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Aygestin (Norethindrone Acetate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

INDICATIONS AND USAGE

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 postmenopausal women for endometrial protection.

DOSAGE AND ADMINISTRATION

Therapy with AYGESTIN (norethindrone acetate tablets, USP) 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 (norethindrone acetate tablets, USP) 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 (norethindrone acetate tablets, USP) therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with AYGESTIN (norethindrone acetate tablets, USP).

Endometriosis

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

HOW SUPPLIED

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 in bottles of 50 tablets.

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

Store at 20º to 25ºC (68º to 77ºF) [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.
Sellersville, PA 18960

Iss. 2/2010

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