Conjugated estrogens and medroxyprogesterone

Estrogen is a female sex hormone made by the ovaries. It is essential for many functions in the body. Conjugated estrogens are a mix of different estrogen hormones.

Medroxyprogesterone is a type of progesterone, a female hormone that plays a key role in managing ovulation and menstruation.

Conjugated estrogens and medroxyprogesterone is a combination medicine used to treat menopause symptoms like hot flashes and changes in the vagina, and to prevent osteoporosis (bone loss) in women who are going through menopause.

Conjugated estrogens and medroxyprogesterone may also be used for other 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 the medicine at the same time each day.

Conjugated estrogens and medroxyprogesterone may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using conjugated estrogens and medroxyprogesterone, to help lower this risk. Report any unusual vaginal bleeding right away.

The 28-day Premphase treatment consists of two differently colored pills, 14 of each color. Carefully follow the patient instructions about which pills to take on days 1 through 14 and which pills to take on days 15 through 28.

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.

If you need major surgery or will be on 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 conjugated estrogens and medroxyprogesterone.

Store at room temperature away from moisture, heat, and light.

You should not use conjugated estrogens and medroxyprogesterone if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, 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.

Conjugated estrogens and medroxyprogesterone may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estrogens should not be used to prevent heart disease, stroke, or dementia.

You should not use this medicine if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• a history of heart attack, stroke, or blood clot;
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use conjugated estrogens and medroxyprogesterone if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using 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.

Conjugated estrogens and medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• a hysterectomy;
• heart disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• kidney disease;
• gallbladder disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• lupus;
• endometriosis or uterine fibroid tumors;
• hereditary angioedema;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• a thyroid disorder; or
• high levels of calcium in your blood.

Using this medicine may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Estrogen lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding.

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

Conjugated estrogens and medroxyprogesterone may cause serious side effects. Call your doctor right away if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your 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 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;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects of conjugated estrogens and medroxyprogesterone may include:

• nausea, gas, stomach pain;
• headache, back pain;
• depression, weakness;
• breast pain;
• itching, thinning scalp hair; or
• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

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.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. 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 significantly raise your risk of blood clots, stroke, or heart attack while using conjugated estrogens and medroxyprogesterone.

Grapefruit may interact with conjugated estrogens and medroxyprogesterone and cause unwanted side effects. Avoid using grapefruit products.

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

Many drugs can affect conjugated estrogens and medroxyprogesterone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all the medicines you are currently taking and any new medicine you start or stop using.