Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Gallifrey (Norethindrone acetate tablets, USP) is available as: 5 mg: White to off white, oval, flat-faced, beveled edge tablet debossed with 257 on one side of the tablet and a score (functional scoring) on the other side. Available as follows: Bottle of 50 tablets NDC 70700-326-50 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Patient Information Leaflet with each prescription.; PRINCIPAL DISPLAY PANEL – 5 mg NDC 70700-326-50 Gallifrey (Norethindrone Acetate Tablets, USP, 5 mg) Rx only 50 Tablets 5 mg Bottle Label
- HOW SUPPLIED Gallifrey (Norethindrone acetate tablets, USP) is available as: 5 mg: White to off white, oval, flat-faced, beveled edge tablet debossed with 257 on one side of the tablet and a score (functional scoring) on the other side. Available as follows: Bottle of 50 tablets NDC 70700-326-50 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
- PRINCIPAL DISPLAY PANEL – 5 mg NDC 70700-326-50 Gallifrey (Norethindrone Acetate Tablets, USP, 5 mg) Rx only 50 Tablets 5 mg Bottle Label
Overview
Gallifrey (Norethindrone acetate tablets, USP), 5 mg oral tablets. Gallifrey, (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. Gallifrey tablets contain the following inactive ingredients: lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The USP Dissolution Test is pending. Norethindrone Acetate Structural Formula
Indications & Usage
Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Gallifrey 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. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
Dosage & Administration
Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Therapy with Gallifrey tablets 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 mg to 10 mg Gallifrey 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 Gallifrey therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Gallifrey. Endometriosis: Initial daily dosage of 5 mg Gallifrey for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Gallifrey is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.
Warnings & Precautions
WARNINGS 1. 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. 2. 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.
Contraindications
Known or suspected pregnancy. There is no indication for norethindrone acetate tablets in pregnancy. (See PRECAUTIONS .) Undiagnosed vaginal bleeding Known, suspected or history of cancer of the breast Active deep vein thrombosis, pulmonary embolism or history of these conditions Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) Impaired liver function or liver disease As a diagnostic test for pregnancy Hypersensitivity to any of the drug components
Adverse Reactions
See WARNINGS and PRECAUTIONS . The following adverse reactions have been observed in women taking progestins: Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Edema Changes in weight (decreases, increases) Changes in the cervical squamo-columnar junction and cervical secretions Cholestatic jaundice Rash (allergic) with and without pruritus Melasma or chloasma Clinical depression Acne Breast enlargement/tenderness Headache/migraine Urticaria Abnormalities of liver tests (i.e., AST, ALT, Bilirubin) Decreased HDL cholesterol and increased LDL/HDL ratio Mood swings Nausea Insomnia Anaphylactic/anaphylactoid reactions Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism) Optic neuritis (which may lead to partial or complete loss of vision)
Drug Interactions
No pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate tablets have been conducted.
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