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MORPHINE SULFATE (NEXTJECT) (morphine sulfate injection, USP)
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MORPHINE SULFATE (NEXTJECT) Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Morphine Sulfate Injection is for intravenous administration.
Morphine Sulfate...
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Dosage Forms and Strengths
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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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Contraindications
4 CONTRAINDICATIONS
Morphine Sulfate Injection is contraindicated in patients with:
- Significant respiratory depression [see Warnings and Precautions (5.2)]
- ...
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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
7 DRUG INTERACTIONS
Table 1 includes clinically significant drug interactions with Morphine Sulfate Injection.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Prolonged use of opioid...
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Drug Abuse and Dependence
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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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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence...
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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis...
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How Supplied/Storage and Handling
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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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Medication Guide
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
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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