Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Par Pharmaceutical
LEVONORGESTREL
LEVONORGESTREL 0.05 mg
PRESCRIPTION DRUG
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use Myzilra® Tablets 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. 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. 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. Known or suspected carcinoma of the breast. Carcinoma of
Myzilra® (levonorgestrel and ethinyl estradiol tablets USP)—triphasic regimen is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 round, film coated tablets as follows: Six beige tablets debossed “93” on one side and “680” on the other side, each containing 0.05 mg levonorgestrel and 0.03 mg ethinyl estradiol; five white tablets debossed “93” on one side and “681” on the other side, each containing 0.075 mg levonorgestrel and 0.04 mg ethinyl estradiol; ten light-yellow tablets debossed “93” on one side and “682” on the other side, each containing 0.125 mg levonorgestrel and 0.03 mg ethinyl estradiol; and seven light-green inert tablets debossed “93” on one side and “743” on the other side. Blister pack tablet dispenser NDC 0603-7625-01 Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49 Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid humid conditions and protect from light by storing tablet blister in the cardboard sleeve provided. References available upon request.
Abbreviated New Drug Application
MYZILRA- LEVONORGESTREL AND ETHINYL ESTRADIOL PAR PHARMACEUTICAL ---------- MYZILRA (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)—TRIPHASIC REGIMEN RX ONLY PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION Each Myzilra cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 beige tablets, each containing 0.05 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); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.04 mg ethinyl estradiol; and phase 3 comprised of 10 light-yellow tablets, each containing 0.125 mg levonorgestrel and 0.03 mg ethinyl estradiol; then followed by 7 light-green inert tablets. The inactive ingredients present are microcrystalline cellulose, FD&C Blue 2, FD&C Red 40, FD&C Yellow 6, D&C Yellow 10, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, and vitamin E. CLINICAL PHARMACOLOGY Combination oral contraceptives primarily 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 Myzilra Tablets 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 consisten Lire le document complet