ASHLYNA- levonorgestrel and ethinyl estradiol and ethinyl estradiol
Glenmark Generics Inc., USA
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke
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, synthetic progestogen and 0.03 mg of ethinyl estradiol USP, and yellow tablets containing 0.01 mg of ethinyl estradiol USP
Levonorgestrel USP
C21 H28 O2 MW: 312.4
Levonorgestrel USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17?)-, (-)-.
Ethinyl Estradiol USP
C20 H24 O2 MW: 296.4
Ethinyl Estradiol USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17?)-.
Each blue tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue aluminum lake, FD&C yellow 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 aluminum lake, D&C yellow 10 aluminum lake.
INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
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 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 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 consecutive days. non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until blue tablet has been taken daily for consecutive days. scheduled period should occur during the 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 blue tablet followed by days taking yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using non-hormonal back-up method of contraception until she has taken blue tablet daily for 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.
CONTRAINDICATIONS
Do not prescribe Ashlyna to women who are known to have the following:
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A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
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Smoke, if over age 35
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Have deep vein thrombosis or pulmonary embolism, now or in the past?
Have cerebrovascular disease
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Have coronary artery disease
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Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) ?
Have inherited or acquired hypercoagulopathies [?
Have uncontrolled hypertension?
Have diabetes with vascular disease?
Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
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Undiagnosed abnormal genital bleeding Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past ?
Liver tumors, benign or malignant, or liver disease ?
Pregnancy, because there is no reason to use COCs during pregnancy
DOSAGE FORMS AND STRENGTHS
Ashlyna tablets (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) are available in extended-cycle tablet dispensers, each containing 13-week supply of tablets: 84 blue tablets, each containing 0.15 mg of levonorgestrel USP and 0.03 mg ethinyl estradiol USP, and yellow tablets each containing 0.01 mg of ethinyl estradiol USP. The blue tablets are round, film-coated, biconvex, unscored tablets debossed with ?E1? on one side and plain on the other. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with ?D8? on one side and plain on the other.
Mechanism of Action
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Ashlyna tablets (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) are available in extended-cycle tablet dispensers, each containing 13-week supply of tablets: 84 blue tablets, each containing 0.15 mg of levonorgestrel USP and 0.03 mg ethinyl estradiol USP, and yellow tablets each containing 0.01 mg of ethinyl estradiol USP. The blue tablets are round, film-coated, biconvex, unscored tablets debossed with ?E1? on one side and plain on the other. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with ?D8? on one side and plain on the other.
NDC 68462-646-93 carton containing individual pouches. Inside each pouch is extended-cycle tablet
dispenser containing 84 blue tablets and yellow tablets.
