MORPHINE SULFATE (NEXTJECT) Contraindications (morphine sulfate injection, USP) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

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 (5.6)]
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.7)]
Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.11)]
Hypersensitivity to morphine (e.g., anaphylaxis) [see Adverse Reactions (6)]

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

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1 INDICATIONS AND USAGE

Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Morphine Sulfate Injection is for intravenous administration.

Morphine Sulfate...

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3 DOSAGE FORMS AND STRENGTHS

Morphine Sulfate Injection, USP is available in the following strengths for intravenous (IV) administration.

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4 CONTRAINDICATIONS

Morphine Sulfate Injection is contraindicated in patients with:

Significant respiratory depression [see Warnings and Precautions (5.2)]
...

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5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Morphine Sulfate Injection contains morphine, a Schedule II controlled substance. As an opioid, Morphine...

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6 ADVERSE REACTIONS

The following serious adverse reactions are described, or described in greater detail, in other sections:

Addiction, Abuse, and Misuse [see Warnings and...

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7 DRUG INTERACTIONS

Table 1 includes clinically significant drug interactions with Morphine Sulfate Injection.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Prolonged use of opioid...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Morphine Sulfate Injection contains morphine, a Schedule II controlled substance.

...

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10 OVERDOSAGE

Clinical Presentation

Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence...

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11 DESCRIPTION

Morphine Sulfate Injection, USP is an opioid agonist, available as 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock). When exposed to air it...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Morphine Sulfate Injection, USP is supplied as a sterile solution in a Single-dose Prefilled NexJect™ Syringe for intravenous administration as follows:

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17 PATIENT COUNSELING INFORMATION

Serotonin Syndrome

Opioids can cause a rare but potentially life-threatening condition resulting from...

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INSTRUCTIONS FOR USE

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if color is darker than pale...

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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LAB-0882-2.0
Revised: 8/...

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Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.