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Drug Catalog - Product Detail

NORETHINDRONE ACETATE, USP TB 5MG 50

NDC Mfr Size Str Form
68462-0304-50 GLENMARK PHARMACEUTICALS 50 5MG TABLET
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Description
DESCRIPTION Norethindrone acetate tablets USP - 5 mg oral tablets Norethindrone acetate 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. Norethindrone acetate tablets USP, 5 mg contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. Structural Formula for Norethindrone Acetate
How Supplied
HOW SUPPLIED Norethindrone acetate tablets USP are available as: 5 mg : White to off-white oval, flat faced beveled edged, uncoated tablets debossed with ‘G with breakline’ on one side and 304 on other side. Available as follows: Bottles of 50 NDC 68462-304-50 Bottles of 500 NDC 68462-304-05 NDC 69189-0305-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital
Indications & Usage
INDICATIONS AND USAGE Norethindrone acetate 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. Norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
Dosage and Administration
DOSAGE AND ADMINISTRATION Therapy with norethindrone acetate 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 norethindrone acetate 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 norethindrone acetate therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate. Endometriosis: Initial daily dosage of 5 mg norethindrone acetate for two weeks. Dosage should be increased by2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.