Finished product reference

Droperidol

Injection · Parenteral · 2.5 mg/1mL · 1 mL

List code
1339
Pharmacologic class
Dopamine-2 Receptor Antagonist
Boxed warning

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.

What it is and how it works

Mechanism class: Dopamine D2 Antagonists

Indications

INDICATIONS AND USAGE Droperidol Injection, USP is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

Dosage and administration (summary)

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.

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.

Warnings and precautions

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…

Pregnancy

Pregnancy Droperidol administered intravenously has been shown to cause a slight increase in mortality of the newborn rat at 4.4 times the upper human dose. At 44 times the upper human dose, mortality rate was comparable to that for control animals.

Storage and supply

HOW SUPPLIED Droperidol Injection, USP is available as: NDC 0143-9515-25, 2.5 mg/mL, 1 mL vials in packages of 25 NDC 0143-9514-25, 2.5 mg/mL, 2 mL vials in packages of 25 Storage: Store at 20° to 25°C (68° to 77°F) . Protect from light.

Source: Droperidol (Droperidol) — US FDA prescribing information, 2022-06-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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