Loxapine (Loxapine) - Indications and Dosage

INDICATIONS AND USAGE

Loxapine is indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.

DOSAGE AND ADMINISTRATION

Loxapine is administered, usually in divided doses, two to four times a day. Daily dosage (in terms of base equivalents) should be adjusted to the individual patient's needs as assessed by the severity of symptoms and previous history of response to antipsychotic drugs.

Oral Administration

Initial dosage of 10 mg twice daily is recommended, although in severely disturbed patients initial dosage up to a total of 50 mg daily may be desirable. Dosage should then be increased fairly rapidly over the first seven to ten days until there is effective control of symptoms of schizophrenia. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. However, as with other drugs used to treat schizophrenia, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.

Maintenance Therapy

For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosages in the range of 20 to 60 mg daily.

HOW SUPPLIED

Loxapine Capsules, USP 5 mg, are Filled Gelatin Capsules Size 2, Cap: Dark Green Opaque/ Body: Dark Green Opaque with Imprint "A-191" on cap and body. Available in bottles of 100’s and 1000’s.

Loxapine Capsules, USP 10 mg, are Filled Gelatin Capsules Size 2, Cap: Yellow Opaque/ Body: Dark Green Opaque with Imprint "A-192" on cap and body. Available in bottles of 100’s and 1000’s.

Loxapine Capsules, USP 25 mg, are Filled Gelatin Capsules Size 2, Cap: Light Green Opaque/ Body: Dark Green Opaque with Imprint "A-193" on cap and body. Available in bottles of 100’s and 1000’s.

Loxapine Capsules, USP 50 mg, are Filled Gelatin Capsules Size 2, Cap: Light Blue Opaque/ Body: Dark Green Opaque with Imprint "A-194" on cap and body. Available in bottles of 100’s and 1000’s.

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

Manufactured by:
Actavis Totowa LLC
990 Riverview Drive
Totowa, NJ 07512 USA

8175-05
10/08