देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Central Texas Community Health Centers
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 CENTRAL TEXAS COMMUNITY HEALTH CENTERS ---------- 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 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. 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 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 Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Injectable progestogen 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2.0 Copper T 380A 0.6 0.8 ® ® ® * Condom (male) without spermicide 3 14 (Female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Parous women 26 40 Vaginal sponge Nulliparous women 9 20 Parous women 20 40 Diaphragm with sper पूरा दस्तावेज़ पढ़ें