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Estraderm
Overview
What is Estraderm?
Estraderm (estradiol transdermal system) is designed to release estradiol through a rate-limiting membrane continuously upon application to intact skin.
Two systems are available to provide nominal delivery of 0.05 or 0.1 mg of estradiol per day via skin of average permeability (interindividual variation in skin permeability is approximately 20%). Each corresponding system having an active surface area of 10 or 20 cm contains 4 or 8 mg of estradiol USP and 0.3 or 0.6 mL of alcohol USP, respectively. The composition of the systems per unit area is identical.
Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17ß-diol.
The structural formula is
The Estraderm system comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a transparent polyester/ethylene vinyl acetate copolymer film, (2) a drug reservoir of estradiol USP and alcohol USP gelled with hydroxypropyl cellulose NF, (3) an ethylene-vinyl acetate copolymer membrane, and (4) an adhesive formulation of light mineral oil NF and polyisobutylene. A protective liner (5) of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used.
The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. Alcohol is also released from the system during use.
What does Estraderm look like?
What are the available doses of Estraderm?
Sorry No records found.
What should I talk to my health care provider before I take Estraderm?
Sorry No records found
How should I use Estraderm?
Sorry No records found
What interacts with Estraderm?
- Estrogens should not be used in individuals with any of the following conditions:
- Undiagnosed abnormal genital bleeding.
- Known, suspected or history of cancer of the breast .
- Known or suspected estrogen-dependent neoplasia.
- Active deep vein thrombosis, pulmonary embolism or a history of these conditions.
- Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
- Liver dysfunction or disease.
- Estraderm (estradiol transdermal system) should not be used in patients with known hypersensitivity to its ingredients.
- Known or suspected pregnancy. There is no indication for Estraderm in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy (see PRECAUTIONS).
What are the warnings of Estraderm?
Isocaine 2% with Levonordefrin 1:20,000 injection (Mepivacaine Hydrochloride and Levonordefrin Injection, USP) contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Isocaine 3% injection (Mepivacaine Hydrochloride Injection USP 3%) is SULFITE FREE.
See BOXED WARNINGS.
The use of unopposed estrogens in women who have a uterus is associated with an increased risk of endometrial cancer.
1. Cardiovascular Disorders
Estrogen and estrogen/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, estrogens should be discontinued immediately.
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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.
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In the Women’s Health Initiative study (WHI), an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE alone compared to placebo.
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In the CE/MPA substudy of WHI an increased risk of coronary heart disease (CHD) events (defined as non-fatal myocardial infarction and CHD death) was observed in women receiving CE/MPA compared to women receiving placebo (37 vs. 30 per 10,000 women-years). The increase in risk was observed in year 1 and persisted.
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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.
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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/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 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 in the placebo group in HERS, HERS II, and overall.
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Large doses of estrogen (5 mg conjugated estrogens 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 non-fatal myocardial infarction, pulmonary embolism, and thrombophlebitis.
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In the Women’s Health Initiative (WHI) study, an increase in VTE has been observed in women receiving CE compared to placebo.
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In the CE/MPA substudy of WHI, a 2-fold greater rate of VTE, including deep vein thrombosis and pulmonary embolism, was observed in women receiving CE/MPA compared to women receiving placebo. The rate of VTE was 34 per 10,000 women-years in the CE/MPA group compared to 16 per 10,000 women-years in the placebo group. The increase in VTE risk was observed during the first year and persisted.
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If feasible, estrogens 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.
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2. Malignant Neoplasms
The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12-fold greater than in non-users and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with the use of estrogens for less than 1 year. The greatest risk appears associated with prolonged use with increased risks of 15- to 24-fold for 5 to 10 years or more, and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued.
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Clinical surveillance of all women taking estrogen/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 estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.
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The use of estrogens 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 estrogens or progestins, doses, or routes of administration.
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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/progestin combination therapy, and a smaller increased risk for estrogen 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 5 years after stopping treatment. In addition, observational studies suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen/progestin combination therapy as compared to estrogen alone therapy.
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In the CE/MPA substudy, 26% of the women reported prior use of estrogen alone and/or estrogen/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 2 groups. Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ between the groups.
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The use of estrogen 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.
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3. 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 vs. 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 vs. placebo was 45 vs. 22 cases per 10,000 women-years, and the absolute excess risk for CE/MPA was 23 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.)
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4. Gallbladder Disease
A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.
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5. Hypercalcemia
Administration of estrogen may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If this occurs, the drug should be stopped and appropriate measures taken to reduce the serum calcium level.
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6. Visual Abnormalities
Retinal vascular thrombosis has been reported in patients receiving estrogens. 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, estrogens should be permanently discontinued.
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What are the precautions of Estraderm?
A. General
Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.
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There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer.
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In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogens on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use.
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In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications.
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Although transdermally administered estrogen therapy avoids first-pass hepatic metabolism, estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued.
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Estrogen 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 T and T serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens 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.
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Because estrogens may cause some degree of fluid retention, conditions which might be influenced by this factor, such as cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed.
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Estrogens should be used with caution in individuals with severe hypocalcemia.
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The CE/MPA substudy of WHI reported that estrogen plus progestin increased the risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA vs. placebo was 1.58 (95% confidence interval 0.77–3.24) but was not statistically significant. The absolute risk for CE/MPA vs. placebo was 4.2 vs. 2.7 cases per 10,000 woman-years. In some epidemiologic studies, the use of estrogen alone, in particular for 10 or more years, has been associated with an increased risk of ovarian cancer. Other epidemiologic studies have not found these associations.
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Endometriosis may be exacerbated with administration of estrogens. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.
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Estrogens 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.
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B. Patient Information
Physicians are advised to discuss the Patient Information leaflet with patients for whom they prescribe Estraderm (estradiol transdermal system).
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C. Laboratory Tests
Estrogen administration should be initiated at the lowest dose for the approved indication and then guided by clinical response, rather than by serum hormone levels (e.g., estradiol, FSH).
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D. Drug/Laboratory Test Interactions
E. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term continuous administration of estrogen, 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 WARNING, WARNINGS and PRECAUTIONS.)
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Long-term, continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
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F. Pregnancy
Estrogens should not be used during pregnancy. (See CONTRAINDICATIONS.)
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G. Nursing Mothers
Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Estraderm is administered to a nursing woman.
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H. Pediatric Use
Estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. Safety and effectiveness in pediatric patients have not otherwise been established.
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Large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short adult stature if treatment is initiated before the completion of physiologic puberty in normally developing children. If estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration.
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Estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. (See INDICATIONS and DOSAGE AND ADMINISTRATION.)
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I. Geriatric Use
Clinical studies of Estraderm did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
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In the Women’s Health Initiative Memory Study (WHIMS), 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 estrogens plus medroxyprogesterone acetate were reported to have a 2-fold increase in the risk of developing probable dementia. Alzheimer’s disease was the most common classification of probable dementia in both the conjugated estrogens 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.)
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What are the side effects of Estraderm?
See BOXED WARNING, WARNINGS and PRECAUTIONS.
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The most commonly reported adverse reaction to Estraderm (estradiol transdermal system) in clinical trials was redness and irritation at the application site. This occurred in about 17% of the women treated and caused approximately 2% to discontinue therapy. Reports of rash have been rare. There have also been rare reports of severe systemic allergic reactions.
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The following additional adverse reactions have been reported with estrogens:
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1. 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.
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2. Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
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3. Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
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4. Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
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5. Skin
Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
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6. Eyes
Retinal vascular thrombosis; intolerance to contact lenses.
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7. Central Nervous System
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
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8. Miscellaneous
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.
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What should I look out for while using Estraderm?
Estrogens should not be used in individuals with any of the following conditions:
See BOXED WARNINGS.
The use of unopposed estrogens in women who have a uterus is associated with an increased risk of endometrial cancer.
What might happen if I take too much Estraderm?
Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
How should I store and handle Estraderm?
Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11Estraderm estradiol transdermal system 0.05 mg/dayPatient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62Estraderm estradiol transdermal system 0.1 mg/dayPatient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62*See DESCRIPTION.Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.REV: JANUARY 2005 T2005-11
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The skin metabolizes estradiol only to a small extent. In contrast, orally administered estradiol is rapidly metabolized by the liver to estrone and its conjugates, giving rise to higher circulating levels of estrone than estradiol. Therefore, transdermal administration produces therapeutic plasma levels of estradiol with lower circulating levels of estrone and estrone conjugates and requires smaller total doses than does oral therapy.
Non-Clinical Toxicology
Estrogens should not be used in individuals with any of the following conditions:See BOXED WARNINGS.
The use of unopposed estrogens in women who have a uterus is associated with an increased risk of endometrial cancer.
The administration of local anesthetic solutions containing vasopressors, such as Levonordefrin, Epinephrine or Norepinephrine, to patients receiving tricyclic antidepressants or monoamine oxidase inhibitors may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
Phenothiazines and butyrophenones may reduce or reverse the pressor effect of Epinephrine.
Solutions containing a vasoconstrictor should be used cautiously in the presence of disease which may adversely affect the patient's cardiovascular system. Serious cardiac arrhythmias may occur if preparations containing a vasoconstrictor are employed in patients during or following the administration of potent inhalation anesthetics.
MEPIVACAINE SHOULD BE USED WITH CAUTION IN PATIENTS WITH KNOWN DRUG ALLERGIES AND SENSITIVITIES. A thorough history of the patient's prior experience with Mepivacaine or other local anesthetics as well as concomitant or recent drug use should be taken (see ). Patients allergic to methylparaben or para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross-sensitivity to agents of the amide type such as Mepivacaine. Since Mepivacaine is metabolized in the liver and excreted by the kidneys, it should be used cautiously in patients with liver and renal disease.
See BOXED WARNING, WARNINGS and PRECAUTIONS.
The most commonly reported adverse reaction to Estraderm (estradiol transdermal system) in clinical trials was redness and irritation at the application site. This occurred in about 17% of the women treated and caused approximately 2% to discontinue therapy. Reports of rash have been rare. There have also been rare reports of severe systemic allergic reactions.
The following additional adverse reactions have been reported with estrogens:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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