Drug Catalog - Product Detail
LEVONORGESTREL/ETHINYL ESTRADIOL/ETHINYL ESTRADIOL (DAYSEE) TB 0.15/0.03/0.01MG 2X91
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0846-13 | LUPIN PHARMACEUTICALS | 91 | 0.15-0.03 &0.01MG | TABLET |
PACKAGE FILES
Generic Name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
Application Number
ANDA091467
Description
11 DESCRIPTION Daysee (levonorgestrel and ethinyl estradiol tablets USP, and ethinyl estradiol tablets USP) is an extended-cycle oral contraceptive consisting of 84 light blue tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 mustard 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 light blue tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, FD and C blue No. 1, FD and C yellow No. 6, iron oxide yellow, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Each mustard tablet contains the following inactive ingredients: FD and C yellow No. 6, hypromellose, iron oxide yellow, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polacrillin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide. The Mustard Tablet i.e. Ethinyl Estradiol Tablets USP meets USP Dissolution Test 2. Levonorgestrel Ethinyl Estradiol
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Daysee [levonorgestrel and ethinyl estradiol tablets USP (0.15 mg/0.03 mg) and ethinyl estradiol tablets USP (0.01 mg)] are available in Extended-Cycle Wallets each containing a 13-week supply of tablets: 84 light blue tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 mustard tablets, each containing 0.01 mg of ethinyl estradiol. The light blue tablets are round, biconvex, film-coated tablets, debossed with "LU" on one side and "V21" on the other side. The 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: Daysee [levonorgestrel and ethinyl estradiol tablets USP (0.15 mg/0.03 mg) and ethinyl estradiol tablets USP (0.01 mg)] is available in an extended cycle wallet of 91 tablets which is packed in a pouch (NDC 68180-846-11). Such two pouches are packed in a carton (NDC 68180-846-13). Storage and Handling Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15°C to 30° C (59°F to 86° F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Daysee™ is indicated for use by females of reproductive potential to prevent pregnancy. Daysee is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive to potential 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 Daysee Begin Daysee on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first light blue tablet that day. For each 91-day course, take in the following order: Start the first blue tablet on the first Sunday after onset of menstruation. Then take one light blue tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) until a light blue tablet has been taken daily for 7 consecutive days. Then take one mustard tablet for 7 consecutive days. Bleeding 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 Daysee, following the same schedule: 84 days taking a light blue 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 a light blue tablet daily for 7 consecutive days. Switching to Daysee 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 light blue tablet for 7 consecutive days. Starting Daysee after Abortion or Miscarriage First-trimester Daysee 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 light blue 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 Daysee 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 light blue tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)]. Starting Daysee after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Daysee 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 light blue 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 Daysee [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)]. 2.2 Dosing Daysee Take one tablet by mouth at the same time every day. The dosage of Daysee is one light blue tablet daily for 84 consecutive days, followed by one mustard tablet daily for 7 days. To achieve maximum contraceptive effectiveness, Daysee 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 Daysee Tablets If one light blue 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 light blue tablet 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 light blue pills 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 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.