Generic Name: norethindrone/ethinyl estradiol (nor-eth-IN-drone/ETH-in-il ess-tra-DYE-ole)
Brand Name: Examples include Loestrin 1/20 and Ovcon 35
Cigarette smoking increases the risk of serious heart and blood vessel side effects from birth control pill use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite significant in women older than 35 years of age. Women who use birth control pills are strongly advised not to smoke.
Norethindrone/ethinyl estradiol is used for:
Prevention of pregnancy. It may also be used to regulate the menstrual cycle. It does NOT protect against HIV infection (AIDS) and other sexually transmitted diseases. It may also be used for other conditions as determined by your doctor.
Norethindrone/ethinyl estradiol is a combination of 2 female sex hormones, estrogen and progestin. Norethindrone/ethinyl estradiol works by preventing the ovaries from releasing eggs. When there is no egg to be fertilized, pregnancy cannot occur. It also thickens the cervical mucus, making it difficult for sperm to enter the uterus.
Do NOT use norethindrone/ethinyl estradiol if:
- you are allergic to any ingredient in norethindrone/ethinyl estradiol
- you are pregnant or think you may be pregnant
- you have or have ever had abnormal growth or cancer of the breast, cervical or uterine cancer, or unexplained vaginal bleeding
- you have or have ever had stoppage or rupture of blood vessels in the brain (stroke); blockage of blood vessels (blood clots) in the legs, lungs, heart (heart attack or angina/chest pain), or other parts of the body; heart valve problems; or severe high blood pressure
- you have liver disease, liver tumors, or yellowing of the eyes or skin during pregnancy or during previous use of norethindrone/ethinyl estradiol or a similar medicine
- you are taking acitretin, aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), protease inhibitors (eg, indinavir), rifamycins (eg, rifampin), St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone
Contact your doctor or health care provider right away if any of these apply to you.
Before using norethindrone/ethinyl estradiol:
Some medical conditions may interact with norethindrone/ethinyl estradiol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines or other substances
- if you smoke cigarettes or are 35 years of age or older
- if you have breast nodules, disease of the breast, an abnormal breast x-ray or mammogram, or a strong family history of breast cancer
- if you have vision problems, depression, diabetes, epilepsy (seizures), gallbladder or liver disease, heart problems, high blood pressure, kidney disease, or migraine headaches
- if you have high cholesterol, triglycerides, or calcium in the blood; pancreas disease; obesity; or uterine fibroids or endometriosis
- if you are going to have surgery or you will be on bed rest
Some MEDICINES MAY INTERACT with norethindrone/ethinyl estradiol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Acitretin, aprepitant, azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), protease inhibitors (eg, indinavir), rifamycins (eg, rifampin), St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease norethindrone/ethinyl estradiol's effectiveness. While on these medicines, you will need an alternative form of birth control (eg, condoms) until your next period after stopping these medicines.
- Beta-blockers (eg, metoprolol), cyclosporine, theophyllines, or troleandomycin because the risk of their side effects or toxicity may be increased by norethindrone/ethinyl estradiol
- Corticosteroids (eg, prednisone) because their side effects, including rounding of the face, weight gain, fluid retention, elevated blood pressure, elevated blood sugar, or skin changes, may be increased by norethindrone/ethinyl estradiol
- Oral anticoagulants (eg, warfarin) because their side effects, including risk of bleeding, may be increased by norethindrone/ethinyl estradiol; however, it is also possible that the effectiveness may also be decreased by norethindrone/ethinyl estradiol
- Lamotrigine because its effectiveness may be decreased by norethindrone/ethinyl estradiol; stopping norethindrone/ethinyl estradiol may lead to severe side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if norethindrone/ethinyl estradiol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use norethindrone/ethinyl estradiol:
Use norethindrone/ethinyl estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with norethindrone/ethinyl estradiol. Talk to your pharmacist if you have questions about this information.
- Take norethindrone/ethinyl estradiol by mouth with food.
- If you have trouble remembering to take norethindrone/ethinyl estradiol, talk to your doctor about how to make pill-taking easier or about using another method of birth control.
- Always have another kind of birth control (eg, condoms) to use as a backup in case you miss pills. Also, always keep an extra, full pack of pills.
- Decide what time of day you want to take your medicine. It is important that you take it at about the same time every day.
- Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
- Do not skip pills even if you do not have sex very often.
- If you miss a dose of norethindrone/ethinyl estradiol, take it as soon as your remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of norethindrone/ethinyl estradiol, refer to the patient information that came with norethindrone/ethinyl estradiol or contact your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use norethindrone/ethinyl estradiol.
Important safety information:
- Norethindrone/ethinyl estradiol may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
- There may be times when you may not have regular menstrual periods after you have taken a pack of norethindrone/ethinyl estradiol for a cycle. If you have taken norethindrone/ethinyl estradiol regularly and missed 1 period, keep taking norethindrone/ethinyl estradiol for the next cycle but be sure to tell your doctor first.
- If you have not taken norethindrone/ethinyl estradiol daily as instructed and missed a period, or if you missed 2 consecutive periods, you may be pregnant. You could get pregnant if you have sex in the 7 days after you miss pills. Do not continue to take norethindrone/ethinyl estradiol until you are sure that you are not pregnant, but continue to use another method of birth control (eg, condoms).
- Contact your doctor if you miss any menstrual periods so that the cause may be determined.
- Follow your doctor's instructions to examine your breasts, and report any lumps to your doctor immediately.
- Tell your doctor or dentist that you take norethindrone/ethinyl estradiol before you receive any medical or dental care, emergency care, or surgery.
- If you will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks in advance. Special precautions may be needed.
- Norethindrone/ethinyl estradiol does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
- Taking certain antibiotics or anticonvulsants while you are using norethindrone/ethinyl estradiol may decrease the effectiveness of norethindrone/ethinyl estradiol. To prevent pregnancy, use an additional form of birth control (eg, condoms) until your next menstrual period.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- Norethindrone/ethinyl estradiol may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to norethindrone/ethinyl estradiol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Diabetes patients - Norethindrone/ethinyl estradiol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Norethindrone/ethinyl estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking norethindrone/ethinyl estradiol.
- Lab tests, including PAP tests, may be performed while you use norethindrone/ethinyl estradiol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Norethindrone/ethinyl estradiol should not be used in CHILDREN or before the patient's first menstrual period; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use norethindrone/ethinyl estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norethindrone/ethinyl estradiol is found in breast milk. Do not breast-feed while taking norethindrone/ethinyl estradiol.
Possible side effects of norethindrone/ethinyl estradiol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast tenderness; bleeding between menstrual periods; change in vaginal mucus; headache; loss of scalp hair; nausea; nervousness; rash; spotty darkening of the skin (especially on the face); stomach cramps and bloating; vaginal infection; vomiting; weight or appetite change.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf or leg pain or swelling; chest pain; coughing of blood; dark urine or light-colored bowel movements; depression; dizziness or fainting; fever; heaviness in the chest; lack of energy or fatigue; loss of appetite; mood change; numbness in arm or leg; partial or complete loss of vision or other vision changes; sleeping problems; slurred speech; stomach pain or tenderness; sudden severe headache; sudden shortness of breath; swelling of the fingers or ankles; weakness on one side of the body; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; vaginal bleeding.Proper storage of norethindrone/ethinyl estradiol:
Store norethindrone/ethinyl estradiol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store norethindrone/ethinyl estradiol in the container it came in, tightly closed, away from heat, moisture, and light. Do not store in the bathroom. Keep norethindrone/ethinyl estradiol out of the reach of children and away from pets.
- If you have any questions about norethindrone/ethinyl estradiol, please talk with your doctor, pharmacist, or other health care provider.
- Norethindrone/ethinyl estradiol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take norethindrone/ethinyl estradiol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about norethindrone/ethinyl estradiol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to norethindrone/ethinyl estradiol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using norethindrone/ethinyl estradiol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.