estradiol and norgestimate

Generic Name: estradiol and norgestimate (ess tra DYE all and nor JESS tih mate)
Brand Name: Prefest, Ortho-Prefest

What is estradiol and norgestimate?

Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Norgestimate is a form of progesterone, a female sex hormone important for the regulation of ovulation and menstruation.

The combination of estradiol and norgestimate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estradiol and norgestimate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about estradiol and norgestimate?

This medication can harm an unborn baby or cause birth defects. Do not use estradiol and norgestimate if you are pregnant.

You should not take estrogens if you have liver disease, circulation problems, a recent stroke or heart attack, unusual vaginal bleeding, a history of breast or uterine cancer, if you have ever had a blood clot, or if you are pregnant.

Before taking estradiol and norgestimate, tell your doctor if you have heart disease, high blood pressure, asthma, kidney disease, a seizure disorder, migraines, lupus, gallbladder disease, underactive thyroid, high levels of calcium in your blood, endometriosis, or if you have had a hysterectomy.

Slideshow: Flashback: FDA Drug Approvals 2013

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you have diabetes, high blood pressure, high cholesterol or triglycerides, if you smoke, or if you are overweight.

Long-term estrogen treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using estradiol and norgestimate long-term.

Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while taking this medication.

What should I discuss with my healthcare provider before taking estradiol and norgestimate?

You should not take estradiol and norgestimate if you are allergic to it, or if you have:

  • liver disease;

  • circulation problems;

  • a recent history of heart attack or stroke;

  • unusual vaginal bleeding that a doctor has not checked;

  • a history of breast, uterine, or hormone-dependent cancer;

  • if you have ever had a blood clot (especially in your lung or your lower body); or

  • if you are pregnant.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you have risk factors such as diabetes, high blood pressure, high cholesterol or triglycerides, smoking, or being overweight.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure;

  • asthma;

  • kidney disease;

  • epilepsy or other seizure disorder;

  • migraines;

  • lupus;

  • gallbladder disease;

  • endometriosis;

  • underactive thyroid; or

  • high levels of calcium in your blood.

Estradiol may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. The norgestimate contained in this medication may lower this risk. If your uterus has not been removed, talk with your doctor about your specific risk of developing uterine cancer while taking estradiol and norgestimate.

Long-term use of conjugated estrogens may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using this medication long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use estradiol and norgestimate if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Estradiol and norgestimate can pass into breast milk and may harm a nursing baby. Estrogens may also slow breast milk production. You should not breast-feed while you are taking this medication.

Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.

How should I take estradiol and norgestimate?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take the medicine at the same time each day.

Estradiol and norgestimate usually comes in a pack of pills that are different colors. In most cases, you will take a pill of one color for three days in a row, followed by taking a pill of the other color for the next three days. This cycle is then repeated throughout your treatment.

Each time you start a new pack, start with the first tablet in the first row of pills. Your medication may come with stickers to mark your weekday schedule on the pack.

Be sure to have a new pack of this medication ready to start on the day after you have finished an entire pill pack.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using estradiol and norgestimate. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking estradiol and norgestimate.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss 2 doses in a row, take the next tablet in order and keep taking only one pill per day. Call your doctor if you miss more than 2 doses of this medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause nausea, vomiting, or vaginal bleeding.

What should I avoid while taking estradiol and norgestimate?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by estradiol and norgestimate.

Estradiol and norgestimate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • unusual vaginal bleeding (especially if you are past menopause);

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden severe headache, confusion, problems with vision, speech, or balance;

  • stabbing chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs;

  • nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;

  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  • swelling in your hands, ankles, or feet; or

  • a lump in your breast.

Less serious side effects may include:

  • mild stomach pain, bloating;

  • back pain, joint pain;

  • flu symptoms;

  • headache;

  • breast pain;

  • loss of scalp hair;

  • vaginal itching or discharge; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Estradiol and norgestimate dosing information

Usual Adult Dose for Atrophic Urethritis:

1 tablet orally once a day.

Usual Adult Dose for Atrophic Vaginitis:

1 tablet orally once a day.

Usual Adult Dose for Postmenopausal Symptoms:

1 tablet orally once a day.

Usual Adult Dose for Prevention of Osteoporosis:

1 tablet orally once a day. In addition to hormonal therapy, adequate calcium intake is important for postmenopausal women who require treatment or prevention of osteoporosis. The average diet of older American women contains 400 to 600 mg of calcium per day. A suggested optimal intake is 1500 mg per day. If dietary intake is insufficient to achieve 1500 mg per day, supplementation may be useful in women who have no contraindication to calcium supplementation.

What other drugs will affect estradiol and norgestimate?

Tell your doctor about all other medicines you use, especially:

  • St. John's wort;

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

  • nefazodone (an antidepressant);

  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

  • a barbiturate such as phenobarbital (Solfoton);

  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

  • seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with estradiol and norgestimate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about estradiol and norgestimate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2012-06-12, 11:35:47 AM.

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