Premarin precautions: Difference between revisions
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==List of precautions== | ==List of precautions== | ||
<font size="4">[ | <font size="4">[[Premarin precautions#Addition of a progestin when a woman has not had a hysterectomy|Addition of a progestin when a woman has not had a hysterectomy]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Elevated blood pressure|Elevated blood pressure]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Hypertriglyceridemia|Hypertriglyceridemia]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Impaired liver function and past history of cholestatic jaundice|Impaired liver function and past history of cholestatic jaundice]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Hypothyroidism|Hypothyroidism]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Fluid retention|Fluid retention]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Hypocalcemia|Hypocalcemia]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Ovarian cancer|Ovarian cancer]]</font> | ||
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<font size="4">[ | <font size="4">[[Premarin precautions#Exacerbation of endometriosis|Exacerbation of endometriosis]]</font> | ||
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estrogens compared with estrogen-alone regimens. These include a possible increased risk of | estrogens compared with estrogen-alone regimens. These include a possible increased risk of | ||
breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL) and | breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL) and | ||
impairment of glucose tolerance. ''[ | impairment of glucose tolerance. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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===Elevated blood pressure=== | ===Elevated blood pressure=== | ||
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idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a | 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 | generalized effect of estrogen therapy on blood pressure was not seen. Blood pressure should be | ||
monitored at regular intervals with estrogen use. ''[ | monitored at regular intervals with estrogen use. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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===Hypertriglyceridemia=== | ===Hypertriglyceridemia=== | ||
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with Premarin 0.625 mg/2.5 mg, 0.45 mg/1.5 mg, and 0.3 mg/1.5 mg compared with placebo | with Premarin 0.625 mg/2.5 mg, 0.45 mg/1.5 mg, and 0.3 mg/1.5 mg compared with placebo | ||
were 32.8, 24.8, 23.3, and 10.7, respectively. After two years of treatment, the mean percent | were 32.8, 24.8, 23.3, and 10.7, respectively. After two years of treatment, the mean percent | ||
changes were 33.0, 17.1, 21.6, and 5.5, respectively. ''[ | changes were 33.0, 17.1, 21.6, and 5.5, respectively. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a | 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 | 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. ''[ | should be exercised and in the case of recurrence, medication should be discontinued. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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===Hypothyroidism=== | ===Hypothyroidism=== | ||
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require increased doses of their thyroid replacement therapy. These patients should have their | 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 | thyroid function monitored in order to maintain their free thyroid hormone levels in an | ||
acceptable range. ''[ | acceptable range. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
<br> | <br> | ||
===Fluid retention=== | ===Fluid retention=== | ||
Because estrogens/progestins may cause some degree of fluid retention, patients with conditions | Because estrogens/progestins 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 | that might be influenced by this factor, such as cardiac or renal dysfunction, warrant careful | ||
observation when estrogens are prescribed. ''[ | observation when estrogens are prescribed. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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===Hypocalcemia=== | ===Hypocalcemia=== | ||
Estrogens should be used with caution in individuals with severe hypocalcemia ''[ | Estrogens should be used with caution in individuals with severe hypocalcemia ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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===Ovarian cancer=== | ===Ovarian cancer=== | ||
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increased risk of ovarian cancer in some epidemiological studies. Other studies did not show a | increased risk of ovarian cancer in some epidemiological studies. Other studies did not show a | ||
significant association. Data are insufficient to determine whether there is an increased risk with | significant association. Data are insufficient to determine whether there is an increased risk with | ||
combined estrogen/progestin therapy in postmenopausal women. ''[ | combined estrogen/progestin therapy in postmenopausal women. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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===Exacerbation of endometriosis=== | ===Exacerbation of endometriosis=== | ||
Endometriosis may be exacerbated with administration of estrogens. ''[ | Endometriosis may be exacerbated with administration of estrogens. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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===Exacerbation of other conditions=== | ===Exacerbation of other conditions=== | ||
Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, | Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, | ||
systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in | systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in | ||
women with these conditions. ''[ | women with these conditions. ''[[Premarin precautions#List of precautions|Return to top]]'' | ||
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Latest revision as of 13:26, 24 September 2011
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
List of precautions
Addition of a progestin when a woman has not had a hysterectomy
Elevated blood pressure
Hypertriglyceridemia
Impaired liver function and past history of cholestatic jaundice
Hypothyroidism
Fluid retention
Hypocalcemia
Ovarian cancer
Exacerbation of endometriosis
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 with estrogen-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. Return to top
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 with estrogen use. Return to top
Hypertriglyceridemia
In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with
elevations of plasma triglycerides leading to pancreatitis and other complications. In the HOPE
study, the mean percent increase from baseline in serum triglycerides after one year of treatment
with Premarin 0.625 mg/2.5 mg, 0.45 mg/1.5 mg, and 0.3 mg/1.5 mg compared with placebo
were 32.8, 24.8, 23.3, and 10.7, respectively. After two years of treatment, the mean percent
changes were 33.0, 17.1, 21.6, and 5.5, respectively. Return to top
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. Return to top
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 T4 and T3 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. Return to top
Fluid retention
Because estrogens/progestins 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. Return to top
Hypocalcemia
Estrogens should be used with caution in individuals with severe hypocalcemia Return to top
Ovarian cancer
Use of estrogen-only products, in particular for ten or more years, has been associated with an
increased risk of ovarian cancer in some epidemiological studies. Other studies did not show a
significant association. Data are insufficient to determine whether there is an increased risk with
combined estrogen/progestin therapy in postmenopausal women. Return to top
Exacerbation of endometriosis
Endometriosis may be exacerbated with administration of estrogens. Return to top
Exacerbation of other conditions
Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria,
systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in
women with these conditions. Return to top
Adapted from the FDA Package Insert.