Pronunciation:

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

Brand Names:

• Premarin
• Premarin Vaginal

Dosage Forms:

• Cream

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—

Female Reproductive Agent

Pharmacologic—

Estrogen

Uses of This Medicine:

Conjugated estrogens is a medicine that contains a mixture of estrogen hormones. Conjugated estrogens vaginal cream is used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by low estrogen levels or menopause. It is also used to treat vaginal pain during sexual intercourse.

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—

Use of Premarin® vaginal cream is not indicated for children.

Older adults—

Although appropriate studies on the relationship of age to the effects of Premarin® vaginal cream 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 this medicine.

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) 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 exactly 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.

This medicine is to be used only in the vagina. Use at bedtime unless your doctor tells you otherwise.

To use the cream:

• Wash your hands with soap and water before and after using this medicine.
• Remove cap from the tube and screw the nozzle end of the applicator to the tube.
• Gently squeeze tube from the bottom to force enough amount into the barrel. Use the marked stopping points on the applicator to measure the correct dose.
• Unscrew the applicator from the tube, and lie on the back with knees drawn up, and gently insert the applicator deeply into the vagina and press plunger downward to its original position.
• Wash the applicator with mild soap and water. Do not use hot water.

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 vaginal dosage form (cream):
  • For treatment of atrophic vaginitis and kraurosis vulvae:
    • Adults—At first, use 0.5 gram (g) into the vagina once a day. Your doctor may adjust your dose as needed. The medicine is used in cycles (using the medicine for 21 days, followed by 7 days without medicine).
    • Children—Use is not recommended.
  • For treatment of painful sexual intercourse:
    • Adults—Use 0.5 gram (g) in the vagina two times a week, or in cycles (using the medicine for 21 days, followed by 7 days without medicine).
    • Children—Use is not recommended.

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. Be sure to keep all appointments.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. This medicine may cause latex or rubber condoms, diaphragms, or cervical caps to break. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medication may increase your risk of, endometrial cancer, 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. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.

Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes or are overweight or smoke cigarettes. Contact your doctor immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for an extended time. This medicine may affect the results of certain medical tests.

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).

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

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

Breast pain

change in vaginal discharge

cough or hoarseness

fever or chills

increased clear or white vaginal discharge

itching of the vagina or genital area

lower back or side pain

pain during sexual intercourse

pain or feeling of pressure in the pelvis

painful or difficult urination

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

vaginal bleeding

Less common

Feeling faint, dizzy, or lightheaded

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

headache

sweating

Incidence not known

Abdominal or stomach bloating

abnormal uterine bleeding or spotting

acne

anxiety

bloody or cloudy urine

breast tenderness, enlargement, pain, or discharge

chest pain or discomfort

decreased vision or other changes in vision

difficulty with swallowing

enlargement of the penis or testes

fast heartbeat

frequent urge to urinate

growth of pubic hair

hives

itching

itching of the vagina or outside genitals

nausea

pain during sexual intercourse

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

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid increase in height

shortness of breath

stomach pain

sudden shortness of breath or troubled breathing

sweating

tightness in the chest

unusual tiredness or weakness

vomiting

wheezing

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

Abdominal or stomach pain

back pain

diarrhea

headache

lack or loss of strength

Less common

Body aches or pain

congestion

increased dryness or soreness of the throat

runny nose

tender, swollen glands in the neck

trouble with swallowing

voice changes

Incidence not known

Abdominal or stomach cramps

changes in weight

decreased or increased interest in sexual intercourse

depression

difficulty with moving

headache, severe and throbbing

heavy bleeding

inability to have or keep an erection

increased hair growth, especially on the face

irritability

itching of the vagina or genitals

leg cramps

loss of scalp hair

loss or increase in sexual ability, desire, drive, or performance

mood changes

muscle pain or stiffness

nervousness

pain

pain in the joints

patchy brown or dark brown discoloration of the skin

poor insight and judgment

problems with memory or speech

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

trouble recognizing objects

trouble thinking and planning

weakness

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.