Label: DROPERIDOL- droperidol injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/13

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  • BOXED WARNING(What is this?)

    WARNING

    Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses.  Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

    Due to its potential for serious proarrhythmic effects and death, droperidol should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).

    Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes) have been reported in patients treated with droperidol. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, droperidol should NOT be administered. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias.

    Droperidol is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.

    Droperidol should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.

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  • SPL UNCLASSIFIED SECTION

    For IV or IM Use Only

    Rx Only

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  • DESCRIPTION

    Droperidol Injection, USP, is a sterile, non-pyrogenic, aqueous solution for intravenous or intramuscular use only.

    Each mL contains:

    Droperidol…………………………………….2.5 mg

    Water for Injection………………………........q.s.

    pH adjusted between 3.0 and 3.8 with lactic acid and, if necessary, with sodium hydroxide.

    Droperidol is a neuroleptic (tranquilizer) agent. Chemically it is 1-(1-[3-(p-fluorobenzoyl)propyl]-1,2,3,6-tetrahydro-4-pyridyl)-2-benzimidazolinone and the structural formula is:

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  • CLINICAL PHARMACOLOGY

    Droperidol produces marked tranquilization and sedation. It allays apprehension and provides a state of mental detachment and indifference while maintaining a state of reflex alertness.

    Droperidol produces an antiemetic effect as evidenced by the antagonism of apomorphine in dogs. It lowers the incidence of nausea and vomiting during surgical procedures and provides antiemetic protection in the postoperative period.

    Droperidol potentiates other CNS depressants. It produces mild alpha-adrenergic blockade, peripheral vascular dilatation and reduction of the pressor effect of epinephrine. It can produce hypotension and decreased peripheral vascular resistance and may decrease pulmonary arterial pressure (particularly if it is abnormally high). It may reduce the incidence of epinephrine-induced arrhythmias but it does not prevent other cardiac arrhythmias.

    The onset of action of single intramuscular and intravenous doses is from three to ten minutes following administration, although the peak effect may not be apparent for up to thirty minutes. The duration of the tranquilizing and sedative effects generally is two to four hours, although alteration of alertness may persist for as long as twelve hours.

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  • INDICATIONS AND USAGE

    Droperidol Injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

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  • CONTRAINDICATIONS

    Droperidol is contraindicated in patients with known or suspected QT prolongation (i.e., QTc interval greater than 440 msec for males or 450 msec for females). This would include patients with congenital long QT syndrome.

    Droperidol is contraindicated in patients with known hypersensitivity to the drug.

    Droperidol is not recommended for any use other than for the treatment of perioperative nausea and vomiting in patients for whom other treatments are ineffective or inappropriate (see WARNINGS).

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  • WARNINGS

    Droperidol should be administered with extreme caution in the presence of risk factors for development of prolonged QT syndrome, such as: 1) clinically significant bradycardia (less than 50 bpm), 2) any clinically significant cardiac disease, 3) treatment with Class I and Class III antiarrhythmics, 4) treatment with monoamine oxidase inhibitors (MAOI's), 5) concomitant treatment with other drug products known to prolong the QT interval (see PRECAUTIONS, Drug Interactions), and 6) electrolyte imbalance, in particular hypokalemia and hypomagnesemia, or concomitant treatment with drugs (e.g., diuretics) that may cause electrolyte imbalance.

    Effects on Cardiac Conduction:

    A dose-dependent prolongation of the QT interval was observed within 10 minutes of droperidol administration in a study of 40 patients without known cardiac disease who underwent extracranial head and neck surgery. Significant QT prolongation was observed at all three dose levels evaluated, with 0.1, 0.175, and 0.25 mg/kg associated with prolongation of median QTc by 37,44, and 59 msec, respectively.

    Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes, ventricular arrhythmias, cardiac arrest, and death) have been observed during post-marketing treatment with droperidol. Some cases have occurred in patients with no known risk factors and at doses at or below recommended doses. There has been at least one case of nonfatal torsade de pointes confirmed by rechallenge.

    Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, droperidol should NOT be administered. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias.

    FLUIDS AND OTHER COUNTERMEASURES TO MANAGE HYPOTENSION SHOULD BE READILY AVAILABLE.

    As with other CNS depressant drugs, patients who have received droperidol should have appropriate surveillance.

    It is recommended that opioids, when required, initially be used in reduced doses.

    As with other neuroleptic agents, very rare reports of neuroleptic malignant syndrome (altered consciousness, muscle rigidity and autonomic instability) have occurred in patients who have received droperidol.

    Since it may be difficult to distinguish neuroleptic malignant syndrome from malignant hyperpyrexia in the perioperative period, prompt treatment with dantrolene should be considered if increases in temperature, heart rate or carbon dioxide production occur.

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  • ADVERSE REACTIONS

    QT interval prolongation, torsade de pointes, cardiac arrest, and ventricular tachycardia have been reported in patients treated with droperidol. Some of these cases were associated with death. Some cases occurred in patients with no known risk factors, and some were associated with droperidol doses at or below recommended doses.

    Physicians should be alert to palpitations, syncope, or other symptoms suggestive of episodes of irregular cardiac rhythm in patients taking droperidol and promptly evaluate such cases (see WARNINGS, Effects on Cardiac Conduction).

    The most common somatic adverse reactions reported to occur with droperidol are mild to moderate hypotension and tachycardia, but these effects usually subside without treatment. If hypotension occurs and is severe or persists, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy.

    The most common behavioral adverse effects of droperidol include dysphoria, postoperative drowsiness, restlessness, hyperactivity and anxiety, which can either be the result of an inadequate dosage (lack of adequate treatment effect) or of an adverse drug reaction (part of the symptom complex of akathisia).

    Care should be taken to search for extrapyramidal signs and symptoms (dystonia, akathisia, oculogyric crisis) to differentiate these different clinical conditions.  When extrapyramidal symptoms are the cause, they can usually be controlled with anticholinergic agents.

    Postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression) have also been reported.

    Other less common reported adverse reactions include anaphylaxis, dizziness, chills and/or shivering, laryngospasm and bronchospasm.

    Elevated blood pressure, with or without pre-existing hypertension, has been reported following administration of droperidol combined with fentanyl citrate or other parenteral analgesics.  This might be due to unexplained alterations in sympathetic activity following large doses; however, it is also frequently attributed to anesthetic or surgical stimulation during light anesthesia.

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  • OVERDOSAGE

    Manifestations: 

    The manifestations of droperidol overdosage are an extension of its pharmacologic actions and may include QT prolongation and serious arrhythmias (e.g., torsade de pointes) (see BOXED WARNING, WARNINGS, and PRECAUTIONS).

    Treatment:

    In the presence of hypoventilation or apnea, oxygen should be administered and respiration should be assisted or controlled as indicated.  A patent airway must be maintained; an oropharyngeal airway or endotracheal tube might be indicated.  The patient should be carefully observed for 24 hours; body warmth and adequate fluid intake should be maintained.  If hypotension occurs and is severe or persists, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy.  (see PRECAUTIONS).

    If significant extrapyramidal reactions occur in the context of an overdose, an anticholinergic should be administered.

    The intravenous Median Lethal Dose of droperidol is 20-43 mg/kg in mice; 30 mg/kg in rats; 25 mg/kg in dogs and 11-13 mg/kg in rabbits.  The intramuscular Median Lethal Dose of droperidol is 195 mg/kg in mice; 104-110 mg/kg in rats; 97 mg/kg in rabbits and 200 mg/kg in guinea pigs.

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  • DOSAGE AND ADMINISTRATION

    Dosage should be individualized.  Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved.

    Vital signs and ECG should be monitored routinely.

    Adult Dosage: The maximum recommended initial dose of droperidol is 2.5 mg IM  or slow IV. Additional 1.25 mg doses of droperidol may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.

    Children’s Dosage: For children two to 12 years of age, the maximum recommended initial dose is 0.1 mg/kg, taking into account the patient's age and other clinical factors. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.

    See WARNINGS and PRECAUTIONS for use of droperidol with other CNS depressants, and in patients with altered response.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  If such abnormalities are observed, the drug should not be administered.

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  • HOW SUPPLIED

    Droperidol Injection USP, (2.5 mg/mL) is available as:

     Product No.  Strength  Size  How Packaged
     NDC 0517-9702-25  5 mg/2 mL  2 mL Single Dose Vial  Boxes of 25

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

    PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.

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  • REFERENCES

    1. Saarnivaara L, Klemola UM, Lindgren L, et al. QT interval of the ECG, heart rate and arterial pressure using propofol, methohexital or midazolam for induction of anaesthesia. Acta Anaesthesiol Scand 1990: 34: 276-81.
    2. Schmeling WT, Warltier DC, McDonald DJ, et al. Prolongation of the QT interval by enflurane, isoflurane and halothane in humans. Anesth Analg 1991:72:137-44.
    3. Spath G. Torsade des pointe oder die andere Ursache des plotz-lichen Herztodes. Wien: Ueberreuter. 1998.
    4. Riley DC, Schmeling WT, al-Wathiqui MH, et al. Prolongation of the QT interval by volatile anesthetics in chronically instrumented dogs. Anesth Analg 1988: 67:741-9.
    5. McConachie I, Keaveny JP, Healy TE, et al. Effects of anaesthesia on the QT interval. Br J Anaesth 1989:63:558-60.
    6. Lawrence KR, Nasraway SA. Conduction disturbances associated with administration of butyrophenone antipsychotics in the critically ill: a review of the literature. Pharmacother 1997: 17(3):531-7.
    7. Lischke V, Behne M, Doelken P, et al. Droperidol causes a dose-dependent prolongation of the QT interval. Anesth Analg 1994:79:983-6.

    AMERICAN
    REGENT, INC.
    SHIRLEY,  NY 11967

    IN9702
    Rev. 1/09

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  • PACKAGE LABEL.PRINICIPAL DISPLAY PANEL - Container

    NDC 0517-9702-25

    DROPERIDOL
    INJECTION, USP

    5 mg/2 mL
    (2.5 mg/mL)

    2 mL SINGLE DOSE VIAL

    FOR IV OR IM USE

    Rx Only

    AMERICAN REGENT, INC.
    SHIRLEY, NY 11967

    Container
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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton

    DROPERIDOL
    INJECTION, USP

    5 mg/2 mL (2.5 mg/mL)

    NDC 0517-9702-25
    25 X 2 mL
    SINGLE DOSE VIALS

    FOR INTRAVENOUS OR INTRAMUSCULAR USE

    Rx Only

    Each mL contains: Droperidol 2.5 mg, Water for Injection q.s. pH adjusted with Lactic Acid and, if necessary, with Sodium Hydroxide. CONTAINS NO PRESERVATIVES. DISCARD UNUSED PORTION. PROTECT FROM LIGHT. STORE IN CARTON UNTIL TIME OF USE.
    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
    Directions for Use: See Package Insert.

    AMERICAN
    REGENT, INC.
    SHIRLEY, NY 11967

    Rev. 11/05

    Carton
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  • INGREDIENTS AND APPEARANCE
    DROPERIDOL 
    droperidol injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-9702
    Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DROPERIDOL (UNII: O9U0F09D5X) (DROPERIDOL - UNII:O9U0F09D5X) DROPERIDOL 2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0517-9702-25 25 in 1 TRAY
    1 2 mL in 1 VIAL, SINGLE-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA072123 09/30/1990
    Labeler - American Regent, Inc. (622781813)
    Establishment
    Name Address ID/FEI Business Operations
    Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-9702, 0517-9702) , LABEL(0517-9702, 0517-9702) , MANUFACTURE(0517-9702, 0517-9702) , PACK(0517-9702, 0517-9702) , STERILIZE(0517-9702, 0517-9702)
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