Drospirenone-Estradiol

Drospirenone-Estradiol is a combination medication used as a hormone replacement therapy to treat the symptoms of menopause, such as hot flashes or vaginal changes (itching, burning, dryness, and urination problems).

• Drospirenone-Estradiol is available under the following different brand names: Angeliq

Common side effects of Drospirenone-Estradiol include:

• dizziness
• lightheadedness
• headache
• stomach upset or pain
• diarrhea
• bloating
• irritability
• mood changes
• changes in sleep patterns
• nausea
• weight gain
• increased/decreased interest in sex
• change in vaginal discharge
• vaginal itching
• irregular vaginal bleeding or spotting
• swelling in the hands or feet
• breast pain or tenderness

Serious side effects of Drospirenone-Estradiol include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat
• heart attack symptoms: chest pain or pressure, pain spreading to the jaw or shoulder, nausea, sweating
• signs of a stroke: sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance
• signs of a blood clot: sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain, or warmth in one or both legs
• sudden vision loss
• swelling, rapid weight gain
• jaundice (yellowing of the skin or eyes)
• memory problems, confusion, unusual behavior
• unusual vaginal bleeding
• a lump in the breast
• high blood sugar: increased thirst, increased urination, dry mouth, fruity breath odor

Rare side effects of Drospirenone-Estradiol 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, lightheadedness, 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

• 0.25 mg/0.5 mg
• 0.5 mg/1 mg

Hormone replacement therapy

Adult and geriatric dosage

• 1 tablet orally daily
• Use the lowest dose that will control symptoms

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.

• Drospirenone-Estradiol has severe interactions with the following drug:
  • fezolinetant
• Drospirenone-Estradiol has serious interactions with the following drugs:
  • amiloride
  • belzutifan
  • calaspargase pegol
  • eplerenone
  • fedratinib
  • isavuconazonium sulfate
  • lonafarnib
  • mavacamten
  • mobocertinib
  • omaveloxolone
  • potassium acid phosphate
  • potassium chloride
  • potassium citrate
  • potassium phosphates, IV
  • spironolactone
  • triamterene
• Drospirenone-Estradiol has moderate interactions with at least 146 other drugs
• Drospirenone-Estradiol has minor interactions with at least 34 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

• Hypersensitivity
• Undiagnosed abnormal genital bleeding
• Known, suspected, or history of cancer of the breast
• Known or suspected estrogen-dependent neoplasia
• Active deep vein thrombosis (DVT), pulmonary embolism (PE), or a history of these conditions
• Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions
• Renal impairment
• Known liver impairment or disease
• Adrenal insufficiency
• Known or suspected pregnancy
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
• Known anaphylactic reaction, angioedema, or hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Drospirenone-Estradiol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Drospirenone-Estradiol?”

Cautions

• Use caution in bone mineral density changes, current/history of depression, diabetes mellitus, hypertension, hyperlipidemia, obesity, endometriosis, family history of breast cancer, DVT/PE, smoking
• Discontinue if the following develop: jaundice, visual problems, 4 to 6 weeks before major surgery, any symptoms of venous thromboembolism (VTE), massive BP increase, unusually severe migraines, or first-time migraines, depression
• Increased risk of post-op thromboembolic complications, arterial/venous thromboembolic disorder, hyperkalemia, exacerbation of endometriosis
• Do not use with conditions that predispose to hyperkalemia
• Conditions exacerbated by fluid retention (e.g., asthma, migraine, cardiac/renal dysfunction, epilepsy)
• Patients on warfarin/oral anticoagulants: estrogens increase thromboembolic risk; an increase in anticoagulant dose may be warranted
• History of migraine with aura
• Cholelithiasis
• Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema
• Consider topical vaginal products when used solely for vulvovaginal atrophy
• Increased risk of ovarian cancer reported in women who used hormonal therapy for menopausal symptoms
• Manage appropriate 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)
• 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 a 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 the 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
• 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 to maintain their free thyroid hormone levels in an acceptable range
• Use caution in individuals with severe hypocalcemia

Pregnancy and Lactation

• Contraindicated in pregnancy
• Lactation
  • Enters breast milk/not recommended