Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Actavis Pharma, Inc.
LEVONORGESTREL
LEVONORGESTREL 90 ug
ORAL
PRESCRIPTION DRUG
Amethyst™ (levonorgestrel and ethinyl estradiol tablets) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contrace
Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with "295 " on one side and "WATSON " on the other side (NDC 52544-295-28). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. References available upon request. Brands listed are the trademarks of their respective owners. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 12/2021
Abbreviated New Drug Application
AMETHYST- LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET ACTAVIS PHARMA, INC. ---------- AMETHYST™ (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 90 MCG/20 MCG) RX ONLY PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT AGAINST TRANSMISSION OF HIV (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES (STDS) SUCH AS CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS B, AND SYPHILIS. DESCRIPTION Twenty-eight (28) white tablets each containing 90 mcg of levonorgestrel (17α)-(–)13- ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are microcrystalline cellulose, lactose monohydrate, magnesium stearate, croscarmellose sodium, and povidone. CLINICAL PHARMACOLOGY MODE OF ACTION 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). PHARMACOKINETICS ABSORPTION No specific investigation of the absolute bioavailability of Amethyst in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first- pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%. A summary of the single dose and multiple dose levonorgestrel and ethinyl estradiol pharmacokinetic parameters for 18 women under fasting conditions is provided in Table 1. The plasma concentrations of levonorgestrel and ethinyl estradiol reached steady- state by approximately day 14. Levonorgestrel and ethinyl estradiol c Pročitajte cijeli dokument