Drug Catalog - Product Detail
LEVONORGESTREL/ETHINYL ESTRADIOL & ETHINYL ESTRADIOL TB TB 0.1/0.02MG & 0.01MG 2X91 DISP.
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
68180-0848-13 | LUPIN PHARMACEUTICALS | 91 | 0.1-0.02 & 0.01MG | TABLET |
PACKAGE FILES
Generic Name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
Application Number
ANDA091674
Description
11 DESCRIPTION Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 mustard tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW: 312.4 Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-. Ethinyl Estradiol C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets include croscarmellose sodium, FD&C yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. Inactive ingredients for the mustard tablets include FD&C Yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. Ethinyl Estradiol Tablets, USP, 0.01 mg meets USP Dissolution Test 2. Levonorgestrel Footer
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Levonorgestrel and Ethinyl Estradiol Tablets, USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets, USP (0.01 mg) are available in Extended-Cycle Wallets, that contains 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol and 7 mustard tablets each containing 0.01 mg of ethinyl estradiol. Orange tablets are round biconvex, film-coated tablets, debossed with "LU" on one side and "T41" on the other side. Mustard tablets are round biconvex, film-coated tablets debossed with "LU" on one side and "V22" on the other side. They are supplied as follows: Levonorgestrel and Ethinyl Estradiol Tablets, USP (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets, USP (0.01 mg) are available in an extended cycle wallet of 91 tablets which is packed in a pouch (NDC 68180-848-11). Such two pouches are packed in a carton (NDC 68180-848-13). Storage and Handling Store at 25° C (77° F); excursions permitted to 15°to 30° C (59°to 86° F) [see USP Controlled Room Temperature] The tablets should not be removed from the protective blister packaging to avoid damage to the product. The wallet card should be kept in the pouch until dispensed to the patient.
Indications & Usage
1 INDICATIONS AND USAGE 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 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy.
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 orange tablet that day. For each 91-day course, take in the following order: Take one orange tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms or spermicide) until an orange tablet has been taken daily for 7 consecutive days. Then take one mustard tablet for 7 consecutive days. A scheduled period should occur during the 7 days that the mustard 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 an orange tablet followed by 7 days taking a mustard 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 an orange 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 an orange 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 an orange 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 an orange 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 an orange 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 tablet [ 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 orange tablet daily for 84 consecutive days, followed by one mustard 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 orange 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 orange 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 orange 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. Additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. If any of the seven mustard 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.