DEMEROL- meperidine hydrochloride injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

MEPERIDINE HYDROCHLORIDE (UNII: N8E7F7Q170) (MEPERIDINE - UNII:9E338QE28F)

Disponible desde:

Hospira, Inc.

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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.

Estado de Autorización:

New Drug Application

Ficha técnica

DEMEROL- MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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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.