Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Amneal Pharmaceuticals NY LLC
LEVONORGESTREL
LEVONORGESTREL 0.1 mg
PRESCRIPTION DRUG
Larissia 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 First Year of Use % of Women Continuing Use at One Year3 Method Typical Use1 Perfect Use2 (1) (2) (3) (4) Chance4 Spermicides5 Periodic abstinence Calendar Ovulation Method Sympto-Thermal6 Post-Ovulation Cap7 Parous Women Nulliparous Women Sponge Parous Women Nulliparous Women Diaphragm7 Withdrawal Condom8 Female (Reality) Male Pill Progestin only Combined IUD Progesterone T Copper T380A LNg 20 Depo-Provera® Levonorgestrel Impl
Larissia (levonorgestrel and ethinyl estradiol tablets, USP, 0.1 mg/0.02 mg) are available as follows: NDC 69238-1531-6 Blister Pack of 28 Tablets 21 active tablets: white, round biconvex, film-coated tablet debossed with “C4” on one side. 7 inert tablets: yellow, round biconvex, film-coated tablet debossed with “C2” on one side. Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Made in Germany Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2017-03
Abbreviated New Drug Application
LARISSIA- LEVONORGESTREL AND ETHINYL ESTRADIOL AMNEAL PHARMACEUTICALS NY LLC ---------- LARISSIA (LEVONORGESTREL AND ETHINYL ESTRADIOL 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 Each active, white tablet (21) contains 0.1 mg of levonorgestrel, USP, d(-)-13β-ethyl- 17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish White 014.17 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, talc, and titanium dioxide. Each inactive, yellow tablet (7) contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish Yellow 024.15 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, ferric oxide red, ferric oxide yellow, talc, and titanium dioxide. TM 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 Aqra d-dokument sħiħ