inapsine- droperidol injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

droperidol (UNII: O9U0F09D5X) (droperidol - UNII:O9U0F09D5X)

Available from:

Taylor Pharmaceuticals

INN (International Name):

droperidol

Pharmaceutical form:

INJECTION

Composition:

2.5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INAPSINE (droperidol) is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures. INAPSINE 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. INAPSINE (droperidol) is contraindicated in patients with known hypersensitivity to the drug. INAPSINE 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).

Product summary:

INAPSINE® (droperidol) Injection is available as: NDC 11098-010-01, 2.5 mg/mL, 1 mL ampules in packages of 10 NDC 11098-010-02, 2.5 mg/mL, 2 mL ampules in packages of 10 NDC 11098-531-01, 2.5 mg/mL, 1 mL vials in packages of 25 NDC 11098-531-02, 2.5 mg/mL, 2 mL vials in packages of 25 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.

Summary of Product characteristics

INAPSINE- DROPERIDOL INJECTION
TAYLOR PHARMACEUTICALS
----------
INAPSINE (DROPERIDOL) INJECTION
FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY
RX ONLY
WARNING
CASES OF QT PROLONGATION AND/OR TORSADE DE POINTES HAVE BEEN REPORTED
IN PATIENTS
RECEIVING INAPSINE 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,
INAPSINE 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 INAPSINE. Based on these reports, all patients
should undergo a 12-lead
ECG prior to administration of INAPSINE 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, INAPSINE should NOT be administered. For patients in whom
the potential benefit of
INAPSINE treatment is felt to outweigh the risks of potentially
serious arrhythmias, ECG
monitoring should be performed prior to treatment and continued for 2
to 3 hours after completing
treatment to monitor for arrhythmias.
INAPSINE is contraindicated in patients with known or suspected QT
prolongation, including
patients with congenital long QT syndrome.
INAPSINE 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 agent