Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
MEPERIDINE HYDROCHLORIDE (UNII: N8E7F7Q170) (MEPERIDINE - UNII:9E338QE28F)
Hospira, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection 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, even at recommended doses [see Warnings and Precautions (5.1)] , reserve DEMEROL Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated - Have not provided adequate analgesia, or are not expected to provide adequate analgesia DEMEROL Injection should not be used for treatment of chronic pain. Prolonged DEMEROL Injection use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. DEMEROL Injection is contraindicated in patients with: - Significant respiratory depressio
For Parenteral Use Solutions of DEMEROL Injection for parenteral use are clear and colorless and are available as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] DEMEROL is not a trademark of Hospira.
New Drug Application
DEMEROL- MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEMEROL™ INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEMEROL INJECTION. DEMEROL (MEPERIDINE HYDROCHLORIDE INJECTION), FOR SUBCUTANEOUS, INTRAMUSCULAR, AND INTRAVENOUS USE, CII INITIAL U.S. APPROVAL: 1942 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; AND MONOAMINE OXIDASE (MAO) INHIBITORS INTERACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ DEMEROL INJECTION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN ALSO LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.1) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.2) PROLONGED USE OF DEMEROL INJECTION DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. IF PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE. (5.3) CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4 INDUCERS) CAN RESULT IN FATAL OVERDOSE OF MEPERIDINE. (5.4, 7) 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 FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE; LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED; AND FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. Preberite celoten dokument