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?

You should not use this medicine if you have: 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, or 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.

Do not use a vaginal ring if you have had a baby within the past 4 weeks. Stop using this medicine and call your doctor if you become pregnant, or if you miss two menstrual periods in a row.

You should not use the vaginal ring if you have:

  • untreated or uncontrolled high blood pressure;
  • a heart valve disorder or history of a heart attack, stroke, or blood clot;
  • bleeding 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);
  • 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 ever had:

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

The hormones in this medicine can 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 or female condom).

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).

After 21 days, remove the ring and 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. You may remove the ring, 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. Talk with your doctor.

Store unused vaginal rings at room temperature for up to 4 months. Protect from heat and light. Dispose of a used vaginal ring 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, rinse it with warm water and reinsert it. If the ring is lost or broken, insert a new ring and stay on the same schedule you started. Carefully follow the Patient Instructions about how to replace a ring that has been out of the vagina for more than 3 hours.

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:

  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke or blood clot --sudden numbness or weakness, severe headache, slurred speech, vision loss, chest pain, leg pain or swelling;
  • toxic shock syndrome --sudden fever, body aches, skin rash, vomiting, diarrhea, and feeling dizzy or light-headed;
  • symptoms of depression --mood changes, thoughts about hurting yourself; or
  • liver problems --loss of appetite, upper stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

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

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of ethinyl estradiol, especially:

  • acetaminophen (Tylenol), ascorbic acid (vitamin C), diltiazem;
  • an antibiotic --clarithromycin, erythromycin;
  • antifungal medicine --fluconazole, itraconazole, ketoconazole, voriconazole;
  • cholesterol medication --atorvastatin (Zocor, Vytorin) or rosuvastatin (Crestor); or
  • HIV/AIDS medication --atazanavir, etravirine, indinavir, ritonavir.

Some drugs can make birth control less effective, which may result in pregnancy. Use a barrier form of birth control (a male condom with spermicide, but not a diaphragm or female condom) with the vaginal ring if you also use any of the following medicines:

  • aprepitant, bosentan, griseofulvin, St. John's wort;
  • antiviral medicine to treat hepatitis C or HIV/AIDS --boceprevir, darunavir, efavirenz, fosamprenavir, lopinavir, nevirapine, ritonavir, telaprevir, tipranavir;
  • tuberculosis medicine --rifabutin, rifampin; or
  • seizure medicine --carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rufinamide, topiramate.

Keep using the barrier birth control for at least 28 days after your last dose of any of these medicines.

These lists are not complete and many other drugs can interact with ethinyl estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using.

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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