Classes
DEA Class; Rx
Common Brand Names; Stadol
- Opioid Analgesics;
- Analgesics, Opioid Partial Agonist
Description
Semisynthetic mixed opiate agonist-antagonist; partial mu-receptor agonist with a ceiling to its pharmacological effects
Immediate-release parenteral form used for moderate to severe pain; transdermal and buccal forms used for continuous therapy for chronic severe pain
Sublingual tablets, dermal implant, and extended-release subcutaneous injection are used for opioid dependence in conjunction with the Drug Addiction Treatment Act (DATA)
Indications
Indicated for pain when use of opioid analgesic is appropriate
Indicated for labor pain in full-term (37 weeks gestation or more) women without fetal distress in early labor
Contraindications
Absolute: opioid dependence, respiratory depression, respiratory failure
Relative: cardiac arrhythmias, cardiovascular disease, coronary insufficiency, myocardial infarction, toxin-mediated diarrhea
Adverse Effects
- Sedation (43%)
- Dizziness (19%)
- Nasal congestion (13%)
- Nausea and/or vomiting (13%)
- Insomnia (11%)
- Anorexia
- Anxiety
- Blurred vision
- Bronchitis
- Confusion
- Constipation
- Cough
- Dizziness
- Dry mouth
- Dyspnea
- Ear pain
- Epistaxis
- Euphoria
- Floating feeling
- Headache
- Lethargy
- Nasal irritation
- Nervousness
- Paresthesia
- Palpitations
- Pharyngitis
- Pruritis
- Rhinitis
- Sensation of heat
- Sinus congestion
- Sinusitis
- Stomach pain
- Sweating/clammy
- Taste abnormalities
- Tinnitus
- Tremor
- URI
- Vasodilation
- Apnea
- Increased/decreased BP
- Bradycardia
- Chest pain
- Respiratory depression
- Tachycardia
Warnings
Drug abuse, emotional lability, head injury, hepatic/renal impairment, incr ICP, GI/urinary obstruction, BPH, hypothyroidism
Less risk of respiratory sedation than with pure opioid agonist
May produce withdrawal in opioid dependent pts
Avoid alcohol
Pregnancy and Lactation
Pregnancy Category: C; D if used for prolonged periods or near term
Lactation: excreted in breast milk, but infant likely exposed to insignificant amounts (AAP Committee states compatible w/ nursing)
Maximum Dosage
The maximum dosage is dependent on route of administration and indication for therapy.
The maximum dosage is dependent on route of administration and indication for therapy.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Butorphanol tartrate
injectable solution: Schedule IV
- 1mg/mL
- 2mg/mL
nasal spray: Schedule IV
- 10 mg/mL (1mg/spray)