Amethia
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AMETHIA tablets are indicated for use by women to prevent pregnancy.
History
There is currently no drug history available for this drug.
Other Information
AMETHIATM tablets are an extended-cycle oral contraceptive consisting of 84 white tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 light blue 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-, (17 α)-, (-)-.
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.
Each white tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium and magnesium stearate.
Each light blue tablet contains the following inactive ingredients: vitamin E, anhydrous lactose, povidone, FD&C Blue #1, colloidal silicon dioxide, corn starch and stearic acid.
Sources
Amethia Manufacturers
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Watson Pharma, Inc.
![Amethia (Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol) Kit [Watson Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amethia | Watson Pharma, Inc.
Take one tablet by mouth at the same time every day. The dosage of AMETHIA tablets is one white tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one light blue ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, AMETHIA tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking AMETHIA 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 light 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 light 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 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 FDA-Approved Patient Labeling.
For postpartum women who are not breastfeeding, start AMETHIA tablets no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on AMETHIA 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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