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All about: Ortho-Est

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Generic Name: Estropipate Tablets (ESS-troe-PIH-pate)
Brand Name: Examples include Ogen and Ortho-Est

Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women with a uterus who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given with another hormone (progestin) for replacement therapy can infrequently cause heart disease (eg, heart attacks), stroke, serious blood clots in the legs or lungs (pulmonary embolism/deep vein thrombosis), dementia, and cancer of the breast. These risks appear to depend on the length of time Ortho-Est is used and the amount of estrogen per dose. Therefore, this medicine should be used for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If using Ortho-Est for an extended period, you should be evaluated at least once a year. Ortho-Est is not effective in preventing or treating a tendency toward miscarriage, nor the threat of miscarriage. Ortho-Est should not be used during pregnancy because its use may result in birth defects or cancer later in the child's life.


Ortho-Est is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, dryness) and vulval or vaginal atrophy, and preventing osteoporosis (brittle bones). It is also used for estrogen replacement therapy after failure of the ovaries and relief of the symptoms of breast cancer.

Ortho-Est is used for relief of the symptoms of breast cancer in selected men.

Ortho-Est is a female hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.

Do NOT use Ortho-Est if:

  • you are allergic to any ingredient in Ortho-Est
  • you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, or have vaginal bleeding of abnormal or unknown cause
  • you have known or suspected breast cancer (unless directed by your doctor) or you have cancers that are estrogen-dependent
  • you have blood clotting problems, liver problems, vein inflammation, or the blood disease porphyria
  • you have had a recent stroke or heart attack

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

Before using Ortho-Est :

Some medical conditions may interact with Ortho-Est . 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, or other substances
  • if you have a family history of breast cancer, high cholesterol, high triglyceride levels, or you have breast lumps or disease or an abnormal mammogram
  • if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
  • if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
  • if you have abnormal calcium levels in the blood, asthma, bone cancer, cancer (eg, breast), certain blood disorder (porphyria), depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
  • if you smoke or will be having surgery

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

  • Thyroid medicines because their effectiveness may be decreased by Ortho-Est
  • Hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), or rifampin because they may decrease this medicine's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ortho-Est 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 Ortho-Est :

Use Ortho-Est as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Ortho-Est . Talk to your pharmacist if you have questions about this information.
  • Take Ortho-Est by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you miss a dose of Ortho-Est , 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 Ortho-Est .

Important safety information:

  • Ortho-Est may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ortho-Est with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Limit alcoholic beverages while you are taking Ortho-Est .
  • Ortho-Est may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
  • Ortho-Est may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
  • Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
  • Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Ortho-Est .
  • Follow your doctor's instructions for examining your breasts, and report any lumps immediately.
  • Additional monitoring of your dose or condition may be necessary if you are presently taking an azole antifungal (eg, itraconazole), carbamazepine, a macrolide antibiotic (eg, erythromycin), ritonavir, cimetidine, or St. John's wort.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Ortho-Est .
  • Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
  • Ortho-Est may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ortho-Est .
  • Diabetes patients - Ortho-Est may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • LAB TESTS will be required to monitor therapy. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a Pap test, at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
  • Ortho-Est should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Ortho-Est if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Ortho-Est is found in breast milk. If you are or will be breast-feeding while you use Ortho-Est , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ortho-Est :

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:

Abnormal hair growth; breast tenderness; changes in sex drive; cramps; depression; dizziness; flushing; hair loss; headache; intolerance to contact lenses; lightheadedness; nausea; reduced tolerance to carbohydrates; stomach bloating and upset; swelling; vaginal infection, bleeding, or spotting; 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); abnormal vaginal bleeding; breast lumps; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, or prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing up blood; dizziness; fainting; mental/mood changes (eg, severe depression, memory loss); pain in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; 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 excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Ortho-Est :

Store Ortho-Est at room temperature 59 to 86 degrees F (15 to 30 degrees C) in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ortho-Est out of the reach of children and away from pets.

General information:

  • If you have any questions about Ortho-Est , please talk with your doctor, pharmacist, or other health care provider.
  • Ortho-Est 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 Ortho-Est . 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 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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