treatment with daily PO conjugated estrogens (0.625 mg) alone in comparison with placebo Unknown whether these findings apply to younger postmenopausal women Dose & duration In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and medroxyprogesterone acetate, as well as for other combinations and dosage forms of estrogens and progestins Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective dosage and for the shortest duration consistent with treatment goals and individual risks Contraindications Known anaphylactic reaction or angioedema Known protein C, protein S, or antithrombin deficiency; other known thrombophilic disorders Active or history of breast cancer Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease Liver disease, liver tumors Uncontrolled hypertension, diabetes mellitus with vascular involvement, jaundice with previous oral contraceptive use Estrogen-dependent neoplasia Undiagnosed abnormal vaginal bleeding Cautions Use caution in diabetes mellitus, hyperlipidemias, hypertension, hypothyroidism, advanced age, hepatic or renal impairment, uterine leiomyomata, porphyria, patients with defects of lipoprotein metabolism, hypertriglyceridemia, ovarian cancer, systemic lupus erhythematosus, exacerbation of endometriosis or other conditions, smoking, diseases exacerbated by fluid retention Manage appropriately risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications Estrogens may be poorly metabolized in patients with impaired liver function; exercise caution in patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy; in the case of recurrence, discontinue medication Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of thyroid replacement therapy; these patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range A 2 to 4-fold increase in risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens reported Retinal vascular thrombosis reported in patients receiving estrogens; discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine; if examination reveals papilledema or retinal vascular lesions, estrogens should be discontinued 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 HDL, raising LDL), and impairment of glucose tolerance Discontinue if any of the following develop: Jaundice, signs of venous thromboembolism, visual problems (may cause contact lens intolerance), massive blood pressure increase, major surgery or prolonged immobilization occurring in 4 weeks, new migraine, depression Women with protein C or S deficiency (inherited thrombophilia), may have increased risk of venous thromboembolism Do not use with conditions that predispose to hyperkalemia Conditions exacerbated by fluid retention (asthma, epilepsy, migraines, cardiac or renal dysfunction) Risk of hypercalcemia in patients with breast cancer and bone metastases Increased risk of ovarian and endometrial cancer reported in women who used hormonal therapy for menopausal symptoms Long-term postmenopausal estrogen treatment has been associated with increased risk of breast cancer, MI, stroke, DVT/PE, and dementia Patients on warfarin or other oral anticoagulants: Estrogens increase thromboembolic risk; increase in anticoagulant dosage may be warranted Discontinue therapy if pancreatitis occurs; estrogen compounds generally associated with increased triglyceride levels Cases of anaphylaxis and angioedema have been reported; exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema Use caution in individuals with severe hypocalcemia Pregnancy category: X Lactation: Use controversial; estrogens are excreted into breast milk in small quantities; use with cautionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Replaces endogenous estrogen; important for development and maintenance of female reproductive system and secondary sexual characteristics Antiandrogenic effect provides benefit in prostate cancer Absorption Bioavailability: Readily absorbed from gastrointestinal (GI) tract Onset: 2-4 weeks (PO-menopause) Peak plasma time: 7 hr (PO) Distribution Protein bound: 80% Metabolism Metabolized in liver to inactive sulfates and glucuronides Metabolites: Estradiol, estrone, estriol Elimination Excretion: Mainly in urine as conjugates with small amount of unchanged drug; most estrogens are also excreted in bile and undergo enterohepatic recycling IV Incompatibilities Additive, syringe, Y-site: Ascorbic acid, acidic solutions, protein hydrolysate IV Compatibilities Solution: D5W, NS, invert sugar solutions Y-site: Heparin/hydrocortisone, potassium chloride, vitamins B and C IV Preparation Reconstitute with 5 mL of diluent provided First withdraw air from vial, then add diluent slowly and aseptically with gentle agitation Stable at 2-8°C for 60 days Do not use if agent darkens or precipitates IV/IM Administration IM: Acceptable IV: Administer slowly to avoid flushing reaction Infusion not recommended; injection into running infusion can be performed Storage Refrigerate reconstituted injection Intact vials are stable for 24 months at room temperature BRAND FORM. UNIT PRICE PILL IMAGE Premarin injection- 25 mg vialPremarin vaginal- 0.625 mg/gram creamPremarin oral- 0.625 mg tabletPremarin oral- 0.45 mg tabletPremarin oral- 0.3 mg tabletPremarin oral- 0.625 mg tabletPremarin oral- 1.25 mg tabletPremarin oral- 0.9 mg tabletCopyright © 2010 First DataBank, Inc.Select a drug:conjugated estrogens injectionconjugated estrogens oralconjugated estrogens vaginalPrint Patient Educationconjugated estrogens injection NO MONOGRAPH AVAILABLE AT THIS TIME USES: Consult your pharmacist. HOW TO USE: Consult your pharmacist. SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Consult your pharmacist. DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. NOTES: No monograph available at this time. MISSED DOSE: Consult your pharmacist. STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. Information last revised July 2016. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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