Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Afaxys Pharma, LLC
LEVONORGESTREL
LEVONORGESTREL 0.15 mg
PRESCRIPTION DRUG
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. NA - not available a Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology : 17th Revised Edition . NY, NY: Ardent Media, Inc., 1998. Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders. A past history of deep-vein thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary-artery disease. Thrombogenic valvulopathies
Chateal (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg) are available in a carton of 3 packages, each package contains 28 tablets: 21 Active Tablets: White to off-white, round, unscored tablets debossed with 209 on one side and plain on the other side. 7 Inert Tablets: Green, round, unscored tablets debossed with 274 on one side and plain on the other side. Package (NDC-50102-130-10) Carton (NDC-50102-130-03) containing 3 Packages Store at 20° to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. References available upon request.
Abbreviated New Drug Application
CHATEAL - LEVONORGESTREL AND ETHINYL ESTRADIOL AFAXYS PHARMA, LLC ---------- CHATEAL® (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG) Rx only CHATEAL (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION 21 white to off-white levonorgestrel and ethinyl estradiol tablets , each containing 0.15 mg of levonorgestrel, (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, (19-nor-17α -pregna-1,3,5 (10)-trien-20-yne- 3,17-diol), and 7 green inert tablets. The inactive ingredients for white to off-white active tablets are Lactose monohydrate, Polacrilin Potassium, Magnesium Stearate. The inactive ingredients for green inert tablets are Lactose monohydrate, Polacrilin Potassium, Magnesium Stearate, yellow oxide of iron and FD&C Blue No.1 Aluminium lake. CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. 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 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 contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ® TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD NA - not avai Baca dokumen lengkapnya