DrugindexOnline^{2nd edition}

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

What is estradiol and norgestimate?

Estradiol is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

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

Together, estradiol and norgestimate are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes" or "hot flushes"); to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause; and to prevent thinning of the bones (osteoporosis).

Estradiol and norgestimate may also be used for purposes other than those listed in this medication guide.

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

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Taking a progestin, such as norgestimate, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norgestimate.

Do not take estradiol and norgestimate if you are pregnant.

Who should not take estradiol and norgestimate?

Do not take estradiol and norgestimate without first talking to your doctor if you have

• a circulation, bleeding, or blood-clotting disorder;

• undiagnosed, abnormal vaginal bleeding; or

• any type of breast, uterine, or hormone-dependent cancer.

Taking estradiol and norgestimate may be dangerous in some cases if you have any of the conditions listed above.

Before taking estradiol and norgestimate, tell your doctor if you have

• high blood pressure, angina, or heart disease;

• high levels of cholesterol or triglycerides in your blood;

• liver disease;
• kidney disease;

• asthma;

• epilepsy;

• migraines;

• depression;

• diabetes;

• gallbladder disease;

• uterine fibroids; or

• had a hysterectomy (uterus removed).

You may not be able to take estradiol and norgestimate, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Estradiol and norgestimate is in the FDA pregnancy category X. This means that the medication will cause birth defects in an unborn baby. Do not take estradiol and norgestimate if you are pregnant or if you are planning a pregnancy. Estradiol and norgestimate may affect milk flow and milk composition. Do not take estradiol and norgestimate without first talking to your doctor if you are breast-feeding a baby.

How should I take estradiol and norgestimate?

Take estradiol and norgestimate exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Treatment with the Ortho-Prefest brand of estradiol and norgestimate consists of taking one pink colored tablet (1 mg estradiol) once a day for three days, followed by taking one white colored tablet (1 mg estradiol and 0.09 mg norgestimate) once a day for three days. This cycle is repeated continuously during treatment. Start with the first tablet in the first row of a package. Place the corresponding weekday schedule sticker in the appropriate space. After all of the tablets from one blister card have been used, take the first tablet from a new blister card on the following day.

Try to take estradiol and norgestimate at the same time each day.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norgestimate.

Store estradiol and norgestimate at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Do not take a double dose of this medication unless otherwise directed by your doctor. If a dose is missed for one or more days, take the next tablet in order. Continue to take only one tablet each day in sequence.

What happens if I overdose?

An overdose of estradiol and norgestimate is unlikely to threaten life. Call an emergency room or poison control center for advice.

Symptoms of a estradiol and norgestimate overdose might include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking estradiol and norgestimate

There are no restrictions on food, beverages, or activity while taking estradiol and norgestimate unless your doctor directs otherwise.

Estradiol and norgestimate side effects

Stop taking estradiol and norgestimate and seek emergency medical attention or call your doctor immediately if you experience any of the following serious side effects:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• shortness of breath or pain in your chest;

• a painful, red, swollen leg;

• abnormal vaginal bleeding;

• pain, swelling, or tenderness in the abdomen;

• severe headache or vomiting, dizziness, faintness or changes in vision or speech;

• yellowing of the skin or eyes; or

• a lump in a breast.

Other, less serious side effects may be more likely to occur. Continue to take estradiol and norgestimate and talk to your doctor if you experience:

• nausea and vomiting;

• tenderness or enlargement of the breasts;

• swelling of your hands or feet;

• spotty darkening of the skin, particularly on the face;

• changes in your menstrual cycle, such as irregular bleeding or spotting;

• headache, migraine, dizziness, faintness, or change in vision including intolerance to contact lenses;

• depression;

• vaginal yeast infections; or

• enlargement of uterine fibroids.

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Taking a progestin, such as norgestimate, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

It is unclear to what extent estrogen and progesterone treatments affect the risk of breast cancer.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect estradiol and norgestimate?

Before taking estradiol and norgestimate, tell your doctor if you are taking any of the following medicines

• insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), chlorpropamide (Diabinese), tolazamide (Tolinase), tolbutamide (Orinase), and others; or

• an anticoagulant (blood thinner) such as warfarin (Coumadin).

You may not be able to take estradiol and norgestimate or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with estradiol and norgestimate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about estradiol and norgestimate written for health professionals that you may read.

• 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.
• 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 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 08/15/2007 2:34:37 PM.