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Premarin
Overview
What is Premarin?
PREMARIN (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of conjugated estrogens.
PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide.
— 0.3 mg tablets also contain: D&C Yellow No. 10 and FD&C Blue No. 2.
— 0.45 mg tablets also contain: FD&C Blue No. 2.
— 0.625 mg tablets also contain: FD&C Blue No. 2 and FD&C Red No. 40.
— 0.9 mg tablets also contain: D&C Red No. 30 and D&C Red No. 7.
— 1.25 mg tablets also contain: black iron oxide, D&C Yellow No. 10 and FD&C Yellow No. 6.
PREMARIN tablets comply with USP Dissolution Test criteria as outlined below:
What does Premarin look like?
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What are the available doses of Premarin?
Sorry No records found.
What should I talk to my health care provider before I take Premarin?
Sorry No records found
How should I use Premarin?
PREMARIN therapy is indicated in the:
When estrogen is prescribed for a postmenopausal 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, 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 (for example at 3-month to 6-month intervals) to determine if treatment is still necessary (see and ). For women with 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.
PREMARIN may be taken without regard to meals.
What interacts with Premarin?
- PREMARIN therapy 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 except in appropriately selected patients being treated for metastatic disease.
- Known or suspected estrogen-dependent neoplasia.
- Active deep vein thrombosis, pulmonary embolism or a history of these conditions.
- Active or recent (within the past year) arterial thromboembolic disease (for example, stroke, myocardial infarction).
- Liver dysfunction or disease.
- Known hypersensitivity to any of the ingredients in PREMARIN.
- Known or suspected pregnancy.
What are the warnings of Premarin?
The benefits of immediate-release oral ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN are so difficult to terminate rapidly, this formulation is not recommended in these settings.
1. Cardiovascular disorders
An increased risk of stroke and deep vein thrombosis (DVT) has been reported with estrogen alone therapy.
An increased risk of stroke, DVT, pulmonary embolism, and myocardial infarction has been reported with estrogen plus progestin therapy.
Should any of these events occur or be suspected, estrogens with or without progestins should be discontinued immediately.
Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.
a. Stroke
In the Women's Health Initiative (WHI) estrogen alone substudy, a statistically significant increased risk of stroke was reported in women receiving daily conjugated estrogens (CE 0.625 mg) compared to placebo (44 versus 32 per 10,000 women-years). The increase in risk was demonstrated in year one and persisted. (See .)
In the estrogen plus progestin substudy of WHI, a statistically significant increased risk of stroke was reported in women receiving daily CE 0.625 mg plus medroxyprogesterone acetate (MPA 2.5 mg) compared to placebo (31 versus 24 per 10,000 women-years). The increase in risk was demonstrated after the first year and persisted. (See .)
b. Coronary heart disease
In the estrogen alone substudy of WHI, no overall effect on coronary heart disease (CHD) events (defined as nonfatal myocardial infarction [MI], silent MI, or CHD death) was reported in women receiving estrogen alone compared to placebo. (See .)
In the estrogen plus progestin substudy of WHI, no statistically significant increase of CHD events was reported in women receiving CE/MPA compared to placebo (39 versus 33 per 10,000 women years). An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5.
In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/progestin Replacement Study; HERS), treatment with daily CE 0.625 mg/MPA 2.5 mg 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 one, but not during the subsequent years. Two thousand three hundred and twenty one (2,321) 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 the HERS, the HERS II, and overall.
c. Venous thromboembolism (VTE)
In the estrogen alone substudy of WHI, the risk of VTE (DVT and pulmonary embolism [PE]), was reported to be increased for women receiving daily CE compared to placebo (30 versus 22 per 10,000 women-years), although only the increased risk of DVT reached statistical significance (23 versus 15 per 10,000 women years). The increase in VTE risk was demonstrated during the first 2 years. (See .)
In the estrogen plus progestin substudy of WHI, a statistically significant 2-fold greater rate of VTE was reported in women receiving daily CE/MPA compared to placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women years) were also demonstrated. The increase in VTE risk was demonstrated during the first year and persisted. (See .)
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.
2. Malignant neoplasms
a. Endometrial cancer
An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in women with a uterus. The reported endometrial cancer risk among unopposed estrogen users with an intact uterus is about 2 to 12 times 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.
Clinical surveillance of all women using estrogen plus progestin therapy 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 postmenopausal estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.
b. Breast cancer
The most important randomized clinical trial providing information about this issue in estrogen alone users is the Women's Health Initiative (WHI) substudy of daily conjugated estrogens (CE 0.625 mg). In the estrogen alone substudy of WHI, after an average 7.1 years of follow-up, daily CE 0.625 mg was not associated with an increased risk of invasive breast cancer (relative risk [RR] 0.80, 95 percent nominal confidence interval [nCI] 0.62-1.04). (see ).
The most important randomized clinical trial providing information about this issue in estrogen plus progestin users is the Women's Health Initiative (WHI) substudy of daily CE 0.625 mg plus medroxyprogesterone acetate (MPA 2.5 mg). In the estrogen plus progestin substudy, after a mean follow-up of 5.6 years, the WHI substudy reported an increased risk of breast cancer in women who took daily CE/MPA. In this substudy, prior use of estrogen alone or estrogen plus progestin therapy was reported by 26 percent of the women. The relative risk of invasive breast cancer was 1.24 (95 percent nCI 1.01-1.54), and the absolute risk was 41 versus 33 cases per 10,000 women-years, for estrogen plus progestin compared with placebo, respectively. 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 versus 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 versus 36 cases per 10,000 women-years for estrogen plus progestin 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 the groups. (See .)
The results from observational studies are generally consistent with those of the WHI clinical trial. Observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller increased risk for estrogen alone therapy, after several years of use. The risk increased with duration of use, and appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to estrogen alone therapy. However, these studies have not found significant variation in the risk of breast cancer among different estrogen plus progestin combinations, doses, or routes of administration.
The use of estrogen alone and 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 healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results.
3. Dementia
In the estrogen alone Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 2,947 hysterectomized women 65 to 79 years of age was randomized to daily conjugated estrogens (CE 0.625 mg) or placebo. In the estrogen plus progestin WHIMS substudy, a population of 4,532 postmenopausal women 65 to 79 years of age was randomized to daily CE 0.625 mg plus medroxyprogesterone acetate (MPA 2.5 mg) or placebo.
In the estrogen alone substudy, after an average follow-up of 5.2 years, 28 women in the estrogen alone group and 19 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE alone versus placebo was 1.49 (95 percent CI 0.83-2.66). The absolute risk of probable dementia for CE alone versus placebo was 37 versus 25 cases per 10,000 women-years. (See and .)
In the estrogen plus progestin substudy, after an average follow-up of 4 years, 40 women in the CE/MPA group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE/MPA versus placebo was 2.05 (95 percent CI 1.21-3.48). The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years. (See and .)
When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI 1.19-2.60). Since both substudies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women. (See and .)
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.
5. Hypercalcemia
Estrogen 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.
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.
7. Angioedema
Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema.
What are the precautions of Premarin?
A. General
1. 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 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.
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, adverse effects on lipoprotein metabolism (lowering HDL, raising LDL) and impairment of glucose tolerance.
2. Elevated blood pressure
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 estrogen therapy on blood pressure was not seen. Blood pressure should be monitored at regular intervals during estrogen use.
3. Hypertriglyceridemia
In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. Consider discontinuation of treatment if pancreatitis or other complications develop.
In the HOPE study, the mean percent increase from baseline in serum triglycerides after one year of treatment with PREMARIN 0.625 mg, 0.45 mg, and 0.3 mg compared with placebo were 34.3, 30.2, 25.1, and 10.7, respectively. After two years of treatment, the mean percent changes were 47.6, 32.5, 19.0, and 5.5, respectively.
4. Impaired liver function and past history of cholestatic jaundice
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.
5. Hypothyroidism
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.
6. Fluid retention
Estrogens may cause some degree of fluid retention. Patients with conditions that might be influenced by this factor, such as cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed.
7. Hypocalcemia
Estrogens should be used with caution in individuals with severe hypocalcemia.
8. Ovarian cancer
The estrogen plus progestin substudy of WHI reported a non-statistically significant increased risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95 percent nCI 0.77 – 3.24). 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-only products, in particular for 5 or more years, has been associated with an increased risk of ovarian cancer. However, the duration of exposure associated with increased risk is not consistent across all epidemiologic studies and some report no association.
9. Exacerbation of endometriosis
Endometriosis may be exacerbated with administration of estrogen therapy.
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.
10. Exacerbation of other conditions
Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in patients with these conditions.
B. Patient Information
Physicians are advised to discuss the contents of the leaflet with patients for whom they prescribe PREMARIN.
C. Laboratory Tests
Serum follicle stimulating hormone and estradiol levels have not been shown to be useful in the management of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy.
Laboratory parameters may be useful in guiding dosage for the treatment of hypoestrogenism due to hypogonadism, castration and primary ovarian failure.
D. Drug/Laboratory Test Interactions
E. Carcinogenesis, Mutagenesis, Impairment of Fertility
(See and .)
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.
F. Pregnancy
PREMARIN should not be used during pregnancy. (See .)
G. Nursing Mothers
PREMARIN should not be used during lactation. 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.
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.
Large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short 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.
Estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. In boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia. (See and .)
I. Geriatric Use
With respect to efficacy in the approved indications, there have not been sufficient numbers of geriatric patients involved in studies utilizing PREMARIN to determine whether those over 65 years of age differ from younger subjects in their response to PREMARIN.
In the estrogen alone substudy of the Women's Health Initiative (WHI) study, 46 percent (n=4,943) were 65 years of age and older, while 7.1 percent (n=767) were 75 years of age and older. There was a higher relative risk (daily conjugated estrogens [CE 0.625 mg] versus placebo) of stroke in women less than 75 years of age compared to women 75 years and older.
In the estrogen alone Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 2,947 hysterectomized women, 65 to 79 years of age, was randomized to daily CE 0.625 mg or placebo. After an average follow-up of 5.2 years, the relative risk (CE versus placebo) of probable dementia was 1.49 (95 percent CI 0.83-2.66). The absolute risk of developing probable dementia with estrogen alone was 37 versus 25 cases per 10,000 women-years compared with placebo.
Of the total number of subjects in the estrogen plus progestin substudy of the Women's Health Initiative study, 44 percent (n=7,320) were 65 years of age and older, while 6.6 percent (n=1,095) were 75 years and older. In women 75 years of age and older compared to women less than 74 years of age, there was a higher relative risk of nonfatal stroke and invasive breast cancer in the estrogen plus progestin group versus placebo. In women greater than 75, the increased risk of nonfatal stroke and invasive breast cancer observed in the estrogen plus progestin group compared to placebo was 75 versus 24 per 10,000 women-years and 52 versus 12 per 10,000 women years, respectively.
In the estrogen plus progestin substudy of WHIMS, a population of 4,532 postmenopausal women, 65 to 79 years of age, was randomized to daily CE 0.625 mg/MPA 2.5 mg or placebo. In the estrogen plus progestin group, after an average follow-up of 4 years, the relative risk (CE/MPA versus placebo) of probable dementia was 2.05 (95 percent CI 1.21-3.48). The absolute risk of developing probable dementia with CE/MPA was 45 versus 22 cases per 10,000 women-years compared with placebo.
Seventy-nine percent of the cases of probable dementia occurred in women that were older than 70 for the CE alone group, and 82 percent of the cases of probable dementia occurred in women who were older than 70 in the CE/MPA group. The most common classification of probable dementia in both the treatment groups and placebo groups was Alzheimer’s disease.
When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI 1.19-2.60). Since both substudies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women. (See and .)
What are the side effects of Premarin?
See
and .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During the first year of a 2-year clinical trial with 2,333 postmenopausal women between 40 and 65 years of age (88% Caucasian), 1,012 women were treated with conjugated estrogens and 332 were treated with placebo. summarizes adverse events that occurred at a rate of ≥ 5%.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
| --Conjugated Estrogens Treatment Group-- | ||||
| Body System | 0.625 mg | 0.45 mg | 0.3 mg | Placebo |
| Adverse event | (n = 348) | (n = 338) | (n = 326) | (n = 332) |
| Any adverse event | 323 (93%) | 305 (90%) | 292 (90%) | 281 (85%) |
| Body as a Whole | ||||
| Abdominal pain Accidental injury Asthenia Back pain Flu syndrome Headache Infection Pain | 56 (16%)21 (6%)25 (7%)49 (14%)37 (11%)90 (26%)61 (18%)58 (17%) | 50 (15%)41 (12%)23 (7%)43 (13%)38 (11%)109 (32%)75 (22%)61 (18%) | 54 (17%)20 (6%)25 (8%)43 (13%)33 (10%)96 (29%)74 (23%)66 (20%) | 37 (11%)29 (9%)16 (5%)39 (12%)35 (11%)93 (28%)74 (22%)61 (18%) |
| Diarrhea Dyspepsia Flatulence Nausea | 21 (6%)33 (9%)24 (7%)32 (9%) | 25 (7%)32 (9%)23 (7%)21 (6%) | 19 (6%)36 (11%)18 (6%)21 (6%) | 21 (6%)46 (14%)9 (3%)30 (9%) |
| Arthralgia Leg cramps Myalgia | 47 (14%)19 (5%)18 (5%) | 42 (12%)23 (7%)18 (5%) | 22 (7%)11 (3%)29 (9%) | 39 (12%)7 (2%)25 (8%) |
| Depression Dizziness Insomnia Nervousness | 25 (7%)19 (5%)21 (6%)12 (3%) | 27 (8%)20 (6%)25 (7%)17 (5%) | 17 (5%)12 (4%)24 (7%)6 (2%) | 22 (7%)17 (5%)33 (10%)7 (2%) |
| Cough increased Pharyngitis Rhinitis Sinusitis Upper respiratory infection | 13 (4%)35 (10%)21 (6%)22 (6%)42 (12%) | 22 (7%)35 (10%)30 (9%)36 (11%)34 (10%) | 14 (4%)40 (12%)31 (10%)24 (7%)28 (9%) | 14 (4%)38 (11%)42 (13%)24 (7%)35 (11%) |
| Pruritus | 14 (4%) | 17 (5%) | 16 (5%) | 7 (2%) |
| Breast pain Leukorrhea Vaginal hemorrhage Vaginal moniliasis Vaginitis | 38 (11%)18 (5%)47 (14%)20 (6%)24 (7%) | 41 (12%)22 (7%)14 (4%)18 (5%)20 (6%) | 24 (7%)13 (4%)7 (2%)17 (5%)16 (5%) | 29 (9%)9 (3%)06 (2%)4 (1%) |
1. Genitourinary system
Abnormal uterine bleeding/spotting
Dysmenorrhea/pelvic pain
Increase in size of uterine leiomyomata
Vaginitis, including vaginal candidiasis
Change in amount of cervical secretion
Change in cervical ectropion
Ovarian cancer
Endometrial hyperplasia
Endometrial cancer
2. Breasts
Tenderness, enlargement, pain, discharge, galactorrhea
Fibrocystic breast changes
Breast cancer
3. Cardiovascular
Deep and superficial venous thrombosis
Pulmonary embolism
Thrombophlebitis
Myocardial infarction
Stroke
Increase in blood pressure
4. Gastrointestinal
Nausea, vomiting
Abdominal cramps, bloating
Cholestatic jaundice
Increased incidence of gallbladder disease
Pancreatitis
Enlargement of hepatic hemangiomas
Ischemic colitis
5. Skin
Chloasma or melasma that may persist when drug is discontinued
Erythema multiforme
Erythema nodosum
Hemorrhagic eruption
Loss of scalp hair
Hirsutism
Pruritus, rash
6. Eyes
Retinal vascular thrombosis
Intolerance to contact lenses
7. Central Nervous System
Headache
Migraine
Dizziness
Mental depression
Exacerbation of chorea
Nervousness
Mood disturbances
Irritability
Exacerbation of epilepsy
Dementia
Possible growth potentiation of benign meningioma
8. Miscellaneous
Increase or decrease in weight
Glucose intolerance
Aggravation of porphyria
Edema
Arthralgias
Leg cramps
Changes in libido
Urticaria, angioedema, anaphylactoid/anaphylactic reactions
Hypocalcemia (preexisting condition)
Exacerbation of asthma
Increased triglycerides
What should I look out for while using Premarin?
PREMARIN therapy should not be used in individuals with any of the following conditions:
See .
What might happen if I take too much Premarin?
Overdosage of estrogen may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in females. Treatment of overdose consists of discontinuation of PREMARIN together with institution of appropriate symptomatic care.
How should I store and handle Premarin?
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.Dispense in a tight, light-resistant container.Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.Dispense in a tight, light-resistant container.PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP. PREMARIN (conjugated estrogens tablets, USP)— Each oval green tablet contains 0.3 mg.— Each oval blue tablet contains 0.45 mg.— Each oval maroon tablet contains 0.625 mg.— Each oval white tablet contains 0.9 mg.— Each oval yellow tablet contains 1.25 mg.The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.They are supplied by as follows:Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a well-closed container, as defined in the USP.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulfate-conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these gonadotropins seen in postmenopausal women.
Non-Clinical Toxicology
PREMARIN therapy should not be used in individuals with any of the following conditions:See .
Drug Interactions:
See and .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During the first year of a 2-year clinical trial with 2,333 postmenopausal women between 40 and 65 years of age (88% Caucasian), 1,012 women were treated with conjugated estrogens and 332 were treated with placebo. summarizes adverse events that occurred at a rate of ≥ 5%.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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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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