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morphine sulfate injection, USP ISECURE, CARPUJECT

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morphine sulfate injection, USP ISECURE, CARPUJECT Quick Finder

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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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 ...
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7 DRUG INTERACTIONS

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

Table 1: Clinically Significant Drug Interactions with Morphine Sulfate...
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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, 10 mg/mL, and 15 mg/mL (1 mL fill in 1.5 mL iSecure™ Single-dose Prefilled Syringe with Luer Lock) and 2 mg/mL, 4...

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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 single-dose Carpuject™ cartridges and iSecure™ syringes 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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