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Norethindrone Acetate
  • Professionals
  • FDA PI

Norethindrone Acetate

Dosage form: tablet
Drug classes:Contraceptives, Progestins

Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.

Norethindrone Acetate 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.

Norethindrone Acetate - 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...