AYGESTIN®

AYGESTIN® is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. AYGESTIN® is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

AYGESTIN®

Therapy with AYGESTIN® must be adapted to the specific indications and therapeutic response of the individual patient.

Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg AYGESTIN® may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing AYGESTIN® therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with AYGESTIN®.

Endometriosis: Initial daily dosage of 5 mg AYGESTIN® for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of AYGESTIN® is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

AYGESTIN® (norethindrone acetate tablets, USP) are available as:
5 mg: White, oval, flat-faced, beveled edge tablet scored on one side. Debossed with 5 AYGESTIN® on the unscored side and B /424 on the scored side.

Available as follows:

Bottle of 50                                             NDC 51285-424-10
Blister Pack of 10 tablets                       NDC 51285-424-69

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

DURAMED PHARMACEUTICALS, INC., A subsidiary of Barr Laboratories, Inc. Pomona, NY 10970
Revised July 2007
FDA rev date: 7/5/2007

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