RVP

Drug Catalog - Product Detail

LEVONORGESTREL/ETHINYL ESTRADIOL & ETHINYL ESTRADIOL TB 0.15/0.03MG & 0.01MG

NDC Mfr Size Str Form
00378-7285-90 MYLAN 91 0.15-0.03 &0.01MG TABLET
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PACKAGE FILES

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Generic Name
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
Application Number
ANDA200492
Description
11 DESCRIPTION Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP are an extended-cycle oral contraceptive consisting of 84 white to off-white tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 light peach tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are: Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each white to off-white tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate and polacrilin potassium. Each light peach tablet contains the following inactive ingredients: anhydrous lactose, dl - α -tocopherol, FD&C Yellow No. 6 (Sunset Yellow) Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone k-25 and polacrilin potassium. Meets USP Dissolution Test 2 for Ethinyl Estradiol 0.01 mg Levonorgestrel Structural Formula Ethinyl Estradiol Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP are available in an Extended-Cycle Tablet Blister Pack, each pouch contains 91 tablets. Each Extended-Cycle Tablet Blister Pack contains a 13-week supply of tablets: 84 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 light peach tablets each containing 0.01 mg of ethinyl estradiol. The white to off-white tablets are round, biconvex tablets debossed with 202 on one side and plain on the other side. The light peach tablets are round, biconvex tablets debossed with 222 on one side and plain on the other side. NDC 0378-7285-90 Carton containing 2 Extended-Cycle Tablet Blister Packs Storage and Handling Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 2.1 How to Start and Take Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets Begin levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first white to off-white tablet that day. For each 91-day course, take in the following order: 1. Start the first white to off-white tablet daily on first Sunday after the onset of menstruation. Then take one white to off-white tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) until a white to off-white has been taken daily for 7 consecutive days. 2. Then take one light peach tablet for 7 consecutive days. Bleeding should occur during the 7 days that the light peach tablets are taken. Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, following the same schedule: 84 days taking a white to off-white tablet followed by 7 days taking a light peach tablet. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a white to off-white tablet daily for 7 consecutive days. Switching to levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant) Start on the Sunday after the patient’s next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 consecutive days. Starting Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets after Abortion or Miscarriage First-trimester Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may be started on the Sunday after an abortion or miscarriage. The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 consecutive days. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1) ]. Starting Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1) ]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ]. 2.2 Dosing Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets Take one tablet by mouth at the same time every day. The dosage of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is one white to off-white tablet daily for 84 consecutive days, followed by one light peach tablet daily for 7 days. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets must be taken exactly as directed, in the order directed, and at intervals not exceeding 24 hours. The failure rate may increase when pills are missed or taken incorrectly. 2.3 Missed Doses Table 1. Instructions for Missed Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets If one white to off-white tablet is missed Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex. If two white to off-white tablets in a row are missed Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. If three or more white to off-white tablets in a row are missed Throw away the missed pills. Continue taking one tablet every day as indicated on the pack until the pack is finished. Bleeding may occur during the week following the missed tablets. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. If any of the seven light peach tablets are missed Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed. 2.4 Advice in Case of Gastrointestinal Disturbances In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.