Drospirenone and estradiol 

What is Drospirenone and estradiol?

Drospirenone is a hormone for women that regulates ovulation as well as menstruation. Estradiol, a hormone for women, is involved in the development and maintenance of female reproductive systems. Combination medicine Drospirenone/Estradiol treats symptoms such as hot flushes and vaginal dryness. It also relieves burning and irritation. Only if your uterus is intact (or you've not undergone a hysterectomy) can you use drospirenone with estradiol. This medication guide does not list all possible uses for estradiol and drospirenone.

Side effects of Drospirenone and estradiol

If you experience any of the following signs and symptoms of an allergy reaction: difficulty breathing, hives or swelling to lips, face throat or tongue

Estradiol and Drospirenone can cause severe side effects. If you experience:

• Heart attack symptoms include chest pain, pressure or pain that spreads to the jaw or shoulders, nausea, and sweating.
• Signs of stroke: sudden numbness, weakness, or headache (especially one side), slurred or shaky speech, or problems with balance or vision;
• Signs of blood clots include sudden vision loss, chest pain that stabs sharply, shortness of breath, blood in your cough or pain or heat in both legs.
• Sudden vision loss;
• Rapid weight gain and swelling
• Jaundice refers to an abnormal yellowing of skin and eyes.
• Memory problems, confusion, and unusual behavior
• Unusual vaginal bleeding
• A lump on your breast
• High blood sugar: increased thirst, increased urination, and a fruity odor

Some of the common side effects associated with drospirenone or estradiol include:

• Headaches and mood swings
• Breakthrough bleeding, vaginal discharge or itching, change in menstrual cycle,
• Breast pain
• Nausea, diarrhea, and stomach pain;
• Fluid retention (swelling, rapid weight gain).

There may be other side effectsCall your physician if experiencing side effects; alternatively call the FDA's hotline at 1-800-FDA-1088 to report it.

Warnings

Drospirenone should be avoided if: you are suffering from undiagnosed bleeding in the vaginal area; you suffer from coronary artery diseases; you suffer from a bleeding disorder; you have kidney or liver disease. You've had an adrenal disorder or had major surgery. Avoid using it if pregnant. Estradiol and Drospirenone may increase the risk that you develop a condition that may result in uterine cancer. Do not ignore any abnormal vaginal bleeding. This medicine should not be taken to treat strokes or dementia.

Before you take this drug

This medicine should not be used if:

• Unusual vaginal bleeding was not examined by a physician.
• A bleeding disorder;
• Coronary artery disease
• Have a history of stroke, heart attack or blood clot.
• Kidney disease
• Liver disease
• An adrenal gland disease;
• A history of cancers of the breast, uterus, or cervix, or of vaginal or ovarian origin;
• If you've had your uterus surgically removed (hysterectomy),

If you get pregnant while on treatment, tell your doctor immediately. This medicine may increase the risk of a stroke or heart attack. This risk is increased if your blood pressure or cholesterol levels are high. This medicine can actually increase the risk of heart disease, stroke, or dementia.

If you've ever:

• High blood pressure and heart disease
• A thyroid condition;
• Gallbladder Disease
• Jaundice can be caused by hormones or pregnancy.
• High triglycerides
• Asthma;
• Epilepsy and other seizure disorders
• Migraine headaches
• Lupus;
• Endometriosis or uterine fibroid tumors;
• High levels of potassium or calcium in the blood or low levels of sodium
• Hereditary Angioedema
• Porphyria is a disorder of enzymes that affects the skin and nervous system.

The use of drospirenone with estradiol can increase the risk of breast cancer. Before using the medicine for a long time, talk to your doctor. Breast milk production can be slowed by this medicine, which lowers the necessary hormone. Breast-feeding is not recommended while on drospirenone or estradiol.

How to take Drospirenone and estradiol?

Read all the instructions or guides that come with your medication and follow all the directions. Follow the directions on your prescription label. You should not chew, crush, dissolve, or break a tablet containing drospirenone. It is best to swallow it whole. Do not take drospirenone or estradiol together. Estradiol and drospirenone can increase the risk that you will develop a condition that could lead to uterine carcinoma. A progestin may be prescribed by your doctor to lower the risk. Any unusual bleeding in the vaginal area should be reported immediately. You may have to temporarily stop taking this medication if you are going through major surgery or if you will need long-term rest. You should let any doctor who treats you know that you use drospirenone or estradiol. You should have your doctor check on you regularly to see if this is a treatment that should be continued. You should self-examine for lumps in your breasts every month and undergo regular mammograms when using this medication. Keep away from heat and moisture at room temperature.

Details on dosage

Adult dose for postmenopausal symptoms:
Vasomotor symptoms:
Take one 0.25 mg/0.5 mg estradiol/drospirenone tablet once daily.
Take one 0.5mg drospirenone/1mg estradiol oral tablet once per day.
Vulvar atrophy and
Take one 0.5mg drospirenone/1mg estradiol oral tablet once per day.
Comments:
Treatment is ongoing.
Women who are not taking estrogens or using a combination of products can start the treatment at any time.
Women who are switching to continuous or cyclic hormonal therapy from a previous cycle should finish their current treatment before making the switch.
Consider using vaginal topical products when they are used exclusively for vulvar or vaginal atrophy.
Uses: treating moderate to severe vasomotor symptomatology and vulvar or vaginal atrophy caused by menopause.

What happens if I miss the dose?

If you miss a dose, take it as soon as possible. However, if the delay is more than 12 hours, you should skip that dose. Take only one dose at a time.

What happens if I overdose?

Call the Poison Help Line at 1-800-222-1222 or seek emergency medical care. Overdose symptoms include nausea, vomiting, and vaginal bleeding.

What should be avoided?

Smoking is harmful. While using estradiol and drospirenone, your chances of having a stroke or heart attack are increased. Grapefruit can cause unwanted side effects when combined with estradiol or drospirenone.Use grapefruit-based products sparingly.

Interaction with other drug

It is sometimes not a good idea to take certain drugs at the same time. Some medications can cause side effects that increase or decrease the effectiveness of another drug you are taking. Drospirenone, estradiol, and other drugs can affect each other. This includes prescription, over-the-counter, herbal, and vitamins. Inform your doctor of all the medicines you are currently taking and those that you will begin or stop.