Vagifem (Estradiol Vaginal) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Drug/laboratory test interactions

Certain endocrine and liver function tests may be affected by estrogen-containing oral contraceptives. The following similar changes may be expected with larger doses of estrogens:

a. Increased prothrombin and factors VII, VIII, IX, and X, decreased antithrombin III; increased norepinephrine induced platelet aggregability.

b. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by PBI, T4 by column, or T4 by radioimmunoassay. Free T4 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.

c. Impaired glucose tolerance.

d. Reduced response to metyrapone test.

e. Reduced serum folate concentration.

f. Increased serum triglyceride and phospholipid concentration.

Contraindications

The use of VAGIFEM is contraindicated in women who exhibit one or more of the following:

1. Known or suspected breast carcinoma.

2. Known or suspected estrogen- dependent neoplasia; e.g. endometrial carcinoma.

3. Abnormal genital bleeding of unknown etiology.

4. Known or suspected pregnancy. (See Precautions)

5. Porphyria.

6. Hypersensitivity to any VAGIFEM constituents.

7. Active thrombophlebitis or thromboembolic disorders.

8. A past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when used in treatment of breast malignancy).

Drug Abuse and Dependence

Overdosage

Numerous reports of ingestion of large doses of estrogen containing oral contraceptives by young children indicate that acute serious ill effects do not occur. Overdosage with estrogens may cause nausea, and withdrawal bleeding may occur in females.