ALFENTANIL (alfentanil injection, USP) | Pfizer Medical Information

alfentanil injection, USP Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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WARNING: ADDICTION, ABUSE, AND MISUSE

Addiction, Abuse, and Misuse

Alfentanil injection exposes patients and...

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1 INDICATIONS AND USAGE

Alfentanil injection is indicated:

as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen.
as an...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Alfentanil injection should be administered only by persons specifically trained in...

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3 DOSAGE FORMS AND STRENGTHS

Alfentanil Injection USP, for intravenous use (equivalent to 500 mcg/mL alfentanil base).

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4 CONTRAINDICATIONS

Alfentanil injection is contraindicated in patients with:

Hypersensitivity to alfentanil (e.g., anaphylaxis) [see Adverse Reactions (6)]...

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5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Alfentanil injection contains alfentanil, a Schedule II controlled substance. As an opioid, alfentanil...

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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 2 includes clinically significant drug interactions with alfentanil 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

Alfentanil injection contains alfentanil, a Schedule II controlled substance.

...

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10 OVERDOSAGE

Clinical Presentation

Acute overdose with alfentanil injection can be manifested by respiratory depression, somnolence...

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11 DESCRIPTION

Alfentanil Injection, USP contains alfentanil, an opioid agonist, chemically designated as N- [1- [2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1- yl) ethyl]-4-(methoxymethyl)-4-piperidinyl]-N-phenylpropanamide...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Alfentanil injection is an opioid agonist. The principal actions of therapeutic value are analgesia and sedation....

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED

Alfentanil Injection, USP for intravenous use contains alfentanil hydrochloride equivalent to 500 mcg/mL of...

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Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1059-3.0

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Report Adverse Event

Pfizer Safety

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:

Pfizer Safety Reporting Site

*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.

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 www.fda.gov/medwatchor by calling
(800)-332-1088.