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Daysee

Daysee Recall

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

DayseeTM (levonorgestrel and ethinyl estradiol tablets USP, and ethinyl estradiol tablets USP) is indicated for use by women to prevent pregnancy.

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History

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Other Information

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:

Structure of Levonorgestrel

Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-, (-)-.

Structure of Ethinyl Estradiol

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.

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Daysee Manufacturers

  • Lupin Pharmaceuticals, Inc.
    Daysee | Lupin Pharmaceuticals, Inc.
    No Recall

    Daysee | Lupin Pharmaceuticals, Inc.

    Daysee | Lupin Pharmaceuticals, Inc.

    Take one tablet by mouth at the same time every day. The dosage of Daysee is one light blue 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, Daysee must be taken exactly as directed and at intervals not exceeding 24 hours.

    Instruct the patient to begin taking Daysee on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first light blue tablet is taken that day. One light blue 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 a light blue 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 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, she should 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. 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 Daysee no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Daysee 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 light blue tablet for 7 consecutive days.

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