HIGHLIGHTS OF PRESCRIBING INFORMATION
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alfentanil injection, USP
alfentanil injection, USP Quick Finder
WARNING: ADDICTION, ABUSE, AND MISUSE
Addiction, Abuse, and Misuse
Alfentanil injection exposes patients and...
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...
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Alfentanil injection should be administered only by persons specifically trained in...
3 DOSAGE FORMS AND STRENGTHS
Alfentanil Injection USP, for intravenous use (equivalent to 500 mcg/mL alfentanil base).
Alfentanil injection is contraindicated in patients with:
- Hypersensitivity to alfentanil (e.g., anaphylaxis) [see Adverse Reactions (6)]...
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse, and Misuse
Alfentanil injection contains alfentanil, a Schedule II controlled substance. As an opioid, alfentanil...
7 DRUG INTERACTIONS
Table 2 includes clinically significant drug interactions with alfentanil injection.
8 USE IN SPECIFIC POPULATIONS
Prolonged use of opioid...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Alfentanil injection contains alfentanil, a Schedule II controlled substance.
Acute overdose with alfentanil injection can be manifested by respiratory depression, somnolence...
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...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Alfentanil injection is an opioid agonist. The principal actions of therapeutic value are analgesia and sedation....
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
Alfentanil Injection, USP for intravenous use contains alfentanil hydrochloride equivalent to 500 mcg/mL of...
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