Moban (Molindone Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

Initial and maintenance doses of MOBAN should be individualized.

Initial Dosage Schedule

The usual starting dosage is 50-75 mg/day.
—Increase to 100 mg/day in 3 or 4 days.
—Based on severity of symptomatology, dosage may be titrated up or down depending on individual patient response.
—An increase to 225 mg/day may be required in patients with severe symptomatology.
    Elderly and debilitated patients should be started on lower dosage.

Maintenance Dosage Schedule

1. Mild-5 mg-15 mg three or four times a day.
2. Moderate-10 mg-25 mg three or four times a day.
3. Severe-225 mg/day may be required.

HOW SUPPLIED

MOBAN (molindone hydrochloride) tablets are supplied in bottles of 100 tablets as follows:

5 mg      Orange, round, biconvex tablet, one face debossed with “Moban 5”, and the
             other face plain.                                                                   NDC 63481-072-70

10 mg    Lavender, round, biconvex tablet, one face debossed with “Moban 10”, and
             the other face plain.                                                              NDC 63481-073-70

25 mg    Green, round, biconvex tablet, one face debossed with “Moban 25”, and the
              other face plain with partial bisect.                                       NDC 63481-074-70

50 mg    Blue, round, biconvex tablet, one face with partial bisect and debossed with
             “Moban 50”, and the other face plain.                                  NDC 63481-076-70

Store at 25°C (77°F); excursions permitted to 15°-30°C (59º-86ºF).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP TIGHTLY CLOSED

^* Benadryl is a registered trademark of Warner-Lambert.
^†Symmetrel is a registered trademark of Endo Pharmaceuticals Inc.
^‡Artane is a registered trademark of Lederle Laboratories.
^§Cogentin is a registered trademark of Merck & Co., Inc.
^¶ Akineton is a registered trademark of Knoll Laboratories.

MOBAN is a registered trademark of Endo Pharmaceuticals Inc.

Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, Pennsylvania 19317

                                              Copyright © Endo Pharmaceuticals Inc. 2008

Printed in U.S.A.                                                                              2004241/June, 2008