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Loxapine (Loxapine) - Description and Clinical Pharmacology



Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f ] [1,4]oxazepine. It is present as the succinate salt.




Each capsule for oral administration, contains loxapine succinate, USP, 6.8 mg, 13.6 mg, 34 mg or 68 mg equivalent to 5 mg, 10 mg, 25 mg, or 50 mg of loxapine base, respectively. Each capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, sodium lauryl sulfate and talc. Each of the empty gelatin capsules contains black iron oxide, FD&C Blue No. 1, gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. In addition, the 10 mg and 25 mg empty gelatin capsules contain D&C Yellow No. 10 and the 25 mg capsules contain FD&C Green No. 3.

The imprinting ink may contain the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze.



Pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such manifestations of tranquilization as calming effects and suppression of aggressive behavior.

In normal human volunteers, signs of sedation were seen within 20 to 30 minutes after administration, were most pronounced within 1½ to 3 hours, and lasted through 12 hours. Similar timing of primary pharmacologic effects was seen in animals.

Absorption, Distribution, Metabolism, and Excretion

Absorption of loxapine following oral or parenteral administration is virtually complete. The drug is removed rapidly from the plasma and distributed in tissues. Animal studies suggest an initial preferential distribution in lungs, brain, spleen, heart, and kidney. Loxapine is metabolized extensively and is excreted mainly in the first 24 hours. Metabolites are excreted in the urine in the form of conjugates and in the feces unconjugated.

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