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Ethinyl Estradiol and Levonorgestrel (Transdermal)

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

Brand name: Twirla
Dosage form: transdermal film (30 mcg–120 mcg)
Drug class: contraceptives

What is Ethinyl Estradiol and Levonorgestrel?

Ethinyl estradiol and levonorgestrel are a combination. Birth control medicine is used to prevent pregnancy.This medication guide does not list all possible uses for levonorgestrel, estradiol, or ethinyl.

Side effects of Ethinyl Estradiol and Levonorgestrel

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

Ethinyl estradiol and levonorgestrel can cause severe side effects. If you experience:

  • Signs of a Stroke: sudden numbness and weakness, especially on one side; severe headache. Problems with speech or vision.
  • Signs of blood clots: sudden vision loss, chest pain that stabs, shortness of breath, blood in the cough, swelling of an arm or leg, etc.
  • Heart attack symptoms: chest pain, pressure or pain in your shoulder or jaw, nausea, and sweating.
  • A severe headache that pounds in the neck or ears.
  • Jaundice
  • You may experience swelling of your ankles or feet, hands, or even both.
  • A change in migraine headaches' pattern or intensity;
  • 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:

  • Menstrual cramps
  • Nausea;
  • Weight gain
  • Headache
  • Skin reactions when a patch is worn include bumps, redness, changes in skin color, and itching rash.

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

Warnings

This medicine should not be used if: you are pregnant, have a history of jaundice, have heart problems, have a coronary artery problem, have diabetes, have health issues caused by the disease (such as kidney, eye, nerve, and blood vessel damage), have severe migraine headaches, or have liver cancer.This medicine may increase the risk of stroke or heart attack, especially if it is used by someone who smokes. If you are older than 35 and smoke, you should avoid using this medication.

Before you take this drug

You are at an even greater risk if you have high blood pressure, diabetes, a data-type="auto" href="https://www.drugs.com/cg/hyperlipidemia.html">high cholesterol/a>, or if you're obese. If you suffer from high blood pressure or diabetes, have high cholesterol, or are obese, you may be at greater risk.The older you get, the greater your chance of having a stroke or heart attack. If you are older than 35 and smoke, it is not recommended that you use levonorgestrel or ethinyl estradiol.The risk of a serious blood clot is higher when using birth control pills than when you use birth control patches.

If you are:

  • 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;
  • Diabetes (if you have had diabetes for more than 20 years and are older than 35),
  • A history of cancers of the breast, uterus, or cervix, or of vaginal or ovarian origin;
  • Unusual vaginal bleeding not checked by your doctor
  • Liver disease, or cancer of the liver;
  • If you're older than 35, it is important to be aware of severe migraine headaches, especially those with aura, numbness, weakness, or changes in vision.
  • If you take any hepatitis C medication containing ombitasvir, paritaprevir, or ritonavir (Viekira).

If you've ever:

  • If you have heart disease, blood clots, or high blood pressure,
  • High cholesterol levels that are not under control;
  • Depression;
  • Migraine headache
  • Jaundice due to pregnancy or hormone birth control
  • Hereditary Angioedema
  • Menstrual irregularities;
  • Dark patches on the face (chloasma)

This medicine should not be used if pregnant. Before using levonorgestrel or ethinyl estradiol, you may have to take a pregnancy test and find out if it is negative. If you suspect you are pregnant, tell your doctor.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 instructions on your medicine. Wear only one patch of skin at a given time. Skin patches should never be cut.Every 7 days, for three weeks (21 days), apply a fresh skin patch. Wear each skin patch for seven full days. Remove the patch on Day 22 and wait seven days before applying another patch. The week without patches should not exceed 7 days.The patch should be applied to dry, clean skin. It shouldn't irritate or break. Clothing that rubs against the patch (such as tight waistbands) is also not recommended.If you are using the medicine for the first time or your patch is loose or off for more than a day, it may be necessary to use a backup birth control method (such as condoms or diaphragms with spermicide). Follow all directions carefully if your patch falls off or becomes loose.

Do not wear a patch for 4 weeks before the surgery and another 2 weeks afterwards if you are going to be bedridden or need major surgery.During the first three months, you may experience breakthrough bleeding. If you have heavy bleeding or miss two or more periods, tell your doctor.Keep patches away from heat and moisture. Store patches at room temperature, away from moisture and heat. Each patch should be kept in the foil pouch it came with until you're ready to use it.Fold the skin patch in half with its sticky side facing out, and dispose of it somewhere where pets and children cannot reach it. Don't flush used patches down the toilet.

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 effectiveness and be more susceptible to venous embolism.

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 efficacy and be more susceptible to venous thromboembolism.

What happens if you miss the dose?

Do not miss a dose of birth control. You may have to switch back up. If you have missed your period for two consecutive months, call your doctor.

You may forget to put on a patch when you start a new cycle.

  • As soon as possible, apply a patch and begin a new period on the day you remembered (3 weeks of wearing weekly patches followed by 1 week without). During the first few days of your cycle, use a backup birth control method such as a diaphragm or condom with spermicide.

You can forget to replace your patch after 3 weeks.

  • Apply a fresh patch on the day you normally change your patch if it's been 24 to 48 hours since it was last changed.
  • Apply a fresh patch if it's been over 48 hours since you last changed your patch. Start a brand new cycle that day. (3 weeks of wearing the weekly patch, followed by 1 week without). During the first seven days, use a backup birth control.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Don't smoke when using levonorgestrel or ethinyl estradiol. This is especially true if you are more than 35 years old.Grapefruit can cause unwanted side effects when combined with levonorgestrel or ethinyl estradiol. Use grapefruit-based products sparingly.The medicine can cause darkening on your face (chloasma), especially if it has happened before during pregnancy. Avoid tanning or sunlight. When you're outdoors, use sunscreen with SPF 30 or greater.Applying makeup, lotions, or powders to your skin after applying a patch is not recommended.

Interaction with other drug

Some drugs may affect the effectiveness of hormonal birth control, which can lead to pregnancy. Inform your doctor of all other medications, including:

  • Bosentan, st. John's wort;
  • Antibiotic or antifungal medicine: fluconazole, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampin, and voriconazole;
  • Antiviral medicines to treat hiv and hepatitis c: atazanavir (boceprevir), darunavir (efavirenz), etravirine (fosamprenavir), lopinavir (nelfinavir), nevirapine (lopinavir), telaprevir, and tipranavir
  • Cholesterol medicine—atorvastatin, rosuvastatin,
  • Seizure medicine: carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rufinamide, and topiramate.

The list of drugs that can affect levonorgestrel or ethinyl estradiol is far from complete. These include prescription, over-the-counter, vitamin, and herb products. This list does not include all possible drug interactions.

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