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estropipate

Generic Name: estropipate (ES troe PIP ate)
Brand Name: Ogen 0.625, Ogen 1.25, Ogen 2.5, Ortho-Est

What is estropipate?

Estropipate is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estropipate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estropipate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about estropipate?

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.

Slideshow: Flashback: FDA Drug Approvals 2013

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estropipate 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.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estropipate.

What should I discuss with my health care provider before using estropipate?

Do not use estropipate 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 estropipate, 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; or

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

If you have any of these conditions, you may not be able to use estropipate, or you may need a dosage adjustment or special tests during treatment.

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estropipate 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 estropipate 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.

Estropipate 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 use estropipate?

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.

You may take estropipate with food or after a meal to reduce stomach upset.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estropipate.

Store this medication 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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an estropipate overdose may include nausea, vomiting, or vaginal bleeding.

What should I avoid while using estropipate?

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

Estropipate 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.

Other less serious side effects are more likely to occur, such as:

  • nausea, vomiting, loss of appetite;

  • swollen breasts;

  • acne or skin color changes;

  • decreased sex drive, impotence, or difficulty having an orgasm;

  • migraine headaches or dizziness;

  • vaginal pain, dryness, or discomfort;

  • swelling of your ankles or feet;

  • depression; or

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

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. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Estropipate Dosing Information

Usual Adult Dose for Osteoporosis:

Dose depends on the presence or absence of an intact uterus.

Recommendations with intact uterus:

Regimen 1 (Continuous Unopposed Estrogen Therapy):

0.625 mg orally once a day.

Regimen 2 (Cyclic Combined Estrogen-Progestin Therapy):

0.625 mg orally once a day for 25 days AND Medroxyprogesterone acetate 5 to 10 mg orally once a day for 10 to 14 days of the cycle.

Regimen 3 (Continuous Combined Estrogen-Progestin Therapy):

0.625 mg orally once a day AND Medroxyprogesterone acetate 2.5 mg orally once a day.

Recommendation following hysterectomy:

0.625 mg orally once a day.

In addition to hormonal therapy, adequate calcium intake is important for postmenopausal women who require treatment or prevention of osteoporosis. The average diet of older American women contains 400 to 600 mg of calcium per day. The optimal intake suggested is 1500 mg per day. If dietary intake is insufficient to achieve 1500 mg per day, dietary supplementation may be useful in women who have no contraindication to calcium supplementation.

Long-term therapy (for more than 5 years) is generally necessary in order to obtain substantive benefits in reducing the risk of bone fracture. Maximal benefits are obtained if estrogen therapy is initiated as soon after menopause as possible. The optimal duration of therapy has not been definitively determined.

Usual Adult Dose for Postmenopausal Symptoms:

Dose depends on the presence or absence of an intact uterus.

Recommendations with intact uterus:

Regimen 1 (Continuous Unopposed Estrogen Therapy):

0.625 mg to 5 mg orally once a day.

Regimen 2 (Cyclic Combined Estrogen-Progestin Therapy):

0.625 mg to 5 mg orally once a day for 25 days AND Medroxyprogesterone acetate 5 to 10 mg orally once a day for 10 to 14 days of the cycle.

Regimen 3 (Continuous Combined Estrogen-Progestin Therapy):

0.625 mg to 5 mg orally once a day AND Medroxyprogesterone acetate 2.5 mg orally once a day.

Recommendation following hysterectomy:

0.625 mg to 5 mg orally once a day.

Many women may require higher dosages during the initiation of therapy. The dosage of estropipate should be adjusted to the minimum dose that will achieve the desired clinical effect.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms should be limited. Treatment for one to five years is generally sufficient. However, long-term therapy (for the treatment/prophylaxis of osteoporosis and for risk reduction of cardiovascular disease) may be considered during the time in which the patient is being treated for postmenopausal symptoms.

Usual Adult Dose for Atrophic Vaginitis:

Dose depends on the presence or absence of an intact uterus.

Recommendations with intact uterus:

Regimen 1 (Continuous Unopposed Estrogen Therapy):

0.625 mg to 5 mg orally once a day.

Regimen 2 (Cyclic Combined Estrogen-Progestin Therapy):

0.625 mg to 5 mg orally once a day for 25 days AND Medroxyprogesterone acetate 5 to 10 mg orally once a day for 10 to 14 days of the cycle.

Regimen 3 (Continuous Combined Estrogen-Progestin Therapy):

0.625 mg to 5 mg orally once a day AND Medroxyprogesterone acetate 2.5 mg orally once a day.

Recommendation following hysterectomy:

0.625 mg to 5 mg orally once a day.

Many women may require higher dosages during the initiation of therapy. The dosage of estropipate should be adjusted to the minimum dose that will achieve the desired clinical effect.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

Usual Adult Dose for Atrophic Urethritis:

Dose depends on the presence or absence of an intact uterus.

Recommendations with intact uterus:

Regimen 1 (Continuous Unopposed Estrogen Therapy):

0.625 mg to 5 mg orally once a day.

Regimen 2 (Cyclic Combined Estrogen-Progestin Therapy):

0.625 mg to 5 mg orally once a day for 25 days AND Medroxyprogesterone acetate 5 to 10 mg orally once a day for 10 to 14 days of the cycle.

Regimen 3 (Continuous Combined Estrogen-Progestin Therapy):

0.625 mg to 5 mg orally once a day AND Medroxyprogesterone acetate 2.5 mg orally once a day.

Recommendation following hysterectomy:

0.625 mg to 5 mg orally once a day.

Many women may require higher dosages during the initiation of therapy. The dosage of estropipate should be adjusted to the minimum dose that will achieve the desired clinical effect.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

Usual Adult Dose for Hypoestrogenism:

1.25 to 7.5 mg orally once a day for 21 days followed by an 8 to 10 day rest period. The dosage of estropipate should be adjusted to the minimum dose that will achieve the desired clinical effect. This schedule is repeated as necessary to produce bleeding. If satisfactory withdrawal bleeding does not occur, a progestin, like medroxyprogesterone acetate, is added on the last several days of the monthly treatment.

Treatment is usually initiated at the expected time of puberty and may continue for prolonged periods.

Therapeutic goals of estrogen-progestin treatment differ at different times in the life of a hypogonadal patient and titration of dosage is often necessary to achieve the desired level of developmental maturation and menstruation.

Usual Adult Dose for Primary Ovarian Failure:

1.5 mg to 7.5 mg

Dose depends on the presence or absence of an intact uterus.

Recommendations with intact uterus:

Regimen 1 (Continuous Unopposed Estrogen Therapy):

1.5 mg to 7.5 mg orally once a day.

Regimen 2 (Cyclic Combined Estrogen-Progestin Therapy):

1.5 mg to 7.5 mg orally once a day for 25 days AND Medroxyprogesterone acetate 5 to 10 mg orally once a day for 10 to 14 days of the cycle.

Regimen 3 (Continuous Combined Estrogen-Progestin Therapy):

1.5 mg to 7.55 mg orally once a day AND Medroxyprogesterone acetate 2.5 mg orally once a day.

Recommendation following hysterectomy:

1.5 mg to 7.5 mg orally once a day.

Many women may require higher dosages during the initiation of therapy. The dosage of estropipate should be adjusted to the minimum dose that will achieve the desired clinical effect.

Usual Adult Dose for Oophorectomy:

1.5 mg to 7.5 mg

Dose depends on the presence or absence of an intact uterus.

Recommendations with intact uterus:

Regimen 1 (Continuous Unopposed Estrogen Therapy):

1.5 mg to 7.5 mg orally once a day.

Regimen 2 (Cyclic Combined Estrogen-Progestin Therapy):

1.5 mg to 7.5 mg orally once a day for 25 days AND Medroxyprogesterone acetate 5 to 10 mg orally once a day for 10 to 14 days of the cycle.

Regimen 3 (Continuous Combined Estrogen-Progestin Therapy):

1.5 mg to 7.5 mg orally once a day AND Medroxyprogesterone acetate 2.5 mg orally once a day.

Recommendation following hysterectomy:

1.5 mg to 7.5 mg orally once a day.

Many women may require higher dosages during the initiation of therapy. The dosage of estropipate should be adjusted to the minimum dose that will achieve the desired clinical effect.

What other drugs will affect estropipate?

Before using estropipate, tell your doctor if you are using any of the following drugs:

  • St. John's wort;

  • phenobarbital (Luminal, Solfoton);

  • phenytoin (Dilantin);

  • a blood thinner such as warfarin (Coumadin);

  • ritonavir (Norvir);

  • cimetidine (Tagamet);

  • carbamazepine (Carbatrol, Tegretol);

  • rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

  • antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

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

There may be other drugs not listed that can affect estropipate. 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 estropipate.
  • 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 1996-2012 Cerner Multum, Inc. Version: 5.07. Revision Date: 2010-12-15, 5:01:39 PM.

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