"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
(Generic versions may still be available.)
LOXITANE is indicated for the treatment of schizophrenia. The efficacy of LOXITANE in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
DOSAGE AND ADMINISTRATION
LOXITANE 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.
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 schizoprenia. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. However, as with other drugs used to treat schizoprenia, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.
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.
LOXITANE®, loxapine succinate capsules, are available in the following strengths:
Loxapine Succinate USP 6.8 mg equivalent to 5 mg loxapine, hard shell, opaque, dark green capsules printed with “Logo” over “WATSON” on one half and “LOXITANE” over “5 mg” on the other, are supplied as follows:
NDC 52544-494-01 - Bottle of 100s
NDC 52544-494-10 - Bottle of 1000s
Loxapine Succinate USP 13.6 mg equivalent to 10 mg loxapine, hard shell, opaque, with yellow body and a dark green cap, printed with “Logo” over “WATSON” on one half and “LOXITANE” over “10 mg” on the other, are supplied as follows:
NDC 52544-495-01 - Bottle of 100s
NDC 52544-495-10 - Bottle of 1000s
Loxapine Succinate USP 34.0 mg equivalent to 25 mg loxapine, hard shell, opaque, with a light-green body and a dark green cap, printed with “Logo” over “WATSON” on one half and “LOXITANE” over “25 mg” on the other, are supplied as follows:
NDC 52544-496-01 - Bottle of 100s
NDC 52544-496-10 - Bottle of 1000s
Loxapine Succinate USP 68.1 mg equivalent to 50 mg loxapine, hard shell, opaque, with a blue body and a dark green cap, printed with “Logo” over “WATSON” on one half and “LOXITANE” over “50 mg” on the other, are supplied as follows:
NDC 52544-497-01 - Bottle of 100s
NDC 52544-497-10 - Bottle of 1000s
Store at 20°-25°C (68°-77°F). [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.
Manufactured By: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA. Distributed by: Watson Pharma, Inc. Corona, CA 92880 USAThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/8/2012
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