BUTORPHANOL TARTRATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

BUTORPHANOL TARTRATE

Composition:

BUTORPHANOL TARTRATE 1 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butorphanol Tartrate Injection is indicated: - as a preoperative or pre-anesthetic medication - as a supplement to balanced anesthesia - for the relief of pain during labor, and - 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 WARNINGS ], reserve Butorphanol Tartrate Injection 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 or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] - Patients with known or suspected gastrointestinal

Product summary:

Butorphanol Tartrate Injection is supplied as follows: 1 mg/mL, 1 mL vial, 10 vials per carton (NDC 0143-9864-10) 2 mg/mL, 1 mL vial, 10 vials per carton (NDC 0143-9867-10) 4 mg/2 mL, 2 mL vial, 10 vials per carton (NDC 0143-9863-10) 20 mg/10 mL, 10 mL vial, 10 vials per carton (NDC 0143-9866-10) Store at 20º-25°C (68º-77°F) [See USP Controlled Room Temperature]. Protect from light. Discard unused portion. Retain in carton until time of use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 Revised: July 2020 PIN199-WES/7

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA 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 AND BENZODIAZEPINES OR
OTHER CNS
DEPRESSANTS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS
ARE INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIR