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Norgestimate and ethinyl estradiol

Generic Name: norgestimate and ethinyl estradiol (nor-JES-ti-mate/ETH-i-nil ES-tra-DYE-ol)
Brand Name: Examples include Ortho-Cyclen and Tri-Sprintec

Cigarette smoking increases the risk of serious heart problems associated with use of norgestimate and ethinyl estradiol. This risk increases with age and with heavy smoking. Women who are older than 35 years old have a greater risk. Women who are older than 35 years old and smoke should not use norgestimate and ethinyl estradiol.


Norgestimate and ethinyl estradiol is used for:

Preventing pregnancy. It may also be used to treat acne in certain patients. It may also be used for other conditions as determined by your doctor.

Norgestimate and ethinyl estradiol is an estrogen and progestin combination. It works by preventing ovulation. It may also change the cervical mucus to prevent the sperm from reaching the egg and change the lining of the uterus to prevent a fertilized egg from implanting in the uterus.

Do NOT use norgestimate and ethinyl estradiol if:

  • you are allergic to any ingredient in norgestimate and ethinyl estradiol
  • you are pregnant or think you may be pregnant
  • you have blood clots (eg, in the legs, lungs, eyes) or a history of blood clots or blood clotting problems
  • you have chest pain caused by angina or a history of heart or brain blood vessel problems, heart attack, or stroke
  • you have known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
  • you have a history of breast cancer
  • you have abnormal vaginal bleeding of an unknown cause
  • you have certain heart valve problems, diabetes that affects circulation, uncontrolled high blood pressure, liver disease, or liver tumor or cancer, or a history of yellowing of the eyes or skin during pregnancy or previous birth control use
  • you have certain types of headaches or migraines with aura
  • you have had surgery and are or will be confined to a bed or a chair for an extended period of time
  • you are older than 35 years old and you smoke

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

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using norgestimate and ethinyl estradiol:

Some medical conditions may interact with norgestimate and 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 have a history of porphyria, diabetes or high blood sugar, gallbladder problems, heart problems (eg, angina), high blood pressure, high cholesterol or triglycerides, high blood calcium levels, kidney or liver problems, mental or mood problems (eg, depression), migraines or headaches, pancreas problems, or seizures
  • if you have endometriosis, growths in the uterus, an abnormal mammogram, irregular menstrual periods, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
  • if a family member has a history of high blood triglyceride levels
  • if you will be confined to a bed or chair for an extended period of time (eg, because of surgery or a long airplane ride)
  • if you smoke, are very overweight, or have fluid retention or swelling problems

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

  • Atorvastatin, azole antifungals (eg, ketoconazole), nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, etravirine, nevirapine), protease inhibitors (eg, boceprevir, ritonavir), or rosuvastatin because they may decrease norgestimate and ethinyl estradiol's effectiveness, resulting in pregnancy or breakthrough bleeding, or they may increase the risk of norgestimate and ethinyl estradiol's side effects
  • Acitretin, aprepitant, armodafinil, barbiturates (eg, phenobarbital), bosentan, carbamazepine, clobazam, colesevelam, felbamate, griseofulvin, hydantoins (eg, phenytoin), mifepristone, modafinil, oxcarbazepine, rifamycins (eg, rifampin), rufinamide, St. John's wort, topiramate, or troglitazone because they may decrease norgestimate and ethinyl estradiol's effectiveness
  • Cyclosporine, prednisolone, theophylline, tizanidine, or voriconazole because the risk of their side effects may be increased by norgestimate and ethinyl estradiol
  • Clofibric acid, lamotrigine, morphine, temazepam, thyroid hormones (eg, levothyroxine), or valproic acid because their effectiveness may be decreased by norgestimate and ethinyl estradiol

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

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

  • An extra patient leaflet is available with norgestimate and ethinyl estradiol. Talk to your pharmacist if you have questions about this information.
  • Take norgestimate and ethinyl estradiol by mouth with or without food.
  • Eating grapefruit or drinking grapefruit juice while you are taking norgestimate and ethinyl estradiol may increase the amount of norgestimate and ethinyl estradiol in your blood, which may increase your risk for side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • If you also take colesevelam, take it 4 hours before or after you take norgestimate and ethinyl estradiol.
  • Talk with your doctor about how you should start to take your first pack of norgestimate and ethinyl estradiol. Take norgestimate and ethinyl estradiol at the same time each day. Take the tablets in the order directed on the blister pack. After taking the last pill in the pack, start taking the first pill from the new pack the very next day.
  • Norgestimate and ethinyl estradiol may not be effective for up to 7 days after you begin taking the first cycle of pills. Use a back-up method of birth control for the first 7 days after you start norgestimate and ethinyl estradiol.
  • For norgestimate and ethinyl estradiol to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
  • Severe vomiting or diarrhea may decrease norgestimate and ethinyl estradiol's effectiveness. Use a back-up method of birth control until you check with your doctor.
  • If you miss a dose of norgestimate and 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 and ethinyl estradiol, read the extra patient information leaflet that comes with norgestimate and ethinyl estradiol or contact you doctor for instructions. You must use a backup method of birth control if you miss more than 1 active dose of norgestimate and ethinyl estradiol. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

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

Important safety information:

  • Norgestimate and 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. Do not smoke or use other tobacco products while taking norgestimate and ethinyl estradiol.
  • Bleeding or spotting may occur while you are taking norgestimate and ethinyl estradiol, especially during the first 3 months. Do not stop taking norgestimate and ethinyl estradiol if this occurs. If bleeding or spotting is persistent or if it occurs after menstrual cycles that were previously regular, contact your doctor.
  • If you miss more than 2 periods in a row or if you miss 1 period when you have not taken your pills correctly, contact your doctor. Also, if you have morning sickness or unusual breast tenderness, contact your doctor. You may be pregnant if any of these occur.
  • You should usually not take norgestimate and ethinyl estradiol within 4 weeks after giving birth or after a second-trimester abortion. Talk with your doctor about how to start taking norgestimate and ethinyl estradiol in these instances.
  • 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 norgestimate and ethinyl estradiol before you receive any medical or dental care, emergency care, or surgery. If possible, norgestimate and ethinyl estradiol should be stopped at least 4 weeks before through 2 weeks after surgery or any time you might be confined to a bed or chair for a long period of time (eg, long plane flight, bedrest, lengthy illness).
  • Norgestimate and 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.
  • You may experience a delay in being able to become pregnant after stopping norgestimate and ethinyl estradiol. This effect may be greater in patients who had irregular periods before starting norgestimate and ethinyl estradiol. Discuss any concerns with your doctor or pharmacist.
  • Certain antibiotics, anticonvulsants, and other medicines may decrease the effectiveness of norgestimate and ethinyl estradiol. Ask your pharmacist if you have questions about which medicines may decrease norgestimate and ethinyl estradiol's effectiveness. To prevent pregnancy while taking these medicines, use an extra form of birth control (eg, condoms). You may also need to use an extra form of birth control for a period of time after you stop taking these medicines. Check with your doctor for more information.
  • If you wear contact lenses and you develop problems with them or other vision changes, contact your doctor.
  • Norgestimate and ethinyl estradiol may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
  • Diabetes patients - Norgestimate and ethinyl estradiol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Norgestimate and ethinyl estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking norgestimate and ethinyl estradiol.
  • Lab tests, including breast exams, PAP tests, physicals, and blood pressure, may be performed while you use norgestimate and 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.
  • Norgestimate and ethinyl estradiol should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use norgestimate and ethinyl estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norgestimate and ethinyl estradiol is found in breast milk. If you are or will be breast-feeding while you use norgestimate and ethinyl estradiol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of norgestimate and 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:

Breast tenderness; bleeding or spotting between menstrual periods; headache; nausea; stomach cramps and bloating; vomiting; weight changes.

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); breast lumps, pain, or discharge; bulging eyes; calf or leg pain, swelling, redness, or tenderness; changes in vision (eg, double vision, vision loss); change in the amount of urine produced; chest pain or pressure; coughing up blood; fainting; fever; mental or mood changes (eg, depression); severe stomach pain or tenderness; severe or persistent dizziness or headache; shortness of breath; sudden, severe nausea or vomiting; swelling of fingers, hands, legs, or ankles; symptoms of liver problems (eg, dark urine, fever, loss of appetite, pale stools, unusual tiredness, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual sweating; unusual or severe vaginal bleeding; vaginal irritation or discharge.

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.

Proper storage of norgestimate and ethinyl estradiol:

Store norgestimate and 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 and ethinyl estradiol out of the reach of children and away from pets.

General information:

  • If you have any questions about norgestimate and ethinyl estradiol, please talk with your doctor, pharmacist, or other health care provider.
  • Norgestimate and 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 and 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 and 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 and 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 health care provider for complete information about the risks and benefits of using norgestimate and ethinyl estradiol.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
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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