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Norgestimate with ethinyl estradiol

Generic Name: norgestimate with ethinyl estradiol (ess-tra-DYE-ole/nor-JES-ti-mate/ETH-in-il ess-tra-DYE-ole)
Brand Name: Prefest

Norgestimate with ethinyl estradiol and similar medicines may increase the risk of heart attacks, strokes, breast cancer, and blood clots. Cigarette smoking increases these risks. Do not use norgestimate with ethinyl estradiol to prevent heart disease, heart attacks, or strokes.


Norgestimate with ethinyl estradiol is used for:

Treating hot flashes, night sweats, and other symptoms associated with menopause. It is also used to prevent thinning bones (osteoporosis) in women past menopause.

Norgestimate with ethinyl estradiol is an estrogen and progestin combination. It helps maintain 2 female sex hormone levels that fall as a woman reaches menopause.

Do NOT use norgestimate with ethinyl estradiol if:

  • you are allergic to any ingredient in norgestimate with ethinyl estradiol
  • you are pregnant
  • you have a history of problems with the blood vessels in the brain or heart, heart valve problems, heart attack, uncontrolled high blood pressure, abnormal or undiagnosed vaginal bleeding, certain cancers (including breast cancer or endometrial cancer), serious liver problems, blood clots, or have had a stroke
  • you are taking troleandomycin

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using norgestimate with ethinyl estradiol:

Some medical conditions may interact with norgestimate with 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 pregnant, planning to become pregnant or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you smoke cigarettes
  • if you have cancer, diabetes, headaches or migraines, endometriosis, epilepsy, high cholesterol or triglyceride levels in the blood, high blood pressure, recent surgery, breast nodules or abnormal mammogram, depression, gallbladder or kidney disease, irregular menstrual periods, urinary tract bleeding, or obesity
  • if you have heart problems, elevated calcium in the blood, yellowing of the skin or eyes, pancreatitis, or tumors in the uterus

Some MEDICINES MAY INTERACT with norgestimate with ethinyl estradiol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole), aprepitant, bosentan, barbiturates (eg, phenobarbital), carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins, rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease norgestimate with ethinyl estradiol's effectiveness
  • Beta-blockers (eg, metoprolol), corticosteroids (eg, hydrocortisone), cyclosporine, theophyllines, or troleandomycin because the risk of their side effects may be increased by norgestimate with ethinyl estradiol
  • Lamotrigine because its effectiveness may be decreased by norgestimate with ethinyl estradiol

This may not be a complete list of all interactions that may occur. Ask your health care provider if norgestimate with 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 norgestimate with ethinyl estradiol:

Use norgestimate with ethinyl estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with norgestimate with ethinyl estradiol. Talk to your pharmacist if you have questions about this information.
  • Take norgestimate with ethinyl estradiol by mouth with or without food.
  • Norgestimate with ethinyl estradiol can be started either on the first day of your menstrual flow or the first Sunday after the start of your menstrual flow. A second form of birth control should be used during the first month of use.
  • Norgestimate with ethinyl estradiol works best if it is taken at the same time each day, not more than 24 hours apart.
  • If you miss a dose of norgestimate with ethinyl estradiol, take it as soon as you 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 norgestimate with ethinyl estradiol, refer to the patient information that came with norgestimate with ethinyl estradiol.

Ask your health care provider any questions you may have about how to use norgestimate with ethinyl estradiol.

Important safety information:

  • Discontinuing norgestimate with ethinyl estradiol while taking lamotrigine may increase the blood levels of lamotrigine and lead to increased side effects such as nausea, dizziness, and visual disturbances.
  • Norgestimate with 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.
  • If you have vomiting or diarrhea for any reason, your medicine may not work as well.
  • Tell your doctor or dentist that you take norgestimate with ethinyl estradiol before you receive any medical or dental care, emergency care, or surgery.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • Norgestimate with ethinyl estradiol may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to norgestimate with ethinyl estradiol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Use of norgestimate with ethinyl estradiol will not prevent the spread of sexually transmitted diseases (STDs).
  • Taking certain antibiotics, anticonvulsants, and other medicines while you are using norgestimate with ethinyl estradiol may decrease the effectiveness of norgestimate with ethinyl estradiol.To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Norgestimate with ethinyl estradiol should not be used in CHILDREN before menstruation has begun.
  • PREGNANCY and BREAST-FEEDING: Do not use norgestimate with ethinyl estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norgestimate with ethinyl estradiol is found in breast milk. If you are or will be breast-feeding while you use norgestimate with ethinyl estradiol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of norgestimate with 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:

Nausea; vomiting; weight change; bleeding between menstrual periods; breast tenderness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf/leg pain or swelling; changes in vision; chest pain; difficulty wearing contact lenses; dizziness or fainting; headache or sudden severe headache; lumps in the breast; missed menstrual period; numbness of an arm or leg; one-sided weakness; persistent or recurrent abnormal vaginal bleeding; severe stomach pain; slurred speech; swelling of fingers or ankles; trouble breathing or shortness of breath; yellowing 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; vomiting.

Proper storage of norgestimate with ethinyl estradiol:

Store norgestimate with ethinyl estradiol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep norgestimate with ethinyl estradiol out of the reach of children and away from pets.

General information:

  • If you have any questions about norgestimate with ethinyl estradiol, please talk with your doctor, pharmacist, or other health care provider.
  • Norgestimate with 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 norgestimate with 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 norgestimate with ethinyl estradiol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to norgestimate with 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 norgestimate with ethinyl estradiol.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

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.

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