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Ortho-Prefest

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

What is Ortho-Prefest (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.

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 other purposes not listed in this medication guide.

What is the most important information I should know about Ortho-Prefest (estradiol and norgestimate)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol and norgestimate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol and norgestimate may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol and norgestimate.

Slideshow: Flashback: FDA Drug Approvals 2013

Long-term estradiol and norgestimate treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol and norgestimate long-term. Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.

What should I discuss with my healthcare provider before taking Ortho-Prefest (estradiol and norgestimate)?

Do not take estradiol and norgestimate without first talking to your doctor if you have
  • a bleeding or blood-clotting disorder;

  • a history of stroke or circulation problems;

  • abnormal vaginal bleeding that a doctor has not checked; or

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

Before using estradiol and norgestimate, tell your doctor if you have:

  • high blood pressure, angina, or heart disease;

  • high cholesterol or triglycerides;

  • liver disease;
  • kidney disease;
  • asthma;

  • epilepsy or other seizure disorder;

  • migraines;

  • diabetes;

  • depression;

  • gallbladder disease;

  • uterine fibroids; or

  • if you have had your uterus removed (hysterectomy).

Estradiol and norgestimate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol and norgestimate may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol and norgestimate.

Long-term estradiol and norgestimate treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol and norgestimate long-term. 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 cause birth defects. Do not use estradiol and norgestimate if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Estradiol and norgestimate can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Ortho-Prefest (estradiol and norgestimate)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medication with a full glass of water.

This medication 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.

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 medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your medicine at the next regularly scheduled time. 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 if you think you have used too much of this medicine. Symptoms of an estradiol and norgestimate overdose may include nausea, vomiting, or vaginal bleeding.

What should I avoid while taking estradiol and norgestimate

There are no restrictions on food, beverages, or activity while using estradiol and norgestimate unless your doctor has told you otherwise.

Ortho-Prefest (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. Call your doctor at once if you have any of these serious side effects:
  • 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 headache, confusion, problems with vision, speech, or balance;

  • pain or swelling in your lower leg;

  • abnormal vaginal bleeding;

  • pain, swelling, or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes); or

  • a lump in your breast.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;

  • swollen breasts;

  • swelling of your hands or feet;

  • problems with wearing contact lenses;

  • acne or skin color changes;

  • migraine headaches or dizziness;

  • vaginal pain, dryness, itching, or discharge;

  • swelling of your ankles or feet;

  • depression;

  • enlargement of uterine fibroids; or

  • changes in your menstrual periods, break-through bleeding.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

See also: Side effects (in more detail)

What other drugs will affect Ortho-Prefest (estradiol and norgestimate)?

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

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

  • a blood thinner such as warfarin (Coumadin).

If you are using any of these drugs, you may not be able to use estradiol and norgestimate or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estradiol and norgestimate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using 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 1996-2006 Cerner Multum, Inc. Version: 1.06. Revision Date: 02/25/2008 9:06:31 AM.
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