Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)
LUPIN LIMITED
PRESCRIPTION DRUG
Levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg and 0.02 mg are 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. 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 contraceptio
Levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg are available in 3 wallets, each containing 28 tablets as follows. Each wallet contains 21 white to off white round bevel edged tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, debossed with "LU" on one side and "T21" on the other side and 7 orange round bevel edged inert tablets debossed with "LU" on one side and "T22" on the other side. They are supplied as follows: Levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg are available in a wallet (NDC 68180-854-11) of 28 tablets, such 3 wallets are packed in a carton (NDC 68180-854-13). Store at 25° C (77° F); excursions permitted to 15°- 30° C (59°- 86° F) [see USP Controlled Room Temperature]
Abbreviated New Drug Application
LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL ESTRADIOL LUPIN LIMITED ---------- LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.1 MG/0.02 MG 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, 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 croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Each inert, orange tablet (7) contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. 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 tablets to 22 women under fasting conditions, maximum serum concent Lue koko asiakirja