Classes
DEA Class; Rx
Common Brand Names; Cilest, Prefest
- Estrogens/Progestins-HRT
Description
Combination oral product; estradiol is the principal human circulating estrogen; norgestimate is a progestin of high progestational and low androgenic activity
Norgestimate is added to estrogen therapy to reduce risk for endometrial hyperplasia
Primarily used together in women with an intact uterus to treat moderate to severe vasomotor and genitourinary symptoms associated with menopause and for the prevention of osteoporosis
Indications
Contraindications
Hypersensitivity
Pregnancy
Estrogen-dependent neoplasia
Current/history of: DVT/PE, arterial thromboembolic disease, breast cancer, liver disease/tumours
Undiagnosed abnormal vaginal bleeding
Jaundice with previous OCP use
Porphyria
History of pruritus gravidarum, pemphigoid gestationis, deterioration of otosclerosis or idiopathic jaundice during pregnancy
Untreated endometrial hyperplasia
Adverse Effects
Common
Headache
Breast pain
Abdominal pain
Back pain
URI
Influenza-like symptoms
Less common
Cardiovascular disease
Deep vein thrombosis
Hypertension
Breast cancer
Endometrial neoplasia
Gallbladder disease
Warnings
Bone mineral density changes, current/history of depression, DM, HTN, hyperlipidemia, hypertriglyceridemia, obesity, endometriosis, family history of breast cancer and DVT/PE, smoking, epilepsy, migraine, renal impairment, severe hypocalcemia, ovarian cancer
Discontinue if the following develop: jaundice, visual problems, 4-6 wk before major surgery, any symptoms of VTE, massive BP increases, unusually severe migraines or first-time migraines, depression
Increased risk of post-op thromboembolic complications
Conditions exacerbated by fluid retention (eg, asthma, migraine, cardiac/renal dysfunction, epilepsy)
Patients on warfarin/oral anticoagulants: Estrogens increase thromboembolic risk; increase in anticoagulant dose may be warranted
History of migraine with aura
Cholelithiasis
Risk of developing dementia
Monitor blood pressure
Pregnancy and Lactation
Pregnancy Category: X
Lactation: enters breast milk; use with caution
Maximum Dosage
1 tablet/day PO, in the order directed on the blister card (e.g., Prefest).
1 tablet/day PO, in the order directed on the blister card (e.g., Prefest).
Not indicated.
Not indicated.
How supplied
Estradiol/norgestimate
tablet
- Pink: 1mg (15 tabs)
- White: 1mg/0.09mg (15 tabs)
