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uninjured Aygestin Generic Name: Norethindrone Acetate Class: Progestins ATC Class: G03AC01 VA Class: HS800 CAS Number: 51-98-9 Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons Introduction Synthetic progestin. a b Uses for Aygestin Amenorrhea Treatment of secondary amenorrhea. a b Endometriosis Treatment of endometriosis. a b Uterine Bleeding Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology such as fibroids or uterine cancer. a b Prevention of Endometrial Changes Associated with Estrogens Not intended, recommended, or approved by FDA for the prevention of endometrial hyperplasia in postmenopausal women receiving estrogen replacement therapy. b Slideshow 10 Common Symptoms That Should Never Be Ignored Aygestin Dosage and Administration Administration Oral Administration Administer orally once daily. b Dosage Available as norethindrone acetate; dosage expressed in terms of the salt. b Individualize dosage according to the condition being treated and the therapeutic response of the patient. b Adults Amenorrhea or Uterine Bleeding Oral 2.5 10 mg daily for 5 10 days. a b To establish dosage cycle for the treatment of secondary amenorrhea or abnormal uterine bleeding, the menstrual cycle is usually considered to be 28 days. a The first day of bleeding is counted as the first day of the cycle. a Begin norethindrone during the assumed latter half of the menstrual cycle to induce optimum secretory transformation of the endometrium that has been adequately primed with endogenous or exogenous estrogen. a b Withdrawal bleeding usually occurs within 3 7 days after discontinuing therapy. a b Planned menstrual cycling may benefit patients with a history of recurrent episodes of uterine bleeding. a b Endometriosis Oral Initially, 5 mg daily for 14 consecutive days. a b Increase dosage by 2.5 mg daily at 14-day intervals until a maximum dosage of 15 mg daily is reached. a b Continue to administer daily ( no cyclic drug-free periods) for 6 9 months. a b Temporarily interrupt therapy for annoying breakthrough bleeding. a b Prescribing Limits Adults Endometriosis Oral Maximum: 15 mg daily. a b Cautions for Aygestin Contraindications Known or suspected pregnancy. b Not effective for any purpose during pregnancy. b Undiagnosed vaginal bleeding. a b Known or suspected breast cancer; history of breast cancer. a b Active DVT or pulmonary embolism; history of DVT or pulmonary embolism. b Active or recent (within past year) arterial thromboembolic disease (e.g., stroke, MI). b Liver disease or dysfunction. a b Use as a pregnancy test. a b Known hypersensitivity to norethindrone acetate or any ingredient in the formulation. a b Warnings/Precautions Warnings Cardiovascular Disorders Appropriately manage risk factors for cardiovascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, obesity) and/or venous thromboembolism (e.g., personal or family history of venous thromboembolism, obesity, systemic lupus erythematosus). b (See Contraindications under Cautions.) Ocular Effects If unexplained, sudden or gradual, partial or complete loss of vision; proptosis or diplopia; papilledema; migraine; or retinal vascular lesions occur, discontinue and initiate appropriate diagnostic and therapeutic measures. a b Do not reinitiate therapy if ocular examination reveals evidence of papilledema or retinal vascular lesions. a b Fetal/Neonatal Morbidity and Mortality Potential adverse effects on the fetus when administered within the first 4 months of pregnancy (masculinization of the female fetus, hypospadias in male neonates, low birth weight). a b (See Contraindications under Cautions.) General Precautions Fluid Retention May cause some degree of fluid retention. b Use with caution and careful monitoring in patients with conditions (e.g., asthma, seizure disorders, migraine headache, cardiac or renal impairment) that might be aggravated by fluid retention. a b Bleeding Irregularities Possible breakthrough or irregular vaginal bleeding. a b Perform adequate diagnostic tests in patients with undiagnosed vaginal bleeding. a b Depression Possible depression. a b Exercise caution in women with a history of depression; discontinue if severe depression recurs during use. a b Physical Examination and Follow-up Physical examination prior to initiation of therapy advised. a Physical examination should include special attention to the breasts and pelvic organs and should include a Papanicolaou test (Pap smear) and relevant laboratory tests. a Metabolic Effects Possible adverse effects on carbohydrate and lipid metabolism. b Choice of progestin, dosage, and regimen may minimize metabolic adverse effects; further study needed to clarify this issue. b Monitor patients with hyperlipidemia or diabetes mellitus carefully. b Estrogen Therapy When used in combination with an estrogen, consider the cautions, precautions, and contraindications associated with estrogens. a Specific Populations Pregnancy Category X. b (See Contraindications and also Fetal/Neonatal Morbidity and Mortality, under Cautions.) Lactation Progestins are distributed into milk; a b caution advised. b Pediatric Use Safety and efficacy not established. b Hepatic Impairment Contraindicated in patients with liver disease or dysfunction. a b Common Adverse Effects Menstrual abnormalities (amenorrhea; frequent, irregular, prolonged, or infrequent bleeding), nausea, weight changes, breast changes (tenderness, enlargement, secretion), headache. b Interactions for Aygestin Changes in the pharmacokinetics of norethindrone reported with some HIV protease inhibitors. c Aygestin Pharmacokinetics Absorption Bioavailability Rapidly deacetylated to norethindrone. b Peak plasma concentration of norethindrone achieved in 2 hours. b Distribution Extent Distributed into human milk. a b Plasma Protein Binding 61% to albumin and 36% to sex hormone binding globulin (SHBG). b Elimination Metabolism Metabolized by reduction, followed by glucuronide and sulfate conjugation. b Elimination Route Excreted in urine and feces, mainly as metabolites. b Half-life Single dose: 8.51 hours. b Stability Storage Oral Tablets 20 25 C. a b Actions Some estrogenic, androgenic, and anabolic activity. a Transforms a proliferative endometrium into a secretory one. a b Inhibits the secretion of pituitary gonadotropins at usual dosages, thereby preventing follicular maturation and ovulation. a Advice to Patients Importance of reading the manufacturer s patient information. a b Importance of advising patients of anticipated menstrual effects. b Importance of discontinuing therapy and contacting clinician if sudden partial or complete vision loss, blurred vision, bulging of the eyes, double vision, or migraine occurs. a b Importance of discontinuing therapy and contacting clinician if any symptoms of thromboembolic and thrombotic disorders occur. b Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. b Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. b Importance of informing patients of other important precautionary information. b (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Norethindrone Acetate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 5 mg* Aygestin (scored) Duramed Norethindrone Acetate Tablets (scored) Barr AHFS DI Essentials. Copyright 2017, Selected Revisions April 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References a. AHFS Drug Information 2007. McEvoy GK, ed. Norethindrone, Norethindrone Acetate. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3235-7. b. Duramed Pharmaceuticals, Inc. Aygestin (norethindrone acetate) tablets prescribing information. Pomona, NY; 2007 Jul. c. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (December 1, 2007). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website (). Next Interactions Print this page Add to My Med List More about Aygestin (norethindrone) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En EspaƱol 5 Reviews Add your own review/rating Generic Availability Drug class: contraceptives Consumer resources Aygestin Aygestin (Advanced Reading) Professional resources Aygestin (FDA) Norethindrone Acetate (AHFS Monograph) Other brands: Camila , Jolivette , Ortho Micronor , Nora-Be , ... +9 more Related treatment guides Abnormal Uterine Bleeding Amenorrhea Endometriosis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Teva Pharmaceuticals USA, Inc. Drug Class Contraceptives Progestins Related Drugs Abnormal Uterine Bleeding Premarin , megestrol , Megace , medroxyprogesterone , Provera , Depo-Provera , norethindrone , conjugated estrogens , More... Amenorrhea progesterone , medroxyprogesterone , Provera , Depo-Provera , Prometrium , norethindrone , Camila , Jolivette , More... Endometriosis medroxyprogesterone , leuprolide , Provera , Depo-Provera , Lupron Depot , norethindrone , Sprintec , Zoladex , More... Aygestin Rating 5 User Reviews 6.0 /10 5 User Reviews 6.0 Rate it! Aygestin Images Aygestin 5 mg (5 AYGESTIN ) View larger images} } if you would like


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