rorrhagia 3.0 0.0
Endometrial disorder§ 1.8 1.4
Vaginitis 8.9 4.1
Pap smear suspicious¶ 5.4 2.7
Vaginal hemorrhage 1.2 0.0
The following additional adverse events have been reported with estrogen and/or progestin therapy.
Genitourinary system: abnormal uterine bleeding/spotting; dysmenorrhea/pelvic pain; increase in size of uterine leiomyomata; vaginitis including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer
Breasts: tenderness; enlargement; pain; nipple discharge; galactorrhea; fibrocystic breast changes; breast cancer
Cardiovascular: deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure
Gastrointestinal: nausea; vomiting, abdominal cramps; bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas
Skin: chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash
Eyes: retinal vascular thrombosis; intolerance to contact lenses
Central nervous system: headache; migraine; dizziness; mental depression; exacerbation of chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia
Miscellaneous: increase or decrease in weight; glucose intolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia (preexisting condition); exacerbation of asthma; increased triglycerides
OVERDOSAGE
Overdosage of estrogen may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in females. Treatment of overdose consists of discontinuation of EstroGel together with institution of appropriate symptomatic care.
DOSAGE AND ADMINISTRATION
EstroGel 1.25 g is the single approved dose for the treatment of moderate to severe vasomotor symptoms and for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. The lowest effective dose of EstroGel for these indications has not been determined. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
When estrogen is prescribed for a postmenopausal woman with a uterus, generally, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reeva luated periodically as clinically appropriate (for example at 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
HOW SUPPLIED
EstroGel is a cle |
