conjugated estrogens (vaginal)

What is the most important information I should know about conjugated estrogens?

You should not use this medicine 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.

What are conjugated estrogens?

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body. Conjugated estrogens are a mixture of estrogen hormones.

Conjugated estrogens are used in the vagina to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse.

Conjugated estrogens may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using conjugated estrogens?

• 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.

Conjugated estrogens vaginal cream can weaken the latex of a condom, diaphragm, or cervical cap. Talk to your doctor about the best birth control methods to use.

Using conjugated estrogens 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.

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.

How should I use conjugated estrogens?

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

Conjugated estrogens are sometimes used on a daily basis. For certain conditions, the medicine is used in a cycle, such as 3 weeks on followed by 1 week off. Follow your doctor's instructions.

To apply this medication, use only the vaginal applicator provided. After each use, take the applicator apart and clean it with mild soap and warm water. Do not use hot or boiling water.

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 vaginal conjugated estrogens.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while using conjugated estrogens?

Grapefruit may interact with conjugated estrogens and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of conjugated estrogens?

• 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 may include:

• headache;
• pelvic pain;
• flushing (warmth, redness, or tingly feeling);
• breast pain; 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.

What other drugs will affect conjugated estrogens?

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

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

Where can I get more information?

Your pharmacist can provide more information about vaginal conjugated estrogens.