No

Estrogen Derivative

For use in women with an intact uterus

Transdermal patch: Treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy; treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure

X

Estrogens/progestins should not be used during pregnancy.

Hypersensitivity to estrogens, progestins, or any components; known or suspected pregnancy; carcinoma of the breast; estrogen-dependent tumor; undiagnosed abnormal vaginal bleeding; thrombophlebitis, thromboembolic disorders, or stroke; hysterectomy

For use only in women with an intact uterus. Use with caution in patients with diseases that may be exacerbated by fluid retention, including asthma, epilepsy, migraine, diabetes, cardiac or renal dysfunction. Use with caution in patients with a history of hypercalcemia, cardiovascular disease, or gallbladder disease. May increase blood pressure. Use with caution in patients with liver dysfunction or disease. May increase risk of venous thromboembolism. Unopposed estrogens may increase the risk of endometrial carcinoma in postmenopausal women (incidence is less likely with the addition of progesterone). Estrogens may increase the risk of breast cancer; estrogen compounds are generally associated with lipid effects such as increased HDL-cholesterol, and decreased LDL-cholesterol; triglycerides may also be increased. Use with caution in patients with familial defects of lipoprotein metabolism. Safety and efficacy in children have not been established. May cause visual abnormalities. Discontinue if papilledema or renal vascular lesions develop.

Cardiovascular: Altered blood pressure, cardiovascular accident, edema, venous thromboembolism

Central nervous system: Dizziness, fatigue, headache, insomnia, mental depression, migraine, nervousness

Dermatologic: Chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, hirsutism, itching, loss of scalp hair, melasma, pruritus, skin rash

Endocrine & metabolic: Breast enlargement, breast tenderness, breast pain, changes in libido

Gastrointestinal: Abdominal pain, bloating, changes in appetite, flatulence, gallbladder disease, nausea, pancreatitis, vomiting, weight gain or loss

Genitourinary: Alterations in frequency and flow of menses, changes in cervical secretions, cystitis-like syndrome, increased size of uterine leiomyomata, premenstrual-like syndrome, vaginal candidiasis, vaginitis

Hematologic: Aggravation of porphyria

Hepatic: Cholestatic jaundice

Local: Application site reaction (transdermal patch)

Neuromuscular & skeletal: Arthralgia, back pain, chorea, myalgia, weakness

Ocular: Intolerance to contact lenses, steeping of corneal curvature

Respiratory: Pharyngitis, pulmonary thromboembolism, rhinitis

Miscellaneous: Allergic reactions, carbohydrate intolerance, flu-like syndrome

Oral:

Time to peak: 5-8 hours

Adults:

Transdermal patch:

Continuous combined regimen: Apply one patch twice weekly

Continuous sequential regimen: Apply estradiol-only patch for first 14 days of cycle, followed by one Combi-Patch® applied twice weekly for the remaining 14 days of a 28-day cycle

Transdermal patch: Apply to clean dry skin. Do not apply transdermal patch to breasts; apply to lower abdomen, avoiding waistline. Rotate application sites.

No information available to require special precautions

No effects or complications reported

Tablet (Activella™): Estradiol 1 mg and norethindrone acetate 0.5 mg (28s)

Transdermal system (CombiPatch™):

9 sq cm: Estradiol 0.05 mg and norethindrone acetate 0.14 mg per day

16 sq cm: Estradiol 0.05 mg and norethindrone acetate 0.25 mg per day