Stadol

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Antidepressants
• Antihistamines
• Barbiturates such as Amytal and Tuinal (amobarbital), Butisol (butabarbital), pentobarbital, phenobarbital, or Seconal (secobarbital)
• ERY-TAB, E.E.S., E-Mycin, and Erythrocin (erythromycin)
• Medications for anxiety, mental illness, or seizures
• Monoamine oxidase inhibitors (MAOIs) including Eldepryl, Emsam, and Zelapar (selegiline), Marplan (isocarboxazid), Nardil (phenelzine), or Parnate (tranylcypromine)
• Other narcotics
• Sedatives
• Sleeping pills
• Sodium oxybate (GHB)
• Theochron and Theolair (theophylline)
• Tranquilizers

Stadol and Alcohol

Alcohol may worsen certain side effects of Stadol. Avoid drinking alcohol while taking the drug.

Stadol and Other Interactions

Stadol may make you dizzy or drowsy. Don't drive or perform any other activity that requires alertness until you know how you respond to Stadol.

Contraindications

Absolute: opioid dependence, respiratory depression, respiratory failure

Relative: cardiac arrhythmias, cardiovascular disease, coronary insufficiency, myocardial infarction, toxin-mediated diarrhea

Cautions

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

IV Compatibilities

Syringe: (partial list) atropine, diphenhydramine, fentanyl, hydroxyzine, meperidine, metoclopramide, midazolam, prochlorperazine, promethazine

Y-site: (partial list) allopurinol, bivalirudin, labetalol, linezolid, propofol

IV Incompatibilities

Syringe: dimenhydrinate, pentobarbital

Y-site: amphotericin B cholesteryl SO4, midazolam

IV Administration

pH: 3.0-5.5

IM/IV injection

Storage

Store at room temp

Protect from freezing

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butorphanol injection in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butorphanol injection.

Along with its needed effects, a medicine 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:

• 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:

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

Some side effects 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to ease pain.
• This medicine is only for use when other pain drugs do not treat your pain well enough or you cannot take them.
• It is used during surgery.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Stadol (butorphanol injection solution) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Stadol. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

CIV

Stadol® (butorphanol tartrate) Injection, USP, for IM or IV use is available as follows:

Stadol NS® (butorphanol tartrate) Nasal Spray

Stadol NS is supplied in a child-resistant prescription vial containing a metered-dose spray pump with protective clip and dust cover, a bottle of nasal spray solution, and a patient instruction leaflet. On average, one bottle will deliver 14–15 doses if no repriming is necessary.

PHARMACIST ASSEMBLY INSTRUCTIONS FOR Stadol NS NASAL SPRAY

The pharmacist will assemble Stadol NS prior to dispensing to the patient, according to the following instructions:

1. Open the child-resistant prescription vial and remove the spray pump and solution bottle.
2. Assemble Stadol NS by first unscrewing the white cap from the solution bottle and screwing the pump unit tightly onto the bottle. Make sure the clear cover is on the pump unit.
3. Return the Stadol NS bottle to the child-resistant prescription vial for dispensing to the patient.

Storage Conditions

Store at 25° C (77° F) controlled room temperature. See USP. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

IMITREX® is the registered trademark of the GlaxoSmithKline Group of Companies.

Distributed by Geneva Pharmaceuticals, Inc.
Dayton, NJ 08810 USA

565001DIL-8
1117206A2
Revised April 2002