DROPERIDOL 2.5 mg/mL
DROPERIDOL · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
DROPERIDOL is a injection, solution containing droperidol at 2.5 mg/mL, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- DROPERIDOL
- Generic Name
- DROPERIDOL
- NDC Code (Product)
0143-9515- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 2.5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA208197
- Drug Class
- Dopamine-2 Receptor Antagonist [EPC]
- Marketing Start
- 06/01/2022
Recall History
Premier Pharmacy Labs Inc
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
SCA Pharmaceuticals
Presence of particulate.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Droperidol Injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.
Dosage & Administration
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…
Warnings
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 …
Contraindications
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 ).
Drug Interactions
Drug Interactions Potentially Arrhythmogenic Agents: Any drug known to have the potential to prolong the QT interval should not be used together with droperidol. Possible pharmacodynamic interactions can occur between droperidol and potentially arrhythmogenic agents such as class I or III antiarrhythmics, antihistamines that prolong the QT interval, antimalarials, calcium channel blockers, neuroleptics that prolong the QT interval, and antidepressants. Caution should be used when patients are taking concomitant drugs known to induce hypokalemia or hypomagnesemia as they may precipitate QT prolongation and interact with droperidol. These would include diuretics, laxatives and supraphysiological use of steroid hormones with mineralocorticoid potential. CNS Depressant Drugs: Other CNS depressant drugs (e.g. barbiturates, tranquilizers, opioids and general anesthetics) have additive or potentiating effects with droperidol. When patients have received such drugs, the dose of droperidol required will be less than usual. Following the administration of droperidol, the dose of other CNS depressant drugs should be reduced.
Adverse Reactions
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 symp…
Frequently Asked Questions
What is DROPERIDOL used for?
DROPERIDOL contains DROPERIDOL. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is DROPERIDOL a controlled substance?
DROPERIDOL is not classified as a controlled substance by the DEA.
What is the generic name for DROPERIDOL?
The generic name for DROPERIDOL is DROPERIDOL. There are 1 other brand versions of DROPERIDOL.
What is the NDC code for DROPERIDOL 2.5 mg/mL?
The NDC (National Drug Code) for DROPERIDOL 2.5 mg/mL is 0143-9515, listed by Hikma Pharmaceuticals USA Inc..