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|Ortho-Est

Ortho-Est

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 planning to become pregnant
• 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 the effectiveness of Ortho-Est may be decreased

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.

• Ortho-Est may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Ortho-Est comes with an additional patient leaflet. Read it carefully and reread it each time you get Ortho-Est refilled.
• 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. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ortho-Est . Using Ortho-Est alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Limit alcoholic beverages.
• 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.
• Smoking while using Ortho-Est may increase your risk of blood clots (especially in women older than 35 years of age).
• 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.
• Limit alcoholic beverages while taking Ortho-Est .
• 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 affect certain lab test results. Make sure laboratory personnel and your doctors know you take Ortho-Est .
• Diabetes patients - Ortho-Est may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting 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 is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Ortho-Est if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Ortho-Est may be excreted in breast milk. If you are or will be breast-feeding while you are taking Ortho-Est , check with your doctor or pharmacist to discuss the 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.

Severe allergic reactions (rash; hives; 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.

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.