Ashlyna
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
Ashlyna (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) is indicated for use by women to prevent pregnancy.
History
There is currently no drug history available for this drug.
Other Information
Ashlyna (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) is an extended-cycle oral contraceptive consisting of 84 blue tablets each containing 0.15 mg of levonorgestrel USP, a synthetic progestogen and 0.03 mg of ethinyl estradiol USP, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol USP.
The structural formulas for the active components are:
Levonorgestrel USP
C21H28O2 MW: 312.4
Levonorgestrel USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.
Ethinyl Estradiol USP
C20H24O2 MW: 296.4
Ethinyl Estradiol USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.
Each blue tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue 1 aluminum lake, FD&C yellow 6 aluminum lake, D&C yellow 10 aluminum lake.
Each yellow tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, FD&C yellow 6 aluminum lake, D&C yellow 10 aluminum lake.
Sources
Ashlyna Manufacturers
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Glenmark Generics Inc., Usa
![Ashlyna (Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol) Kit [Glenmark Generics Inc., Usa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ashlyna | Glenmark Generics Inc., Usa
Take one tablet by mouth at the same time every day. The dosage of Ashlyna (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) is one blue tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Ashlyna must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking Ashlyna on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first blue tablet is taken that day. One blue tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a blue tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow 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 Ashlyna, following the same schedule: 84 days taking a blue tablet followed by 7 days taking a yellow 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 blue 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 Ashlyna no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Ashlyna 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 blue tablet for 7 consecutive days.
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