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Ethinyl estradiol and etonogestrel (Vaginal route)

Pronunciation:

e-toe-noe-JES-trel, ETH-i-nil es-tra-DYE-ol

Brand Names:

  • NuvaRing

Dosage Forms:

  • Insert, Extended Release

Warnings:

Vaginal route(Insert, Extended Release)

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke .

Classifications:

Therapeutic—

Contraceptive

Pharmacologic—

Progestin

Uses of This Medicine:

The etonogestrel and ethinyl estradiol vaginal ring is a flexible combination contraceptive vaginal ring. Ethinyl estradiol is a kind of estrogen (ES-troh-jen) and etonogestrel is a kind of progesterone (proe-JES-ter-one). These are both female hormones used for contraception. The etonogestrel and ethinyl estradiol vaginal ring releases these hormones and is used to prevent pregnancy.

Etonogestrel and ethinyl estradiol vaginal ring will not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) . The use of latex (rubber) condoms or abstinence (not having intercourse) is recommended for protection from these diseases.

Etonogestrel and ethinyl estradiol vaginal ring is available only from your doctor or other authorized health care professional.

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:

In deciding whether to use the combined contraceptive vaginal ring as a method of birth control, you need to consider the risks of using it as well as the good it can do. This is a decision you, your sexual partner, and your health care professional will make. For etonogestrel and ethinyl estradiol vaginal ring the following should be considered:

Allergies—

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.

Children—

Studies with this contraceptive ring have been done only in adult patients, and it is not expected to cause different side effects in children than it does in adults. The etonogestrel and ethinyl estradiol vaginal ring is not intended for use in children or adolescents who have not yet started menstruating.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known if this works the same way in younger adults as it does in older adults. There is no specific information comparing the use of etonogestrel and ethinyl estradiol vaginal ring in the elderly with use in other age groups. The etonogestrel and ethinyl estradiol vaginal ring is not intended for use in women older than child-bearing age.

Other medicines—

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.

  • Boceprevir
  • Carbamazepine
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Felbamate
  • Fentanyl
  • Isotretinoin
  • Mitotane
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Piperaquine
  • Theophylline
  • Tizanidine

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.

  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Colesevelam
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etoricoxib
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Ginseng
  • Griseofulvin
  • Lamotrigine
  • Licorice
  • Modafinil
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Roflumilast
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Telaprevir
  • Tipranavir
  • Topiramate
  • Troglitazone
  • Troleandomycin
  • Valdecoxib
  • Voriconazole
  • Warfarin

Other interactions—

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.

  • Caffeine
  • 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 (nonmenstrual)— The use of etonogestrel and ethinyl estradiol vaginal ring may delay diagnosis or worsen this condition. The reason for the bleeding should be determined before etonogestrel and ethinyl estradiol vaginal ring is used.
  • Breast cancer (now or in the past or if suspected) or
  • Cancer of the lining of the uterus, cervix or vagina (now or in the past) or
  • Cancer that worsens when estrogen is present (now or in the past) or
  • Confined to bed or inability to move for long period of time or
  • Coronary artery disease (now or in the past) or
  • Diabetes mellitus with blood vessel problems or
  • Headache (severe) with changes in vision, loss of coordination, inability to move, numbness in arms or legs, or fainting or
  • High blood pressure, severe or
  • Jaundice while using birth control pills or
  • Jaundice during pregnancy or
  • Liver disease (active) or
  • Liver tumors or
  • Surgery (major) or
  • Problems with circulation or blood clots, now or in the past, such as:
  • Blood clots in your brain or
  • Blood clots in your legs or
  • Blood clots in your lungs or
  • Blood clots in your eyes
  • Problems with heart valves—These conditions may increase your chance of serious side effects.
  • Coronary artery disease risk factors such as:
  • Diabetes (sugar diabetes) or
  • High blood pressure or
  • High cholesterol or
  • Obesity—These conditions may increase your chance of serious side effects when using etonogestrel and ethinyl estradiol vaginal ring.
  • Depression or
  • Diabetes mellitus (sugar diabetes) or
  • Headache of type not experience before or
  • High blood pressure or
  • Kidney disease or
  • Migraine headache or
  • Problems with too much insulin in your blood or
  • Problems with too much sugar in your blood—This medication may make this condition worse.
  • Menstrual vaginal bleeding (lack of or heavy)—This problem may occur when contraceptive medicine is stopped, especially if it has happened in the past.
  • Smoking cigarettes—Smoking may increase your chance of serious side effects, especially if you are over 35 years of age or smoke 15 cigarettes or more a day.
  • Swollen ankles, feet, or hands—This medication may make this condition worse. This medicine may also make other medical problems worse when your body keeps too much water or fluid.

Proper Use of This Medicine:

This etonogestrel and ethinyl estradiol vaginal ring comes with patient information. You must understand this information. You should keep a copy for reference. Be sure you understand possible problems with the etonogestrel and ethinyl estradiol vaginal ring , especially side effects, risks, and signs of a serious problem.

It is important to know how and when to insert, remove, or replace etonogestrel and ethinyl estradiol vaginal ring. If you have any questions about this ask your doctor. It is very important to follow the instructions on when to insert and remove your etonogestrel and ethinyl estradiol vaginal ring.

Pregnancy must be ruled out if there is a problem or change in your regimen. It is important to use additional methods of contraception if there was a problem or change in the regimen. Back-up contraception must be used until the ring has been in place for seven days.

Dosing—

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.

  • For vaginal dosage form
    • For preventing pregnancy:
      • Adults—One ring inserted into the vagina for three weeks. The ring is removed for a one week break and the old ring is disposed of. A new ring is inserted one week after the last ring was removed and left in place for three weeks. Note: The ring must be inserted on the appropriate day and left in place for three weeks. This means that the ring is removed three weeks later on the same day of the week it was inserted and at about the same time.

Missed dose—

Call your doctor or pharmacist for instructions.

If the etonogestrel and ethinyl estradiol vaginal ring has slipped out of the vagina and it has been out less than three hours, you should still be protected from pregnancy. If the etonogestrel and ethinyl estradiol vaginal ring has been out of the vagina for more than three hours you may not adequately be protected from pregnancy, and you must use an extra method of birth control until the etonogestrel and ethinyl estradiol vaginal ring has been in place for seven days in a row. For additional information changes or problems with your regimen consult your patient information leaflet or ask your doctor.

Storage—

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.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular annual visits. Your doctor may want to see you more often than once a year.

It is very important that you tell your doctor if you think that you might be pregnant or if you miss a period.

This product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Side Effects of This Medicine:

The risk of serious adverse effects is unlikely for most women using the etonogestrel and ethinyl estradiol vaginal ring. However, oral combination hormonal contraceptives have been associated with unwanted effects which may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not determined
Abdominal fullness
abdominal pain or tenderness usually after eating a meal
blurred vision
changes in skin color
chest pain or discomfort
confusion
constipation
diarrhea
dizziness
gaseous abdominal pain
headache
inability to speak
nausea
nervousness
numbness of hands
pain or discomfort in arms, jaw, back or neck
pain
pains in chest, groin, or legs, especially calves of legs
pounding in the ears
prominent superficial veins over affected area with tenderness and warmth
recurrent fever
seizures
severe headaches of sudden onset
shortness of breath
slow or fast heartbeat
sudden loss of coordination
sudden onset of slurred speech
sudden vision changes
sudden and severe weakness in arm and/or leg on one side
sweating
swelling
swelling of foot or leg on one side of the body
temporary blindness
vomiting or vomiting of blood
yellow eyes or skin
Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Menstrual changes
nausea
vaginal bleeding
vomiting

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:

More Common
Cough
fever
headache
itching of the vagina or genital area
pain during sexual intercourse
pain or tenderness around eyes and cheekbones
sore throat
stuffy or runny nose
thick, white vaginal discharge with no odor or with a mild odor
tightness of chest or wheezing
weight gain
Less common
Crying
depersonalization
false or unusual sense of well-being
hoarseness
mental depression
paranoia
quick to react or overreact emotionally
rapidly changing moods, mild feeling of sadness or discouragement that come and go
Incidence not determined
Absent, missed, or irregular menstrual periods
bloody vaginal discharge
brown, blotchy spots on exposed skin
chills
clay-colored stools
contact lenses intolerance
dark urine
decreased amount or quality of milk
dry mouth
dry skin
fatigue
flushed
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
rash
soreness, swelling, or discharge from the breast or breasts
trouble getting pregnant
unexplained weight loss
unusual tiredness or weakness

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: 4/4/2014

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