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Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol

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Overview

What is Ashlyna?

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

CHO MW: 312.4

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

Ethinyl Estradiol, USP

CHO 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:

Each yellow tablet contains the following inactive ingredients:

e.



What does Ashlyna look like?



What are the available doses of Ashlyna?

Ashlyna™ (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) consists of 84 blue tablets containing 0.15 mg levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP and 7 yellow tablets containing 0.01 mg ethinyl estradiol, USP. ()

What should I talk to my health care provider before I take Ashlyna?

How should I use Ashlyna?

Ashlynais indicated for use by women to prevent pregnancy.

Take one tablet by mouth at the same time every day. The dosage of Ashlyna 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 .

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.


What interacts with Ashlyna?

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What are the warnings of Ashlyna?

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What are the precautions of Ashlyna?

Sorry No Records found


What are the side effects of Ashlyna?

Sorry No records found


What should I look out for while using Ashlyna?

Do not prescribe Ashlyna to women who are known to have the following:


What might happen if I take too much Ashlyna?

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.


How should I store and handle Ashlyna?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light.Product: 50090-0414NDC: 50090-0414-0 30 mL in a VIAL, MULTI-DOSE Product: 50090-0414NDC: 50090-0414-0 30 mL in a VIAL, MULTI-DOSE


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

Non-Clinical Toxicology
Do not prescribe Ashlyna to women who are known to have the following:

Heparin preparations containing sodium bisulfite reduce the absorption peak of Indocyanine Green in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis.

Stop Ashlyna if an arterial or deep venous thrombotic event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The excess risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.

Use of Ashlyna provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year).

If feasible, stop Ashlyna at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Ashlyna no earlier than 4 to 6 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), and hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop Ashlyna if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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