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Loxapine (Loxapine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

Loxapine capsules are administered, usually in divided doses, 2 to 4 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 7 to 10 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 mg to 60 mg daily.

HOW SUPPLIED:

Loxapine Capsules, USP are available containing loxapine succinate, USP 13.6 mg, 34 mg or 68 mg equivalent to 10 mg, 25 mg or 50 mg of loxapine base, respectively.

The 10 mg capsules have a hard-shell gelatin capsule with an olive opaque cap and a yellow opaque body axially printed with MYLAN over 7010 in black ink on both the cap and body. The capsule is filled with white to off-white powder. They are available as follows:

NDC 51079-901-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).

The 25 mg capsules have a hard-shell gelatin capsule with an olive opaque cap and a light green opaque body axially printed with MYLAN over 7025 in black ink on both the cap and body. The capsule is filled with white to off-white powder. They are available as follows:

NDC 51079-902-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).

The 50 mg capsules have a hard-shell gelatin capsule with an olive opaque cap and a light blue opaque body axially printed with MYLAN over 7050 in black ink on both the cap and body. The capsule is filled with white to off-white powder. They are available as follows:

NDC 51079-903-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).

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

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-8571 R6
12/12

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