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sufentanil citrate injection, USP

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sufentanil citrate injection, USP Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: ADDICTION, ABUSE, AND MISUSE

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Sufentanil Citrate Injection exposes users...

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1 INDICATIONS AND USAGE

Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:

  • as an analgesic adjunct in the maintenance of balanced general...
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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Sufentanil Citrate Injection should be administered only by persons specifically...

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3 DOSAGE FORMS AND STRENGTHS

Sufentanil Citrate Injection, USP 50 mcg/mL (equivalent to 50 mcg/mL sufentanil base).

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4 CONTRAINDICATIONS

Sufentanil Citrate Injection is contraindicated in patients with:

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5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance. As an opioid,...

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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

    6.1 Clinical...

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7 DRUG INTERACTIONS

Table 3 includes clinically significant drug interactions with Sufentanil Citrate Injection.

Table 3: Clinically Significant Drug Interactions with Sufentanil Citrate...
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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

Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance.

...
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10 OVERDOSAGE

Clinical Presentation

Acute overdose with Sufentanil Citrate Injection can be manifested by respiratory depression,...

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11 DESCRIPTION

Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sufentanil is an opioid agonist. When used in balanced general anesthesia, sufentanil has been reported to be as...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

Epidural Use in Labor and Delivery

Epidural sufentanil was tested in 340 patients in two (one single-center and one...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Sufentanil Citrate Injection, USP equivalent to 50 mcg/mL sufentanil is supplied in the following single-dose containers:

...
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