Norethindrone: profile and news

FDA Approves New Oral Contraceptive Loestrin 24 Fe (norethindrone ... Feb 20, 2006
Chilcott announced that the US Food and Drug Administration (FDA) has approved its 24-day oral contraceptive, Loestrin(R) 24 Fe (norethindrone acetate and ... - DG News

FDA OKs Warner Chilcott's contraceptive Feb 20, 2006
The specialty pharmaceutical company said the Food and Drug Administration has OK'd its 24-day oral contraceptive Loestrin 24 Fe (norethindrone acetate and ... - United Press International

FDA Approves EMEND(R) (aprepitant), in Combination with Other ... Jan 11, 2006
...given once daily for 14 days as a 100-mg capsule with an oral contraceptive containing 35 mcg of ethinyl estradiol and 1 mg of norethindrone, decreased the AUC ... - Business Wire (press release),

Menopause Society Postmenopausal Hormone Therapy and Breast Cancer ... Nov 17, 2005
Oral hormone therapy with 17?-estradiol and 17?-estradiol in combination with norethindrone acetate in the prevention of bone loss in early postmenopausal women ... - PharmaLive.com (press release),

Barr Confirms FTC Lawsuit Related to Generic Ovcon-35(R) License Nov 7, 2005
Ovcon-35(R) is a regimen of oral contraceptives that contains 0.4 mg of norethindrone and 0.035 mg of ethinyl estradiol and is indicated for the prevention of ... - PR Newswire (press release),

Chewable birth control pill approved Sep 13, 2005
...market. Ovcon 35 contains a progestin (norethindrone) and an estrogen (ethinyl estradiol) found in products that are already marketed. ... - SheKnows.com,

FDA Safety Labeling Changes: Activella, Duramorph PF, Nutropin Sep 7, 2005
2005 — The US Food and Drug Administration (FDA) approved in June revisions to safety labeling to advise that use of estradiol/norethindrone acetate tablets ... - Medscape (subscription)

International Approvals: Adderall XR, Gynazole-1, Leuplin SR Aug 29, 2005
...by the US Food and Drug Administration (leuprolide acetate [Lupron], made by Tap Pharmaceutical Products, Inc.) for use alone and with norethindrone acetate 5 ... - Medscape (subscription)

Scientist George Rosenkranz 06 Aug 2005
...other pains. A few months later, its research team created the synthetic, or man-made, hormone norethindrone. Originally envisioned ... - Investor's Business Daily (subscription)

Chewable birth control pill approved Aug 4, 2005
...market. Ovcon 35 contains a progestin (norethindrone) and an estrogen (ethinyl estradiol) found in products that are already marketed. ... - SheKnows.com <**results**>

Antares Pharma Unveils Proprietary Anti-Anxiety Transdermal Gel Jun 30, 2005
...development, including estradiol ATD(TM) gel for hormone therapy; testosterone ATD(TM) gel to treat female sexual dysfunction; estradiol/norethindrone ATD(TM ... - Yahoo News (press release)

Hormone therapy market rallies Jun 16, 2005
Noven’s advanced menopausal hormone therapy is a combination patch containing estradiol and a progestogen, norethindrone acetate. ... - Med Ad News (subscription),

Effects of Low-Dose Hormone Therapy on Menopausal Symptoms, Bone ... Jun 9, 2005
Kurman RJ, Felix JC, Archer DF, Nanayati N, Arce J, Moyer DL. Norethindrone acetate and estradiol-induced endometrial hyperplasia. Obstet Gynecol 2000;96:373-9. ... - RedNova.com,

News For Your Web Site Apr 19, 2005
...given once daily for 14 days as a 100-mg capsule with an oral contraceptive containing 35 mcg of ethinyl estradiol and 1 mg of norethindrone, decreased the AUC ... - dBusinessNews Newark

Study Suggests Zonegran(R) (zonisamide) Capsules Are Not Likely to ... Apr 12, 2005
...suggest Zonegran does not significantly reduce the effectiveness of oral contraceptives (OCs) that contain ethinyl estradiol (EE) and norethindrone (NOR), two ... - Yahoo News

FDA Safety Labeling Changes: CombiPatch, Antidepressants Mar 23, 2005
...approved in January revisions to safety labeling to advise healthcare professionals of the following changes: estradiol plus norethindrone acetate transdermal ... - Medscape (subscription)

Other information

Indication
For use as an oral contraceptive in the prevention of pregnancy.

Pharmacology
Norethindrone is a synthetic oral progestin. It is used for contraception or to treat such conditions as secondary amenorrhea, abnormal uterine bleeding, and endometriosis. As an oral contraceptive, norethindrone is available as either a single agent or in combination with an estrogen.

Mechanism Of Action
Progestins diffuse freely into target cells and bind to the progesterone receptor. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH surge.

Drug Category
Contraceptives, Oral, Synthetic; Progestins; ATC:G03CA

Brand Names/Synonyms
Anhydrohydroxynorprogesterone; Anovulatorio; Anovule; Aygestin; Binovum; Brevicon; Brevinor; Brevinor 21; Brevinor 28; Brevinor-1 21; Brevinor-1 28; CCRIS 484; Camila; Ciclovulan; Conceplan; Conludaf; Conludag; Demulen; ENT; Errin; Estrinor; Ethinylnortestosterone; Ethynylmortestosterone; Ethynylnortestosterone; Gencept; Genora; Gestest; HSDB 3370; Jenest; Jenest-28; Levlen; Loestrin; Menzol; Microneth; Micronett; Micronor; Micronovum; Milli; Mini-Pe; Mini-Pill; Minovlar; Modicon; N.E.E.; NET; NSC-9564; Necon; Nelova; Neocon; Nodiol; Nor-Q.D.; Nor-Qd; Noraethisteronum; Noralutin; Norcept; Norcept-E; Norcolut; Nordette; Noresthisterone; Norethadrone; Norethin; Norethin 1/35 E; Norethin 1/50 M; Norethindrone; Norethindrone Acetate; Norethindrone Norethisterone; Norethisteron; Norethisterone; Norethisterone [Progestins]; Norethisteronum [Inn-Latin]; Norethyndron; Norethynodron; Norethynodrone; Noretisterona [Inn-Spanish]; Noretisterone [Dcit]; Norfor; Norgestin; Noriday; Noriday 28; Norimin; Norinyl; Norlestrin; Norlutate; Norluten; Norlutin; Norluton; Normapause; Norpregneninlone; Norpregneninolone; Norpregneninotone; Orlest; Ortho 1 35; Ortho 7 7 7; Ortho-Novum; Ortho-Novum 1 35; Ortho-Novum 1 50; Ortho-Novum 7 7 7; Ovcon; Ovral; Ovrette; Ovysmen; Ovysmen 0.5 35; Ovysmen 1 35; Palonyl; Perovex; Primolut N; Primolut-N; Proluteasi; SC 4640; Synphase; Synphasic 28; Tri-Levlen; Tri-Norinyl; Triella; Trinovum; Trinovum 21; Utovlan; Utovlar

Dosage Forms
TABLET

Absorption
Absolute oral bioavailability approximately 64%

Interactions
Interactions for Norethindrone:

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.

Chemical IUPAC Name
17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydrocyclopenta[a]phenanthren-3-one

Chemical Formula
C20H26O2

Half Life
7 hours

Drug Type
Approved Drug

# Accession No
APRD00679

CAS Registry Number
68-22-4