"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
For intravenous or intramuscular use only
Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving Inapsine (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, INAPSINE (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 INAPSINE (droperidol) . Based on these reports, all patients should undergo a 12-lead ECG prior to administration of INAPSINE (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, INAPSINE (droperidol) should NOT be administered. For patients in whom the potential benefit of INAPSINE (droperidol) 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 (droperidol) is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.
INAPSINE (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.
INAPSINE contains droperidol, a neuroleptic (tranquilizer) agent. Inapsine (droperidol) Injection is available in ampoules and vials. Each milliliter contains 2.5 mg of droperidol in an aqueous solution adjusted to pH 3.4 ± 0.4 with lactic acid. Droperidol is chemically identified as 1-(1-[3-(p-fluorobenzoyl) propyl]-1,2,3,6-tetrahydro-4-pyridyl)-2-benzimidazolinone with a molecular weight of 379.43. The structural formula of droperidol is:
Molecular formula: C22H22FN3O2, partition coefficient in n-octanol: water: 3.46, pKa: 7.46
INAPSINE (droperidol) is a sterile, non-pyrogenic, aqueous solution for intravenous or intramuscular injection.
What are the possible side effects of droperidol (Inapsine)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have any of these serious side effects:
- feeling like you might pass out;
- dizziness, fainting, fast or pounding heartbeat, fluttering in your chest;
- chest tightness and trouble breathing;
- fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
- confusion, hallucinations;
- tremor (uncontrolled shaking); or
Last reviewed on RxList: 6/5/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Inapsine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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