Lice Buyer's Guide: Treatment Product Reviews Go Now

Norethindrone/ ethinyl estradiol chewable tablets

Generic Name: norethindrone/ethinyl estradiol (nor-ETH-in-drone/ETH-i-nil ES-tra-DYE-ol/FER-us FUE-ma-rate)
Brand Name: Lo Minastrin Fe

Cigarette smoking increases the risk of serious heart problems associated with use of norethindrone/ethinyl estradiol chewable tablets. 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 norethindrone/ethinyl estradiol chewable tablets.


Norethindrone/ ethinyl estradiol chewable tablets is used for:

Preventing pregnancy. It may be used for other conditions as determined by your doctor.

Norethindrone/ethinyl estradiol chewable tablets is a combination progesterone and estrogen birth control pill. It also contains iron. It works by preventing ovulation. It may also change 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 norethindrone/ ethinyl estradiol chewable tablets if:

  • you are allergic to any ingredient in norethindrone/ethinyl estradiol chewable tablets
  • you are pregnant or think you may be pregnant
  • you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), or certain blood vessel problems (eg, in the brain or heart, bleeding in the brain, heart attack, stroke)
  • you have a history of breast cancer; endometrial, cervical, or vaginal cancer; or estrogen-dependent or progestin-dependent cancer
  • you have certain types of headaches or migraines; uncontrolled high blood pressure; undiagnosed abnormal vaginal bleeding; or diabetes that affects circulation, nerves, eyes, or kidneys
  • you have liver disease or liver tumors
  • you have certain heart problems (eg, heart valve problems, certain types of irregular heartbeat)
  • 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
  • you are older than 35 years old and you have migraines

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 norethindrone/ ethinyl estradiol chewable tablets:

Some medical conditions may interact with norethindrone/ethinyl estradiol chewable tablets. 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 endometriosis, growths in the uterus, 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 you have a history of heart problems (eg, heart failure, angina), depression, diabetes or high blood sugar, headaches or migraines, gallbladder problems, high blood cholesterol or lipid levels, high blood pressure, kidney or liver problems, blood or bleeding problems, chloasma (dark skin patches), chorea (jerky, involuntary movements of the face, arms, or legs), varicose veins, thyroid problems, pancreas problems (eg, pancreatitis), seizures, a condition called hereditary angioedema, or cancer
  • if a family member has a history of high blood triglyceride levels
  • if you smoke, are very overweight, are past menopause or you have not yet had your first menstrual period, or have fluid retention or swelling problems
  • if you have a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use
  • if you have given birth or otherwise ended a pregnancy within the past 4 weeks

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

  • Atorvastatin or tranexamic acid because they may increase the risk of norethindrone/ethinyl estradiol chewable tablets's side effects
  • Azole antifungals (eg, ketoconazole), nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, efavirenz), or protease inhibitors (eg, boceprevir, ritonavir) because they may decrease norethindrone/ethinyl estradiol chewable tablets's effectiveness, resulting in pregnancy or breakthrough bleeding, or they may increase the risk of norethindrone/ethinyl estradiol chewable tablets's side effects
  • Acitretin, aprepitant, armodafinil, barbiturates (eg, phenobarbital), bosentan, carbamazepine, clobazam, dabrafenib, felbamate, griseofulvin, hydantoins (eg, phenytoin), mifepristone, modafinil, oxcarbazepine, rifamycins (eg, rifampin), rufinamide, St. John's wort, topiramate, or troglitazone because they may decrease norethindrone/ethinyl estradiol chewable tablets's effectiveness, resulting in breakthrough bleeding or pregnancy
  • Corticosteroids (eg, prednisolone), cyclosporine, lomitapide, theophylline, tizanidine, troleandomycin, or voriconazole because the risk of their side effects may be increased by norethindrone/ethinyl estradiol chewable tablets
  • Lamotrigine, methyldopa, penicillamine, tetracyclines (eg, doxycycline), thyroid hormones, or valproic acid because their effectiveness may be decreased by norethindrone/ethinyl estradiol chewable tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if norethindrone/ethinyl estradiol chewable tablets 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 chewable tablets:

Use norethindrone/ethinyl estradiol chewable tablets 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 chewable tablets. Talk to your pharmacist if you have questions about this information.
  • Take norethindrone/ethinyl estradiol chewable tablets by mouth with or without food.
  • Chew and swallow the blue tablet as directed followed by a full glass of water. The white tablet and the brown tablet are swallowed whole.
  • Talk with your doctor about how you should start to take your first pack of norethindrone/ethinyl estradiol chewable tablets. Take norethindrone/ethinyl estradiol chewable tablets 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.
  • Norethindrone/ethinyl estradiol chewable tablets 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 norethindrone/ethinyl estradiol chewable tablets.
  • If you are switching from another birth control pill to norethindrone/ethinyl estradiol chewable tablets, start norethindrone/ethinyl estradiol chewable tablets on the same day that you would have started a new pack of your previous birth control pills. If you are switching to norethindrone/ethinyl estradiol chewable tablets from another type of hormonal birth control (eg, patch, vaginal ring), ask your doctor or pharmacist about when to start taking norethindrone/ethinyl estradiol chewable tablets.
  • Severe vomiting or diarrhea may decrease norethindrone/ethinyl estradiol chewable tablets's effectiveness. Talk with your doctor about what to do if severe vomiting or diarrhea occurs while you take norethindrone/ethinyl estradiol chewable tablets. If you vomit or have diarrhea within 3 to 4 hours after you take norethindrone/ethinyl estradiol chewable tablets, this should be considered a missed dose.
  • For norethindrone/ethinyl estradiol chewable tablets 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.
  • If you also take colesevelam, take it 4 hours before or after you take norethindrone/ethinyl estradiol chewable tablets.
  • On the days you take the brown tablets (iron), certain other medicines should not be taken at the same time. If you take antacids, bisphosphonates (eg, etidronate), cephalosporins (eg, cefdinir), methyldopa, quinolones (eg, ciprofloxacin), tetracyclines (eg, minocycline), thyroid hormones (eg, levothyroxine), or thrombopoietin mimetics (eg, eltrombopag), ask your doctor or pharmacist how to take them with the iron tablets.
  • If you miss a dose of norethindrone/ethinyl estradiol chewable tablets, take it as soon as possible. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup form of birth control if you only miss 1 pill. If you miss more than 1 dose, read the extra patient information leaflet that comes with norethindrone/ethinyl estradiol chewable tablets or contact your doctor for instructions. You must use a backup form of birth control (eg, condom, spermicides) if you miss more than 1 dose. 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 norethindrone/ethinyl estradiol chewable tablets.

Important safety information:

  • Norethindrone/ethinyl estradiol chewable tablets may increase the risk of a stroke, a heart attack, blood clots, high blood pressure, or similar problems. The risk is greater if you smoke. Do not smoke or use other tobacco products while taking norethindrone/ethinyl estradiol chewable tablets.
  • Bleeding or spotting may occur while you are taking norethindrone/ethinyl estradiol chewable tablets, especially during the first 3 months. Do not stop taking norethindrone/ethinyl estradiol chewable tablets 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.
  • Tell your doctor or dentist that you take norethindrone/ethinyl estradiol chewable tablets before you receive any medical or dental care, emergency care, or surgery. If possible, norethindrone/ethinyl estradiol chewable tablets 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).
  • You should usually not take norethindrone/ethinyl estradiol chewable tablets within 4 weeks after giving birth or after a second-trimester abortion. Talk with your doctor about how to start taking norethindrone/ethinyl estradiol chewable tablets in these instances.
  • If you start to take norethindrone/ethinyl estradiol chewable tablets after giving birth and you have not yet had a period, use an extra form of birth control for 7 days after you start to take norethindrone/ethinyl estradiol chewable tablets.
  • Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.
  • Norethindrone/ethinyl estradiol chewable tablets may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
  • You may experience a delay in being able to become pregnant after stopping norethindrone/ethinyl estradiol chewable tablets. This effect may be greater in patients who had irregular periods before starting norethindrone/ethinyl estradiol chewable tablets. Discuss any concerns with your doctor or pharmacist.
  • Norethindrone/ethinyl estradiol chewable tablets does not stop the spread of HIV and other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not run out of medicine. Your chance of becoming pregnant may be increased if you do not take norethindrone/ethinyl estradiol chewable tablets every day as directed.
  • Certain antibiotics, anticonvulsants, and other medicines may decrease the effectiveness of norethindrone/ethinyl estradiol chewable tablets. Ask your pharmacist if you have questions about which medicines may decrease norethindrone/ethinyl estradiol chewable tablets'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.
  • Diabetes patients - Norethindrone/ethinyl estradiol chewable tablets 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 chewable tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking norethindrone/ethinyl estradiol chewable tablets.
  • Lab tests, including breast exams, Pap tests, and blood pressure may be performed while you use norethindrone/ethinyl estradiol chewable tablets. 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 chewable tablets 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 norethindrone/ethinyl estradiol chewable tablets if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norethindrone/ethinyl estradiol chewable tablets is found in breast milk. Do not breast-feed while taking norethindrone/ethinyl estradiol chewable tablets.

Possible side effects of norethindrone/ ethinyl estradiol chewable tablets:

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:

Acne; bleeding or spotting between menstrual periods; bloating; breast tenderness; headache; mild stomach pain; nausea; weight changes; vomiting.

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; unusual hoarseness); bulging eyes; breast pain, lumps, or discharge; calf or leg pain, swelling, or tenderness; change in amount of urine produced; chest pain or pressure; confusion; coughing of blood; fainting; irregular heartbeat; left-sided jaw, neck, shoulder, or arm pain; mental or mood changes (eg, anxiety, depression); migraines; missed menstrual period; numbness or weakness of an arm or leg; one-sided weakness; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe or persistent trouble sleeping; severe stomach pain or tenderness; shortness of breath; slurred speech; sudden, severe vomiting; swelling of the fingers, hands, legs, or ankles; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual or severe vaginal bleeding; unusual tiredness or weakness, vaginal irritation or discharge; vision changes (eg, sudden vision loss, double vision).

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 norethindrone/ethinyl estradiol chewable tablets:

Store norethindrone/ethinyl estradiol chewable tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep norethindrone/ethinyl estradiol chewable tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about norethindrone/ethinyl estradiol chewable tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Norethindrone/ethinyl estradiol chewable tablets 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 chewable tablets 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 chewable tablets. 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 chewable tablets. 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 chewable tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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.

Hide
(web4)