Stadol injection

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.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with butorphanol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to butorphanol: injection solution

Other dosage forms:

• nasal spray

Along with its needed effects, butorphanol (the active ingredient contained in Stadol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking butorphanol:

• Cough producing mucus
• difficulty breathing
• shortness of breath
• tightness in chest
• wheezing

• Blurred vision
• chest pain
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, pounding, or irregular heartbeat or pulse
• nervousness
• pounding in the ears
• slow or fast heartbeat

• Bluish lips or skin
• false beliefs that cannot be changed by facts
• not breathing
• seizures

Get emergency help immediately if any of the following symptoms of overdose occur while taking butorphanol:

• Change in consciousness
• extremely shallow or slow breathing
• irregular heartbeats
• loss of consciousness
• shortness of breath
• swelling in hands and feet

Some side effects of butorphanol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness
• nausea
• sleepiness or unusual drowsiness
• vomiting

• Bad unusual or unpleasant (after) taste
• bloody nose
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• clammy skin
• congestion
• continuing ringing or buzzing or other unexplained noise in ears
• cough
• dry mouth
• dryness or soreness of throat
• ear pain
• false or unusual sense of well-being
• fear or nervousness
• feeling of warmth or heat
• fever
• floating feeling
• flushing or redness of skin, especially on face and neck
• headache
• hearing loss
• heat sensation on body
• hoarseness
• loss of appetite
• nasal irritation
• runny nose
• shakiness
• skin itching
• sleeplessness
• sneezing
• stomach pain
• stuffy nose
• tender, swollen glands in neck
• trouble in swallowing
• trouble sleeping
• unable to sleep
• voice changes
• weight loss

• Sweating
• unusual tiredness or weakness

• Dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• lack or loss of strength
• problems in speaking
• sensation of spinning

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 (the active ingredient contained in Stadol) 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 (the active ingredient contained in Stadol) 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 (the active ingredient contained in Stadol) 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 (the active ingredient contained in Stadol) 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 (the active ingredient contained in Stadol) [Ref]

Other

Elderly patients may be more sensitive to the effects of butorphanol (the active ingredient contained in Stadol) 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 Stadol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.