Complete SPL Sections#
BOXED WARNING SECTION
BOXED WARNING SECTION
Addiction, Abuse, and Misuse Because the use of Butorphanol Tartrate Nasal Spray exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Butorphanol Tartrate Nasal Spray, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Butorphanol Tartrate Nasal Spray are essential [see WARNINGS ] . Accidental Exposure Accidental exposure of even one dose of Butorphanol Tartrate Nasal Spray, especially in children, can result in a fatal overdose of butorphanol [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Butorphanol Tartrate Nasal Spray and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS , PRECAUTIONS; Drug Interactions ] . Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS ]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ] . Cytochrome P450 3A4 Interaction The concomitant use of Butorphanol Tartrate Nasal Spray with all cytochrome P450 3A4 inhibitors may result in an increase in butorphanol plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in butorphanol plasma concentration. Monitor patients receiving Butorphanol Tartrate Nasal Spray and any CYP3A4 inhibitor or inducer [see CLINICAL PHARMACOLOGY , WARNINGS , PRECAUTIONS; Drug Interactions ] .
DESCRIPTION
DESCRIPTION SECTION
Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl)morphinan-3,14-diol [S-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). The molecular formula is C 21 H 29 NO 2 •C 4 H 6 O 6 , which corresponds to a molecular weight of 477.55 g/mol and the following structural formula: Butorphanol tartrate, USP is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol Tartrate Nasal Spray, USP is an aqueous solution of butorphanol tartrate for administration as a metered spray to the nasal mucosa. Each bottle of Butorphanol Tartrate Nasal Spray, USP contains 2.5 mL of a 10 mg/mL solution of butorphanol tartrate with sodium chloride, citric acid, and benzethonium chloride in purified water with sodium hydroxide and/or hydrochloric acid added to adjust the pH to 5.0. The pump reservoir must be fully primed [see PATIENT INSTRUCTIONS ] prior to initial use. After initial priming each metered spray delivers an average of 1.0 mg of butorphanol tartrate and the 2.5 mL bottle will deliver an average of 14 to 15 doses of Butorphanol Tartrate Nasal Spray, USP. If not used for 48 hours or longer, the unit must be reprimed [see PATIENT INSTRUCTIONS ]. With intermittent use requiring repriming before each dose, the 2.5 mL bottle will deliver an average of 8 to 10 doses of Butorphanol Tartrate Nasal Spray, USP depending on how much repriming is necessary.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Butorphanol Tartrate Nasal Spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ] , reserve Butorphanol Tartrate Nasal Spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Butorphanol Tartrate Nasal Spray should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Butorphanol Tartrate Nasal Spray is contraindicated in: Patients with significant respiratory depression [see WARNINGS ] . Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] . Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] . Patients with hypersensitivity to butorphanol tartrate, the preservative benzethonium chloride, or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS ] .
WARNINGS
WARNINGS SECTION
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
OVERDOSAGE
OVERDOSAGE SECTION
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
HOW SUPPLIED
HOW SUPPLIED SECTION
Butorphanol Tartrate Nasal Spray, USP is supplied in a child-resistant vial containing a 2.5 mL bottle of nasal spray solution (10 mg/mL) and a metered-dose spray pump with protective clip and dust cover, a bottle of nasal spray solution, and a patient instruction leaflet and medication guide. On average, one bottle will deliver 14 to 15 doses if no repriming is necessary. Butorphanol Tartrate Nasal Spray, USP, 10 mg/mL NDC 0054-3090-36: 2.5 mL Bottle.
PHARMACIST ASSEMBLY INSTRUCTIONS FOR BUTORPHANOL TARTRATE NASAL SPRAY, USP
SPL UNCLASSIFIED SECTION
The pharmacist will assemble Butorphanol Tartrate Nasal Spray prior to dispensing to the patient, according to the following instructions: Open the child-resistant prescription vial and remove the spray pump and solution bottle. Assemble Butorphanol Tartrate Nasal Spray 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. Return the Butorphanol Tartrate Nasal Spray bottle to the child-resistant prescription vial for dispensing to the patient with patient instruction leaflet and medication guide. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000400/02 Revised January 2024
PATIENT INSTRUCTIONS
SPL UNCLASSIFIED SECTION
for BUTORPHANOL TARTRATE NASAL SPRAY, USP Rx only PATIENT INSTRUCTIONS Take medication as directed by your physician. For proper use of the nasal spray, read the following instructions carefully. NOTE: VIALS DO NOT APPEAR “FULL.” THEY ARE PRE-FILLED TO DELIVER ON AVERAGE 14 TO 15 ONE (1) MG DOSES. (THE USUAL DOSE IS 1 MG-ONE SPRAY IN ONE NOSTRIL.) THE UNIT MUST BE PRIMED WITH ONE OR TWO STROKES IF NOT USED FOR 48 HOURS OR LONGER. Note: With intermittent use requiring repriming before each dose, the 2.5 mL bottle will deliver an average of 8 to 10 doses of butorphanol tartrate nasal spray. When not in use, store spray unit in child-resistant container. Butorphanol Tartrate Nasal Spray should not be used by anyone other than the person for whom it was prescribed. To prevent this, and to reduce the chance of children taking the drug it is important to dispose of any excess Butorphanol Tartrate Nasal Spray just as soon as it is no longer needed. The best way to safely dispose of the unit is to unscrew the cap, rinse the bottle and spray assembly under the water faucet, and dispose of the parts in a waste can where children cannot easily get to them. Figure 1 Blow nose gently to clear both nostrils. Figure 2 Pull clear cover off pump unit. Remove protective clip from neck of pump unit. Figure 3 Prime Butorphanol Tartrate Nasal Spray by placing nozzle between first and second finger with thumb on the bottom of bottle. Pump sprayer unit FIRMLY and QUICKLY until a fine spray appears (up to 7 to 8 strokes). Figure 4 Insert spray tip approximately 1 cm (width of small finger) into one nostril, pointing the tip toward the back of the nose. Figure 5 Close other nostril with your forefinger and tilt head slightly forward. Figure 6 Pump spray unit firmly and quickly by pushing down on the “finger grips” of the pump unit and against the thumb at the bottom of the bottle. Sniff gently with your mouth closed. Figure 7 After spraying, remove pump unit from nose. Tilt your head backwards and sniff gently a few more seconds. Your doctor will tell you whether a two spray dose is needed. If needed, administer a second spray in the other nostril, following steps 4 through 7. Replace protective clip and clear cover, respectively, (Fig. 2) after each dose. USUAL DOSE: ONE Spray. Spray ONLY ONCE into ONLY ONE nostril. DO NOT spray into both nostrils unless directed by your doctor. DO NOT repeat sooner than directed by your doctor.
Medication Guide
SPL MEDGUIDE SECTION
Butorphanol Tartrate Nasal Spray, USP CIV (bue tor’ fa nol tar’ trate) Rx only Butorphanol Tartrate Nasal Spray is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about Butorphanol Tartrate Nasal Spray: Get emergency help or call 911 right away if you take too much Butorphanol Tartrate Nasal Spray (overdose). When you first start taking Butorphanol Tartrate Nasal Spray, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. Taking Butorphanol Tartrate Nasal Spray with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death. Never give anyone else your Butorphanol Tartrate Nasal Spray. They could die from taking it. Selling or giving away Butorphanol Tartrate Nasal Spray is against the law. Store Butorphanol Tartrate Nasal Spray securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take Butorphanol Tartrate Nasal Spray if you have: Severe asthma, trouble breathing, or other lung problems. A bowel blockage or have narrowing of the stomach or intestines. Previously had an allergic reaction to butorphanol or the preservative benzethonium chloride. Before taking Butorphanol Tartrate Nasal Spray, tell your healthcare provider if you have a history of: Head injury, seizures Liver, kidney, thyroid problems Problems urinating Pancreas or gallbladder problems Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: Noticing your pain getting worse. If your pain gets worse after you take Butorphanol Tartrate Nasal Spray, do not take more of Butorphanol Tartrate Nasal Spray without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Butorphanol Tartrate Nasal Spray. Pregnant or planning to become pregnant. Use of Butorphanol Tartrate Nasal Spray for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Breastfeeding. Butorphanol passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs. Living in a household where there are small children or someone who has abused street or prescription drugs. Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Butorphanol Tartrate Nasal Spray with certain other medicines can cause serious side effects that could lead to death. When taking Butorphanol Tartrate Nasal Spray: Do not change your dose. Take Butorphanol Tartrate Nasal Spray exactly as prescribed by your healthcare provider. See the detailed Patient Instructions for information about how to take Butorphanol Tartrate Nasal Spray. Use the lowest dose possible for the shortest time needed. For acute (short-term) pain, you may only need to take Butorphanol Tartrate Nasal Spray for a few days. You may have some Butorphanol Tartrate Nasal Spray left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused Butorphanol Tartrate Nasal Spray. Take your prescribed dose every 3 to 4 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time. Call your healthcare provider if the dose you are taking does not control your pain. If you have been taking Butorphanol Tartrate Nasal Spray regularly, do not stop taking Butorphanol Tartrate Nasal Spray without talking to your healthcare provider. After you stop taking Butorphanol Tartrate Nasal Spray, dispose of unused Butorphanol Tartrate Nasal Spray by unscrewing the cap, rinsing the bottle, and placing the parts in a waste container. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While taking Butorphanol Tartrate Nasal Spray DO NOT: Drive or operate heavy machinery, until you know how Butorphanol Tartrate Nasal Spray affects you. Butorphanol Tartrate Nasal Spray can make you sleepy, dizzy, or lightheaded. Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Butorphanol Tartrate Nasal Spray may cause you to overdose and die. The possible side effects of Butorphanol Tartrate Nasal Spray: Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of Butorphanol Tartrate Nasal Spray. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 For more information, please call 1-800-962-8364. This Medication Guide has been approved by the U.S. Food and Drug Administration. KEEP OUT OF THE REACH OF CHILDREN. C50000400/02 Revised January 2024
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0054- 3090 -36 2.5 mL Butorphanol Tartrate Nasal Spray, USP CIV 10 mg per mL For Nasal Use Only. Rx only
