Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D)
Hikma Pharmaceuticals USA Inc.
BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE 1 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE INJECTION, SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- 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 Přečtěte si celý dokument