BUTORPHANOL TARTRATE- butorphanol tartrate spray

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D)

Tersedia dari:

Bryant Ranch Prepack

Rute administrasi :

NASAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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): - 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. Butorphanol tartrate nasal spray is contraindicated in: - Patients with significant respiratory depression [see WARNINGS] - Patients with acute or severe bronchial asthma in an unmonitored settin

Ringkasan produk:

Butorphanol tartrate nasal spray, USP is supplied in a child-resistant plastic container 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.On average, one bottle will deliver 14 to 15 doses if no repriming is necessary. Butorphanol Tartrate Nasal Spray USP, 10 mg/mL NDC: 72162-2099-02: 2.5 mL in a BOTTLE. Storage Conditions Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store butorphanol tartrate nasal spray securely and dispose of properly [see PRECAUTIONS/ INFORMATION FOR PATIENTS]. PHARMACIST ASSEMBLY INSTRUCTIONS FOR BUTORPHANOL TARTRATE NASAL SPRAY, USP The pharmacist will assemble butorphanol tartrate nasal spray prior to dispensing to the patient, according to the following instructions: 1. Open the child-resistant plastic container and remove the spray pump and solution bottle. 2. 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. 3. Return the butorphanol tartrate nasal spray bottle to the child-resistant plastic container for dispensing to the patient with patient instruction leaflet and medication guide. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Butorphanol Tartrate Nasal Spray, USP 10 mg/mL
(bue-TOR-fa-nol TAR-trate)
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. Store
butorphanol tartrate nasal spray away from children and in a safe
place to prevent stealing or
abuse. Selling or giving away butorphanol tartrate nasal spray is
against the law.
•
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

Karakteristik produk

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY
BRYANT RANCH PREPACK
----------
PRESCRIBING INFORMATION
RX ONLY
BUTORPHANOL TARTRATE NASAL SPRAY USP, 10 MG/ML CIV
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
BUTORPHANOL TARTRATE NASAL SPRAY
ADDICTION, ABUSE, AND MISUSEBECAUSE 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
[SEEWARNINGS].
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 DOSE 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 BUTORPHANOLTARTRATE NASAL
SPRAY, ESPECIALLY IN CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
BUTORPHANOL TARTRATE[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
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 A