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Generic Name: estropipate (ES-troe-PIP-ate)
Brand Name: Ortho-Est

Ogen should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens with or without progestins have been shown to increase the risk of heart disease (including heart attacks), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Ogen. Talk with your doctor if you have questions about the benefits and risks of using Ogen.

Ogen should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Ogen.

Ogen is used for:

Treating certain conditions caused by menopause (eg, hot flashes; vaginal itching, burning, or dryness). It is used to prevent osteoporosis (weak bones) in women who have been through menopause. It is also used for estrogen replacement therapy in certain conditions where the body does not make enough estrogen.

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

Do NOT use Ogen if:

  • you are allergic to any ingredient in Ogen
  • you are pregnant or suspect you may be pregnant
  • you have vaginal bleeding of unknown cause, known or suspected breast cancer or estrogen-dependent growths, or a history of breast cancer
  • you have an active blood clot (eg, in the leg or lung), a history of blood clots, or liver problems
  • you have had a recent (within the past year) stroke or heart attack

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

Before using Ogen:

Some medical conditions may interact with Ogen. 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 a family member has a history of breast cancer or blood clots (eg, in the leg, lung, eye)
  • if you have had yellowing of the eyes or skin during pregnancy or with past estrogen use
  • if you have high or low blood calcium levels or a history of asthma, a certain blood disorder (porphyria), diabetes, eye or vision problems, gallbladder disease, pancreas inflammation (pancreatitis), heart problems, high blood pressure, high cholesterol or triglyceride levels, kidney problems, a certain type of liver growth (hemangioma), mental or mood problems (eg, depression), thyroid problems, or migraine headaches
  • if you have a history of breast lumps or an abnormal mammogram, endometriosis, cancer (eg, ovarian), fluid-retention or swelling (edema), lupus, or seizures (epilepsy)
  • if you smoke or use other tobacco products, are overweight, you still have a uterus, or you will be having surgery or will be on bedrest

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

  • Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Ogen
  • Clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir because they may increase the risk of Ogen's side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifamycins (eg, rifampin), or St. John's wort because they may decrease Ogen's effectiveness

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

Use Ogen 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 Ogen. Talk to your pharmacist if you have questions about this information.
  • Take Ogen by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Eating grapefruit or drinking grapefruit juice while you are taking Ogen may increase the amount of Ogen in your blood, which may increase your risk for side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • If you miss a dose of Ogen, 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 Ogen.

Important safety information:

  • Ogen 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.
  • Ogen 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 Ogen.
  • Follow your doctor's instructions for examining your breasts, and report any lumps immediately.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • Tell your doctor or dentist that you take Ogen before you receive any medical or dental care, emergency care, or surgery.
  • 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, bedrest), notify your doctor beforehand. You may need to stop Ogen 4 to 6 weeks beforehand as directed by your doctor.
  • If you are taking Ogen to prevent osteoporosis, 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.
  • Ogen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ogen.
  • Diabetes patients - Ogen may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood pressure measurements, blood hormone levels, and liver function, may be performed to monitor your condition or check for side effects. You should have regular complete physical examinations, including blood pressure measurements, Pap tests (for vaginal cancer), and yearly breast and pelvic examinations. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments. Be sure to keep all doctor and lab appointments.
  • Use Ogen with caution in the ELDERLY; they may be more sensitive to its effects.
  • Ogen should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Ogen if you are pregnant. If you think you may be pregnant, contact your doctor right away. Ogen is found in breast milk. If you are or will be breast-feeding while you use Ogen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ogen:

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:

Breast tenderness or enlargement; changes in sex drive; hair loss; headache; nausea; stomach cramps, bloating, or upset.

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; unusual hoarseness); abnormal vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); breast lumps or pain; calf or leg pain, redness, swelling, tenderness, or warmth; changes in vision (eg, double vision, loss of vision); chest pain; coughing up blood; dizziness; fainting; mental or mood changes (eg, depression); migraine; new or worsening seizures; nipple discharge; pain, swelling, or tenderness in the stomach; severe or persistent headache; sudden shortness of breath; swelling of the hands, ankles, or feet; symptoms of a heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of a stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual vaginal discharge, itching, or odor; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea or vomiting.

Proper storage of Ogen:

Store Ogen at room temperature, below 77 degrees F (25 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ogen out of the reach of children and away from pets.

General information:

  • If you have any questions about Ogen, please talk with your doctor, pharmacist, or other health care provider.
  • Ogen 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Ogen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ogen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ogen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Ogen.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.