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morphine sulfate injection, USP VIAL
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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.
morphine sulfate injection, USP VIAL Quick Finder
Highlights
Boxed Warning
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; 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
Preservative-free morphine sulfate injection is indicated for:
- the management of pain severe enough to require use of an opioid analgesic by intravenous administration, and for...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Do Not Use Preservative-free morphine sulfate injection in Continuous...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 5 mg/10 mL (0.5 mg/mL) Preservative-free fliptop vials
Injection: 10 mg/10 mL (1 mg/mL) Preservative-free fliptop vials
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Contraindications
4 CONTRAINDICATIONS
Preservative-free morphine sulfate injection is contraindicated in patients with:
- Significant respiratory depression [see Warnings and...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Risks with Neuraxial Administration
Control of pain by neuraxial opioid delivery is always accompanied by considerable risk to the...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Life-Threatening Respiratory Depression [see...
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Drug Interactions
7 DRUG INTERACTIONS
Table 1 includes clinically significant drug interactions with preservative-free 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
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Preservative-free morphine sulfate injection contains morphine, a Schedule II controlled drug substance.
...
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with preservative-free morphine sulfate injection can be manifested by respiratory...
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Description
11 DESCRIPTION
Preservative-free morphine sulfate injection (morphine sulfate injection) is an opioid agonist, available as a sterile, nonpyrogenic isobaric solution of morphine sulfate in strengths of 0.5 mg or 1 mg...
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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
...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Preservative-free morphine sulfate injection (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL), in vials,...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either 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.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.