Morphine (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Black Box Warning
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WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL
See full prescribing information for complete Boxed Warning.
Morphine sulfate extended-release exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1)
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow morphine sulfate extended-release capsules whole to avoid exposure to a potentially fatal dose of morphine. (5.2) Accidental ingestion of morphine sulfate extended-release capsules, especially in children, can resultin fatal overdose of morphine. (5.2) Prolonged use of morphine sulfate extended-release during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. (5.3) Instruct patients not to consume alcohol or any products containing alcohol while taking morphine sulfate extended-release because co-ingestion can result in fatal plasma morphine levels. (5. |
Overview
Morphine (injection) is an analgesic opioid that is FDA approved for the {{{indicationType}}} of Oramorph(R) SR 15, 30, 60, and 100 mg have been discontinued from the market [6].View additional information.
Pain, chronic, IntractableView additional information.
Pain, chronic (Severe), in patients requiring a long-term daily around-the-clock opioid analgesicView additional information.
Pain (Moderate to Severe), Not responsive to non-narcotic analgesicsView additional information.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Dermatologic: Pruritus (up to 80% )
Gastrointestinal: Constipation (9% or greater ), Nausea (oral, 7% and greater than 10% ; epidural or intrathecal, 15% to 70% ), Vomiting (greater than 10% )
Neurologic: Dizziness (6% ), Headache (less than 2% to greater than 10% ), Lightheadedness, Somnolence ( 3% or greater )
Ophthalmic: Miosis
Renal: Urinary retention (oral, less than 5% ; epidural/intrathecal, 15% to 70% ).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Morphine (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Morphine in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Morphine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Morphine (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Morphine in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Morphine in pediatric patients.
Contraindications
There is limited information regarding Morphine (injection) Contraindications in the drug label.
Warnings
|
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL
See full prescribing information for complete Boxed Warning.
Morphine sulfate extended-release exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1)
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow morphine sulfate extended-release capsules whole to avoid exposure to a potentially fatal dose of morphine. (5.2) Accidental ingestion of morphine sulfate extended-release capsules, especially in children, can resultin fatal overdose of morphine. (5.2) Prolonged use of morphine sulfate extended-release during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. (5.3) Instruct patients not to consume alcohol or any products containing alcohol while taking morphine sulfate extended-release because co-ingestion can result in fatal plasma morphine levels. (5. |
There is limited information regarding Morphine (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Morphine (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Morphine (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Morphine (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Morphine (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Morphine (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Morphine (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Morphine (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Morphine (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Morphine (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Morphine (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Morphine (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Morphine (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Morphine (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Morphine (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Morphine (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Morphine (injection) Administration in the drug label.
Monitoring
There is limited information regarding Morphine (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Morphine (injection) and IV administrations.
Overdosage
There is limited information regarding Morphine (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Morphine (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Morphine (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Morphine (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Morphine (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Morphine (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Morphine (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Morphine (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Morphine (injection) How Supplied in the drug label.
Storage
There is limited information regarding Morphine (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Morphine (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Morphine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Morphine (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Morphine (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.