Norgestimate Ethinyl Estradiol

Norgestimate-Ethinyl Estradiol is a prescription birth control pill used to help prevent pregnancy. It is a combined oral contraceptive containing norgestimate 0.25 mg, a progestin, and ethinyl estradiol 0.035 mg, an estrogen.

• It mainly works by preventing ovulation.
• It also changes cervical mucus, making it harder for sperm to reach an egg.
• Each pack contains 21 active hormonal tablets followed by 7 inactive reminder tablets.
• It is taken every day rather than only when you have sex.
• It does not protect against HIV or other sexually transmitted infections.
• It is not intended for emergency contraception.

A healthcare provider should review your health history, smoking status, and current medications before prescribing this type of birth control.

Take one tablet by mouth every day at about the same time, following the order shown in your pack. You take 21 active tablets followed by 7 inactive reminder tablets, then start your next pack on schedule without adding extra days between packs.

• Taking the active pills consistently is important for maintaining pregnancy protection.
• The 7 reminder tablets do not contain contraceptive hormones.
• Missing one active pill is handled differently from missing two or more pills.
• Backup contraception may be needed in some missed-pill situations.
• Special instructions apply when first starting the medication, switching birth control methods, vomiting, or having diarrhea.

Follow the Patient Information that comes with your medication for detailed starting and missed-pill instructions. Contact your healthcare provider or pharmacist if you are unsure what to do.

Possible side effects include nausea or vomiting, breast tenderness, spotting or changes in menstrual bleeding, abdominal discomfort, weight changes, migraine, and mood changes. Some people may also have a lighter period 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 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 take so your provider can decide whether this birth control pill is appropriate for you.

For this specific product, the prescribing information lists pregnancy prevention as the approved use. It does not list acne treatment as an indication. Other birth control products containing norgestimate and ethinyl estradiol may have different FDA-approved uses, so those claims should not automatically be applied to this medication. If acne treatment is one of your goals, tell your healthcare provider so they can discuss options that are appropriate for you.

If you miss one active pill, take it as soon as you remember and take your next pill at the usual time. This can mean taking two pills in one day. Backup contraception is not required for one missed active pill. Instructions are different if you miss two or more pills, so follow the Patient Information or contact your healthcare provider or pharmacist.

The light green reminder pills do not contain contraceptive hormones. If you miss one, discard the missed pill and continue taking the remaining tablets on schedule. Backup contraception is not required because of a missed reminder pill. Be sure to start your next pack on time after finishing the reminder-pill portion of your current pack.

Vomiting or diarrhea may affect how reliably an active pill is absorbed and could reduce pregnancy protection. The Patient Information recommends using backup contraception until you have checked with a healthcare professional. Continue following your pack unless your provider tells you otherwise, and contact them for guidance if vomiting or diarrhea continues.

A missed 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.

Yes. Some medicines and supplements can reduce pregnancy protection. Examples include rifampin, certain seizure medicines, and St. John’s wort. Backup contraception may sometimes be needed. Not all antibiotics have this effect, so tell your healthcare provider and pharmacist about everything you take rather than stopping or changing another medicine on your own.

NORGESTIMATE AND ETHINYL ESTRADIOL Tablets USP, 0.25 mg/0.035 mg / Source: DailyMed

Link: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=beabee48-1912-47bf-a9b5-d5c426c4fcc2&type=display / Published: April 13, 2012