Aygestin (norethindrone) 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.

Therapy with Aygestin® (norethindrone acetate tablets, USP) must be adapted to the specific indications and therapeutic response of the individual patient. This dosage schedule assumes the interval between menses to be 28 days.

Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg Aygestin (norethindrone) may be given daily for 5 to 10 days during the second half of the theoretical menstrual cycle to produce an optimum 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 (norethindrone) therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Aygestin (norethindrone) .

Endometriosis: Initial daily dosage of 5 mg Aygestin (norethindrone) for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Aygestin (norethindrone) 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, biconvex tablet, scored on one side.

Debossed with 5 Aygestin (norethindrone) on the unscored side and B /424 on the scored side. Available in bottle of:
50.............NDC 51285-424-10

Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [See USP].

Dispense in a well-closed container.

Duramed Pharmaceuticals, Inc. A subsidiary of Barr Laboratories, Inc. Pomona, NY 10970. Revised: July 2003.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.