Estradiol Vaginal (Page 5 of 7)

B. P atient I nformation

Physicians are advised to discuss the PATIENT INFORMATION leaflet with women for whom they prescribe Estradiol Vaginal Cream, USP, 0.01%.

C. Laboratory Tests

Serum FSH and estradiol levels have not been shown to be useful in the management of moderate to severe symptoms of vulvar and vaginal atrophy.

D. D rug- L aboratory T est I nteractions

  1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
  2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone levels, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Women on thyroid replacement therapy may require higher dose of thyroid hormone.
  3. Other binding proteins may be elevated in serum, i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
  4. Increased plasma high-density lipoprotein (HDL) and HDL2 cholesterol subfraction concentrations, reduced low-density lipoprotein (LDL) cholesterol concentration, increased triglycerides levels.
  5. Impaired glucose tolerance.

E. C arcinogenesis , M utagenesis , and Impairment of Fertility

Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See BOXED WARNINGS, WARNINGS and PRECAUTIONS.)

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. P regnancy

Estradiol Vaginal Cream, USP, 0.01% should not be used during pregnancy [see CONTRAINDICATIONS].

There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.

G. N ursing Mothers

Estradiol Vaginal Cream, USP, 0.01% 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 milk of women receiving estrogen therapy. Caution should be exercised when Estradiol Vaginal Cream, USP, 0.01% is administered to a nursing woman.

H. P ediatric U se

Estradiol Vaginal Cream, USP, 0.01% is not indicated in children. Clinical studies have not been conducted in the pediatric population.

I. Geriatric Use

There have not been sufficient numbers of geriatric patients involved in studies utilizing Estradiol Vaginal Cream, USP, 0.01% to determine whether those over 65 years of age differ from younger subjects in their response to Estradiol Vaginal Cream, USP, 0.01%.

The Women’s Health Initiative Study

In the WHI estrogen-alone substudy (daily CE (0.625 mg)-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see CLINICAL STUDIES and WARNINGS].

In the WHI estrogen plus progestin substudy (daily CE (0.625 mg) plus MPA (2.5 mg) versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see CLINICAL STUDIES and WARNINGS].

The Women’s Health Initiative Memory Study

In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see CLINICAL STUDIES and WARNINGS].

Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women 10 [see CLINICAL STUDIES and WARNINGS].

ADVERSE REACTIONS

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

Systemic absorption may occur with the use of Estradiol Vaginal Cream, USP, 0.01%. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.

The following adverse reactions have been reported with estrogen and/or progestin therapy.

1. Genitourinary S ystem

Abnormal uterine bleeding or spotting; dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in cervical secretion; cystitis-like syndrome; application site reactions of vulvovaginal discomfort including burning and irritation; genital pruritus; ovarian cancer; endometrial hyperplasia; endometrial cancer.

2. Breasts

Tenderness, enlargement, pain, nipple discharge, fibrocystic breast changes; breast cancer.

3. Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; myocardial infarction; stroke; increase in blood pressure.

4. Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; increased incidence of gallbladder disease.

5. Skin

Chloasma that may persist when drug is discontinued; loss of scalp hair; hirsutism; rash.

6. Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

7. Central N ervous S ystem

Headache; migraine; dizziness; mental depression; nervousness; mood disturbances; irritability; dementia.

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