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All about: Estradiol/Norethindrone Tablets

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Generic Name: Estradiol/Norethindrone Tablets (ES-tra-DYE-ol/nor-ETH-in-drone)
Brand Name: Activella

Estradiol/Norethindrone should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens, with or without progestins, have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Estradiol/Norethindrone. Talk with your doctor if you have questions about the benefits and risks of using Estradiol/Norethindrone.

Estradiol/Norethindrone should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Estradiol/Norethindrone.

Estradiol/Norethindrone is used for:

Treating certain moderate to severe symptoms of menopause (eg, hot flashes; dryness, itching, or burning in or around the vagina). It is also used to prevent osteoporosis (weakened bones) in certain women after menopause. It may also be used for other conditions as determined by your doctor.

Estradiol/Norethindrone is a combination of estrogen and progestin hormones. It works by replacing natural progestin and estrogen in women who can no longer produce enough of these hormones.

Do NOT use Estradiol/Norethindrone if:

  • you are allergic to any ingredient in Estradiol/Norethindrone
  • you are pregnant or think you may be pregnant
  • you have liver problems, undiagnosed abnormal vaginal bleeding, or estrogen-dependent growths
  • you have a history of blood clots (eg, in the lungs, legs, eyes) or breast cancer
  • you have had recent (within the past year) bleeding in the brain, stroke, heart attack, or other serious blood vessel problems

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

Before using Estradiol/Norethindrone:

Some medical conditions may interact with Estradiol/Norethindrone. 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 (eg, corn), or other substances
  • if you have had your uterus removed (hysterectomy), or you have a history of endometrial, cervical, or vaginal cancer; endometriosis; growths in the uterus; uterine fibroids; abnormal mammograms; or lumps in the breast
  • if you have a history of asthma, kidney problems, heart problems (eg, heart failure), high blood pressure, blood vessel problems, heart attack, stroke, high cholesterol or lipid levels, diabetes, depression, dementia, gallbladder problems, or pancreas problems
  • if you have high or low blood calcium levels or a history of cancer, growths in the liver, lupus, blood problems (eg, porphyria), migraine headaches, seizures, thyroid problems, or vision loss
  • if you have a history of fluid retention (swelling) or tobacco use, or if you are very overweight
  • if a member of your family has ever had a blood clot (eg, in the lung, leg)
  • if you have a history of jaundice (yellowing of the eyes or skin) caused by pregnancy or estrogen use
  • 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)

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

  • Troleandomycin because the risk of jaundice (yellowing of the skin or eyes) and liver problems may be increased
  • Macrolide antibiotics (eg, erythromycin) because they may increase the risk of Estradiol/Norethindrone's side effects
  • Azole antifungals (eg, ketoconazole) or HIV protease inhibitors (eg, ritonavir) because they may decrease Estradiol/Norethindrone's effectiveness or increase the risk of Estradiol/Norethindrone's side effects
  • Acitretin, aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John's wort, tetracyclines (eg, doxycycline), or troglitazone because they may decrease Estradiol/Norethindrone's effectiveness
  • Beta-blockers (eg, propranolol), corticosteroids (eg, prednisone), or theophylline because the risk of their side effects may be increased by Estradiol/Norethindrone
  • Lamotrigine or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Estradiol/Norethindrone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Estradiol/Norethindrone 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 Estradiol/Norethindrone:

Use Estradiol/Norethindrone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Estradiol/Norethindrone. Talk to your pharmacist if you have questions about this information.
  • Take Estradiol/Norethindrone by mouth with or without food.
  • When you start a new dispenser of Estradiol/Norethindrone, turn the inner disk so the current day of the week is lined up with the little plastic tab. To take the first tablet, pull the plastic tab up and break it off. Tip the tablet out of the dispenser. Every day after that, turn the outer transparent dial once space clockwise, as shown by the arrow. Tip the tablet for that day out of the dispenser.
  • Grapefruit or grapefruit juice may increase the risk of Estradiol/Norethindrone's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while taking Estradiol/Norethindrone.
  • Take Estradiol/Norethindrone on a regular schedule to get the most benefit from it. Taking Estradiol/Norethindrone at the same time each day will help you remember to take it.
  • Continue to take Estradiol/Norethindrone even if you feel well. Do not miss any doses.
  • If you miss a dose of Estradiol/Norethindrone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Estradiol/Norethindrone.

Important safety information:

  • Estradiol/Norethindrone may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
  • Tell your doctor or dentist that you take Estradiol/Norethindrone before you receive any medical or dental care, emergency care, or surgery. Estradiol/Norethindrone should be discontinued at least 4 to 6 weeks before surgery or any time you will be confined to a chair or bed for a long period of time (eg, a long plane flight). Talk to your doctor about the safe use of Estradiol/Norethindrone if any of these conditions apply to you.
  • Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about whether you should take a calcium and vitamin D supplement while you use Estradiol/Norethindrone.
  • Estradiol/Norethindrone may cause dark patches on your face (melasma). Exposure to the sun may make these patches darker. Ask your doctor whether you should use sunscreen or wear protective clothing when your skin is exposed to the sun, sunlamps, or tanning booths.
  • If you wear contact lenses and you develop problems with them or with your vision, contact your doctor as soon as possible.
  • Diabetes patients - Estradiol/Norethindrone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Estradiol/Norethindrone may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Estradiol/Norethindrone.
  • You should talk with your doctor regularly to determine whether or not you still need to take Estradiol/Norethindrone.
  • Lab tests, including mammograms, Pap smear, and blood pressure, may be performed while you use Estradiol/Norethindrone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • You should perform monthly breast self-exams and receive yearly breast exams from your doctor while you are taking Estradiol/Norethindrone. Talk with your doctor if you are unsure how to properly perform a breast self-exam. Report any lumps to your doctor right away.
  • Estradiol/Norethindrone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not take Estradiol/Norethindrone if you are pregnant. If you think you may become pregnant, contact your doctor right away. Estradiol/Norethindrone is found in breast milk. If you are or will be breast-feeding while you use Estradiol/Norethindrone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Estradiol/Norethindrone:

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:

Back pain; breast tenderness or pain; headache; mild hair loss; nausea; stomach cramps, bloating, or pain; vaginal spotting or breakthrough bleeding; 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; unusual hoarseness); calf or leg pain, swelling, or tenderness; chest pain; confusion; discharge from the nipples; fainting; irregular heartbeat; lumps in the breast; mental or mood changes (eg, depression, irritability, memory loss); numbness of an arm or leg; one-sided weakness; severe or persistent breast pain; severe or persistent dizziness, headache, or stomach pain; severe, persistent, or recurring abnormal vaginal bleeding; speech changes (eg, slurred speech); sudden severe nausea or vomiting; sudden shortness of breath; sudden unusual weight gain; swelling of hands or feet; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include severe or persistent nausea or vomiting; severe or unusual vaginal bleeding.

Proper storage of Estradiol/Norethindrone:

Store Estradiol/Norethindrone 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 Estradiol/Norethindrone out of the reach of children and away from pets.

General information:

  • If you have any questions about Estradiol/Norethindrone, please talk with your doctor, pharmacist, or other health care provider.
  • Estradiol/Norethindrone 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.

This information is a summary only. It does not contain all information about Estradiol/Norethindrone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition
Copyright © 2007 Wolters Kluwer Health, Inc.

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