Estradiol and progesterone

Estradiol and progesterone is used in menopausal adult women to reduce symptoms of moderate to severe "hot flashes".

Estradiol and progesterone may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food every evening.

If you need surgery, or will be on bed rest, tell your healthcare provider ahead of time that you are using estradiol and progesterone. You may need to stop using the medicine for a short time.

You will need frequent medical tests, and your next dose may change based on your response to treatment.

Your doctor will need to check your progress on a regular basis to determine how long you should use estradiol and progesterone. You may need a pelvic exam, breast exam, and mammogram every year while using estradiol and progesterone. Follow your doctor's instructions.

Ask your doctor before stopping the medicine.

estradiol and progesterone can affect the results of certain medical tests. Tell any doctor who treats you that you are using estradiol and progesterone.

Store at room temperature away from moisture and heat.

You should not take estradiol and progesterone if your uterus has been removed or if you have or have ever had: vaginal bleeding that has not been checked by your doctor, liver disease, a bleeding or blood clotting disorder, a heart attack, a stroke, a blood clot, or cancer of the breast or uterus.

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

You should not take estradiol and progesterone if you are allergic to it, or if you have or have ever had:

• unusual vaginal bleeding that has not been checked by a doctor;
• a bleeding or blood clotting disorder;
• a heart attack, stroke, or blood clot;
• hormone related cancer such as breast or uterine cancer; or
• liver disease.

This medicine is for use only in a woman who has not had her uterus removed (hysterectomy).

Estradiol and progesterone should not be used to prevent heart disease, stroke, or dementia. Using this medicine may increase your risk of blood clots, dementia, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Tell your doctor if you have or have ever had:

• heart problems;
• high blood pressure;
• gallbladder problems;
• fluid retention;
• diabetes;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• systemic lupus erythematosus (SLE);
• endometriosis or uterine fibroid tumors;
• hereditary angioedema;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• high triglycerides;
• a family history of breast cancer;
• hypoparathyroidism;
• a thyroid disorder;
• abnormal levels of calcium in your blood;
• liver problems such as a liver tumor or jaundice (caused by pregnancy or hormones); or
• kidney disease.

Do not use estradiol and progesterone if you are pregnant. Tell your doctor right away if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Estradiol and progesterone can increase your risk of blood clots, stroke, or heart attack. Get emergency medical help if you have: chest pain, pain, swelling or warmth in your leg, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath or trouble breathing.

Estradiol and progesterone may cause serious side effects. Call your doctor at once if you have:

• change in the pattern or severity of migraine headaches;
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding;
• lump in your breast;
• changes in vision;
• abnormal lab results such as increased fat in your blood (triglycerides) or thyroid hormone levels;
• increased blood pressure--severe headache, pounding in your neck or ears;
• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
• signs of gallbladder, liver, or pancreas problems--chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, loss of appetite, upper stomach pain (that may spread to your back), vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes); or
• low or high blood calcium levels--constipation, increased thirst or urination, muscle spasms, weight loss, tingly feeling (around your mouth, or in your fingers and toes).

Common side effects of estradiol and progesterone may include:

• pelvic pain;
• vaginal bleeding or discharge;
• breast tenderness; or
• nausea, headache.

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.

Usual Adult Dose for Postmenopausal Symptoms:

1 capsule (estradiol 1 mg/progesterone 100 mg) orally once a day in the evening with foodComments: -Hormone replacement therapy should be limited to the shortest duration consistent with treatment goals and risks for the individual women. -Reevaluate periodically to determine if treatment is still necessary. Use: Treatment of moderate to severe vasomotor symptoms due to menopause.

Take the medicine (with food) as soon as you remember, 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.

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

Avoid smoking. It can greatly increase your risk of blood clots, dementia, stroke, or heart attack while using estradiol and progesterone.

Grapefruit may interact with estradiol and progesterone and cause side effects. Avoid consuming grapefruit products.

Sometimes it is not safe to use certain medicines together. Some drugs can change how much of other drugs is in your blood, which may lead to more side effects or reduce how well the medicines work.

Many drugs can affect estradiol and progesterone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you take.

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