Estradiol is a female hormone involved in development and maintenance of the female reproductive system.
The combination of drospirenone and estradiol is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medication is for use only if you have a uterus (if you have not had a hysterectomy).
Drospirenone and estradiol should not be used to prevent heart disease, strokes, or dementia, because this medicine may actually increase your risk of developing these conditions.
Drospirenone and estradiol may also be used for purposes not listed in this medication guide.
Do not use drospirenone and estradiol if you are pregnant or plan to become pregnant.
You should not take this medicine if you have any of the following conditions: a bleeding or blood-clotting disorder, circulation problems, unusual vaginal bleeding, kidney disease, liver disease, an adrenal gland disorder, if you have had a hysterectomy, if you have had a heart attack a stroke, or if you have ever had breast or uterine cancer, or a blood clot (especially in your lung or your lower body).
Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of female hormone medication.
Stop using drospirenone and estradiol and call your doctor at once if you have chest pain, sudden numbness or weakness, a sudden severe headache, confusion, problems with vision or speech, or if you have pain, swelling, warmth, or redness in one or both legs.
Call your doctor right away if you have a breast lump, unusual vaginal bleeding, or jaundice (yellowing of the skin or eyes).
Drospirenone and estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
You should not take this medicine if you are allergic to drospirenone or estradiol, or if you have:
- a bleeding or blood-clotting disorder, or circulation problems;
- unusual vaginal bleeding that has not been checked by a doctor;
- kidney disease;
- liver disease;
- an adrenal gland disorder;
- a history of hormone-related cancer such as breast or uterine cancer;
- if you have had your uterus removed (hysterectomy);
- if you are pregnant or plan to become pregnant;
- if you have had a heart attack or stroke; or
- if you have ever had a blood clot (especially in your lung or your lower body).
- heart disease, high blood pressure;
- risk factors for coronary artery disease (such as smoking, being overweight, or a family history of coronary artery disease);
- high cholesterol or triglycerides;
- diabetes;
- a thyroid disorder;
- high levels of calcium, sodium, or potassium in your blood;
- endometriosis;
- gallbladder disease;
- asthma;
- severe migraines (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
- a history of jaundice caused by pregnancy or birth control pills;
- epilepsy or other seizure disorder;
- hereditary angioedema (an immune system disorder);
- a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;
- systemic lupus erythematosus (SLE); or
- porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).
FDA pregnancy category X. Do not use drospirenone and estradiol if you are pregnant or plan to become pregnant. Tell your doctor right away if you become pregnant during treatment.
The hormones in drospirenone and estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.
Drospirenone Estradiol Side Effects
Stop using drospirenone and estradiol and call your doctor at once if you have a serious side effect such as:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, problems with vision, speech, or balance;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- confusion, unusual thoughts or behavior;
- abnormal vaginal bleeding;
- high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
- severe pain in your upper stomach spreading to your back, vomiting;
- itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- a breast lump.
- mild nausea or stomach pain, diarrhea;
- mild headache;
- irregular vaginal bleeding, spotting;
- breast pain or tenderness;
- weight gain, swelling in your hands or feet;
- mood changes; or
- vaginal itching or discharge.
Drospirenone Estradiol Interactions
Avoid drinking alcohol while you are taking this medication.
Grapefruit and grapefruit juice may interact with drospirenone and estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
Tell your doctor about all other medicines you use, especially:
- eplerenone (Inspra);
- heparin;
- ritonavir (Norvir, Kaletra);
- St. John's wort;
- an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or rifampin (Rifater, Rifadin, Rifamate);
- an antifungal medication such as ketoconazole (Nizoral) or itraconazole (Sporanox);
- aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;
- a blood thinner such as warfarin (Coumadin, Jantoven);
- a diuretic ("water pill") such as spironolactone (Aldactone), triamterene (Dyrenium, Dyazide, Maxzide), amiloride (Midamor), or eplerenone (Inspra);
- heart or blood pressure medications such as benazepril (Lotensin), candesartan (Atacand), enalapril (Vasotec), fosinopril (Monopril), irbesartan (Avapro, Avalide), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar), ramipril (Altace), valsartan (Diovan), telmisartan (Micardis);
- a potassium supplement such as Klor-Con, K-Dur, K-Tab; or
- seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Solfoton).
Drospirenone Estradiol Dosage
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.Do not crush, chew, or break a drospirenone and estradiol tablet. Swallow it whole.
Try to take drospirenone and estradiol at the same time each day.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking drospirenone and estradiol.
Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while taking drospirenone and estradiol.
Store at room temperature away from moisture and heat.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe nausea or vaginal bleeding.
If you are less than 24 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
