INDICATIONS AND USES
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.
DOSAGE AND ADMINISTRATION
Therapy with Aygestin 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 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 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.
HOW SUPPLIED
Each white, scored Aygestin® Tablet contains
5 mg norethindrone acetate, USP, in bottles of 50 (NDC 59911-5894-1).
Store at room temperature (approximately 25°
C)
Dispense in a well-closed container as defined
in the USP
Aygestin® (norethindrone acetate tablets, USP)
white, scored 5 mg tablets, in bottles of 50, for oral administration.
ESI Lederle Inc.
Philadelphia, PA 19101
| |
