Premarin precautions

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

List of precautions

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]

precautions#Elevated blood pressure|Elevated blood pressure]

precautions#Hypertriglyceridemia|Hypertriglyceridemia]

precautions#Impaired liver function and past history of cholestatic jaundice|Impaired liver function and past history of cholestatic jaundice]

precautions#Hypothyroidism|Hypothyroidism]

precautions#Fluid retention|Fluid retention]

precautions#Hypocalcemia|Hypocalcemia]

precautions#Ovarian cancer|Ovarian cancer]

precautions#Exacerbation of endometriosis|Exacerbation of endometriosis]

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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. precautions#List of precautions|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. precautions#List of precautions|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. precautions#List of precautions|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. precautions#List of precautions|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. precautions#List of precautions|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. precautions#List of precautions|Return to top]

Hypocalcemia

Estrogens should be used with caution in individuals with severe hypocalcemia precautions#List of precautions|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. precautions#List of precautions|Return to top]

Exacerbation of endometriosis

Endometriosis may be exacerbated with administration of estrogens. precautions#List of precautions|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. precautions#List of precautions|Return to top]

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Adapted from the FDA Package Insert.