Estrogens Conjugated, Synthetic

Estrogens Conjugated, Synthetic is used for the treatment of moderate to severe vasomotor symptoms due to menopause and for moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

• Estrogens Conjugated, Synthetic is available under the following different brand names: Cenestin DSC, Enjuvia DSC

Common side effects of Estrogens Conjugated, Synthetic include:

• nausea
• vomiting
• bloating
• stomach cramps
• breast tenderness/pain/swelling
• headache
• changes in weight or appetite
• freckles or darkening of facial skin
• increased hair growth
• loss of scalp hair
• problems with contact lenses
• vaginal itching or discharge
• changes in the menstrual periods
• decreased sex drive
• nervousness
• dizziness
• tired feeling

Serious side effects of Estrogens Conjugated, Synthetic include:

• cardiovascular disorders
• malignant neoplasms

Rare side effects of Estrogens Conjugated, Synthetic include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 0.3 mg
• 0.45 mg
• 0.625 mg
• 0.9 mg
• 1.25 mg

Menopausal Vasomotor Symptoms

Adult dosage

• 0.45-1.25 mg orally every day

Atrophic Vaginits, Kraurosis Vulvae, Perimenopausal Dyspareunia

Adult dosage

• Oral 0.3 mg every day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Estrogens Conjugated, Synthetic has severe interactions with the following drugs:
  • fezolinetant
  • ospemifene
• Estrogens Conjugated, Synthetic has serious interactions with at least 32 other drugs
• Estrogens Conjugated, Synthetic has moderate interactions with at least 166 other drugs
• Estrogens Conjugated, Synthetic has minor interactions with at least 36 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Documented hypersensitivity; active or history of breast cancer, arterial thromboembolic disease (stroke, myocardial infarction [MI]), thrombophlebitis, deep vein thrombosis (DVT)/Pulmonary embolism (PE), thrombogenic valvular disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
• Known anaphylactic reaction or angioedema to drug or components
• Uncontrolled hypertension, diabetes mellitus with vascular involvement
• Jaundice with prior oral contraceptive use
• History of migraine with aura
• Estrogen-dependent neoplasia
• Undiagnosed abnormal vaginal bleeding
• Liver disease, liver tumors
• Known or suspected pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Estrogens Conjugated, Synthetic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Estrogens Conjugated, Synthetic?”

Cautions

• Caution in history of hyperlipidemias, hypertension, hepatic/renal impairment, uterine leiomyomata, porphyria, patients with defects of lipoprotein metabolism, hypertriglyceridemia, ovarian cancer, systemic lupus erythematosus, and the elderly
• Discontinue if the following develop jaundice, any signs of venous thromboembolism (VTE), migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery
• Discontinue 4 weeks before major surgery or prolonged immobilization
• Do not use with conditions that predispose to hyperkalemia
• There are, possible risks that may be associated with use of progestins with estrogens compared to estrogen-alone regimens, including a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering high-density lipoprotein, raising low-density lipoprotein), and impairment of glucose tolerance
• Use caution in patients with asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas; exacerbations may occur
• Increased risk of ovarian and endometrial cancer
• Long-term postmenopausal estrogen treatment has been associated with increased risk of MI, stroke, DVT/PE, and dementia
• Patients on warfarin/oral anticoagulants: estrogens increase thromboembolic risk; increase in anticoagulant dose may be warranted
• Not approved for osteoporosis prevention
• Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema
• Estrogens increase the risk of gallbladder disease
• Estrogen administration reported to lead to severe hypercalcemia in women with breast cancer and bone metastases; if hypercalcemia occurs, discontinue use and take appropriate measures to reduce serum calcium level
• Estrogens may cause some degree of fluid retention; monitor any woman with a condition(s) that might predispose her to fluid retention, such as cardiac or renal impairment; discontinue estrogen-alone therapy, with evidence of medically concerning fluid retention
• Retinal vascular thrombosis may occur; discontinue therapy, if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine, pending visual examination; permanently discontinue if examination reveals papilledema or renal vascular lesions
• Consider discontinuation of therapy if pancreatitis occurs; in women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis
• Monitor thyroid function in order to maintain free thyroid hormone levels in an acceptable range; women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy; monitor thyroid function in women during treatment to maintain their free thyroid hormone levels in an acceptable range
• Use with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur; consider whether benefits of estrogen therapy, outweigh risks
• A few cases of malignant transformation of residual endometrial implants reported in women treated post-hysterectomy with estrogen-alone therapy; consider addition of progestin in women known to have residual endometriosis post-hysterectomy

Pregnancy and Lactation

• Drug is not indicated for use in pregnancy; there are no data with use in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and nongenital birth defects (including cardiac anomalies or limb- reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy
• Lactation
  • Estrogens are present in human milk and can reduce milk production in breastfeeding women; reduction is less likely to occur once breastfeeding is well- established; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child or underlying maternal condition