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Ethinyl Estradiol and Levonorgestrel 

Generic name: ethinyl estradiol and levonorgestrel [ETH-in-ill-ess-tra-DYE-ol-and-LEE-vo-nor-JESS-trel]

Brand names: Afirmelle, Altavera, Amethyst, Aubra, Aubra EQ,… show all 28 brands
Forms of dosage: oral tablet (with iron, 20 mg to 100 mg); 30 mg to 0.15 mg; triphasic (20 mg to 100 mg);…show all two forms
Drug class: contraceptives

What is Ethinyl Estradiol and Levonorgestrel ?

Ethinyl estradiol and levonorgestrel are used to stop pregnancy. Many brands and forms of levonorgestrel and ethinyl are available. This leaflet does not list all available brands.This medication guide does not list all possible uses for levonorgestrel or ethinyl estradiol.

Side effects of Ethinyl Estradiol and Levonorgestrel

If you experience any of the following symptoms of an allergy reaction, seek immediate medical attention: difficulty breathing, hives, swelling in your lips, face, throat, or tongue.

Some birth control pills can cause severe side effects. Call your doctor immediately if:

  • Signs of a Stroke: sudden numbness, weakness, or tremors (particularly on one side); a severe headache; slurred words; problems with balance.
  • Signs of blood clots: sudden vision loss, chest pain, shortness of breath, blood in the cough, or swelling of an arm or leg.
  • Heart attack symptoms: chest pressure or pain, spreading pain to the jaw or shoulder
  • If you have liver disease, look for symptoms such as fatigue, nausea, dark urine or stools with a clay color, fever, and jaundice.
  • Increased blood pressure—severe head pain, blurred or distorted vision, and a pounding sensation in the neck, ears, or shoulders;
  • Problems related to your gallbladder include chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, and severe upper abdominal pain that spreads to your back;
  • You may experience swelling of your ankles or feet, hands, or even both.
  • Changes in migraine headache patterns or severity;
  • A breast lump, or
  • Symptoms of depression include sleep problems, fatigue, feeling weak, and changes in mood.

Some of the common side effects associated with ethinyl estradiol or levonorgestrel include:

  • You may experience nausea or vomiting, especially when taking the medicine for the first time.
  • Breast tenderness
  • Bleeding
  • Acne is a darkening or discoloration of the facial skin.
  • Weight gain or weight loss
  • Contact lenses are causing problems.

There may be other side effects. For medical advice on side effects, call your doctor. Report side effects to the FDA by calling them at 1-800-FDA-1088.

Warnings

Avoid using birth control pills while pregnant or after having a recent baby.Birth control pills should be avoided if: you are suffering from uncontrolled hypertension, heart problems, circulatory issues (especially in diabetes), liver diseases or cancers of the liver, migraine headaches that last for days, if your surgery is going to take place soon, if you are smoking and you're over 35 years old, if a previous heart attack or stroke has occurred, if there was a blood clot or jaundice due to pregnancy, birth control pills, or a cancerous breast, uterus, or cerviPill birth control can raise your chances of a stroke or heart attack.If you are older than 35 and smoke, it is not recommended that you take levonorgestrel or ethinyl estradiol.

Before you take this drug

This medicine increases your risk of blood clots and strokes. If you suffer from high blood pressure, diabetes, high cholesterol, or are overweight, you're at even greater risk. The risk of stroke and blood clots is greatest during the first year you take birth control pills. You are at high risk if you start taking this medication again after a break of 4 weeks.The older you get, the greater your chance of having a stroke or heart attack. This risk is increased by the amount you smoke. If you are older than 35 and smoke, it is not recommended that you take birth control pills.Avoid using it if pregnant. Tell your doctor immediately if you are pregnant or have missed more than two periods. Wait at least four weeks after giving birth to take birth control pills.

If you are pregnant, or if:

  • Untreated high blood pressure or hypertension
  • Heart disease (chest discomfort, coronary artery diseases, history of stroke, or blood clots);
  • An increased risk for blood clots as a result of a blood disorder or heart disease;
  • Circulatory problems, especially if they are caused by diabetes
  • A history of cancers of the uterus, breast, vagina, cervix, or ovaries;
  • Unusual vaginal bleeding not checked by your doctor
  • Liver disease, or cancer of the liver;
  • Severe migraine headaches, especially in older people over 35.
  • Pregnancy or birth control pills have been known to lead to jaundice.
  • If you take any hepatitis C medication containing ombitasvir, paritaprevir, or ritonavir (Technivie).

If you've ever:

  • If you have heart disease, blood clots, high blood pressure, or are at risk of blood clots, then this is the right product for you.
  • If you have high triglycerides or cholesterol or are overweight,
  • Depression;
  • A seizure or migraine headache;
  • Gallbladder Disease
  • Liver or kidney disease
  • Menstrual irregularities;
  • Fibrocystic Breast Disease lumps, nodules, or abnormal mammograms

Levonorgestrel and ethinyl estradiol may slow down the production of breast milk. This medicine should not be used while breastfeeding.

How to take Ethinyl Estradiol and Levonorgestrel ?

Read all the instructions or guides that come with your medication and follow all the directions. Follow the directions on your prescription label.First, take your pill the day after you start your period. When you start taking ethinyl estradiol or levonorgestrel, it may be necessary to take backup birth control such as spermicides, condoms, etc. You should follow your doctor's advice.One pill per day is recommended, but no more than one every 24 hours. Start a fresh pack of pills the next day when the old ones run out. If you don't take one daily pill, it is possible to become pregnant. Refill your prescription before the pills run out.Some birth control packages contain seven reminder pills that help you maintain your cycle. Usually, your period begins while you're using the reminder pills.

The chewable pill (tablet) should be chewed and swallowed with water. If you wish, you can swallow the tablet whole. It is best to take it with an empty stomach.If you have severe nausea or diarrhea, use backup birth control.During the first three months, you may experience bleeding. If the bleeding persists or becomes very heavy, tell your doctor.You may have to temporarily stop taking this medication if you are going through major surgery or if you will need long-term rest. You should let any doctor who treats you know that you use birth control pills.You will have to see your doctor frequently if you are taking birth-control pills.Keep away from heat, moisture, and light.

Details on dosage

Adult dose for contraception:

Oral Tablets: Take 1 tablet once daily at the same hour each day, in the exact order indicated on the blister package.
Transdermal System
Cycle of four weeks: Wear one patch every week for three consecutive weeks. There was no patch during the fourth week.
Comments:
To achieve maximum contraceptive effectiveness, the tablets should not be taken more than 24 hours apart.
Tablets can be taken on Sunday, the day after menstruation begins (Sunday start), or the first day of menstruation.
The first transdermal product should be used within the first 24 hours after menstruation.
Prevent pregnancy with this product.
Transdermal application is only recommended for women who have a body mass index (BMI) less than or equal to 30 kg/m2. Women with BMIs greater than 30 kg/m2 may experience reduced efficacy and be more susceptible to thromboembolism.

The usual pediatric dose for contraception is:

For postmenarcheal females:
Oral Tablets: Take 1 tablet once daily at the same hour each day, in the exact order indicated on the blister package.
Transdermal System
Cycle of four weeks: Wear one patch every week for three consecutive weeks. There was no patch during the fourth week.
Comments:
To achieve maximum contraceptive effectiveness, the tablets should not be taken more than 24 hours apart.
Tablets can be taken on Sunday, the day after menstruation begins (Sunday start), or the first day of menstruation.
The first transdermal product should be used within the first 24 hours after menstruation.
Prevent pregnancy with this product.
Transdermal application is only recommended for women who have a body mass index (BMI) less than or equal to 30 kg/m2. Women with BMIs greater than 30 kg/m2 may experience reduced effectiveness and be more susceptible to venous thromboembolism.

What happens if I miss the dose?

Please read the instructions that come with your medication. You are more likely to become pregnant if you miss a pill.Take two active pills the next day if you forget. Take one pill a day until the remainder of the package is used.Take two pills a day in two consecutive days if you missed two active pills back to back in the first or second week. Take one pill a day until the end of your pack. After missing a pill, use a backup birth control method for at least seven days.You can start fresh the next day if your Day 1 starter pack is empty. You can continue taking the pill until Sunday if you started on Sunday. Throw out the remaining pills on Sunday and begin a brand new package that same day.You can start over if you missed three pills consecutively in the first, second, or third week. You can continue to take a tablet every day up until Sunday if you started on Sunday. Throw out the remaining pills on Sunday and begin a brand new package that same day.You may miss your period if you don't take two active pills or more. Call your doctor if you have missed two periods in a month. You might be pregnant.You can throw away the missed pill and continue taking one pill per day until you finish your pack.

What happens if I overdose?

Call the Poison Help Line at 1-800-222-1222 or seek emergency medical care. Overdose symptoms include nausea, vomiting, and drowsiness.

What should be avoided?

Don't smoke when taking birth-control pills, particularly if you are more than 35 years old.The birth control pill will not shield you against sexually transmissible diseases, including HIV and AIDS. The only wayto prevent these diseases is by using a condom.

Interaction with other drug

Herbal remedies and prescription medicines may also interact with birth-control pills. Birth control pills can be less effective if you take certain drugs. This may lead to pregnancy. Inform your doctor of all the medications you are taking and those that you stop or start using.

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