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estradiol and norgestimate

Generic Name: estradiol and norgestimate (ES tra DYE ol and nor JES ti mate)
Brand Name: Prefest, Ortho-Prefest

What is estradiol and norgestimate?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Norgestimate is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and norgestimate is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women.

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

Important Information

You should not use this medicine if had a hysterectomy, or if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

Estradiol and norgestimate may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia. Long-term use may increase your risk of cancer of the breast, uterus, or ovaries.

Before taking this medicine

You should not use this medicine if you are allergic to estradiol or norgestimate, if you have had a hysterectomy, or if you have:

  • unusual vaginal bleeding that has not been checked by a doctor;

  • liver disease;

  • a history of heart attack, stroke, or blood clot; or

  • a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use estradiol and norgestimate if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

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

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • heart disease;

  • liver problems, or jaundice caused by pregnancy or taking hormones;

  • kidney disease;

  • gallbladder disease;

  • asthma;

  • epilepsy or other seizure disorder;

  • migraines;

  • lupus;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • endometriosis or uterine fibroid tumors;

  • a thyroid disorder; or

  • high levels of calcium in your blood.

Long-term use of estradiol may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Estradiol lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding.

How should I take estradiol and norgestimate?

Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended.

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 3 days in a row, and then take a pill of the other color for the next 3 days in a row. 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 medicine may come with stickers to mark your weekday schedule on the pack.

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

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

If you need major surgery with long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol and norgestimate.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using 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 medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking estradiol and norgestimate?

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol and norgestimate.

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Estradiol and norgestimate side effects

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

Call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

  • swelling or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes);

  • memory problems, confusion, unusual behavior;

  • unusual vaginal bleeding, pelvic pain;

  • a lump in your breast; or

  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

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
-Start with the first tablet in the first row

Comments:
-Consider topical vaginal products if using solely for vulvar and vaginal atrophy.
-Re-evaluate vulvar and vaginal atrophy patients at 3 to 6 month intervals to determine if treatment is still necessary.
-If one or more tablets are missed, resume therapy with the next available tablet and continue to take one tablet per day in sequence.

Use(s): Treatment of moderate to severe vasomotor symptoms or vulvar and vaginal atrophy associated with menopause

Usual Adult Dose for Atrophic Vaginitis:

1 tablet orally once a day
-Start with the first tablet in the first row

Comments:
-Consider topical vaginal products if using solely for vulvar and vaginal atrophy.
-Re-evaluate vulvar and vaginal atrophy patients at 3 to 6 month intervals to determine if treatment is still necessary.
-If one or more tablets are missed, resume therapy with the next available tablet and continue to take one tablet per day in sequence.

Use(s): Treatment of moderate to severe vasomotor symptoms or vulvar and vaginal atrophy associated with menopause

Usual Adult Dose for Postmenopausal Symptoms:

1 tablet orally once a day
-Start with the first tablet in the first row

Comments:
-Consider topical vaginal products if using solely for vulvar and vaginal atrophy.
-Re-evaluate vulvar and vaginal atrophy patients at 3 to 6 month intervals to determine if treatment is still necessary.
-If one or more tablets are missed, resume therapy with the next available tablet and continue to take one tablet per day in sequence.

Use(s): Treatment of moderate to severe vasomotor symptoms or vulvar and vaginal atrophy associated with menopause

Usual Adult Dose for Prevention of Osteoporosis:

1 tablet orally once a day
-Start with the first tablet in the first row

Comments:
-Consider therapy only for patients at significant osteoporosis risk.
-Consider using non-estrogen medications.
-Osteoporosis risk is decreased by weight bearing exercise and adequate calcium and vitamin D intake.
-Postmenopausal women require an average of 1500 mg of elemental calcium daily.
-When not contraindicated, calcium supplementation may be helpful for patients with suboptimal dietary intake.
-Vitamin D supplementation of 400 to 800 IU per day may be needed to ensure adequate intake.
-If one or more tablets are missed, resume therapy with the next available tablet and continue to take one tablet per day in sequence.

Use(s): Prevention of postmenopausal osteoporosis

What other drugs will affect estradiol and norgestimate?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with estradiol and norgestimate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

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: 5.01.

Date modified: January 03, 2018
Last reviewed: December 13, 2017

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