Drospirenone and Estradiol (Systemic)

Drospirenone ( droh-SPYE-re-none) and estradiol (es-tra-DYE-ole ) are female hormones called progestins and estrogens that make up this combination medicine. These female hormones are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen in postmenopausal women who still have a uterus. Estrogen helps relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness. Estrogen can also help to relieve a genital skin condition called vaginal or vulvar atrophy. Progestin helps to regulate the effects of estradiol.

This medicine is available only with your doctor’s prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For drospirenone/estradiol, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to drospirenone or estradiol. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Drospirenone/estradiol should not be used during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Breast-feeding: Drospirenone/estradiol passes into the breast milk and can change the content or lower the amount of breast milk. Use of this medicine is not recommended in nursing mothers.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. However, use of drospirenone/estradiol by postmenopausal women 65 years of age and older may increase the chances of dementia.

Other medicines: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Abnormal genital or vaginal bleeding of unknown causes or
• Adrenal gland problems or
• Breast cancer, known, suspected or history of, or
• Cancer of the uterus or
• Liver problems or disease: This medicine should NOT be used.

• Asthma or
• Diabetes or
• Endometriosis or
• Epilepsy (seizures) or
• High cholesterol or triglycerides (or history of) or
• Hypocalcemia (too little calcium in the blood) or
• Hyponatremia (too little sodium in the blood) or
• Liver tumor, benign, or
• Lupus or
• Migraine or
• Porphyria (problem with metabolism causing stomach pain and mental confusion): This medicine should be used with caution. It can cause these conditions to become worse.

• Blood clots in deep veins or the pulmonary artery or
• Heart attack, active or recent (within the past year) or
• Stroke, active or recent: This medicine should NOT be used.

• Blood clot risk factors (e.g., obesity, personal or family history of blood clots, or lupus) or
• Heart disease risk factors (e.g., diabetes, high cholesterol, high blood pressure, obesity, tobacco use): Your doctor will help you lower your chances of having heart disease.

• Heart problems or
• Liver problems: These conditions could be affected by fluid retention (e.g., water weight gain). The patient should be observed when taking this medicine because estradiol may cause some fluid retention.

• Hypothyroid (too little thyroid hormone): Dose of thyroid medicine may need to be increased.

Dosing:

Read the enclosed patient leaflet carefully before taking this medicine.

You should not take this medicine if you have had a hysterectomy.

You should not take this medicine to prevent heart disease or dementia.

Tell your doctor if you take any medicine or supplement that increases potassium levels. Your doctor may want to prescribe a different medicine for you or have your blood tested to check potassium levels.

Swallow the tablet whole. Do not crush or chew.

The dose of drospirenone/estradiol will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of drospirenone/estradiol. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage forms (tablets)
  • For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
    • Adults: Oral, 1 tablet (drospirenone 0.5 mg/ estradiol 1 mg) once a day.

Missed dose:

Call your doctor or pharmacist for instructions.

Storage:

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visitsevery 3 to 6 months to discuss whether you need to continue taking this medicine.

If you are going to have surgery or will be on bed rest, you need to inform your doctor. You may need to stop taking drospirenone/estradiol during this time.

Check with your doctor immediately if vaginal bleeding occurs.

It is important that you check your breasts by self-examination regularly and have clinical examinations and mammographies as required by your doctor. Report unusual breast lumps or discharge right away.

If you are scheduled for any lab tests, tell your doctor or lab technician that you are taking this medicine. Certain blood tests are affected by estradiol.

Tell your doctor about any risk factors for heart disease that you may have, such as high blood pressure, diabetes, tobacco use, high cholesterol, and obesity. It is important that you work with your doctor to lower these risk factors.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Breast pain; full or bloated feeling ; heavy nonmenstrual vaginal bleeding; pressure in the stomach; surgery; swelling of abdominal or stomach area 
  
  

• Less common
  • Bloating or swelling of face, arms, hands, legs, or feet; change in vaginal discharge; increased clear or white vaginal discharge; pain or feeling of pressure in pelvis; rapid weight gain; tingling of hands or feet; unusual weight gain or loss; vaginal bleeding 
  
  

• Incidence not known
  • Abdominal pain; anxiety; blurred vision; change in vision; chest pain or discomfort; clear or bloody discharge from nipple; confusion;  constipation; cough; coughing up blood; depression; difficulty in speaking; dimpling of breast skin; dizziness or lightheadedness; double vision; dry mouth; fainting ; fast heartbeat; headache ; headache, severe and throbbing;  inability to move arms, legs, or facial muscles;  inability to speak; incoherent speech; increased urination; inverted nipple ; loss of appetite; lump in breast or under the arm; metallic taste; muscle weakness; nausea and vomiting ; numbness or weakness in your arm or leg, or on one side of your body; pain or discomfort in arms, jaw, back, or neck; pain or redness in your lower leg (calf); persistent crusting or scaling of nipple ; poor insight and judgment;  problems with memory, vision, speech, or walking;  redness or swelling of breast; seeing double; shortness of breath; slow speech; sore on the skin of the breast that does not heal; sudden or severe headache; sudden shortness of breath or troubled breathing; sweating; thirst; trouble recognizing objects ; trouble thinking and planning;  trouble walking; unusual tiredness or weakness; weight loss 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Accidental injury; back pain; body aches or pain; chills; diarrhea; difficulty in breathing; ear congestion; fever, sneezing, or sore throat; general feeling of discomfort or illness ; joint pain; loss of voice ; muscle aches and pains;  nasal congestion; pain in arms or legs; pain or tenderness around eyes and cheekbones;  runny nose; shivering;  stuffy or runny nose; sweating;  tightness of chest or wheezing; trouble sleeping  
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

In the U.S.:

• Estrogen-progestin
• Ovarian hormone therapy agent