Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol
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Uses
Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP are indicated for use by women to prevent pregnancy.
History
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Other Information
Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP provide an 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
C21H28O2 MW: 312.4
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-.
Ethinyl Estradiol
C20H24O2 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.
Sources
Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol Manufacturers
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Lupin Pharmaceuticals, Inc.
![Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol ( Levonorgestrel And Ethinyl Estradiol ) Kit [Lupin Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol | Lupin Pharmaceuticals, Inc.
Take one tablet by mouth at the same time every day. The dosage of levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet is one orange tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one mustard ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first orange tablet is taken that day. One orange tablet should be taken daily for 84 consecutive days, followed by one mustard tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until an orange tablet has been taken daily 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, she should 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.
If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
For patient instructions regarding missed pills, see PATIENT COUNSELING INFORMATION (17.2).
For postpartum women who are not breastfeeding, start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets no earlier than four to six weeks postpartum. If the patient starts on levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days.
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