מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)
Ingenus Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
Norethindrone acetate tablets are 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 tablets are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - 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
Norethindrone acetate tablets, USP are available as: 5 mg: White to off-white, oval, flat beveled edged tablet. 'P658' is engraved on one side, and a breakline on the reverse. Available as follows: Bottle of 50 NDC 50742-267-50 Bottle of 500 NDC 50742-267-05 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Rx Only Revised: 05/2019 I0093 Rev B Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Made in China ingenus
Abbreviated New Drug Application
NORETHINDRONE ACETATE- NORETHINDRONE ACETATE TABLET INGENUS PHARMACEUTICALS, LLC ---------- NORETHINDRONE ACETATE TABLETS, USP RX ONLY 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 to yellowish-white, crystalline powder. Norethindrone acetate tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Meets USP dissolution Test 2. CLINICAL PHARMACOLOGY Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone. PHARMACOKINETICS _Absorption:_ Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate is rapidly absorbed from norethindrone acetate tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of norethindrone following single oral administration of norethindrone acetate tablets in 29 healthy female volunteers are summarized in Table 1. TABLE 1 Pharmacokinetic Parameters after a Single Dose of norethindrone acetate tablets in Healthy Women Norethindrone acetate tablets (n=29) Arithmetic Mean ± SD Norethindrone (NET) AUC(0-inf)(ng/mL*h) 166.90±56.28 C (ng/mL) 26.19±6.19 t (h) 1.83±0.58 t (h) 8.51±2.19 AUC= area under the curve C = maximum plasma concentration t = time at maximum plasma concentration t = half-life SD = standard deviation Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions max max 1/2 max max 1/2 _Effect of Food:_ The effect of food administration on the pharmacokinetics of norethindrone קרא את המסמך השלם