Aygestin (norethindrone acetate tablets, USP) - 5 mg oral tablets. Aygestin (norethindrone) , (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. Aygestin (norethindrone) Tablets contain the following inactive ingredients: lactose, magnesium stearate, and microcrystalline cellulose.

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See “WARNINGS” for further information on Retinal vascular thrombosis, Thrombotic and thromboembolism events, and Use in pregnancy. 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 cervical erosion and cervical secretions.
Cholestatic jaundice.
Rash (allergic) with and without pruritus.
Melasma or chloasma.
Mental depression.
Acne.
Breast enlargement/tenderness.
Headache/migraine.
Urticaria.
Abnormalities of liver tests (i.e., AST, ALT, Bilirubin).
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).
Progestins may alter the result of pregnanediol determinations. The following laboratory results may be altered by the concomitant use of estrogens with progestins:
Hepatic function.
Coagulation tests - increase in prothrombin, factors VII, VIII, IX, and X.
Increase in PBI, BEI, and a decrease in T3 uptake.
Reduced response to metyrapone test. The following adverse reactions have been observed in patients receiving estrogen-progestogen combination drugs:

1. Rise in blood pressure in susceptible individuals.
2. Premenstrual-like syndrome.
3. Changes in libido.
4. Changes in appetite.
5. Cystitis-like syndrome.
6. Headache.
7. Nervousness.
8. Dizziness.
9. Fatigue.
10. Backache.
11. Hirsutism.
12. Loss of scalp hair.
13. Erythema multiforme.
14. Erythema nodosum.
15. Hemorrhagic eruption.
16. Itching.

In view of these observations, patients on progestogen therapy should be carefully observed. Read the Aygestin (norethindrone) Side Effects Center for a complete guide to possible side effectsLearn More »

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Therapy with Aygestin® (norethindrone acetate tablets, USP) must be adapted to the specific indications and therapeutic response of the individual patient. This dosage schedule assumes the interval between menses to be 28 days. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg Aygestin (norethindrone) may be given daily for 5 to 10 days during the second half of the theoretical menstrual cycle to produce an optimum 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) therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Aygestin (norethindrone) . Endometriosis: Initial daily dosage of 5 mg Aygestin (norethindrone) for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Aygestin (norethindrone) 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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No information provided. Read the Aygestin Drug Interactions Center for a complete guide to possible interactions Learn More »

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Aygestin (norethindrone) 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.

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Known or suspected pregnancy.
Thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a past history of these conditions.
Markedly impaired liver function or liver disease.
Known or suspected carcinoma of the breast.
Undiagnosed vaginal bleeding.
Missed abortion.
As a diagnostic test for pregnancy.
Hypersensitivity to norethindrone acetate tablets.Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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Aygestin® (norethindrone acetate tablets, USP) are available as: 5 mg: White, oval, flat-faced, beveled edge, biconvex tablet, scored on one side. Debossed with 5 Aygestin (norethindrone) on the unscored side and B /424 on the scored side. Available in bottle of:
50.............NDC 51285-424-10 Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [See USP]. Dispense in a well-closed container. Duramed Pharmaceuticals, Inc. A subsidiary of Barr Laboratories, Inc. Pomona, NY 10970. Revised: July 2003. Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

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General Precautions

1. The pretreatment physical examination should include special reference to breasts and pelvic organs, as well as a Papanicolaou smear.
2. Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, cardiac or renal dysfunctions, require careful observation.
3. In cases of breakthrough bleeding, as in all cases of irregular bleeding per vagina, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated.
4. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
5. Any possible influence of prolonged progestogen therapy on pituitary, ovarian, adrenal, hepatic, or uterine functions awaits further study.
6. Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism. The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified. Women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy.
7. The age of the patient constitutes no absolute limiting factor, although treatment with progestogens may mask the onset of the climacteric.
8. The pathologist should be advised of progestogen therapy when relevant specimens are submitted.

Information for the Patient See PATIENT INFORMATION section. Carcinogenesis, Mutagenesis, and Impairment of Fertility Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established. Pregnancy Category X Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. Hypospadias occurs in about 5 to 8 per 1, 000 male births and is about doubled with exposure to these drugs. Some progestational drugs induce mild virilization of the external genitalia of female fetuses. Nursing Mothers Detectable amounts of progestogens have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

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