonist-antagonist; precise mechanism of action is unknown; interacts with an kappa and sigma opiate receptor site in the CNS and exerts agonistic effects; opiate antagonistic effect results from competitive inhibition at the opiate receptor
• Well absorbed
• Extensively metabolized by liver; CYP450: Unknown
• Excreted in urine (70-80%), feces (15%)
• Half life:
• 4.56 hr (young)
• 5.61 hr (geriatric)
• CrCl <30 mL/min: 10.5 hr
• Hepatic impairment: 16.8 hr

US Trade Name(s)

• Stadol (Discontinued)
• Stadol preservative free (Discontinued)

US Availability

butorphanol (generic)

• INJ: 1 mg/mL (1 mL vial)
• INJ: 2 mg/mL (2, 10 mL vial)

butorphanol preservative free (generic)

• INJ: 1 mg/mL (1 mL vial)
• INJ: 2 mg/mL (1, 2, 10 mL vial)

Stadol

• INJ: 2 mg/mL

Stadol preservative free

• INJ: 1 mg/mL
• INJ: 2 mg/mL

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

Narcotics

Pricing data from www.DrugStore.com in U.S.A.

• Butorphanol Tartrate 10 MG/ML SOLN [Bottle] (MYLAN)
  2.5 ml = $56.99
  7.5 ml = $156.99

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.