Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Physicians Total Care, Inc.
LEVONORGESTREL
LEVONORGESTREL 0.1 mg
PRESCRIPTION DRUG
Aviane 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 Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of Women Experiencing an Unintended Pregnancy within the % of Women Continuing Method Typical Use Perfect Use Levonorgestrel In a clinical trial with levonorgestrel and ethinyl estradiol 0.10 mg/0.02 mg tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7
Aviane® – 28 tablets (0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets, USP) are packaged in blister cards, each containing 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, coated and debossed with dp on one side and 016 on the other side. Each light-green tablet is round and debossed with dp on one side and 519 on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. REFERENCES AVAILABLE UPON REQUEST.
Abbreviated New Drug Application
AVIANE - LEVONORGESTREL AND ETHINYL ESTRADIOL PHYSICIANS TOTAL CARE, INC. ---------- AVIANE - 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP) RX ONLY Iss. 8/2009 11001539 9045 PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION 21 orange active tablets each containing 0.10 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 Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate and titanium dioxide. 7 Light-green, inert tablets each contain: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch. LEVONORG ESTREL ETHINYL ESTRADIOL MOLECULAR WEIG HT: 312.4 5 C H O MOLECULAR WEIG HT: 296.4 0 C H O 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 Aviane (levonorgestrel and ethinyl estradiol tablets, USP) in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not ® 21 28 2 20 24 2 ® 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 Læs hele dokumentet