Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)
Lupin Pharmaceuticals, Inc.
PRESCRIPTION DRUG
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD NA - not available Levonorgestrel and Ethinyl Estradiol Tablet is contraindicated in females who are known to have or develop the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep-vein-thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary-artery disease. Current diagnosis or history of breast cancer, which may be hormone sensitive. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic adenomas and carcinomas. Known or suspected pregnancy. Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).
Levonorgestrel and ethinyl estradiol tablets USP (tablets-triphasic regimen) are available in a blister containing 28 tablets (NDC 68180-857-71). Three such blisters are packed in a carton (NDC 68180-857-73). Each cycle contains 28 tablets as follows: References available upon request. The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) – 454 775 INDIA Revised: June 2022
Abbreviated New Drug Application
LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. ---------- DETAILED PATIENT LABELING This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. INTRODUCTION Any woman who considers using oral contraceptives (the birth-control pill or the pill) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health-care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your health- care provider’s advice with regard to regular check-ups while you are on the pill. EFFECTIVENESS OF ORAL CONTRACEPTIVES Oral contraceptives or "birth-control pills" or "the pill" are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1.0 % when used perfectly, without missing any pills. Typical failure rates are less than 3.0% per year. The chance of becoming pregnant increases with each missed pill during the menstrual cycle. In comparison, typical failure rates for other nonsurgical methods of birth control during first year of use are as follows: TABLE: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD NA - not available Method Perfect use Average use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera® (Injectable progestogen) Đọc toàn bộ tài liệu
LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL ESTRADIOL LUPIN PHARMACEUTICALS, INC. ---------- LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.05 MG/0.03 MG, 0.075 MG/0.04 MG AND 0.125 MG/0.03 MG RX ONLY Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION Each levonorgestrel and ethinyl estradiol tablets USP cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 light blue tablets, each containing 0.05 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta- hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white to off white tablets, each containing 0.075 mg levonorgestrel and 0.04 mg ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each containing 0.125 mg levonorgestrel and 0.03 mg ethinyl estradiol; then followed by 7 orange inert tablets. The inactive ingredients present in the light blue, white to off white and pink tablets are corn starch, lactose monohydrate, magnesium stearate and povidone. Each light blue tablet also contains FD & C Blue #1. Each pink tablet also contains FD & C Red #40. Each inactive orange tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate and microcrystalline cellulose. CLINICAL PHARMACOLOGY Mechanism of Action Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation. INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I 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 and the IUD, depends upon Đọc toàn bộ tài liệu