Amethia Lo
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
AMETHIA Lo tablets are indicated for use by women to prevent pregnancy.
History
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Other Information
Levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets provide an oral contraceptive regimen of 84 white tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 blue tablets each containing 0.01 mg 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, (17 α)-.
Inactive ingredients for the white tablets include lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, and magnesium stearate.
Inactive ingredients for the blue tablets include anhydrous lactose, corn starch, stearic acid, povidone, colloidal silicon dioxide, Vitamin E and FD&C Blue # 1 aluminum lake.
Sources
Amethia Lo Manufacturers
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Watson Pharma, Inc.
![Amethia Lo (Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol) Kit [Watson Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amethia Lo | Watson Pharma, Inc.
Take one tablet by mouth at the same time every day. The dosage of AMETHIA Lo tablets is one white tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one blue ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, AMETHIA Lo tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking AMETHIA Lo tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first white tablet is taken that day. One white tablet should be taken daily for 84 consecutive days, followed by one blue tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a white tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the blue 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 AMETHIA Lo tablets, following the same schedule: 84 days taking a white tablet followed by 7 days taking a blue 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 a white 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 AMETHIA Lo tablets no earlier than four to six weeks postpartum. If the patient starts on AMETHIA Lo 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 a white tablet for 7 consecutive days.
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