Indicated for:

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause

When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. 

Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure

Prevention of Postmenopausal Osteoporosis

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non estrogen medication should be carefully considered.

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin.

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed, persistent or recurring abnormal genital bleeding.

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.

Reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other forms of estrogens.

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

Reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.

Reported estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.

Reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. 

Climara should be placed on a clean, dry area of the lower abdomen (below the umbilicus) or upper quadrant of the buttock. Climara should not be applied to or near the breasts.

The sites of application must be rotated, with an interval of at least 1-week allowed between applications to the same site.

Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

Climara is contraindicated in patients with:

• Undiagnosed abnormal genital bleeding 
• Known, suspected, or history of breast cancer
• Known or suspected estrogen-dependent neoplasia
• Active DVT, PE or a history of these conditions 
• Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions 
• Known liver impairment or disease
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders 
• Known or suspected pregnancy 
• A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.

Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases.

In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis.

A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy.

Estrogen administration leads to increased thyroid-binding globulin (TBG) levels.

Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.

Estrogens may cause some degree of fluid retention. Women with conditions that might be influenced by this factor, such as a cardiac or renal impairment, warrant careful observation when estrogen-alone is prescribed.

Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.

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 women with these conditions.

Retinal vascular thrombosis has been reported in women 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.

Inducers of CYP3A4 such as St.John’s wort (hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in  the uterine bleeding profile.

Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.

Climara should not be used during pregnancy.

Climara should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen therapy.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Use in male patients. GoToSource 

• Vascular malformations of the gastrointestinal tract. GoToSource 

• Turner syndrome. GoToSource 

• Adjunctive therapy for severe mental illness. GoToSource 

• Fibroids. GoToSource

Venous thromboembolism and acute myocardial infarction. GoToSource

Endometrial cancer. GoToSource

Breast cancer. GoToSource

Ovarian cancer. GoToSource

Non-hodgkin lymphoma. GoToSource

Gallbladder and bladder cancer. GoToSource 

Increased risk of cholecystectomy (surgical removal of gallbladder). GoToSource 

Increased risk of stroke. GoToSource

Dementia. GoToSource

Pancreatitis (inflammation of the pancreas). GoToSource

Increased risk of meningioma. GoToSource

Lawsuits filed ovarian and breast cancers.