Levonorgestrel + Ethinyl Estradiol

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Generic Name: Levonorgestrel + Ethinyl Estradiol Brand Name(s): Generics only. No brands available.

Uses

What is Levonorgestrel + Ethinyl Estradiol used for?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin (levonorgestrel) and an estrogen (ethinyl estradiol). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body.

Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne.

Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How should I take Levonorgestrel + Ethinyl Estradiol?

Take this medication by mouth as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.

It is very important to continue taking this medication exactly as prescribed by your doctor. Follow the package instructions to find the first tablet, start with the first tablet in the pack, and take them in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.

Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.

Begin taking this medication on the first Sunday following the beginning of your menstrual period. If your period begins on a Sunday, begin taking this medication on that day. Your pill pack contains 84 active pills (with hormones) and 7 inactive pills (without hormones). Take one active pill daily for 84 days in a row. The day after you finish all the active pills, start taking one inactive pill daily for 7 days in a row. You should have your period during the week you are taking the inactive pills. The day after you take the last inactive tablet in the pack, start a new pack whether or not you have your period. If you do not get your period, consult your doctor.

If this is the first time you are using this medication, use an additional form of non-hormonal birth control (such as condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start on the first day of your period, you do not need to use back-up birth control the first week.

Ask your doctor or pharmacist about how to switch from other forms of hormonal birth control (such as patch, other birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

How do I store Levonorgestrel + Ethinyl Estradiol?

Levonorgestrel + Ethinyl Estradiol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Levonorgestrel + Ethinyl Estradiol in the bathroom or the freezer. There may be different brands of Levonorgestrel + Ethinyl Estradiol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Levonorgestrel + Ethinyl Estradiol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Levonorgestrel + Ethinyl Estradiol?

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or levonorgestrel; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, family medical history (especially angioedema), gallbladder problems, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), kidney disease, liver disease (including tumors), stroke, swelling (edema), thyroid problems, unexplained vaginal bleeding.

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

This medication may decrease breast milk production. A small amount passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Levonorgestrel + Ethinyl Estradiol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Levonorgestrel + Ethinyl Estradiol. Levonorgestrel + Ethinyl Estradiol is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Levonorgestrel + Ethinyl Estradiol?

Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

You should not have your period during the 3 months that you are taking the active pills. Instead, you will have your period once every 3 months, during the week that you are taking the inactive pills. This effect is normal with this product. However, if you do not have your period while taking the inactive pills, contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Levonorgestrel + Ethinyl Estradiol?

Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane), ospemifene, tamoxifen, tizanidine, tranexamic acid, certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir).

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain laboratory tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.

Levonorgestrel + Ethinyl Estradiol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Levonorgestrel + Ethinyl Estradiol?

Levonorgestrel + Ethinyl Estradiol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Levonorgestrel + Ethinyl Estradiol?

Levonorgestrel + Ethinyl Estradiol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Levonorgestrel + Ethinyl Estradiol.

What is the dose of Levonorgestrel + Ethinyl Estradiol for an adult?

Usual Adult Dose for Contraception

1 tablet orally once a day

Comments: To be taken at the same time each day.

Renal Dose Adjustments

Use with caution; monitor blood pressure closely.

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Elderly patients: Not indicated in postmenopausal women.

Changing from another oral contraceptive: Start on the same day that a new pack of the previous oral contraceptive would have started.

Changing from a transdermal patch: Start on the day when the next application would have been scheduled.

Changing from a vaginal ring: Start on the day when the next insertion would have been scheduled.

Changing from an injectable formulation: Start on the day when the next injection would have been scheduled

Changing from an intrauterine system (IUS) contraceptive:

-Start on the day of the removal of the IUS

-If the IUS is not removed on the first day of the menstrual cycle, additional nonhormonal contraceptives (e.g., condoms and spermicide) is needed for the first 7 days of the first cycle pack.

Changing from an implant: Start on the day when the implant is removed.

Following a first trimester abortion or miscarriage:

-May be started immediately; an additional method of contraception is not required if started immediately.

-If not started within 5 days after termination of pregnancy, an additional nonhormonal method of contraception (e.g., condoms and spermicide) is to be used for the first 7 days of the first cycle pack.

Following a second trimester abortion or miscarriage:

-Do not start until 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.

-Follow the instructions for Sunday start, as desired and use additional non-hormonal contraception (e.g., condoms and spermicide) for the first 7 days of the patient’s first cycle pack.

Following childbirth:

-Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.

-Follow the instructions for women not currently using hormonal contraception.

-Not recommended for use in lactating women

-If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use.

What is the dose of Levonorgestrel + Ethinyl Estradiol for a child?

Usual Pediatric Dose for Contraception

1 tablet orally once a day

Comments: To be taken at the same time each day.

Precautions

Safety and efficacy have been established in female patients of reproductive age; use prior to menarche is not indicated.

How is Levonorgestrel + Ethinyl Estradiol available?

Levonorgestrel + Ethinyl Estradiol is available in the following dosage forms and strengths:

  • Oral Tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Levonorgestrel + Ethinyl Estradiol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: March 17, 2018 | Last Modified: March 17, 2018

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