Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Synthetic Conjugated Estrogens-A is a mixture of estrogen hormones used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse.

Synthetic Conjugated Estrogens-A should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Synthetic Conjugated Estrogens-A may also be used for other purposes not listed in this medication guide.

Synthetic Conjugated Estrogens-A can cause birth defects in an unborn baby. Do not use Synthetic Conjugated Estrogens-A if you are pregnant. Do not use this medication if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer.

Long-term treatment with conjugated estrogens may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using Synthetic Conjugated Estrogens-A long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Synthetic Conjugated Estrogens-A.

Synthetic Conjugated Estrogens-A should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Use Synthetic Conjugated Estrogens-A exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Synthetic Conjugated Estrogens-A are usually prescribed for only a short time and are most often used in a cycle, such as 3 weeks on followed by 1 week off. Some conditions require daily use and others require use only twice a week during the treatment period. Follow the directions on your prescription label.

To apply Synthetic Conjugated Estrogens-A, 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.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis if you are using Synthetic Conjugated Estrogens-A long term.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using conjugated estrogens. You may need to stop using the medicine for a short time.

Synthetic Conjugated Estrogens-A can affect the results of certain medical tests. Tell any doctor who treats you that you are using conjugated estrogens.

Store this medication at room temperature away from moisture and heat.

Usual Adult Dose for Atrophic Vaginitis:

Treatment of Atrophic Vaginitis and Kraurosis Vulvae:

Conjugated estrogens topical synthetic A (Duramed): 1 gram intravaginally daily for one week followed by 1 gram intravaginally twice a week.

Do not use Synthetic Conjugated Estrogens-A if you are pregnant, or if you have:

• a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

• abnormal vaginal bleeding that a doctor has not checked;

• liver disease; or

• any type of breast, uterine, or hormone-dependent cancer.

Before using Synthetic Conjugated Estrogens-A, tell your doctor if you are allergic to any drugs, or if you have:

• high blood pressure, heart disease, or circulation problems;

• a personal or family history of stroke;

• endometriosis;

• liver or kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• diabetes;

• underactive thyroid;

• high cholesterol or triglycerides;

• high or low levels of calcium in your blood;

• porphyria;

• systemic lupus erythematosus (SLE);

• gallbladder disease; or

• if you have had your uterus removed (hysterectomy).

Synthetic Conjugated Estrogens-A increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Synthetic Conjugated Estrogens-A.

Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using Synthetic Conjugated Estrogens-A long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use Synthetic Conjugated Estrogens-A if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. You should know that Synthetic Conjugated Estrogens-A vaginal cream can weaken the latex of a condom, diaphragm, or cervical cap. Talk to your doctor about the best contraceptive methods to use. Conjugated estrogens can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not use Synthetic Conjugated Estrogens-A in anyone under 18 years old without the advice of a doctor.

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use your medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

Do not smoke while using Synthetic Conjugated Estrogens-A. Smoking can increase your risk of blood clots, stroke, or heart attack caused by Synthetic Conjugated Estrogens-A.

Get emergency medical help if you have any of these signs of an allergic reaction to Synthetic Conjugated Estrogens-A: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• pain or swelling in your lower leg;

• abnormal vaginal bleeding;

• migraine headache;

• pain, swelling, or tenderness in your stomach;

• confusion, problems with memory or concentration;

• jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet; or

• a breast lump.

Less serious Synthetic Conjugated Estrogens-A vaginal cream side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;

• breast pain, tenderness, or swelling;

• freckles or darkening of facial skin;

• increased hair growth, loss of scalp hair;

• changes in weight or appetite;

• problems with contact lenses;

• vaginal itching or discharge;

• changes in your menstrual periods, decreased sex drive; or

• headache, nervousness, dizziness, tired feeling.

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.

Before using conjugated estrogens, tell your doctor if you are using any of the following medicines:

• a blood thinner such as warfarin (Coumadin);

• a thyroid medication such as levothyroxine (Synthroid);

• insulin or diabetes medicine taken by mouth;

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• ketoconazole (Nizoral) or itraconazole (Sporanox);

• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and there may be other drugs that can interact with Synthetic Conjugated Estrogens-A. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.