BUTORPHANOL TARTRATE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Hospira, Inc.

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Butorphanol Tartrate Injection is indicated Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS ), reserve butorphanol tartrate 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 Injection is contraindicated in: - Patients with significant respiratory depression (see WARNINGS) - Patients with acute of 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 or any of the formulation excipients (e.g., anaphylaxis) (see WARNINGS) Butorphanol Tartrate Injection contains butorphanol, a Schedule IV controlled substance. Butorphanol Tartrate

Tuoteyhteenveto:

Butorphanol Tartrate Injection, USP is supplied as follows: Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature). Protect from light.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE INJECTION, SOLUTION
HOSPIRA, INC.
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BUTORPHANOL TARTRATE INJECTION, USP CIV
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME;
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
BUTORPHANOL TARTRATE INJECTION 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 INJECTION, AND MONITOR
ALL PATIENTS REGULARLY
FOR THE DEVELOPMENT OF THESE BEHAVIORS OR CONDITIONS (SEE WARNINGS).
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF BUTORPHANOL
TARTRATE INJECTION. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY
DURING INITIATION OF
BUTORPHANOL TARTRATE INJECTION OR FOLLOWING A DOSE INCREASE (SEE
WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF BUTORPHANOL TARTRATE INJECTION 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 (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 (SEE WARNINGS, PRECAUTIONS; DRUG INTERACTIONS).
RESERVE CONCOMITANT PRESCRIBING OF BUTORPHANOL TARTRATE AND
BENZODIAZEPINES OR OTHER
CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT
OPTIONS ARE
INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED.
FOLLOW