Butorphanol injection

Stadol

Butorphanol is an opioid pain medication. An opioid is sometimes called a narcotic.

Butorphanol is used to treat moderate to severe pain. It is also used as part of anesthesia for surgery, or during early labor (if childbirth is expected to be more than 4 hours away).

Butorphanol may also be used for purposes not listed in this medication guide.

Butorphanol is injected into a muscle or into a vein through an IV. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Follow all directions on your prescription label. Butorphanol can slow or stop your breathing. Never use butorphanol in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Butorphanol may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away butorphanol is against the law.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Do not stop using butorphanol suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using butorphanol.

Store butorphanol at room temperature away from moisture and heat.

Since butorphanol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A butorphanol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Butorphanol injection is used to relieve pain. It may also be given before a surgery, when giving birth, or with general anesthesia before an operation. It belongs to the group of medicines called narcotic analgesics (pain medicines). Butorphanol acts on the central nervous system (CNS) to relieve pain.

When butorphanol injection is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

butorphanol is to be given only by or under the direct supervision of your doctor.

Applies to butorphanol: injectable solution, nasal spray

Other

The manufacturer has reported that in clinical trials (n=2,446), approximately half of the patients received butorphanol injection and the other half received butorphanol nasal spray. The type and incidence of side effects with butorphanol by either route were consistent with those commonly found with opioid analgesics.[Ref]

Nervous system

Nervous system effects including somnolence (43%), dizziness (19%), insomnia (11%), anxiety, confusion, euphoria, floating feeling, nervousness, paresthesia, and tremor have been reported.[Ref]

Respiratory

Respiratory effects including nasal congestion (13%), bronchitis, cough, dyspnea, epistaxis, nasal irritation, pharyngitis, rhinitis, sinus congestion, sinusitis, and upper respiratory infection have all been predominantly reported from long term trials with butorphanol nasal spray.[Ref]

Gastrointestinal

Gastrointestinal effects including nausea and/or vomiting (13%), anorexia, constipation, dry mouth, and stomach pain have been reported.[Ref]

General

Asthenia/lethargy, headache, and a sensation of heat have been reported.[Ref]

Cardiovascular

Cardiovascular effects including vasodilation and palpitations have been predominantly reported from long term trials with butorphanol nasal spray.[Ref]

Dermatologic

Dermatologic effects including sweating/clammy skin and pruritus have been reported.[Ref]

Other

Ear pain, tinnitus, and unpleasant taste have been predominantly reported from trials with butorphanol nasal spray.[Ref]

Ocular

Ocular effects including blurred vision have been reported.[Ref]

Musculoskeletal

Musculoskeletal effects including a case of fibrous myopathy have been reported in a patient abusing intramuscular butorphanol.[Ref]

Other

Elderly patients may be more sensitive to the effects of butorphanol. Clinical studies of butorphanol administered via the intranasal route have reported that elderly patients had an increased frequency of headache, dizziness, drowsiness, vertigo, constipation, nausea and/or vomiting, and nasal congestion, compared with younger patients.[Ref]

Some side effects of butorphanol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial dose: 1 mg intravenously once. Depending on the severity of the pain, effective intravenous doses range from 0.5 to 2 mg.

An initial dose of 2 mg of butorphanol intramuscularly once may be appropriate for patients who will be able to remain recumbent if drowsiness or dizziness occurs. Depending on the severity of the pain, effective intramuscular doses range from 1 to 4 mg.

Alternatively, an initial dose of 1 mg of butorphanol by nasal administration (1 spray in one nostril) once. Adherence to this dose has been reported to have led to a reduced incidence of drowsiness and dizziness. If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be administered. Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be appropriate in patients who will be able to remain recumbent if drowsiness or dizziness occurs.

Initial doses may be repeated after 3 to 4 hours if necessary. (This includes the initial dosage sequence of 1 mg by nasal administration followed by a second 1 mg dose in 60 to 90 minutes if necessary. This sequence may be repeated 3 to 4 hours after the second dose if necessary.)

Subsequent doses may be determined by patient response, rather than being scheduled at fixed dosing intervals.

Dose adjustments may be needed in patients with renal dysfunction.

Data not available