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)
Par Pharmaceutical
LEVONORGESTREL
LEVONORGESTREL 0.1 mg
ORAL
PRESCRIPTION DRUG
ORSYTHIA® (levonorgestrel and ethinyl estradiol tablets USP) 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. TABLE II 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, the IUD, and levonorgestrel implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Injectable Progestogen 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, temp
ORSYTHIA® (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 tablets as follows: 21 active tablets, pink, round, film-coated tablet debossed with "93" on one side and "684" on the other side. 7 inert tablets, light-green, round, film-coated tablet debossed with "93" on one side and "743" on the other side. Blister pack tablet dispenser NDC 0603-7634-01 Boxes of 3 blister pack tablet dispensers NDC 0603-7634-49 Boxes of 6 blister pack tablet dispensers NDC 0603-7634-17 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. References available upon request.
Abbreviated New Drug Application
ORSYTHIA- LEVONORGESTREL AND ETHINYL ESTRADIOL PAR PHARMACEUTICAL ---------- ORSYTHIA (LEVONORGESTREL (0.1 MG) AND ETHINYL ESTRADIOL (0.02 MG) TABLETS USP) 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 21 pink active tablets each containing 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β- hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl- 1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are FD&C red #40 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and vitamin E. 7 light-green inert tablets, each containing FD&C blue #2, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol and pregelatinized starch. 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 levonorgestrel and ethinyl estradiol 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%. ® After a single dose of levonorgestrel and ethinyl estradiol to 22 women under f Pročitajte cijeli dokument