What is the most important information I should know about drospirenone and estradiol?
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 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, or heart attack. Drospirenone and estradiol should not be used to prevent heart disease, stroke, or dementia. Long-term use may also increase your risk of breast cancer.
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. This medicine 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.
What should I discuss with my healthcare provider before taking drospirenone and estradiol?
You should not use this medicine 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;
- kidney disease;
- liver disease;
- 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.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- heart disease, high blood pressure;
- a thyroid disorder;
- gallbladder disease;
- jaundice caused by pregnancy or taking hormones;
- high triglycerides (a type of fat in the blood);
- asthma;
- epilepsy or other seizure disorder;
- migraine headaches;
- lupus;
- 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).
Long-term use of 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. Do not take this medicine in larger or smaller amounts or for longer than recommended.
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 with 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 missed dose as soon as you remember. If you are more than 24 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.
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 this medicine.
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.
What are the possible side effects of drospirenone and estradiol?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medicine and call your doctor at once if you have:
- unusual vaginal bleeding;
- swelling or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes);
- a breast lump;
- memory problems confusion, unusual behavior;
-
heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
-
high potassium --nausea, weakness, tingly feeling, irregular heartbeats, loss of movement;
-
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;
-
high levels of calcium in your blood --nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy; or
-
increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.
Common side effects may include:
- headache, mood changes;
- vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
- breast pain;
- 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.
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 interact with 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.
Where can I get more information?
Your pharmacist can provide more information about drospirenone and estradiol.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 5.01. Revision date: 11/27/2017.
