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conjugated estrogens

Pronunciation

Generic Name: conjugated estrogens (oral) (KON joo gay ted ES troe jenz)
Brand Name: Cenestin, Enjuvia, Premarin, Premarin Intravenous

What are conjugated estrogens?

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Conjugated estrogens are a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Conjugated estrogens are sometimes used as part of cancer treatment in women and men.

Conjugated estrogens may also be used for purposes not listed in this medication guide.

What is the most important information I should know about conjugated estrogens?

You should not use this medicine if you have any of the following conditions: a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, history of an allergic reaction to estrogens, a hormone-related cancer such as breast or uterine cancer, or a history of heart attack, stroke, or blood clot.

Slideshow: Flashback: FDA Drug Approvals 2013

Do not use if you are pregnant.

Conjugated estrogens may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

Conjugated estrogens should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

What should I discuss with my healthcare provider before taking conjugated estrogens?

You should not use conjugated estrogens if you have:

  • a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

  • abnormal vaginal bleeding that has not been checked by a doctor;

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

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • if you are pregnant or may become pregnant; or

  • if you have ever had an allergic reaction to estrogens.

Conjugated estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot. Talk with your doctor about your individual risks.

To make sure conjugated estrogens are safe for you, tell your doctor if you have:

  • unusual vaginal bleeding;

  • heart disease;

  • asthma;

  • epilepsy or other seizure disorder;

  • liver or kidney disease;

  • hereditary angioedema;

  • endometriosis;

  • a thyroid disorder;

  • lupus;

  • high levels of calcium in your blood (hypercalcemia);

  • migraines;

  • gallbladder disease; or

  • risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40, or if you have had a hysterectomy).

Do not use conjugated estrogens if you are pregnant. Use effective birth control, and tell your doctor right away if you become pregnant while you are using this medicine.

Conjugated estrogens can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take conjugated estrogens?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Conjugated estrogens may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using conjugated estrogens, to help lower this risk. Report any unusual vaginal bleeding right away.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Conjugated estrogens are sometimes taken on a daily basis. For certain conditions, the medicine is given in a cycle, such as 3 weeks on followed by 1 week off. Follow your doctor's instructions.

If you see what looks like part of a conjugated estrogen tablet in your stool, talk with your doctor.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using conjugated estrogens.

Store at room temperature away from moisture and heat. Keep the medicine container tightly closed.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

What should I avoid while taking conjugated estrogens?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by conjugated estrogens.

Conjugated estrogens side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • abnormal vaginal bleeding;

  • a lump in your breast;

  • confusion, problems with memory or concentration;

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • breast pain or tenderness;

  • headache;

  • swelling in your hands or feet;

  • vaginal itching or discharge, changes in your menstrual periods, light vaginal bleeding or spotting;

  • hair loss; or

  • nausea, vomiting, bloating, stomach cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Conjugated estrogens dosing information

Usual Adult Dose for Osteoporosis:

0.3 mg to 1.25 mg orally once a day.

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.

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. 1500 mg per day has been suggested as optimal intake. 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.

When used solely for the prevention of postmenopausal osteoporosis, approved non-estrogen treatments should carefully be considered, and estrogen and combined estrogen-progestin products should only be considered for women with significant risk of osteoporosis that outweighs the risks of the drug.

Usual Adult Dose for Postmenopausal Symptoms:

0.3 mg to 1.25 mg orally once a day.

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.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Usual Adult Dose for Atrophic Urethritis:

1/2 to 1 applicatorful (2 to 4 g) vaginally once a day.

-or-

0.3 mg to 1.25 mg orally once a day.

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.

Long-term therapy with conjugated estrogen vaginal cream is not recommended. Attempts to discontinue or taper use should be made at three to six month intervals. Conjugated estrogens administered by vaginal application are systemically absorbed (although systemic absorption is variable and unreliable). For the treatment of atrophic vaginitis/urethritis, vaginal creams offer no advantage over oral formulations of conjugated estrogens but the potentially favorable systemic effects of oral therapy are less reliably obtained.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Usual Adult Dose for Atrophic Vaginitis:

1/2 to 1 applicatorful (2 to 4 g) vaginally once a day.

-or-

0.3 mg to 1.25 mg orally once a day.

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.

Long-term therapy with conjugated estrogen vaginal cream is not recommended. Attempts to discontinue or taper use should be made at three to six month intervals. Conjugated estrogens administered by vaginal application are systemically absorbed (although systemic absorption is variable and unreliable). For the treatment of atrophic vaginitis/urethritis, vaginal creams offer no advantage over oral formulations of conjugated estrogens but the potentially favorable systemic effects of oral therapy are less reliably obtained.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Usual Adult Dose for Hypoestrogenism:

2.5 to 7.5 mg orally once a day repeated for 20 days, then off 10 days until menses occur.

Conjugated estrogens (and other exogenous estrogens) have been used for the treatment of hypoestrogenism due to ovarian disease or hypogonadotropic hypogonadism in young women who require development and maintenance of female secondary sexual characteristics. Treatment is usually initiated at the expected time of puberty and may continue for prolonged periods. Often a progestin, like medroxyprogesterone acetate, is added on the last several days of the monthly treatment.

Usual Adult Dose for Abnormal Uterine Bleeding:

5 to 25 mg IM or IV every 6 to 12 hours until bleeding stops.

Usual Adult Dose for Prostate Cancer:

1.25 to 2..5 mg orally 3 times a day.

Conjugated estrogen therapy for prostate cancer should only be considered for palliation in the treatment of metastatic disease in select patients.

Usual Adult Dose for Oophorectomy:

0.3 mg to 1.25 mg orally once a day.

Usual Adult Dose for Primary Ovarian Failure:

0.3 mg to 1.25 mg orally once a day.

Usual Adult Dose for Breast Cancer--Palliative:

10 mg three times a day for at least three months. Conjugated estrogen therapy for breast cancer should only be considered for palliation in the treatment of metastatic disease in select patients.

What other drugs will affect conjugated estrogens?

Other drugs may interact with conjugated estrogens, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about conjugated estrogens.
  • 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: 10.01. Revision Date: 2015-06-30, 8:10:05 AM.

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