Ethinyl estradiol and etonogestrel (Vaginal route)
e-toe-noe-JES-trel, ETH-i-nil es-tra-DYE-ol
- Insert, Extended Release
Warnings:Vaginal route(Insert, Extended Release)
Women over 35 years old who smoke should not use etonogestrel/ethinyl estradiol vaginal ring. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use .
Uses of This Medicine:
Etonogestrel and ethinyl estradiol combination is used to prevent pregnancy. It is a flexible birth control vaginal ring that contains two types of hormones, etonogestrel and ethinyl estradiol. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than vaginal rings. Discuss your options for birth control with your doctor.
This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies on the relationship of age to the effects of etonogestrel and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.
Appropriate studies on the relationship of age to the effects of etonogestrel and ethinyl estradiol combination have not been performed in the geriatric population. This medicine should not be used in elderly women.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Paclitaxel Protein-Bound
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Eslicarbazepine Acetate
- Mycophenolate Mofetil
- Mycophenolic Acid
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
- Breast cancer, or history of or
- Diabetes with kidney, eye, nerve, or blood vessel damage or
- Heart attack, history of or
- Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
- Hypertension (high blood pressure), poorly controlled or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Liver disease, including tumors or cancer or
- Major surgery in near future, with prolonged periods of immobilization or
- Migraine headache or
- Stroke, history of or
- Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
- Angioedema (swelling of the face, tongue, or throat), inherited or
- Chloasma gravidarum (skin disorder during pregnancy), history of or
- Cholestasis (bile problem) during pregnancy, history of or
- Cervical cancer or
- Depression, history of or
- Gallbladder disease or
- Hypertension (high blood pressure) or
- Toxic shock syndrome, history of or
- Vaginal or cervical erosion or ulcers—Use with caution. May make these conditions worse.
- Diabetes or
- Hyperlipidemia (high cholesterol or fats in the blood), or family history of or
- Kidney disease or
- Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.
Proper Use of This Medicine:
To make using vaginal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.
This combination medicine is in a ring that is placed into your vagina and releases small amounts of medicine that is absorbed into your body.
It is important to know how and when to insert, remove, or replace NuvaRing®. Read and follow the patient instructions carefully. Ask your doctor or pharmacist if you have any questions.
NuvaRing® is used in a 4 week cycle. You must insert it in the vagina on the appropriate day and keep it in place for 3 weeks. Then, remove the vaginal ring 3 weeks later on the same day of the week it was inserted and at about the same time. During the 1-week break, you will usually have your menstrual period.
While using this medicine, do not use a vaginal diaphragm. Instead, use a male condom with spermicide as an additional form of birth control method during the first 7 days to prevent pregnancy.
If you are switching from a combination hormonal method (eg, pills, patch) to using NuvaRing®, start using this medicine on any day. Do not start using this medicine any later than the day you would start your next birth control pill or patch.
If you are switching from a progestin-only method (eg, progestin-only pill, implant, injection, intrauterine system) to using NuvaRing®, start using it on the day after you used your last progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use an additional barrier method of birth control (eg, male condom with spermicide) for the first 7 days.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Your doctor may ask you to start using the vaginal ring on the first day of your menstrual period called First day start. You may also start on Day 2 to Day 5 of your menstrual period, but you need to use an extra form of birth control (eg, male condoms with spermicide) for the first 7 days of NuvaRing® use in the first cycle.
- For vaginal dosage form (ring):
- For contraception (to prevent pregnancy):
- Adults—One ring inserted into the vagina. The ring must remain in place continuously for 3 weeks, followed by 1 week ring-free interval. Then, a new ring is inserted 1 week after the last ring was removed.
- Children—Use and dose must be determined by your doctor.
- For contraception (to prevent pregnancy):
Call your doctor or pharmacist for instructions.
If NuvaRing® has slipped out of the vagina and it has been out less than 3 hours, you should still be protected from pregnancy. If NuvaRing® has been out of the vagina for more than 3 hours, you may not adequately be protected from pregnancy, and must use an extra method of birth control until NuvaRing® has been in place for 7 days in a row.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store this medicine for up to 4 months after you receive it.
Place the used NuvaRing® in the re-sealable foil pouch and put it in a thrash can where children and pets cannot get to it. Do not flush the ring down the toilet.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular annual visits to make sure this medicine is working properly and does not cause unwanted effects. Your doctor may also want to check your blood pressure while using this medicine.
Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.
- If this should occur, continue using NuvaRing®.
- The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
- If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.
You may be pregnant if:
- You miss a period and NuvaRing® was out of the vagina for more than 3 hours during the 3 weeks of ring use
- You miss a period and waited longer than 1 week to insert a new ring
- You missed two periods in a row
- You have left NuvaRing® in place for longer than 4 weeks.
If you suspect that you may be pregnant, stop using this medicine immediately and check with your doctor.
Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using NuvaRing®, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.
Toxic shock syndrome (TSS) may occur while using this medicine. Call your doctor right away if you have any of the following symptoms: sudden high fever, diarrhea, dizziness, fainting, vomiting, muscle aches, or a sunburn-like rash.
Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Using this medicine may increase your risk of breast cancer or cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if you experience abnormal vaginal bleeding.
This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Abdominal or stomach fullness
- abdominal or stomach pain or tenderness usually after eating a meal
- blurred vision
- changes in skin color
- chest pain or discomfort
- gaseous abdominal or stomach pain
- inability to speak
- numbness of the hands
- pain or discomfort in the arms, jaw, back, or neck
- pains in the chest, groin, or legs, especially calves of the legs
- pounding in the ears
- prominent superficial veins over the affected area with tenderness and warmth
- recurrent fever
- severe headaches of sudden onset
- slow or fast heartbeat
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- sudden and severe weakness in the arm or leg on one side
- swelling of the foot or leg on one side of the body
- temporary blindness
- vomiting or vomiting of blood
- yellow eyes or skin
- Symptoms of overdose
- Menstrual changes
- vaginal bleeding
- More common
- itching of the vagina or genital area
- pain during sexual intercourse
- pain or tenderness around the eyes and cheekbones
- sore throat
- stuffy or runny nose
- thick, white vaginal discharge with no odor or with a mild odor
- tightness of the chest
- weight gain
- Less common
- false or unusual sense of well-being
- mental depression
- quick to react or overreact emotionally
- rapidly changing moods, mild feeling of sadness or discouragement that come and go
- Incidence not known
- Absent, missed, or irregular menstrual periods
- bloody vaginal discharge
- brown, blotchy spots on exposed skin
- clay-colored stools
- contact lenses intolerance
- dark urine
- decreased amount or quality of milk
- dry mouth
- dry skin
- fruit-like or unpleasant breath odor
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
- soreness, swelling, or discharge from the breast or breasts
- trouble getting pregnant
- unexplained weight loss
- unusual tiredness or weakness
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014