pix [1%:<60 years of age, and within 10 years of menopause onset. Therapy does not need to be routinely discontinued in women> 60 years of age and may continue in women >65 years of age who have persistent vasomotor symptoms or quality of life issues after discussing the benefits and risks of treatment. Possible adjustments to safer lower-dose and/or route of administration should be evaluated at an annual exam which also considers a review of comorbidities (NAMS 2017) Premenopausal women: Not for use prior to menopause. Surgical patients: Whenever possible, estrogens should be discontinued at least 4-6 weeks prior to elective surgery associated with an increased risk of thromboembolism or during periods of prolonged immobilization. Other warnings/precautions: Laboratory changes: The use of estrogens and/or progestins may change the results of some laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). Drospirenone can also cause an increase in plasma renin activity and plasma aldosterone. The dose, route, and the specific estrogen/progestin influences these changes. In addition, personal risk factors (eg, cardiovascular disease, smoking, diabetes, age) also contribute to adverse events; use of specific products may be contraindicated in women with certain risk factors. Risks vs benefits: [US Boxed Warning]: Estrogens with or without progestin should be used for the shortest duration possible at the lowest effective dose consistent with treatment goals and risks for the individual woman . Hormone therapy for menopausal symptoms is generally initiated in healthy symptomatic women within 10 years of menopause or <60 years of age who do not have contraindications for use (NAMS 2017; Stuenkel 2015). Patients should be reevaluated as clinically appropriate to determine if treatment is still necessary. Available data related to treatment risks are from Women s Health Initiative (WHI) studies, which evaluated oral CE 0.625 mg with or without MPA 2.5 mg relative to placebo in postmenopausal women. Other combinations and dosage forms of estrogens and progestins were not studied. Outcomes reported from clinical trials using CE with or without MPA should be assumed to be similar for other doses and other dosage forms of estrogens and progestins until comparable data becomes available. Women who are early in menopause, who are in good cardiovascular health, and who are at low risk for adverse cardiovascular events can be considered candidates for estrogen with or without progestin therapy for the relief of menopausal symptoms (ACOG 565 2013). Women at high risk of cardiovascular disease or intermediate to high risk of breast cancer should use nonhormonal therapy to treat vasomotor symptoms of menopause (Stuenkel 2015). Use of a transdermal product should be considered over an oral agent in women requiring systemic therapy who have moderate risk factors for coronary heart disease (ACOG 556 2013; Schenck-Gustafsson 2011; Stuenkel 2015). Nonoral routes of therapy are recommended for women at increased risk for venous thromboembolism (Stuenkel 2015). Vulvar and vaginal atrophy use: Moderate-to-severe symptoms of vulvar and vaginal atrophy include vaginal dryness, dyspareunia, and atrophic vaginitis. [The combined conditions of vulvovaginal atrophy and urinary tract dysfunction is also referred to as genitourinary syndrome of menopause (GSM) (Portman 2014; Stuenkel 2015)]. When used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered (NAMS 2017; NAMS 2013; Stuenkel 2015). Monitoring Parameters Routine physical examination that includes blood pressure and Papanicolaou smear, breast exam, mammogram. Monitor for signs of endometrial cancer. Adequate diagnostic measures, including endometrial sampling, if indicated, should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding. Monitor for loss of vision, sudden onset of proptosis, diplopia, migraine; signs and symptoms of thromboembolic disorders; glycemic control in patients with diabetes; lipid profiles in patients being treated for hyperlipidemias; thyroid function in patients on thyroid hormone replacement therapy. Serum potassium during the first month of therapy in patients at risk for hyperkalemia and who are on chronic strong CYP3A4 inhibitors Menopausal symptoms: Assess need for therapy periodically Note: Monitoring of FSH and serum estradiol is not useful when managing vasomotor symptoms associated with menopause or vulvar and vaginal atrophy. Pregnancy Considerations Use is contraindicated in pregnant women. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience diarrhea, cramps, bloating, edema, enlarged breasts, or dark patches on face. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, or numbness or tingling feeling), angina, shortness of breath, coughing up blood, severe headache, severe nausea, severe vomiting, severe abdominal pain, severe dizziness, passing out, bulging eyes, contact lens discomfort, vision changes, lump in breast, breast soreness or pain, nipple discharge, vaginitis, vaginal bleeding, depression, mood changes, memory impairment, or swelling in hands or feet (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about drospirenone/estradiol Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 22 Reviews Add your own review/rating Drug class: sex hormone combinations Consumer resources Drospirenone and estradiol Drospirenone and estradiol (Advanced Reading) Professional resources Other brands: Angeliq Related treatment guides Postmenopausal Symptoms> ] Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA WADA Class Anti-Doping Classification Drospirenone / estradiol Rating 22 User Reviews 8.1 /10 22 User Reviews 8.1 Rate it! Drug Class Sex hormone combinations Related Drugs sex hormone combinations Prempro , Lo Loestrin Fe , Estratest , Microgestin Fe 1 / 20 , Activella , Loestrin 24 Fe Postmenopausal Symptoms estradiol , Premarin , Estrace , Prempro , conjugated estrogens topical , Climara , Estrogel , Vivelle , Premarin Vaginal , Vivelle-Dot , Menest , Minivelle , Estratest , Delestrogen , Activella , Femring , Evamist , Lopreeza , CombiPatch , estradiol / norethindrone , Divigel , Mimvey , More... reduction
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