ethinyl estradiol and etonogestrel (vaginal ring)
What is the most important information I should know about this medicine?
Do not use the vaginal ring if you are pregnant or if you have recently had a baby.
You should not use this medicine if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Smoking can greatly increase your risk of blood clots, stroke, or heart attack.
What is ethinyl estradiol and etonogestrel?
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?
You should not use the vaginal ring if you have:
- untreated or uncontrolled high blood pressure;
- heart disease (coronary artery disease, a heart valve disorder, history of heart attack, stroke, or blood clot);
- an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
- circulation problems (especially if caused by diabetes);
- a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
- 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;
- if you smoke and are over 35 years old; or
- if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).
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.
Do not use a vaginal ring if you are pregnant, or if you had a baby within the past 4 weeks. Remove the vaginal ring and call your doctor if you become pregnant, or if you miss two menstrual periods in a row.
Tell your doctor if you have ever had:
- heart disease, high blood pressure, or if you are prone to having blood clots;
- high cholesterol or triglycerides (a type of fat in the blood);
- 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.
Using this medicine can increase your risk of blood clots, stroke, or heart attack. This risk 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.
You should not breast-feed while using a ethinyl estradiol and etonogestrel vaginal ring.
How should I use this medicine?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
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). Do not wear more than one ring at a time.
For 7 days after inserting your first vaginal ring, you may need to use back-up birth control (condoms or spermicide, but not a diaphragm or female condom).
After 21 days, remove the ring and wait 7 full days before inserting a new ring. Avoid leaving the ring in place for longer than 3 weeks. Call your doctor if you get off schedule, or if you have trouble removing a vaginal ring.
You may have breakthrough bleeding. Tell your doctor if this bleeding continues or is very heavy.
If you need major surgery or will be on long-term 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 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?
An overdose of ethinyl estradiol and etonogestrel is not expected to be dangerous, but may cause nausea or vaginal bleeding. A broken vaginal ring will not cause an overdose.
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 may interact with ethinyl estradiol and etonogestrel and lead to unwanted side effects. Avoid the use of grapefruit products.
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 --sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
- heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- 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 other drugs you take, which may increase side effects or make the medications less effective.
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;
- efavirenz, nevirapine;
- antiviral medicine to treat hepatitis C or HIV/AIDS --nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir;
- tuberculosis medicine --rifabutin, rifampin; or
- seizure medicine --carbamazepine, felbamate, 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.
This list is not complete and many other drugs may affect ethinyl estradiol and etonogestrel. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your doctor or 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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