Label: ULTIVA- remifentanil hydrochloride injection, powder, lyophilized, for solution

  • NDC Code(s): 72078-034-00, 72078-034-01, 72078-035-00, 72078-035-02, view more
  • Packager: Mylan Institutional LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 20, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ULTIVA safely and effectively. See full prescribing information for ULTIVA.   ULTIVA® (remifentanil hydrochloride), for injection ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ULTIVA

    Addiction, Abuse, and Misuse

    Because the use of ULTIVA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

    Life-Threatening Respiratory Depression

    Serious, life-threatening, or fatal respiratory depression may occur with use of ULTIVA, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ULTIVA are essential [see Warnings and Precautions (5.2)].

    Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

    Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of ULTIVA and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].

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  • 1 INDICATIONS AND USAGE
    ULTIVA is indicated for intravenous (IV) administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. • For ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosage and Administration Instructions - Monitor patients closely for respiratory depression when initiating therapy and following dosage increases with ULTIVA and adjust the ...
  • 3 DOSAGE FORMS AND STRENGTHS
    For injection: 1 mg, 2 mg, and 5 mg:   3 mL Vial - 1 mg lyophilized powder -   5 mL Vial - 2 mg lyophilized powder - 10 mL Vial - 5 mg lyophilized powder
  • 4 CONTRAINDICATIONS
    ULTIVA is contraindicated: • For epidural or intrathecal administration due to the presence of glycine in the formulation [see Nonclinical Toxicology (13)]. • In patients with hypersensitivity to ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Addiction, Abuse, and Misuse - ULTIVA contains remifentanil, a Schedule II controlled substance. As an opioid, ULTIVA exposes users to the risks of addiction, abuse, and misuse [see Drug ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Life-Threatening ...
  • 7 DRUG INTERACTIONS
    Table 18 includes clinically significant drug interactions with ULTIVA. Table 18: Clinically Significant Drug Interactions with ULTIVA - Benzodiazepines and other Central Nervous System ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with remifentanil ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - ULTIVA contains remifentanil, a Schedule II controlled substance. 9.2 Abuse - ULTIVA contains remifentanil, a substance with high potential for misuse and abuse ...
  • 10 OVERDOSAGE
    Clinical Presentation - Acute overdose with remifentanil can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin ...
  • 11 DESCRIPTION
    ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - ULTIVA is a µ-opioid agonist with rapid onset and peak effect, and short duration of action. The µ-opioid activity of ULTIVA is antagonized by opioid antagonists such ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term studies in animals to evaluate the carcinogenic potential of remifentanil have not been ...
  • 14 CLINICAL STUDIES
    ULTIVA was evaluated in 3,341 patients undergoing general anesthesia (n = 2,706) and monitored anesthesia care (n = 639). These patients were evaluated in the following settings: inpatient (n ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows: NDC NumberContainerConcentrationQuantity - 72078-034-01 -   3 mL Single-Dose Vial - 1 mg ...
  • 17 PATIENT COUNSELING INFORMATION
    Addiction, Abuse, and Misuse - Inform patients that the use of ULTIVA, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see ...
  • PRINCIPAL DISPLAY PANEL – 1 mg
    NDC 72078-034-01 - Ultiva® CII - (remifentanil HCl) for Injection - 1 mg - Equivalent to - 1 mg of remifentanil - For Intravenous Use Only - Rx only - 10 x 1 mg Single-Dose Vials - Sterile. Usual ...
  • PRINCIPAL DISPLAY PANEL – 2 mg
    NDC 72078-035-02 - Ultiva® CII - (remifentanil HCl) for Injection - 2 mg - Equivalent to - 2 mg of remifentanil - For Intravenous Use Only - Rx only - 10 x 2 mg Single-Dose Vials - Sterile. Usual ...
  • PRINCIPAL DISPLAY PANEL – 5 mg
    NDC 72078-036-05 - Ultiva® CII - (remifentanil HCl) for Injection - 5 mg - Equivalent to - 5 mg of remifentanil - For Intravenous Use Only - Rx only - 10 x 5 mg Single-Dose Vials - Sterile. Usual ...
  • INGREDIENTS AND APPEARANCE
    Product Information