Norethindrone Ethinyl Estradiol

Norethindrone-Ethinyl Estradiol is a prescription birth control pill used to help prevent pregnancy. This 1 mg/0.02 mg product contains norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. It is a generic version of Junel 1/20.

• It is a combined oral contraceptive.
• It mainly works by preventing ovulation.
• It also changes cervical mucus, making it harder for sperm to reach an egg.
• This product contains 21 active hormonal tablets in each pack.
• After the 21 tablets, there are 7 days without tablets before starting the next pack.
• It does not protect against HIV or other sexually transmitted infections.

ake one tablet by mouth every day at about the same time for 21 days. After finishing all 21 tablets, take no tablets for 7 days, then start your next pack on schedule on the eighth day.

• Do not extend the tablet-free period beyond 7 days.
• Taking your active pills consistently is important for maintaining pregnancy protection.
• Missing one pill is handled differently from missing two or more pills.
• Backup contraception may be needed after certain missed-pill situations.
• Special instructions also apply if you vomit, have diarrhea, start your next pack late, or switch from another birth control method.

Possible side effects include nausea or vomiting, headache, breast tenderness, spotting or changes in menstrual bleeding, abdominal discomfort, dizziness, and mood changes. Some people may also have lighter bleeding or occasionally miss a period. This is not a complete list of possible effects.

• Combined birth control pills can increase the risk of serious blood clots, heart attack, and stroke.
• Seek urgent medical care for severe chest pain, sudden shortness of breath, severe leg or calf pain, sudden vision loss, or sudden weakness, numbness, or trouble speaking.
• Contact your healthcare provider if you develop significant new or worsening headaches or other concerning symptoms.
• People over age 35 who smoke cigarettes should not use this medication because smoking increases the risk of serious cardiovascular problems.

See Important Safety Information and full Prescribing Information.

This medication requires a prescription, and your healthcare provider should review your health history before prescribing it. Tell them if you smoke or have a history of blood clots, stroke, heart problems, migraines, high blood pressure, diabetes, liver problems, breast cancer, depression, or unexplained vaginal bleeding. Also mention pregnancy, breastfeeding, recent childbirth, upcoming major surgery, or long periods of limited movement. Share all prescription medicines, over-the-counter products, and supplements you use so your provider can decide whether this combined birth control pill is appropriate for you.

This specific Norethindrone Acetate-Ethinyl Estradiol product contains 21 active hormonal tablets rather than a full 28-day pack of tablets. After you finish the 21 pills, there are 7 days when you do not take a tablet. You then start your next pack on the eighth day. This is different from Junel Fe products, which include reminder tablets during the final week. Follow the instructions for the exact product you receive and do not extend the tablet-free period beyond 7 days.

If you miss one active pill, take it as soon as you remember and take your next pill at the usual time. This may mean taking two pills in one day. According to the Patient Information, backup contraception is not required after one missed pill. Instructions are different if you miss two or more pills, so check the Patient Information or contact your healthcare provider or pharmacist if that happens.

Starting your next pack late extends the hormone-free interval beyond the recommended 7 days and may reduce pregnancy protection. Start the new pack as soon as possible and follow the Patient Information for backup contraception instructions. If you had sex without backup contraception during the extended break or are unsure how late you are, contact your healthcare provider or pharmacist for guidance.

Vomiting or diarrhea may affect how reliably your body absorbs an active pill and could reduce pregnancy protection. The Patient Information recommends using backup contraception in this situation until you have checked with a healthcare professional. Continue following your pack unless your provider gives you different instructions, and contact them if vomiting or diarrhea continues.

A missed withdrawal period does not always mean you are pregnant. However, pregnancy should be considered if you miss a period after not taking your pills correctly. If you miss two periods in a row even though you took your pills as directed, contact your healthcare provider so pregnancy can be ruled out before continuing to rely on the pill.

Yes. Some medicines can reduce pregnancy protection. Rifampin and certain seizure medicines are examples listed in the prescribing information, and backup contraception may sometimes be needed. Not all antibiotics have this effect. Tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter product, and supplement you take rather than stopping or changing another medicine on your own.

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Tablets USP, 1 mg/0.02 mg / Source: DailyMed

Link: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=89948751-bd6e-4e9c-b87c-8782706c1097 / Published: January 15, 2024