Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)
Actavis Pharma, Inc.
NORETHINDRONE
NORETHINDRONE 0.5 mg
PRESCRIPTION DRUG
New Drug Application
TRI-NORINYL- NORETHINDRONE AND ETHINYL ESTRADIOL ACTAVIS PHARMA, INC. ---------- TRI-NORINYL (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP) REVISED: FEBRUARY 2014 RX ONLY PHYSICIAN LABELING PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. ORAL CONTRACEPTLVE AGENTS DESCRIPTION TRI-NORINYL provides a continuous oral contraceptive regimen of 7 blue tablets, 9 yellow-green tablets, 5 more blue tablets, and then 7 orange tablets. Each blue tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each yellow-green tablet contains norethindrone 1 mg and ethinyl estradiol 0.035 mg, and each orange tablet contains inert ingredients. Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-nor-17α-pregn- 4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol. Their structural formulae follow. The yellow-green TRI-NORINYL tablets contain the following inactive ingredients: D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch. The blue TRI-NORINYL tablets contain the following inactive ingredients: FD&C Blue No. 1, lactose, magnesium stearate, povidone, and starch. ® The inactive orange tablets contain the following inactive ingredients: FD&C Yellow No. 6, lactose, microcrystalline cellulose, and magnesium stearate. CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotrophins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation). INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products such as Norinyl, which contain 50 mcg of estrogen Izlasiet visu dokumentu