Drospirenone and estradiol
Generic name: drospirenone and estradiol [ droe-SPYE-re-none-and-ES-tra-DYE-ole ]
Brand name: Angeliq
Dosage form: oral tablet (0.25 mg-0.5 mg; 0.5 mg-1 mg)
Drug class: Sex hormone combinations
What is drospirenone and estradiol?
Drospirenone is a female hormone that helps regulate ovulation and menstruation.
Estradiol is a female hormone involved in development and maintenance of the female reproductive system.
Drospirenone and estradiol is a combination medicine used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. drospirenone and estradiol is for use only if you have a uterus (if you have not had a hysterectomy).
Drospirenone and estradiol may also be used for purposes not listed in this medication guide.
You should not use this medicine if you have: undiagnosed vaginal bleeding, coronary artery disease, a bleeding disorder, kidney disease, liver disease, an adrenal gland disorder, if you will have major surgery, if you have had a hysterectomy, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Do not use if you are pregnant.
Drospirenone and estradiol may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.
Taking this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Drospirenone and estradiol should not be used to prevent heart disease, stroke, or dementia.
Before taking this medicine
You should not use drospirenone and estradiol if you are allergic to drospirenone or estradiol, or if you have:
unusual vaginal bleeding that a doctor has not checked;
a bleeding disorder;
coronary artery disease;
a history of heart attack, stroke, or blood clot;
an adrenal gland disorder;
a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina; or
if you have had your uterus removed (hysterectomy).
Do not use drospirenone and estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.
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.
Tell your doctor if you have ever had:
heart disease, high blood pressure;
a thyroid disorder;
high triglycerides (a type of fat in the blood);
epilepsy or other seizure disorder;
endometriosis or uterine fibroid tumors;
high levels of calcium or potassium in your blood, or low sodium levels;
hereditary angioedema (an immune system disorder); or
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).
Using drospirenone and estradiol may increase your risk of breast cancer. Talk with your doctor about your risk before using this medicine long term.
This medicine lowers the hormone needed to produce breast milk and can slow breast milk production. You should not breast-feed while taking drospirenone and estradiol.
How should I take drospirenone and estradiol?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Do not crush, chew, break, or dissolve a drospirenone and estradiol tablet. Swallow it whole.
Take this medicine at the same time each day.
Drospirenone and estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.
If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using drospirenone and estradiol.
Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using this medicine.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.
What should I avoid while taking drospirenone and estradiol?
Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using drospirenone and estradiol.
Grapefruit may interact with drospirenone and estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.
Drospirenone and estradiol side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Drospirenone and estradiol may cause serious side effects. Call your doctor at once if you have:
heart attack symptoms--chest pain or pressure, pain spreading to your 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 your breast; or
high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.
Common side effects of drospirenone and estradiol may include:
headache, mood changes;
vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
nausea, diarrhea, stomach pain; or
fluid retention (swelling, rapid weight gain).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drospirenone and estradiol dosing information
Usual Adult Dose for Postmenopausal Symptoms:
One 0.25 mg drospirenone/0.5 mg estradiol tablet orally once a day
One 0.5 mg drospirenone/1 mg estradiol tablet orally once a day
Vulvar and vaginal atrophy:
One 0.5 mg drospirenone/1 mg estradiol tablet orally once a day
-Treatment is continuous.
-Women not on estrogens, or those on a continuous combination product may start treatment anytime.
-Women switching from continuous sequential or cyclic hormone therapy should complete their current cycle before switching.
-When used solely for vulvar and vaginal atrophy, consider using topical vaginal products.
Uses: Treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause
What other drugs will affect drospirenone and estradiol?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect drospirenone and estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
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