FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
- Cardiovascular Disorders
Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. - Visual Abnormalities
Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
AYGESTIN® (norethindrone acetate tablets, USP) - 5 mg oral tablets.
AYGESTIN® (norethindrone acetate tablets, USP), (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. The structural formula is as follows:
C22H28O3 M.W. 340.46
AYGESTIN® (norethindrone acetate tablets, USP) contain the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose.
Sources
Aygestin Manufacturers
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Teva Women’s Health, Inc.
Aygestin | Teva Women's Health, Inc.
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).
EndometriosisInitial 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.
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