Dilution Inapsine ® - Droperidol

Droperidol (Inapsine ® )

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Usual Diluents

D5W, NS

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

[1 to 3 mg/ 50 ml] [30 min]
[4 to 10 mg/ 100 ml] [As directed]

------Continuous infusion------
[25 mg/ 500 ml] [As directed]

Stability / Miscellaneous

Stability data:

Drug

Stability
Refrigerated

Stability
Room Temp.

Reconstituted
Vial/Powder

Notes

Droperidol - Inapsine

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

Solution

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.

Protect from light. Retain in carton until time of use.

Label: Do not Refrigerate.
Actions: Marked sedation/ antiemetic.

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 Warnings, Adverse Reactions, Contraindications, and Precautions).

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 I.V. opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.

DOSAGE AND ADMINISTRATION
Dosage should be individualized. Some of the factors to be considered in determining dose are age, body weight, physical status, underlying pathological condition, use of other drugs, the 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 I.M. or slow I.V. 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.

Pediatric 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 for use of droperidol with other CNS depressants and in patients with altered response.

Premedication: 2.5 to 10mg IV / IM. Usually 1.25 to 2.5 mg q3-6h prn.

Continuous infusion: 25 mg/500 ml D5W at 1 mg/hr initially for treatment of hyperemesis gravidarum (give 1 to 2.5 mg loading initially). May increase by 0.25 mg at 4hr intervals if patient not responding (usual range: 1 to 1.25 mg/hr). Also add benadryl 50mg q6h until infusion is stopped. When patient is ready to take oral meds switch to reglan 10mg qid + hydroxyzine 50mg.

HOW SUPPLIED
Droperidol Injection, USP 2.5 mg/mL is supplied in 2 mL (5 mg) single-dose ampuls packaged in cartons of ten (List No. 1187).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Source: [package insert]: