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Butorphanol Tartrate (Butorphanol Tartrate)

Trade Name : Butorphanol Tartrate

West-Ward Pharmaceuticals Corp.

SPRAY, METERED

Strength 10 mg/mL

BUTORPHANOL TARTRATE Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Butorphanol Tartrate (Butorphanol Tartrate) which is also known as Butorphanol Tartrate and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 10 mg/mL per ml. Read more

Butorphanol Tartrate (Butorphanol Tartrate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Arrayn- Addiction, Abuse, and Misuse
  • 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 patientu2019s risk prior to prescribing Butorphanol Tartrate Nasal Spray, and monitor all patients regularly for the development of these behaviors and conditions n
  • Array
  • Arrayn- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products []. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of Butorphanol Tartrate Nasal Spray. Monitor for respiratory depression, especially during initiation of Butorphanol Tartrate Nasal Spray or following a dose increase .
  • Array
  • Arrayn- Accidental Exposure
  • Accidental exposure of butorphanol, especially by children, can result in a fatal overdose of butorphanol n
  • Array
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of Butorphanol Tartrate Nasal Spray during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available n
  • Arrayn- Array
  • Array
  • Arrayn- 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 inducern
  • Array
  • Arrayn- 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 n
  • 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 CHNOu2022CHO, which corresponds to a molecular weight of 477.55 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 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 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.
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  • 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, even at recommended doses [see ], reserve Butorphanol Tartrate Nasal Spray for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
  • Butorphanol Tartrate Nasal Spray is contraindicated in:
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  • 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.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
  • Store Butorphanol Tartrate Nasal Spray securely and dispose of properly [see ].
  • The pharmacist will assemble Butorphanol Tartrate Nasal Spray prior to dispensing to the patient, according to the following instructions:
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10001972/09
  • Revised August 2019
  • for BUTORPHANOL TARTRATE NASAL SPRAY USP
  • 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 u201cFULL.u201d 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
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  • 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.
  • KEEP OUT OF THE REACH OF CHILDREN.
  • 10001972/09
  • Revised August 2019
  • No data

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