LOXITANE 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 in capsules as the succinate salt, and in the concentrate and parenteral primarily as the hydrochloride salt.

CAPSULES Each capsule contains loxapine succinate equivalent to 5, 10, 25, or 50 mg of loxapine base and the following inactive ingredients: Blue 1, Gelatin, Lactose, Magnesium Stearate, Titanium Dioxide, and Yellow 10. Additionally, the 5 mg capsule contains Red 33, the 10 mg capsule contains Red 28 and Red 33, and the 25 mg capsule contains FD&C Yellow No. 6.

ORAL CONCENTRATE Each mL contains loxapine hydrochloride equivalent to 25 mg of loxapine base and propylene glycol as an inactive ingredient.

Hydrochloric acid and, if necessary, sodium hydroxide are used to adjust pH to approximately 5.8 during manufacture.

INTRAMUSCULAR (Sterile) - Not for Intravenous Use - Each mL contains loxapine hydrochloride equivalent to 50 mg of loxapine base. Inactive Ingredients: Polysorbate 80 NF 5% w/v, Propylene Glycol 70% v/v, and Water for Injection qs ad 100% v.

Hydrochloric acid and, if necessary, sodium hydroxide are used to adjust pH to approximately 5.5 during manufacture.

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