ethinyl estradiol and etonogestrel (vaginal ring)

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Pronunciation: ETH in il es tra DYE ole and et oh noe JES trel

Brand: NuvaRing

What is the most important information I should know about this medicine?

Do not use this medicine if you are pregnant or if you have recently had a baby.

You should not use this medicine if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not use the vaginal ring if you smoke and are older than 35 years of age.

What is ethinyl estradiol and etonogestrel?

The ethinyl estradiol and etonogestrel vaginal ring contains female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and etonogestrel vaginal ring is used as contraception to prevent pregnancy.

Ethinyl estradiol and etonogestrel may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using this medicine?

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using the vaginal ring. Your risk is also high when you insert a new ring after not wearing one for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use the vaginal ring if you smoke and are older than 35 years of age.

This medicine can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using an ethinyl estradiol and etonogestrel vaginal ring.

You should not use the ethinyl estradiol and etonogestrel vaginal ring if you have:

  • untreated or uncontrolled high blood pressure;
  • heart disease (coronary artery disease; uncontrolled heart valve disorder; history of heart attack, stroke, or blood clot);
  • a blood-clotting disorder or circulation problems;
  • problems with your eyes, kidneys or circulation caused by diabetes;
  • a history of hormone-related cancer such as breast or uterine cancer;
  • unusual vaginal bleeding that has not been checked by a doctor;
  • severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
  • liver disease or liver cancer; or
  • if you smoke and are over 35 years old.

To make sure the vaginal ring is safe for you, tell your doctor if you have:

  • high blood pressure, high cholesterol or triglycerides;
  • depression;
  • diabetes, underactive thyroid, gallbladder disease;
  • seizures, epilepsy, or migraine headaches;
  • a history of irregular menstrual cycles, toxic shock syndrome, or easy vaginal irritation;
  • a history of jaundice caused by pregnancy or birth control pills;
  • a family history of breast cancer;
  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram; or
  • if you have recently had a miscarriage or abortion during the first trimester of pregnancy.

The hormones in this medicine can pass into breast milk and may harm a nursing baby. These hormones may also slow breast milk production. Do not use if you are breast feeding a baby.

How should I use this medicine?

Follow all directions on your prescription label. Do not wear more than one ring at a time. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Your doctor will tell you which day to insert the first vaginal ring you use. During the first 7 days, you may need to use back-up birth control (condoms or spermicide, but not a diaphragm).

The vaginal ring will not prevent pregnancy if you wear it only during intercourse. You must wear the ring around-the-clock for 3 full weeks (21 days).

Remove the ring on the same day of the week it was inserted, at about the same time of day. Wait 7 full days before inserting a new ring. Avoid leaving the vaginal ring in place for longer than 3 weeks. Call your doctor if you get off schedule.

The ring should stay in place during sexual intercourse. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse. Do not leave the ring out for longer than 3 hours.

You may have breakthrough bleeding. Tell your doctor if this bleeding continues or is very heavy.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using the vaginal ring.

Store unused vaginal rings for up to 4 months at room temperature. Protect from heat and light. To dispose of a used vaginal ring, place it in the foil pouch it came in and throw it away where children and pets cannot get to it. Do not flush the ring down a toilet.

What happens if I miss a dose?

If a ring falls out during the 3-week wearing time, rinse it with warm water and reinsert it. If the ring is lost or broken, insert a new ring as soon as possible and stay on the same schedule you started. Do not leave a ring out for longer than 3 hours.

During week 1 or 2: If a ring has been out of the vagina for more than 3 hours, you may not be protected from pregnancy.

During week 3: If a ring has been out of the vagina for more than 3 hours, throw it away. Insert a new ring and start a new 3-week cycle. If the removed ring had been in place for at least 1 week, you may wait another 7 days before you insert a new ring.

Always use back-up birth control until a new or replaced ring has been in place for 7 days in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using this medicine?

Do not smoke while using the vaginal ring, especially if you are older than 35 years of age.

Grapefruit and grapefruit juice may interact with ethinyl estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

This medicine will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of this medicine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot --chest pain, sudden cough, wheezing, coughing up blood, swelling or warmth in one or both legs;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • a change in the pattern or severity of migraine headaches;
  • swelling in your hands, ankles, or feet;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Common side effects may include:

  • headache;
  • vaginal irritation or discharge, pain in your cervix;
  • menstrual cramps;
  • mood changes, decreased sex drive;
  • nausea, vomiting, stomach pain;
  • breast pain or tenderness;
  • acne; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ethinyl estradiol and etonogestrel?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • acetaminophen (Tylenol), aprepitant, ascorbic acid (vitamin C), bosentan (Tracleer), or St. John's wort;
  • phenobarbital (Solfoton) and other barbiturates;
  • an antibiotic or antifungal medicine;
  • cholesterol medication--atorvastatin (Zocor, Vytorin) or rosuvastatin (Crestor);
  • drugs to treat hepatitis C;
  • HIV or AIDS medicine--atazanavir, etravirine, indinavir, ritonavir;
  • medicine to treat tuberculosis; or
  • seizure medications.

This list is not complete. Other drugs may interact with ethinyl estradiol and etonogestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make birth control less effective, which may result in pregnancy. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and etonogestrel.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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