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AYGESTIN (norethindrone acetate tablets USP) 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 (norethindrone acetate tablets USP) is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopaus al women for endometrial protection.
DOSAGE AND ADMINISTRATION
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 bleedingmay benefit from planned menstrual cycling with AYGESTIN.
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) is available as:
5 mg: White, oval, flat-faced, beveled edge, tablet scored on one side. Debossed with 5 AYGESTIN on the unscored side and stylized b / 424 on the scored side. Available in bottles of 50 tablets (NDC 51285-424-10).
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
TEVA WOMEN'S HEALTH, INC. Subsidiary of TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. Revised: Oct 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/19/2016
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