Drug Catalog - Product Detail
LOXAPINE SUCCINATE 5MG CP 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00527-1394-01 | LANNETT | 100 | 5MG | CAPSULE |
PACKAGE FILES
Generic Name
LOXAPINE
Substance Name
LOXAPINE SUCCINATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090695
Description
DESCRIPTION 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, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25 or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue #1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone. loxapine-molec-structure
How Supplied
HOW SUPPLIED Loxapine Capsules, USP are available in the following strengths: Loxapine Succinate, USP 6.8 mg equivalent to 5 mg loxapine, opaque, with a dark green body and cap, imprinted with logo "LANNETT" on the cap and "1394" on the body are supplied as follows: NDC 0527-1394-01 –Bottle of 100s NDC 0527-1394-10 –Bottle of 1000s Loxapine Succinate, USP 13.6 mg equivalent to 10 mg loxapine, yellow opaque body and dark green opaque cap, imprinted with logo "LANNETT" on the cap and "1395" on the body are supplied as follows: NDC 0527-1395-01 –Bottle of 100s NDC 0527-1395-10 –Bottle of 1000s Loxapine Succinate, USP 34.0 mg equivalent to 25 mg loxapine, light green opaque body and dark green opaque cap, imprinted with logo "LANNETT" on the cap and "1396" on the body are supplied as follows: NDC 0527-1396-01 –Bottle of 100s NDC 0527-1396-10 –Bottle of 1000s Loxapine Succinate, USP 68.1 mg equivalent to 50 mg loxapine, light blue opaque body and dark green opaque cap, imprinted with logo "LANNETT" on the cap and "1397" on the body are supplied as follows: NDC 0527-1397-01 –Bottle of 100s NDC 0527-1397-10 –Bottle of 1000s Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Dispense in a tight, child-resistant container. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70541F Rev. 09/24
Indications & Usage
INDICATIONS AND USAGE Loxapine Capsules, USP are 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
DOSAGE AND ADMINISTRATION Loxapine Capsules, USP are 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.