Conjugated estrogens (vaginal)

Estrogen is a female hormone made by the ovaries. It is important for many functions in the body. Conjugated estrogens are a combination of estrogen hormones.

Conjugated estrogens are used in the vagina to help with menopausal symptoms like dryness, burning, irritation, and painful sexual intercourse.

Conjugated estrogens 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.

Conjugated estrogens 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, to help lower this risk. Report any unusual vaginal bleeding right away.

Conjugated estrogens are sometimes used daily. 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 regularly to determine whether you should continue this treatment. Self-examine your breasts for lumps monthly, and have regular mammograms.

If you need major surgery or will be on long-term bed rest, you may need to stop using conjugated estrogens for a short time. Any doctor or surgeon who treats you should know that you are using vaginal conjugated estrogens.

Store at room temperature away from moisture and heat.

Do not use if you are pregnant.

You should not use conjugated estrogens 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.

Conjugated estrogens 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. Estrogen should not be used to prevent heart disease, stroke, or dementia.

You should not use conjugated estrogens 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 if you are pregnant. Use effective birth control if you are not past menopause. Tell your doctor if you think you may be pregnant.

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.

Estrogen 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 conjugated estrogens 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.

This medicine is not approved for use by anyone younger than 18 years old.

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 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 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.

Usual Adult Dose for Atrophic Vaginitis:

Initial dose: 0.5 grams intravaginally in a cyclic regimen: daily for 21 days, then off for 7 daysMaintenance dose: 0.5 to 2 grams intravaginally in a cyclic regimen: daily for 21 days, then off for 7 daysComments:-Adjust dose based on individual responseUses: Treatment of atrophic vaginitis and kraurosis vulvae

Usual Adult Dose for Postmenopausal Symptoms:

0.5 grams intravaginally twice weekly (e.g. Monday and Thursday)OR0.5 grams intravaginally in a cyclic regimen: daily for 21 days, then off for 7 daysUses: Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include drowsiness, vomiting, stomach pain, breast pain, or vaginal bleeding.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using conjugated estrogens (vaginal).

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

Sometimes it is not safe to use certain medications together. Some drugs can change the amount of other drugs in your blood, which may increase side effects or make the medications work less effectively.

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