Pronunciation:

KON-joo-gay-ted ES-troe-jenz sin-THET-ik A

Brand Names:

• Cenestin

Warnings:

Estrogen treatment alone increases the risk of endometrial cancer in a woman with a uterus. Adding a progestin to estrogen therapy may reduce the risk of endometrial hyperplasia, a precursor to endometrial cancer. However, addition of a progestin to estrogen therapy may increase the risk of invasive breast cancer. Undertake adequate diagnostic measures, including directed or random endometrial sampling if indicated, to rule out malignancy in postmenopausal women with abnormal vaginal bleeding. Estrogen treatment alone increased risks of stroke and deep vein thrombosis (DVT), while estrogen plus progestin increased risks of stroke, DVT, myocardial infarction, and pulmonary emboli in postmenopausal women (50 to 79 years of age). Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Prescribe estrogen with or without progestins at the lowest effective dose and for the shortest duration .

Classifications:

Pharmacologic—

Estrogen

Uses of This Medicine:

Conjugated estrogens synthetic A is used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen. It is also used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by menopause.

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—

Cenestin® is not indicated for use in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Cenestin® in the elderly. However, elderly patients are more likely to have breast cancer, dementia, or stroke, 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.

• Cosyntropin

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.

• Levothyroxine

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 (eg, 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
• Surgery with a long period of inactivity 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
• 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 carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.

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 treatment of moderate to severe hot flashes and other symptoms caused by menopause:
    • Adults—At first, 0.45 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children—Use is not recommended.
  • For treatment of atrophic vaginitis caused by menopause:
    • Adults—0.3 milligrams (mg) once a day.
    • 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.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine over a long period of time may increase your risk of breast cancer, endometrial 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 if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

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. This medicine may also 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 (eg, 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

Bloating or swelling of the face, arms, hands, lower legs, or feet

cough

cramps

difficulty with swallowing

dizziness

fast heartbeat

heavy bleeding

hives, itching, or skin rash

itching of the vagina or genital area

normal menstrual bleeding occurring earlier, possibly lasting longer than expected

pain during sexual intercourse

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

rapid weight gain

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

tightness in the chest

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Acid or sour stomach

backache

belching

change in vaginal discharge

clear or bloody discharge from the nipple

confusion

decrease in the amount of urine

difficulty with speaking

dimpling of the breast skin

double vision

headache

heartburn

inability to move the arms, legs, or facial muscles

inability to speak

indigestion

inverted nipple

loss of appetite

lump in the breast or under the arm

noisy, rattling breathing

pain or feeling of pressure in the pelvis

pain, redness, or swelling in the arm or leg

persistent crusting or scaling of the nipple

redness or swelling of the breast

slow speech

sore on the skin of the breast that does not heal

stomach discomfort, upset, or pain

swelling of the abdominal or stomach area

swelling of the fingers, hands, feet, or lower legs

troubled breathing at rest

vaginal bleeding

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

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

excess air or gas in the stomach or intestines

fear or nervousness

heartburn

increased clear or white vaginal discharge

indigestion

lack or loss of strength

loss of bladder control

nausea

passing gas

runny nose

sneezing

stuffy nose

vomiting

Less common

Back pain

increased appetite

Incidence not known

Breast pain, swelling, or tenderness

discouragement

enlarged breasts

feeling sad or empty

hair loss or thinning of the hair

irritability

lack of appetite

loss of interest or pleasure

sleepiness or unusual drowsiness

tiredness

trouble concentrating

trouble sleeping

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.