Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)
Watson Pharma, Inc.
NORETHINDRONE
NORETHINDRONE 1 mg
PRESCRIPTION DRUG
New Drug Application
NECON- NORETHINDRONE AND MESTRANOL WATSON PHARMA, INC. ---------- NECON 1/50 (NORETHINDRONE AND MESTRANOL TABLETS USP, 1 MG/0.05 MG) REVISED: JUNE 2007 IN-5377/S RX ONLY PHYSICIAN LABELING ORAL CONTRACEPTIVE AGENTS DESCRIPTION _NECON 1/50 _Tablets provide a continuous oral contraceptive regimen consisting of 21 white tablets containing norethindrone 1 mg and mestranol 0.05 mg and 7 orange tablets containing inert ingredients. Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-Nor-17α-pregn- 4-en-20-yn-3-one. Mestranol is an estrogen with the chemical name 3-Methoxy-19-nor-17α-pregna- 1,3,5(10)-trien-20-yn-17-ol. Their structural formulae follow: The white Necon 1/50 tablets contain the following inactive ingredients: lactose, magnesium stearate, povidone, and starch. The inactive orange tablets contain the following 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 Necon 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table l lists the typical accidental pregnancy rates for users ® _®_ ® ® 1 of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE L: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNAN Izlasiet visu dokumentu