Drugs Details

Drugs Info of Ogen 0.625, Ogen 1.25, Ogen 2.5
Drugs Details
  • Drugs Type  : FDA
  • Date : 23rd Feb 2015 05:17 am
  • Brand Name : Ogen 0.625, Ogen 1.25, Ogen 2.5
  • Generic Name : estropipate (Pronunciation: ES troe PIP ate)
Descriptions

OGEN (estropipate tablets), (formerly piperazine estrone sulfate), is a natural estrogen (estropipate) ic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste — properties which are ideally suited for oral administration. The amount of piperazine in OGEN (estropipate) is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)-trien-17-one,3-(sulfooxy)-, compound with piperazine (1:1). The structural formula may be represented as follows:

 OGEN (estropipate) Structural Formula Illustration

OGEN (estropipate) is available as tablets for oral administration containing either 0.75 mg (OGEN .625), 1.5 mg (OGEN 1.25), or 3 mg (OGEN 2.5) estropipate (Calculated as sodium estrone sulfate 0.625 mg, 1.25 mg, and 2.5 mg, respectively).

Inactive Ingredients

Each tablet contains: Colloidal silicon dioxide, dibasic potassium phosphate, hydrogen (estropipate) ated vegetable oil wax, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and tromethamine.

OGEN (estropipate) .625 also contains: D&C Yellow No. 10 and FD&C Yellow No. 6.

OGEN (estropipate) 1.25 also contains: FD&C Yellow No. 6.

OGEN (estropipate) 2.5 also contains: FD&C Blue No. 2.

What are the possible side effects of estropipate (Ogen 0.625, Ogen 1.25, Ogen 2.5)?

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...

Read All Potential Side Effects and See Pictures of Ogen »

What are the precautions when taking estropipate (Ogen)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels,...

Read All Potential Precautions of Ogen »


This monograph has been modified to include the generic and brand name in many instances.

Indications

OGEN (estropipate) is indicated in the:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
  3. Treatment of hypoestrogen (estropipate) ism due to hypogonadism, castration or primary ovarian failure.
  4. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen (estropipate) medications are not considered to be appropriate.
    The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400–800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

Dosage Administration

When estrogen (estropipate) is prescribed for a woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen (estropipate) , alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See BOXED WARNINGS and WARNINGS.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

  1. For treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Attempts to discontinue or taper medication should be made at 3month to 6-month intervals. Usual dosage ranges:
    Vasomotor symptoms—One OGEN .625 (0.75 mg estropipate) tablet to two OGEN 2.5 (3 mg estropipate) tablets per day. The lowest dose that will control symptoms should be chosen. If the patient has not menstruated within the last two months or more, cyclic administration is started arbitrarily. If the patient is menstruating, cyclic administration is started on day 5 of bleeding.
    Vulval and vaginal atrophy—One OGEN .625 (0.75 mg estropipate) tablet to two OGEN 2.5 (3 mg estropipate) tablets daily, depending upon the tissue response of the individual patient. The lowest dose that will control symptoms should be chosen. Administer cyclically.
  2. For treatment of female hypoestrogen (estropipate) ism due to hypogonadism, castration, or primary ovarian failure. Usual dosage ranges: Female hypogonadism—A daily dose of one OGEN 1.25 (1.5 mg estropipate) tablet to three OGEN 2.5 (3 mg estropipate) tablets may be given for the first three weeks of a theoretical cycle, followed by a rest period of eight to ten days. The lowest dose that will control symptoms should be chosen. If bleeding does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen (estropipate) therapy necessary to produce bleeding may vary depending on the responsiveness of the endometrium. If satisfactory withdrawal bleeding does not occur, an oral progestogen (estropipate) may be given in addition to estrogen (estropipate) during the third week of the cycle.
    Female castration or primary ovarian failure—A daily dose of one OGEN 1.25 (1.5 mg estropipate) tablet to three OGEN 2.5 (3 mg estropipate) tablets may be given for the first three weeks of a theoretical cycle, followed by a rest period of eight to ten days. Adjust dosage upward or downward according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.
    Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.
  3. For prevention of osteoporosis. A daily dose of one OGEN .625 (0.75 mg estropipate) tablet for 25 days of a 31-day cycle per month.
 

I

How Supplied

OGEN (estropipate tablets, USP) is supplied as OGEN .625 (0.75 mg estropipate; calculated as sodium estrone sulfate 0.625 mg), yellow, scored tablets, imprinted U 3772, NDC 0009-3772-01; OGEN 1.25 (1.5 mg estropipate; calculated as sodium estrone sulfate 1.25 mg), peach-colored, scored tablets, imprinted U 3773, NDC 0009-3773-01; and OGEN 2.5 (3 mg estropipate; calculated as sodium estrone sulfate 2.5 mg), blue, scored tablets, imprinted U 3774, NDC 0009-3774-01. Tablets of all three dosage levels are standardized to provide uniform estrone activity and are scored to provide dosage flexibility. All tablet sizes of OGEN (estropipate) are available in bottles of 100.

Recommended storage: Store below 77°F (25°C)

Distributed by : Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. July 2006.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

The following additional adverse reactions have been reported with estrogen (estropipate) s and/or progestin therapy.

Genitourinary system

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis; including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

Eyes

Retinal vascular thrombosis; steepening of corneal curvature; intolerance to contact lenses.

Central nervous system

Headache, migraine, dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; changes in libido; triglycerides.

Read the Ogen (estropipate) Side Effects Center for a complete guide to possible side effects

Interactions

Drug/ Laboratory Test Interactions

  1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII— X complex, II—VII—X complex, and betathromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen (estropipate) and fibrinogen (estropipate) activity; increased plasminogen (estropipate) antigen and activity.
  2. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone, levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
  3. Other binding proteins may be elevated in serum, (i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen (estropipate) /renin substrate, alpha-l-antitrypsin, ceruloplasmin).
  4. Increased plasma HDL and HDL2 subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.
  5. Impaired glucose tolerance.
  6. Reduced response to metyrapone test.
  7. Reduced serum folate concentration.

Read the Ogen Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

See BOXED WARNINGS

Cardiovascular disorders

Estrogen (estropipate) and estrogen (estropipate) /progestin therapy have been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). Should any of these occur or be suspected, estrogen (estropipate) s should be discontinued immediately.

Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/ or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

Coronary heart disease and stroke

In the Women's Health Initiative (WHI) study, an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE compared to placebo. These observations are preliminary, and the study is continuing. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

In the CE/MPA substudy of WHI, an increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction and CHD death) was observed in women receiving CE/MPA compared to women receiving placebo (37 vs. 30 per 10,000 womenyears). The increase in risk was observed in year one and persisted.

In the same substudy of WHI, an increased risk of stroke was observed in women receiving CE/MPA compared to women receiving placebo (29 vs. 21 per 10,000 women-years). The increase in risk was observed after the first year and persisted.

In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen (estropipate) /Progestin Replacement Study; HERS) treatment with CE/MPA (0.625 mg/2.5 mg per day) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty one women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in HERS, HERS II, and overall.

Large doses of estrogen (estropipate) (5 mg conjugated estrogen (estropipate) s per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis.

Venous thromboembolism (VTE)

In the Women's Health study (WHI) an increase in VTE has been observed in women receiving CE compared to placebo. These observations are preliminary, and the study is continuing.

In the CE/MPA treatment substudy of WHI, a 2-fold greater rate of VTE, including deep venous thrombosis and pulmonary embolism, was observed in women receiving treatment with CE/MPA compared to women receiving placebo. The rate of VTE was 34 per 10,000 woman-years in the CE/MPA group compared to 16 per 10,000 woman-years in the placebo group. The increase in VTE risk was observed during the first year and persisted.

If feasible, estrogen (estropipate) s should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.

Malignant neoplasms

Endometrial cancer

The use of unopposed estrogen (estropipate) s in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen (estropipate) users is about 2–to-12 fold greater than in nonusers, and appears dependent on duration of treatment and on estrogen (estropipate) dose. Most studies show no significant increased risk associated with use of estrogen (estropipate) s for less than one year. The greatest risk appears associated with prolonged use, with increased risks of 15–to-24 fold for five to ten years or more and this risk has been shown to persist for at least 8 to 15 years after estrogen (estropipate) therapy is discontinued. Clinical surveillance of all women taking estrogen (estropipate) /progestin combinations is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogen (estropipate) s results in a different endometrial risk profile than synthetic estrogen (estropipate) s of equivalent estrogen (estropipate) dose. Adding a progestin to estrogen (estropipate) therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Breast cancer

The use of estrogen (estropipate) s and progestins by postmenopausal women has been reported to increase the risk of breast cancer. The most important randomized clinical trial providing information about this issue is the Women's Health Initiative (WHI) substudy of CE/ MPA (see CLINICAL PHARMACOLOGY, Clinical Studies). The results from observational studies are generally consistent with those of the WHI clinical trial and report no significant variation in the risk of breast cancer among different estrogen (estropipate) s or progestins, doses, or routes of administration.

The CE/MPA substudy of WHI reported an increased risk of breast cancer in women who took CE/MPA for a mean follow-up of 5.6 years. Observational studies have also reported an increased risk for estrogen (estropipate) /progestin combination therapy, and a smaller increased risk for estrogen (estropipate) alone therapy, after several years of use. In the WHI trial and from observational studies, the excess risk increased with duration of use. From observational studies, the risk appeared to return to baseline in about five years after stopping treatment. In addition, observational studies suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen (estropipate) /progestin combination therapy as compared to estrogen (estropipate) alone therapy.

In the CE/MPA substudy, 26% of the women reported prior use of estrogen (estropipate) alone and/or estrogen (estropipate) /progestin combination hormone therapy. After a mean follow-up of 5.6 years during the clinical trial, the overall relative risk of invasive breast cancer was 1.24 (95% confidence interval 1.01–1.54), and the overall absolute risk was 41 vs. 33 cases per 10,000 women-years, for CE/MPA compared with placebo. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 vs. 25 cases per 10,000 women-years, for CE/MPA compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 vs. 36 cases per 10,000 women-years for CE/MPA compared with placebo. In the same substudy, invasive breast cancers were larger and diagnosed at a more advanced stage in the CE/MPA group compared with the placebo group. Metastatic disease was rare with no apparent difference between the two groups. Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ between groups.

The use of estrogen (estropipate) plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a health care provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results.

Dementia

In the Women's Health Initiative Memory Study (WHIMS), 4,532 generally healthy postmenopausal women 65 years of age and older were studied, of whom 35% were 70 to 74 years of age and 18% were 75 or older. After an average follow-up of 4 years, 40 women being treated with CE/MPA (1.8%, n= 2,229) and 21 women in the placebo group (0.9%, n= 2,303) received diagnoses of probable dementia. The relative risk for CE/MPA versus placebo was 2.05 (95% confidence interval 1.21 – 3.48), and was similar for women with and without histories of menopausal hormone use before WHIMS. The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years. It is unknown whether these findings apply to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies and PRECAUTIONS, Geriatric Use.)

Gallbladder disease

A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogen (estropipate) s has been reported.

Hypercalcemia

Estrogen (estropipate) administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

Visual abnormalities

Retinal vascular thrombosis has been reported in patients receiving estrogen (estropipate) s. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogen (estropipate) s should be permanently discontinued.

Precautions

See BOXED WARNINGS

Cardiovascular disorders

Estrogen (estropipate) and estrogen (estropipate) /progestin therapy have been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). Should any of these occur or be suspected, estrogen (estropipate) s should be discontinued immediately.

Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/ or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

Coronary heart disease and stroke

In the Women's Health Initiative (WHI) study, an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE compared to placebo. These observations are preliminary, and the study is continuing. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

In the CE/MPA substudy of WHI, an increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction and CHD death) was observed in women receiving CE/MPA compared to women receiving placebo (37 vs. 30 per 10,000 womenyears). The increase in risk was observed in year one and persisted.

In the same substudy of WHI, an increased risk of stroke was observed in women receiving CE/MPA compared to women receiving placebo (29 vs. 21 per 10,000 women-years). The increase in risk was observed after the first year and persisted.

In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen (estropipate) /Progestin Replacement Study; HERS) treatment with CE/MPA (0.625 mg/2.5 mg per day) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty one women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in HERS, HERS II, and overall.

Large doses of estrogen (estropipate) (5 mg conjugated estrogen (estropipate) s per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis.

Venous thromboembolism (VTE)

In the Women's Health study (WHI) an increase in VTE has been observed in women receiving CE compared to placebo. These observations are preliminary, and the study is continuing.

In the CE/MPA treatment substudy of WHI, a 2-fold greater rate of VTE, including deep venous thrombosis and pulmonary embolism, was observed in women receiving treatment with CE/MPA compared to women receiving placebo. The rate of VTE was 34 per 10,000 woman-years in the CE/MPA group compared to 16 per 10,000 woman-years in the placebo group. The increase in VTE risk was observed during the first year and persisted.

If feasible, estrogen (estropipate) s should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.

Malignant neoplasms

Endometrial cancer

The use of unopposed estrogen (estropipate) s in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen (estropipate) users is about 2–to-12 fold greater than in nonusers, and appears dependent on duration of treatment and on estrogen (estropipate) dose. Most studies show no significant increased risk associated with use of estrogen (estropipate) s for less than one year. The greatest risk appears associated with prolonged use, with increased risks of 15–to-24 fold for five to ten years or more and this risk has been shown to persist for at least 8 to 15 years after estrogen (estropipate) therapy is discontinued. Clinical surveillance of all women taking estrogen (estropipate) /progestin combinations is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogen (estropipate) s results in a different endometrial risk profile than synthetic estrogen (estropipate) s of equivalent estrogen (estropipate) dose. Adding a progestin to estrogen (estropipate) therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Breast cancer

The use of estrogen (estropipate) s and progestins by postmenopausal women has been reported to increase the risk of breast cancer. The most important randomized clinical trial providing information about this issue is the Women's Health Initiative (WHI) substudy of CE/ MPA (see CLINICAL PHARMACOLOGY, Clinical Studies). The results from observational studies are generally consistent with those of the WHI clinical trial and report no significant variation in the risk of breast cancer among different estrogen (estropipate) s or progestins, doses, or routes of administration.

The CE/MPA substudy of WHI reported an increased risk of breast cancer in women who took CE/MPA for a mean follow-up of 5.6 years. Observational studies have also reported an increased risk for estrogen (estropipate) /progestin combination therapy, and a smaller increased risk for estrogen (estropipate) alone therapy, after several years of use. In the WHI trial and from observational studies, the excess risk increased with duration of use. From observational studies, the risk appeared to return to baseline in about five years after stopping treatment. In addition, observational studies suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen (estropipate) /progestin combination therapy as compared to estrogen (estropipate) alone therapy.

In the CE/MPA substudy, 26% of the women reported prior use of estrogen (estropipate) alone and/or estrogen (estropipate) /progestin combination hormone therapy. After a mean follow-up of 5.6 years during the clinical trial, the overall relative risk of invasive breast cancer was 1.24 (95% confidence interval 1.01–1.54), and the overall absolute risk was 41 vs. 33 cases per 10,000 women-years, for CE/MPA compared with placebo. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 vs. 25 cases per 10,000 women-years, for CE/MPA compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 vs. 36 cases per 10,000 women-years for CE/MPA compared with placebo. In the same substudy, invasive breast cancers were larger and diagnosed at a more advanced stage in the CE/MPA group compared with the placebo group. Metastatic disease was rare with no apparent difference between the two groups. Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ between groups.

The use of estrogen (estropipate) plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a health care provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results.

Dementia

In the Women's Health Initiative Memory Study (WHIMS), 4,532 generally healthy postmenopausal women 65 years of age and older were studied, of whom 35% were 70 to 74 years of age and 18% were 75 or older. After an average follow-up of 4 years, 40 women being treated with CE/MPA (1.8%, n= 2,229) and 21 women in the placebo group (0.9%, n= 2,303) received diagnoses of probable dementia. The relative risk for CE/MPA versus placebo was 2.05 (95% confidence interval 1.21 – 3.48), and was similar for women with and without histories of menopausal hormone use before WHIMS. The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years. It is unknown whether these findings apply to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies and PRECAUTIONS, Geriatric Use.)

Gallbladder disease

A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogen (estropipate) s has been reported.

Hypercalcemia

Estrogen (estropipate) administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

Visual abnormalities

Retinal vascular thrombosis has been reported in patients receiving estrogen (estropipate) s. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogen (estropipate) s should be permanently discontinued.

 

OverDose

General

Addition of a progestin when a woman has not had a hysterectomy

Studies of the addition of a progestin for 10 or more days of a cycle of estrogen (estropipate) administration, or daily with estrogen (estropipate) in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen (estropipate) treatment alone.

Endometrial hyperplasia may be a precursor to endometrial cancer.

There are, however, possible risks that may be associated with the use of progestins with estrogen (estropipate) s compared to estrogen (estropipate) -alone regimens. These include a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL) and impairment of glucose tolerance.

Elevated blood pressure

In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogen (estropipate) s. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen (estropipate) s on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen (estropipate) use.

Hypertriglyceridemia

In patients with pre-existing hypertriglyceridemia, estrogen (estropipate) therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications.

Impaired liver function and past history of cholestatic jaundice

Estrogen (estropipate) s may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen (estropipate) use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued.

Hypothyroidism

Estrogen (estropipate) administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogen (estropipate) s may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.

Fluid retention

Because estrogen (estropipate) s may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogen (estropipate) s are prescribed.

Hypocalcemia

Estrogen (estropipate) s should be used with caution in individuals with severe hypocalcemia.

Ovarian cancer

The CE/MPA substudy of WHI reported that estrogen (estropipate) plus progestin increased the risk of ovarian cancer. After an average followup of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95% confidence interval 0.77 – 3.24) but was not statistically significant. The absolute risk for CE/MPA versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen (estropipate) alone, in particular for ten or more years, has been associated with an increased risk of ovarian cancer. Other epidemiologic studies have not found these associations.

Exacerbation of endometriosis

Endometriosis may be exacerbated with administration of estrogen (estropipate) s. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen (estropipate) alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.

Exacerbation of other conditions

Estrogen (estropipate) s may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.

Patient Information

Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe OGEN (estropipate) .

Laboratory Tests

Estrogen (estropipate) administration should be initiated at the lowest dose approved for the indication and then guided by clinical response rather than by serum hormone levels (e.g., estradiol, FSH).

Carcinogen (estropipate) esis, Mutagenesis, Impairment Of Fertility

Long-term continuous administration of estrogen (estropipate) , with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)

Long-term continuous administration of natural and synthetic estrogen (estropipate) s in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.

Pregnancy

OGEN (estropipate) should not be used during pregnancy. (See CONTRAINDICATIONS.)

Nursing Mothers

Estrogen (estropipate) administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogen (estropipate) s have been identified in the milk of mothers receiving this drug. Caution should be exercised when OGEN (estropipate) is administered to a nursing woman.

Geriatric Use

In the Women's Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n= 3,729) were 65 to 74 while 18% (n= 803) were 75 and over. Most women (80%) had no prior hormone therapy use. Women treated with conjugated estrogen (estropipate) s plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer's disease was the most common classification of probable dementia in both the conjugated estrogen (estropipate) s plus medroxyprogesterone acetate group and the placebo group. Ninety percent of the cases of probable dementia occurred in the 54% of women that were older than 70. (See WARNINGS, Dementia.)

General

Addition of a progestin when a woman has not had a hysterectomy

Studies of the addition of a progestin for 10 or more days of a cycle of estrogen (estropipate) administration, or daily with estrogen (estropipate) in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen (estropipate) treatment alone.

Endometrial hyperplasia may be a precursor to endometrial cancer.

There are, however, possible risks that may be associated with the use of progestins with estrogen (estropipate) s compared to estrogen (estropipate) -alone regimens. These include a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL) and impairment of glucose tolerance.

Elevated blood pressure

In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogen (estropipate) s. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen (estropipate) s on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen (estropipate) use.

Hypertriglyceridemia

In patients with pre-existing hypertriglyceridemia, estrogen (estropipate) therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications.

Impaired liver function and past history of cholestatic jaundice

Estrogen (estropipate) s may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen (estropipate) use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued.

Hypothyroidism

Estrogen (estropipate) administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogen (estropipate) s may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.

Fluid retention

Because estrogen (estropipate) s may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogen (estropipate) s are prescribed.

Hypocalcemia

Estrogen (estropipate) s should be used with caution in individuals with severe hypocalcemia.

Ovarian cancer

The CE/MPA substudy of WHI reported that estrogen (estropipate) plus progestin increased the risk of ovarian cancer. After an average followup of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95% confidence interval 0.77 – 3.24) but was not statistically significant. The absolute risk for CE/MPA versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen (estropipate) alone, in particular for ten or more years, has been associated with an increased risk of ovarian cancer. Other epidemiologic studies have not found these associations.

Exacerbation of endometriosis

Endometriosis may be exacerbated with administration of estrogen (estropipate) s. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen (estropipate) alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.

Exacerbation of other conditions

Estrogen (estropipate) s may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.

Patient Information

Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe OGEN (estropipate) .

Laboratory Tests

Estrogen (estropipate) administration should be initiated at the lowest dose approved for the indication and then guided by clinical response rather than by serum hormone levels (e.g., estradiol, FSH).

Carcinogen (estropipate) esis, Mutagenesis, Impairment Of Fertility

Long-term continuous administration of estrogen (estropipate) , with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)

Long-term continuous administration of natural and synthetic estrogen (estropipate) s in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.

Pregnancy

OGEN (estropipate) should not be used during pregnancy. (See CONTRAINDICATIONS.)

Nursing Mothers

Estrogen (estropipate) administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogen (estropipate) s have been identified in the milk of mothers receiving this drug. Caution should be exercised when OGEN (estropipate) is administered to a nursing woman.

Geriatric Use

In the Women's Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n= 3,729) were 65 to 74 while 18% (n= 803) were 75 and over. Most women (80%) had no prior hormone therapy use. Women treated with conjugated estrogen (estropipate) s plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer's disease was the most common classification of probable dementia in both the conjugated estrogen (estropipate) s plus medroxyprogesterone acetate group and the placebo group. Ninety percent of the cases of probable dementia occurred in the 54% of women that were older than 70. (See WARNINGS, Dementia.)


This monograph has been modified to include the generic and brand name in many instances.


This monograph has been modified to include the generic and brand name in many instances.

ContrainDications

Serious ill effects have not been reported following acute ingestion of large doses of estrogen (estropipate) -containing oral contraceptives by young children. Overdosage of estrogen (estropipate) may cause nausea and vomiting, and withdrawal bleeding may occur in females.

Clinical Pharamacology

OGEN (estropipate) should not be used in women with any of the following conditions:

  1. Undiagnosed abnormal genital bleeding.
  2. Known, suspected, or history of cancer of the breast.
  3. Known or suspected estrogen (estropipate) -dependent neoplasia.
  4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
  5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
  6. Liver dysfunction or disease.
  7. OGEN (estropipate) should not be used in patients with known hypersensitivity to its ingredients.
  8. Known or suspected pregnancy. There is no indication for OGEN (estropipate) in pregnancy.

There appears to be little or no increased risk of birth defects in children born to women who have used estrogen (estropipate) s and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS.)


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

OGEN®
estropipate tablets, USP

Read this Patient Information before you start taking OGEN (estropipate) and read what you get each time you refill OGEN (estropipate) . There may be new information. This information does not take the place of talking to your health care provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OGEN (estropipate) (AN ESTROGEN (estropipate) HORMONE)?

  • Estrogen (estropipate) s increase the chances of getting cancer of the uterus.

Report any unusual vaginal bleeding right away while you are taking estrogen (estropipate) s. Vaginal bleeding after menopause may be a warning sign of cancer of the uterine (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.

  • Do not use estrogen (estropipate) s with or without progestins to prevent heart disease, heart attacks or strokes.

Using estrogen (estropipate) s with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer and blood clots. You and your health care provider should talk regularly about whether you still need treatment with OGEN (estropipate) .

What is OGEN (estropipate) ?

OGEN (estropipate) is a medicine that contains estrogen (estropipate) hormones.

What is OGEN (estropipate) used for?

OGEN (estropipate) is used during and after menopause to:

  • reduce moderate or severe hot flashes.

Estrogen (estropipate) s are hormones made by a woman's ovaries. The ovaries normally stop making estrogen (estropipate) s when a woman is between 45 to 55 years old. This drop in body estrogen (estropipate) levels causes the “change of life” or menopause (the end of monthly menstrual periods).

Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen (estropipate) levels causes “surgical menopause”.

When the estrogen (estropipate) levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they do not need to use estrogen (estropipate) s. In other women, symptoms can be more severe. You and your health care provider should talk regularly about whether you still need treatment with OGEN (estropipate) .

  • treat moderate to severe dryness, itching, and burning in and around the vagina.

You and your health care provider should talk regularly about whether you still need treatment with OGEN (estropipate) to control these problems.

If you use OGEN (estropipate) only to treat your dryness, itching, and burning in and around your vagina, talk with your health care provider about whether a topical vaginal product would be better for you.

help reduce your chances of getting osteoporosis (thin weak bones).

Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use OGEN (estropipate) only to prevent osteoporosis from menopause, talk with your health care provider about whether a different treatment or medicine without estrogen (estropipate) s might be better for you. You and your health care provider should talk regularly about whether you should continue with OGEN (estropipate) .

Weight-bearing exercise, like walking or running, and taking calcium and vitamin D supplements may also lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your health care provider before starting them.

OGEN (estropipate) is also used to:

treat certain conditions in women before menopause if their ovaries do not make enough estrogen (estropipate) naturally.

Who should not take OGEN (estropipate) ?

Do not start taking OGEN (estropipate) if you:

  • have unusual vaginal bleeding.
  • currently have or have had certain cancers.

Estrogen (estropipate) s may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your health care provider about whether you should take OGEN (estropipate) .

  • had a stroke or heart attack in the past year.
  • currently have or have had blood clots.
  • currently have or have had liver problems.
  • are allergic to OGEN (estropipate) or any of its ingredients.

See the end of this leaflet for a list of ingredients in OGEN (estropipate) .

  • think you may be pregnant.

Tell your health care provider:

  • if you are breastfeeding.

The hormone in OGEN (estropipate) can pass into your milk.

  • about all of your medical problems.

Your health care provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

  • about all the medicines you take.

This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how OGEN (estropipate) works. OGEN (estropipate) may also affect how your other medicines work.

  • if you are going to have surgery or will be on bed rest.

You may need to stop taking estrogen (estropipate) s.

How should I take OGEN (estropipate) ?

Take OGEN (estropipate) as directed by your health care provider. OGEN (estropipate) comes in three strengths. Check with your health care provider periodically to make sure you are using the appropriate dose.

  1. Start at the lowest dose and talk to your health care provider about how well that dose is working for you.
  2. Estrogen (estropipate) s should be used at the lowest dose possible for your treatment only as long as needed. The lowest effective dose of OGEN (estropipate) has not been determined. You and your health care provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with OGEN (estropipate) .

What are the possible side effects of estrogen (estropipate) s?

Less common but serious side effects include:

  • Breast cancer
  • Cancer of the uterus
  • Stroke
  • Heart attack
  • Blood clots
  • Gallbladder disease
  • Ovarian cancer

These are some of the warning signs of serious side effects:

  • Breast lumps
  • Unusual vaginal bleeding
  • Dizziness and faintness
  • Changes in speech
  • Severe headaches
  • Chest pain
  • Shortness of breath
  • Pains in your legs
  • Changes in vision
  • Vomiting

Call your health care provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps, bloating
  • Nausea and vomiting

Other side effects include:

  • High blood pressure
  • Liver problems
  • High blood sugar
  • Fluid retention
  • Enlargement of benign tumors of the uterus (“fibroids”)
  • Vaginal yeast infections
  • Hair loss

These are not all the possible side effects of OGEN (estropipate) . For more information, ask your health care provider or pharmacist.

What can I do to lower my chances of getting a serious side effect with OGEN (estropipate) ?

Talk with your health care provider regularly about whether you should continue taking OGEN (estropipate) . If you have a uterus, talk to your health care provider about whether the addition of a progestin is right for you. See your health care provider right away if you get vaginal bleeding while taking OGEN (estropipate) . Have a breast exam and mammogram (breast X-ray) every year unless your health care provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast examinations more often. If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your health care provider for ways to lower your chances for getting heart disease.

General information about safe and effective use of OGEN (estropipate)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take OGEN (estropipate) for conditions for which it was not prescribed. Do not give OGEN (estropipate) to other people, even if they have the same symptoms you have. It may harm them. Keep OGEN (estropipate) out of the reach of children.

This leaflet provides a summary of the most important information about OGEN (estropipate) . If you would like more information, talk with your health care provider or pharmacist. You can ask for information about OGEN (estropipate) that is written for health professionals. You can get more information by calling the toll free number 1-888-691-6813.

What are the ingredients in OGEN?

OGEN contains estropipate as the active ingredient. OGEN (estropipate) also contains colloidal silicon dioxide, dibasic potassium phosphate, hydrogen (estropipate) ated vegetable oil wax, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and tromethamine.

The color ingredients are:

OGEN (estropipate) .625 (yellow tablet): D&C Yellow No. 10 and FD&C Yellow No. 6.

OGEN (estropipate) 1.25 (peach tablet): FD&C Yellow No. 6.

OGEN (estropipate) 2.5 (blue tablet): FD&C Blue No. 2.

(Updated July 2006)


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ESTROGENS - ORAL

 

(ES-troe-jenz)

 

COMMON BRAND NAME(S): Cenestin, Enjuvia, Estrace, Femtrace, Ogen, Premarin

 

WARNING: Estrogens, either used alone or with another hormone (progestin), have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia.

Estrogens can increase the risk of cancer of the uterus (endometrial cancer). Taking a progestin as directed by your doctor can help decrease this risk. Tell your doctor right away if you have any unusual vaginal bleeding.

In postmenopausal women, estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogens alone do not appear to increase the risk of breast cancer when used for up to 7 years. Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries.

The risk for serious side effects may depend on the dose of estrogen and the length of time it is used. Therefore, this medication should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of this medication with your doctor and check with him/her regularly (for example, every 3 to 6 months) to see if you still need to take this medication. If you will be taking this medication long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.

 

USES: This medication is a female hormone. It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

Certain estrogen products may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen treatment.

Certain estrogen products may also be used by men and women to treat cancers (certain types of prostate cancer, breast cancer that has spread to other parts of the body) and by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure).

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. You may take it with food or right after a meal to prevent stomach upset.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day as directed. Follow your dosing schedule carefully. Do not increase your dose or take this medication more often or for a longer time than directed.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Tell your doctor promptly if you see the tablet in your stool.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Ogen (estropipate) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking an estrogen product. You may need to stop this medication for a time or take special precautions.

This drug may cause blotchy, dark areas of the skin on the face (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

Children may be more sensitive to the side effects of this drug. It may affect their growth/development. Discuss the possible effects of this medication with the doctor, and monitor your child's growth periodically.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane, letrozole), fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene.

This medication may interfere with certain laboratory tests (including metyrapone test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding.

 

NOTES: Do not share this medication with others.

Keep all regular medical and laboratory appointments. You should have regular complete physical exams (for example, once a year) which include laboratory and medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, pap smear) to monitor your progress and check for side effects. Follow your doctor's instructions for examining your own breasts, and report any lumps right away. Consult your doctor for more details.

Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Keep your mind active with mental exercises (such as reading, solving crossword puzzles) to help prevent dementia. Talk to your doctor about lifestyle changes that might benefit you.

Lifestyle changes that may help reduce hot flashes include stopping smoking, dressing lightly or in layers, avoiding/limiting certain foods (spicy foods, caffeine, alcohol), reducing stress, and exercising regularly.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised May 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Ogen 0.625, Ogen 1.25, Ogen 2.5

Generic Name: estropipate (Pronunciation: ES troe PIP ate)

  • What is estropipate (Ogen)?
  • What are the possible side effects of estropipate (Ogen)?
  • What is the most important information I should know about estropipate (Ogen)?
  • What should I discuss with my health care provider before using estropipate (Ogen)?
  • How should I use estropipate (Ogen)?
  • What happens if I miss a dose (Ogen)?
  • What happens if I overdose (Ogen)?
  • What should I avoid while using estropipate (Ogen)?
  • What other drugs will affect estropipate (Ogen)?
  • Where can I get more information?

What is estropipate (Ogen)?

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.

Estropipate 0.75 mg-BAR

round, yellow, imprinted with barr, 555 727

What are the possible side effects of estropipate (Ogen)?

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.

Read the Ogen (estropipate) Side Effects Center for a complete guide to possible side effects

Learn More »

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

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.

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.

Side Effects Centers
  • Ogen

Patient Detailed How Take

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

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 (Ogen)?

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.

Side Effects Centers
  • Ogen

Patient Detailed Avoid Taking

What happens if I miss a dose (Ogen)?

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 (Ogen)?

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 (Ogen)?

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

What other drugs will affect estropipate (Ogen)?

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.

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 1996-2013 Cerner Multum, Inc. Version: 5.07. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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