MORPHINE SULFATE injection

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Morphine Sulfate (UNII: X3P646A2J0) (Morphine - UNII:76I7G6D29C)

Tilgængelig fra:

Meridian Medical Technologies, Inc.

INN (International Name):

Morphine Sulfate

Sammensætning:

Morphine Sulfate 10 mg in 0.7 mL

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Morphine Sulfate 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 Morphine Sulfate 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 Morphine Sulfate Injection is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)] - Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Pr

Produkt oversigt:

Morphine Sulfate Injection,10 mg/0.7 mL, is supplied as single-dose auto-injectors in packages of 10 or 100. The National Stock Code number for Morphine Sulfate Injection is NSN 6505-01-302-5530 and the National Drug Code number is NDC 11704-235-01. For military use, the auto-injectors are supplied through the Directorate of Medical Materiel, Defense Supply Center Philadelphia or other analogous agency. Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. Store at 25°C (77°F); Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature] Avoid freezing. Morphine sulfate single-dose auto-injectors have a significant risk of illicit diversion and should be handled strictly in accordance with current directives in order to assure their availability under emergency conditions.

Autorisation status:

New Drug Application

Produktets egenskaber

MORPHINE SULFATE- MORPHINE SULFATE INJECTION
MERIDIAN MEDICAL TECHNOLOGIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MORPHINE SULFATE
INJECTION.
MORPHINE SULFATE INJECTION, FOR INTRAMUSCULAR USE, CII
INITIAL U.S. APPROVAL: 1941
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE
WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
MORPHINE SULFATE INJECTION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE,
AND MISUSE, WHICH CAN LEAD TO
OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND
MONITOR CLOSELY FOR THESE BEHAVIORS
AND CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION AND FOLLOWING ANY SUBSEQUENT INCREASE IN THE FREQUENCY OF
INJECTIONS. (5.2)
PROLONGED USE OF MORPHINE SULFATE 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 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. (5.4, 7)
RECENT MAJOR CHANGES
Dosage and Administration (2)
10/2019
Warnings and Precautions (5.2)
10/2019
INDICATIONS AND USAGE
Morphine Sulfate Injection is an opioid agonist indicat