<p><strong>Addition of a progestin when a woman has not had a hysterectomy</strong>: 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 an increased risk of breast cancer.<br />
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<strong>Unexpected abnormal vaginal bleeding</strong>: In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.<br />
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<strong>Elevated blood pressure</strong>: Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy.<br />
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<strong>Hypertriglyceridemia</strong>: In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.<br />
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<strong>Hepatic Impairment and/or past history of cholestatic jaundice</strong>: Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women 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.<br />
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<strong>Fluid Retention</strong>: Progestins may cause some degree of fluid retention. Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed.<br />
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<strong>Hypocalcemia</strong>: Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.<br />
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<strong>Exacerbation of other conditions</strong>: Estrogen plus progestin 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 women with these conditions.</p>