Pronunciation:

KON-joo-gay-ted ES-troe-jenz

Brand Names:

• Premarin

Dosage Forms:

• Tablet

Warnings:

Endometrial Cancer, Cardiovascular Disorders, Breast Cancer and Probable DementiaEstrogen-Alone TherapyThere is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.Women's Health Initiative estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis.The Women’s Health Initiative Memory Study estrogen-alone ancillary study of Women’s Health Initiative reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.Estrogen Plus Progestin TherapyEstrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.The Women’s Health Initiative estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism, and myocardial infarction.The Women’s Health Initiative estrogen plus progestin substudy reported increased risks of invasive breast cancer.The Women’s Health Initiative Memory Study estrogen plus progestin ancillary study of Women’s Health Initiative reported an increased risk of probable dementia in postmenopausal women 65 years of age and older .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Estrogen

Uses of This Medicine:

Conjugated estrogens are a medicine that contains a mixture of estrogen hormones. It is used to treat moderate to severe hot flashes, changes in and around the vagina, and other symptoms of menopause or low amounts of estrogen (hypoestrogenism). This medicine is also used to prevent osteoporosis (thinning of the bones) after menopause.

Conjugated estrogens tablet is also used to treat symptoms of breast and prostate cancer that have spread through the body in men and women. It is also used to treat certain conditions in women before menopause if their ovaries do not make enough estrogen naturally.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of conjugated estrogens have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected.

Older adults—

Although appropriate studies on the relationship of age to the effects of conjugated estrogens have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving conjugated estrogens.

Breast-feeding—

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Etoricoxib
• Ginseng
• Levothyroxine
• Licorice
• Tipranavir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or
• Breast cancer, known or suspected, or a history of or
• Heart attack, active or history of or
• Liver disease or
• Protein C, protein S, or other known blood clotting disorders or
• Stroke, active or history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Asthma or
• Cancer, history of or
• Diabetes or
• Edema (fluid retention or body swelling) or
• Endometriosis or
• Epilepsy (seizures) or
• Gallbladder disease or
• Heart disease or
• Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
• Hypercalcemia (high calcium in the blood) or
• Hypertension (high blood pressure) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Hypocalcemia (low calcium in the blood), severe or
• Hypothyroidism (an underactive thyroid) or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver tumors or
• Migraine headache or
• Porphyria (an enzyme problem) or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). It is recommended that you receive calcium and vitamin D supplements while receiving this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prevention of hot flashes, vulvar and vaginal atrophy caused by menopause or osteoporosis after menopause:
    • Adults—At first, 0.3 milligram (mg) once a day. Your doctor may adjust your dose as needed. The medicine may be taken everyday, or in cycles (taking the medicine for 25 days, followed by 5 days without medicine).
    • Children—Use and dose must be determined by your doctor.
  • For treatment of advanced prostate cancer in men:
    • Adults—1.25 to 2.5 (taken as two tablets) milligrams (mg) three times a day.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of breast cancer in men and women:
    • Adults—10 milligrams (mg) three times a day, for at least 3 months.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of hypoestrogenism due to female hypogonadism:
    • Adults—0.3 to 0.625 milligram (mg) once a day, taken in cycles (taking the medicine for 3 weeks, followed by 1 week without medicine). Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of hypoestrogenism due to female castration or primary ovarian failure:
    • Adults—1.25 milligrams (mg) once a day, taken in cycles (taking the medicine for 3 weeks, followed by 1 week without medicine). Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using large doses of this medicine over a long period of time may increase your risk of heart attack, stroke, blood clots, dementia, breast cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine.

Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.

Using this medicine alone may increase your risk of getting cancer of the uterus (womb). Check with your doctor right away if you have unusual vaginal bleeding while you are using this medicine.

Stop using this medicine and check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Heavy non-menstrual vaginal bleeding

Less common

Body aches or pain

chills

cough

difficulty with breathing

ear congestion

fever

headache

loss of voice

nasal congestion

runny nose

sneezing

sore throat

unusual tiredness or weakness

Incidence not known

Abdominal or stomach pain and tenderness

acid or sour stomach

anxiety

backache

belching

bloody stools

blurred vision

breast tenderness, enlargement, pain, or discharge

change in vaginal discharge

change in vision

changes in skin color

chest pain or discomfort

clay-colored stools

clear or bloody discharge from the nipple

confusion

constipation

dark urine

diarrhea

difficulty with speaking

dimpling of the breast skin

dizziness or lightheadedness

double vision

fainting

fast heartbeat

full or bloated feeling or pressure in the stomach

headache, severe and throbbing

heartburn

hives

hoarseness

inability to move the arms, legs, or facial muscles

inability to speak

indigestion

inverted nipple

irritation

itching

joint pain, stiffness, or swelling

loss of appetite

lump in the breast or under the arm

migraine headache

nausea

pain or discomfort in the arms, jaw, back, or neck

pain or feeling of pressure in the pelvis

pain, redness, or swelling in the arm or leg

pain, tenderness, or swelling of the foot or leg

painful or tender cysts in the breasts

pains in the stomach, side, or abdomen, possibly radiating to the back

persistent crusting or scaling of the nipple

poor insight and judgment

problems with memory or speech

rash

rectal bleeding

redness of the skin

redness or swelling of the breast

shortness of breath

slow speech

sore on the skin of the breast that does not heal

stomach discomfort or upset

sudden shortness of breath or troubled breathing

sweating

swelling of the abdominal or stomach area

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

trouble recognizing objects

trouble thinking and planning

trouble walking

troubled breathing or swallowing

unpleasant breath odor

vaginal bleeding

vomiting

vomiting of blood

wheezing

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

excess air or gas in the stomach or intestines

itching of the vagina or genital area

lack or loss of strength

pain during sexual intercourse

passing gas

thick, white vaginal discharge with no odor or with a mild odor

Less common

Increased clear or white vaginal discharge

leg cramps

Incidence not known

Blistering, peeling, or loosening of the skin

cramps

decreased interest in sexual intercourse

diarrhea

difficulty with moving

heavy bleeding

hives or welts

inability to have or keep an erection

increased hair growth, especially on the face

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

irritability

itching of the vagina or outside genitals

joint or muscle pain

loss in sexual ability, desire, drive, or performance

loss of scalp hair

mental depression

mood changes

muscle stiffness

pain

pain during sexual intercourse

pain in the ankles or knees

painful, red lumps under the skin, mostly on the legs

patchy brown or dark brown discoloration of the skin

rash

red, irritated eyes

sores, ulcers, or white spots in the mouth or on the lips

swelling of the breasts or breast soreness in both females and males

thick, white curd-like vaginal discharge without odor or with mild odor

unexpected or excess milk flow from the breasts

weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.