Estradiol and progesterone

Estradiol and progesterone

Estradiol and progesterone

What is Estradiol and Progesterone?

Estradiol and progesterone is a combination medicine used to treat moderate to severe hot flashes during menopause.

Estradiol and progesterone should only be used in women whose uterus has not been removed.

Estradiol and progesterone may also be used for purposes not listed in this medication guide.

Side effects of estradiol and progesterone

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Estradiol and progesterone can cause serious side effects. Call your doctor immediately if you have:

• Heart attack symptoms – chest pain or feeling of pressure, pain spreading to the 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;

• Signs of a blood clot - sudden loss of vision, shortness of breath, coughing up blood, pain or warmth in one or both legs;

• swelling, rapid weight gain;

• jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding, pelvic pain;

• a lump in your breast; or

• High levels of calcium in the blood – nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects of estradiol and progesterone can include:

• pelvic pain;

• vaginal bleeding or discharge;

• breast tenderness; or

• Headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

You should not use estradiol and progesterone if you have had your uterus removed or if you have undiagnosed vaginal bleeding, liver disease, or a blood clotting disorder, if you are having major surgery, or if you have ever had a heart attack, stroke, blood clot, or cancer of the breast, uterus/cervix, or vagina.

Estradiol may increase your risk of developing a condition that can lead to uterine cancer.Call your doctor if you have vaginal bleeding.

Using this medicine may increase your risk of blood clots, stroke, heart attack, or breast, uterine, or ovarian cancer.Estradiol and progesterone should not be used to prevent heart disease, stroke, or dementia.

Before you take this medicine

You should not take estradiol and progesterone if you have had your uterus removed or if you:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease;

• an increased risk of blood clots due to a heart problem or hereditary blood disorder;

• a history of heart attack, stroke, or blood clots; or

• a history of hormone-related cancer or cancer of the breast, uterus/cervix or vagina.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• Gallbladder disease;

• liver problems or jaundice caused by pregnancy or taking hormones;

• kidney disease;

• Diabetes;

• Asthma;

• epilepsy or other seizure disorders;

• Migraine;

• lupus;

• endometriosis or uterine fibroid tumors;

• hereditary angioedema;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• a thyroid disease; or

• high levels of calcium in your blood.

Estradiol and progesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

Estrogens can increase the risk of blood clots, strokes, or heart attacks. You are at even greater risk if you have high blood pressure, diabetes, high cholesterol, are overweight or are a smoker.

Estrogens can also increase your risk of breast, uterine, or ovarian cancer. Talk to your doctor about this risk.

Estradiol and progesterone should not be used in pregnant or breastfeeding women.

How should I take estradiol and progesterone?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

Take with food.

If you need major surgery or need to be on bed rest for a long time, you may need to stop taking estradiol and progesterone for a short time. Any doctor or surgeon who treats you should know that you are taking estradiol and progesterone.

Call your doctor if you experience unusual vaginal bleeding.

Your doctor should check your progress regularly (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps monthly and have a mammogram every year while using estradiol and progesterone.

Store at room temperature, protected from moisture and heat.

Estradiol and progesterone dosage information

Usual Adult Dose for Postmenopausal Symptoms:

Take 1 capsule (estradiol 1 mg/progesterone 100 mg) orally once daily in the evening with food

Comments:
-Hormone replacement therapy should be limited to the shortest duration appropriate to the treatment goals and risks for individual women.
– Reassess regularly to determine whether treatment is still needed.

Application: Treatment of moderate to severe vasomotor symptoms due to menopause.

What happens if I miss a dose?

Take the medicine (with food) as soon as possible, but skip the missed dose if your next dose is due in less than 2 hours. Do not take two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid while taking estradiol and progesterone?

Avoid smoking. It may significantly increase your risk of blood clots, stroke, or heart attack if you take estradiol and progesterone.

Grapefruit may interact with this medicine and cause unwanted side effects. Avoid using grapefruit products.

What other drugs affect estradiol and progesterone?

Sometimes it is not safe to take certain medications at the same time. Some medications can affect the blood levels of other medications you are taking, which may increase side effects or make the medications less effective.

Many medications can interact with estradiol and progesterone. This includes prescription and over-the-counter medications, vitamins and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

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More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.