BUTORPHANOL TARTRATE spray

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mylan Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

BUTORPHANOL TARTRATE

Σύνθεση:

BUTORPHANOL TARTRATE 10 mg in 1 mL

Οδός χορήγησης:

NASAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), 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: Butorphanol tartrate nasal spray contains butorphanol, a Schedule IV controlled substance. Butorphanol tartrate nasal spray contains butorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Butorphanol tartrate nasal spray can be abused and is subject to misuse, addiction, and criminal diversion (see WARNINGS). All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of

Περίληψη προϊόντος:

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 (NDC 0378-9639-43; individual unit). A Medication Guide and Patient Instructions are enclosed. On average, one bottle will deliver 14 to 15 doses if no repriming is necessary. Store at 15° to 30°C (59° to 86°F). [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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide and Patient Instructions with each prescription. Store butorphanol tartrate nasal spray securely and dispose of properly (see PRECAUTIONS: Information for Patients/Caregivers). PHARMACIST ASSEMBLY INSTRUCTIONS FOR BUTORPHANOL TARTRATE NASAL SPRAY: The pharmacist will assemble butorphanol tartrate nasal spray prior to dispensing to the patient, according to the following instructions:

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Butorphanol Tartrate Nasal Spray, USP
(bue tor' fa nol tar' trate) CIV
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 i

Αρχείο Π.Χ.Π.

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE SPRAY
MYLAN PHARMACEUTICALS INC.
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WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
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 PATIENT’S
RISK PRIOR TO PRESCRIBING BUTORPHANOL TARTRATE NASAL SPRAY, AND
MONITOR ALL PATIENTS REGULARLY
FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS (SEE WARNINGS).
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 (SEE WARNINGS). 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
•
•
•
•
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 (SEE
WARNINGS).
ACCIDENTAL EXPOSURE
ACCIDENTAL EXPOSURE OF BUTORPHANOL, ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF
BUTORPHANOL (SEE WARNINGS).
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