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Inapsine (Droperidol) - Description and Clinical Pharmacology

 
 



FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY

Rx only

DESCRIPTION

INAPSINE contains droperidol, a neuroleptic (tranquilizer) agent. INAPSINEĀ® (droperidol) Injection is available in ampules 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 l-(l-[3-(p-fluorobenzoyl) propyl]-l,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 is a sterile, non-pyrogenic, aqueous solution for intravenous or intramuscular injection.

CLINICAL PHARMACOLOGY

INAPSINE (droperidol) produces marked tranquilization and sedation. It allays apprehension and provides a state of mental detachment and indifference while maintaining a state of reflex alertness.

INAPSINE produces an antiemetic effect as evidenced by the antagonism of apomorphine in dogs. It lowers the incidence of nausea and vomiting during surgical procedures and provides antiemetic protection in the postoperative period.

INAPSINE potentiates other CNS depressants. It produces mild alpha-adrenergic blockade, peripheral vascular dilatation and reduction of the pressor effect of epinephrine. It can produce hypotension and decreased peripheral vascular resistance and may decrease pulmonary arterial pressure (particularly if it is abnormally high). It may reduce the incidence of epinephrine-induced arrhythmias, but it does not prevent other cardiac arrhythmias.

The onset of action of single intramuscular and intravenous doses is from three to ten minutes following administration, although the peak effect may not be apparent for up to thirty minutes. The duration of the tranquilizing and sedative effects generally is two to four hours, although alteration of alertness may persist for as long as twelve hours.

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