Generic Name and Formulations:
Estradiol (as hemihydrate) 10mcg; vaginal inserts.
Indications for VAGIFEM:
Atrophic vaginitis due to menopause.
1 insert intravaginally once daily for 2 weeks, then 1 insert twice weekly. Reevaluate periodically.
Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (eg, stroke, MI) or a history of these conditions. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known liver impairment or disease. Known angioedema. Known or suspected pregnancy.
Increased risk of cardiovascular disorders (eg, stroke, DVT). Endometrial, breast, or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Consider the addition of a progestin in patients with an intact uterus to avoid endometrial hyperplasia. History of hypertriglyceridemia. Hepatic impairment. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Caution in asthma, diabetes, epilepsy, migraines, porphyria, SLE, hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Discontinue if jaundice, cardiac events, severe hypercalcemia or pancreatitis occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Nursing mothers.
May be antagonized by CYP3A4 inducers (eg, St. John's Wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice).
See full labeling. Upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, diarrhea; increased risk of gallbladder disease, thromboembolic disorders.
Vaginal inserts—8, 18 (w. applicators)
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Adjunctive Therapies for Bipolar Disorder Show Promise, Need More Evidence
- Improving Performance of Everyday Activities Is Critical in Schizophrenia
- Analysis Finds Lithium Maintenance Most Effective as Monotherapy in Bipolar Disorder
- Web-Based Intervention Targets Parental Behaviors That May Affect Adolescent Anxiety, Depression
- Abnormalities of Cortical Thickness in Bipolar Disorder With Auditory Hallucinations
- The Way to the Head May Be Through the Gut: Probiotics for Depression
- Suicide-Screening Toolkit Can Help Identify Youths at High Risk for Suicide
- Agoraphobia: An Evolving Understanding of Definitions and Treatment
- Parental Pressure to Diet Linked With Long-term Harm in Adolescents
- Does Access to Medical Cannabis Reduce Risk for Opioid Abuse?
- Antidepressants Increase Seizure Risk in Youth and Severely Depressed
- Examining Associations Between Diabetes and Effects on Cognition
- Untreated Depression Common in Women of Childbearing Age
- Incidence of Psychiatric Disorders in Rheumatoid Arthritis
- Effect of Antidepressant Class, Dose on Pediatric Anxiety Disorders