These highlights do not include all the information needed to use MIDAZOLAM IN SODIUM CHLORIDE INJECTION safely and  effectively. See full prescribing information for MIDAZOLAM IN SODIUM CHLORIDE INJECTION. MIDAZOLAM IN SODIUM CHLORIDE injection, for intravenous use, CIV Initial U.S. Approval: 1985

Midazolam in Sodium Chloride by

Drug Labeling and Warnings

Midazolam in Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by Hikma Farmaceutica, Hikma Pharmaceuticals USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MIDAZOLAM IN SODIUM CHLORIDE- midazolam in sodium chloride injection 
Hikma Farmaceutica

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use MIDAZOLAM IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for MIDAZOLAM IN SODIUM CHLORIDE INJECTION.
MIDAZOLAM IN SODIUM CHLORIDE injection, for intravenous use, CIV

Initial U.S. Approval: 1985

ADVERSE REACTIONS

The most common adverse reactions (≥15%) were decreased tidal volume, decreased respiratory rate, and apnea. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Revised: 5/2023

FULL PRESCRIBING INFORMATION: CONTENTS*

6 ADVERSE REACTIONS

  • * Sections or subsections omitted from the full prescribing information are not listed.
    		•

    FULL PRESCRIBING INFORMATION

    6 ADVERSE REACTIONS

    The following serious adverse reactions are discussed in greater detail in other sections:

     

    The following adverse reactions have been identified from literature or postmarketing reports of midazolam. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease (23.3% of patients following intravenous administration) and apnea (15.4% of patients following intravenous administration), as well as variations in blood pressure and pulse rate. The majority of serious adverse reactions, particularly those associated with oxygenation and ventilation, have been reported when midazolam is administered with other medications capable of depressing the central nervous system. The incidence of such events is higher in patients undergoing procedures involving the airway without the protective effect of an endotracheal tube, (e.g., upper endoscopy and dental procedures).

    Adults

    Table 2: Additional Adverse Reactions Reported Subsequent to Intravenous Administration as a Single Sedative/anxiolytic/amnestic Agent in Adult Patients:

    hiccoughs (3.9%)                                                 Local effects at the intravenous site

    nausea (2.8%)                                                      tenderness (5.6%)

    vomiting (2.6%)                                                   pain during injection (5%)

    coughing (1.3%)                                                  redness (2.6%)

    "oversedation" (1.6%)                                          induration (1.7%)

    headache (1.5%)                                                  phlebitis (0.4%)

     drowsiness (1.2%)      

    Pediatric Patients

    The following adverse events related to the use of intravenous midazolam in pediatric patients were reported in the medical literature: desaturation 4.6%, apnea 2.8%, hypotension 2.7%, paradoxical reactions 2%, hiccough 1.2%, seizure-like activity 1.1% and nystagmus 1.1%. The majority of airway-related events occurred in patients receiving other CNS depressing medications and in patients where midazolam was not used as a single sedating agent.

    Neonates

    There have been reports of hypotensive episodes and seizures following the administration of midazolam to neonates, [see Warnings and Precautions (5.9)].

    Other Adverse Reactions Occurring at an Incidence of <1% Following Intravenous Injection as a Single Sedative/Anxiolytic/Amnesia Agent

    Respiratory: Laryngospasm, bronchospasm, dyspnea, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea

    Cardiovascular: Bigeminy, premature ventricular contractions, vasovagal episode, bradycardia, tachycardia, nodal rhythm

    Gastrointestinal: Acid taste, excessive salivation, retching

    CNS/Neuromuscular: Retrograde amnesia, euphoria, hallucination, confusion, argumentativeness, nervousness, anxiety, grogginess, restlessness, emergence delirium or agitation, prolonged emergence from anesthesia, dreaming during emergence, sleep disturbance, insomnia, nightmares, athetoid movements, seizure-like activity, ataxia, dizziness, dysphoria, slurred speech, dysphonia, paresthesia

    Special Senses: Blurred vision, diplopia, nystagmus, pinpoint pupils, cyclic movements of eyelids, visual disturbance, difficulty focusing eyes, ears blocked, loss of balance, light-headedness

    Integumentary: Hive-like elevation at injection site, swelling or feeling of burning, warmth or coldness at injection site

    Hypersensitivity: Allergic reactions including anaphylactic reactions, hives, rash, pruritus

    Miscellaneous: Yawning, lethargy, chills, weakness, toothache, faint feeling, hematoma

    PRINCIPAL DISPLAY PANEL 50 mL

    High Alert Medication

    NDC 0143-9379-01 Rx only

    Midazolam in 0.9% Sodium Chloride Injection CIV

    50 mg per 50 mL (1 mg/mL)

    For Intravenous Use ONLY  - Do Not Dilute

    Inner label

    PRINCIPAL DISPLAY PANEL 100 mL

    High Alert Medication

    NDC 0143-9380-01 Rx only

    Midazolam in 0.9% Sodium Chloride Injection CIV

    100 mg per 100 mL (1 mg/mL)

    For Intravenous Use ONLY - Do Not Dilute

    inner 100mL
    MIDAZOLAM IN SODIUM CHLORIDE 
    midazolam in sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62778-348
    Route of AdministrationINTRAVENOUSDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62778-348-4010 in 1 CARTON05/19/2023
    11 in 1 POUCH
    150 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21615905/19/2023
    MIDAZOLAM IN SODIUM CHLORIDE 
    midazolam in sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62778-349
    Route of AdministrationINTRAVENOUSDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC) MIDAZOLAM1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62778-349-4010 in 1 CARTON05/19/2023
    11 in 1 POUCH
    1100 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21615905/19/2023
    Labeler - Hikma Farmaceutica (452742943)
    Registrant - Hikma Pharmaceuticals USA Inc. (001230762)

    Revised: 5/2023
    Document Id: 6801857e-7f43-40a0-ba2e-f68ee23f0ead
    Set id: a947e2ef-2e18-4fd3-9db4-17e871c198be
    Version: 2
    Effective Time: 20230519
     
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