Esclim

Serious ill effects have not been reported following acute ingestion of large doses of estrogen containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.

Esclim is part of the drug class:

• Natural and semisynthetic estrogens, plain

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delaviridine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate)
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of estradiol drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with topical, oral, and injectable forms of estradiol including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not take estradiol if you:

• are allergic to estradiol or to any of its ingredients
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• have a history of blood clots
• have liver disease
• are pregnant or possibly pregnant

Grapefruit and grapefruit juice may interact with estradiol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking estradiol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to estradiol or to any of its ingredients
• have or have ever had asthma
• have seizures
• have migraine headaches
• have endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body)
• have uterine fibroids (growths in the uterus that are not cancer)
• have or have had yellowing of the skin or eyes, especially during pregnancy or while you were using an estrogen product
• have very high or very low levels of calcium in your blood
• have porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system) or gallbladder, thyroid, pancreas, liver or kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

CARDIOVASCULAR AND OTHER RISKS 

ESTROGENS WITH AND WITHOUT PROGESTINS SHOULD NOT BE USED FOR THE PREVENTION OF CARDIOVASCULAR DISEASE OR DEMENTIA.

THE WOMEN’S HEALTH INITIATIVE (WHI) STUDY REPORTED INCREASED RISKS OF MYOCARDIAL INFARCTION, STROKE, INVASIVE BREAST CANCER, PULMONARY EMBOLI, AND DEEP VEIN THROMBOSIS IN POSTMENOPAUSAL WOMEN (50 TO 79 YEARS OF AGE) DURING 5 YEARS OF TREATMENT WITH ORAL CONJUGATED ESTROGENS (CE 0.625 MG) COMBINED WITH MEDROXYPROGESTERONE ACETATE (MPA 2.5 MG) RELATIVE TO PLACEBO.

THE WOMEN’S HEALTH INITIATIVE MEMORY STUDY (WHIMS), A SUBSTUDY OF WHI, REPORTED INCREASED RISK OF DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE OR OLDER DURING 4 YEARS OF TREATMENT WITH ORAL CONJUGATED ESTROGENS PLUS MEDROXYPROGESTERONE ACETATE RELATIVE TO PLACEBO. IT IS UNKNOWN WHETHER THIS FINDING APPLIES TO YOUNGER POSTMENOPAUSAL WOMEN.

OTHER DOSES OF ORAL CONJUGATED ESTROGENS WITH MEDROXYPROGESTERONE ACETATE, AND OTHER COMBINATIONS AND DOSAGE FORMS OF ESTROGENS AND PROGESTINS WERE NOT STUDIED IN THE WHI CLINICAL TRIALS AND, IN THE ABSENCE OF COMPARABLE DATA, THESE RISKS SHOULD BE ASSUMED TO BE SIMILAR. BECAUSE OF THESE RISKS, ESTROGENS WITH OR WITHOUT PROGESTINS SHOULD BE PRESCRIBED AT THE LOWEST EFFECTIVE DOSES AND FOR THE SHORTEST DURATION CONSISTENT WITH TREATMENT GOALS AND RISKS FOR THE INDIVIDUAL WOMAN.

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).
• To help prevent weakening of bones (osteoporosis) in women past menopause.
• In the treatment of selected cases of breast cancer in men and women.
• In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.

Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.

Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

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.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

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

• Breast pain (in females and males)
• fast heartbeat
• fever
• hives
• hoarseness
• increased breast size (in females and males)
• irritation of the skin
• itching of the skin
• joint pain, stiffness, or swelling
• rash
• redness of the skin
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet
• swelling of the feet and lower legs
• tightness in the chest
• troubled breathing or swallowing
• weight gain (rapid)
• wheezing

• Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
• chest pain
• chills
• cough
• heavy non-menstrual vaginal bleeding
• lumps in, or discharge from, breast (in females and males)
• pains in the stomach, side, or abdomen
• yellow eyes or skin

• Headache (sudden or severe)
• loss of coordination (sudden)
• loss of vision or change of vision (sudden)
• pains in the chest, groin, or leg, especially in the calf of leg
• shortness of breath (sudden and unexplained)
• slurring of speech (sudden)
• weakness or numbness in the arm or leg

• Abdominal or stomach bloating
• abdominal or stomach cramps
• acid or sour stomach
• anxiety
• backache
• belching
• blindness
• blistering, peeling, or loosening of the skin
• blue-yellow color blindness
• blurred vision
• change in vaginal discharge
• changes in skin color
• changes in vision
• chest discomfort
• clay-colored stools
• clear or bloody discharge from nipple
• confusion
• constipation
• convulsions
• dark urine
• decrease in the amount of urine
• decreased vision
• depression
• diarrhea
• difficulty with breathing
• difficulty with speaking
• dimpling of the breast skin
• dizziness
• double vision
• dry mouth
• eye pain
• fainting
• fluid-filled skin blisters
• full feeling in upper abdomen or stomach
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• inability to move the arms, legs, or facial muscles
• inability to speak
• incoherent speech
• increased urination
• indigestion
• inverted nipple
• irregular heartbeats
• light-colored stools
• lightheadedness
• loss of appetite
• loss of bladder control
• lump under the arm
• metallic taste
• migraine headache
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain
• muscle spasm or jerking of all extremities
• muscle weakness
• nausea
• noisy breathing
• numbness or tingling of the hands, feet, or face
• pain in the ankles or knees
• pain or discomfort in the arms, jaw, back or neck
• pain or feeling of pressure in the pelvis
• pain, tenderness, swelling of the foot or leg
• painful or tender cysts in the breasts
• painful, red lumps under the skin, mostly on the legs
• pains in the chest, groin, or legs, especially calves of the legs
• partial or complete loss of vision in the eye
• pelvic pain
• persistent crusting or scaling of nipple
• pinpoint red or purple spots on the skin
• prominent superficial veins over affected area
• red, irritated eyes
• redness or swelling of the breast
• sensitivity to the sun
• severe headaches of sudden onset
• skin thinness
• skin warmth
• slow speech
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach discomfort, upset, or pain
• sudden loss of consciousness
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• swelling of the abdominal or stomach area
• swelling of the fingers or hands
• thirst
• tremor
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• weight loss

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:

• Abnormal growth filled with fluid or semisolid material
• accidental injury
• bladder pain
• bloated full feeling
• bloody or cloudy urine
• body aches or pain
• coating or white patches on tongue
• congestion
• cough producing mucus
• decrease in amount of urine
• difficult, burning, or painful urination
• discouragement
• dryness of the throat
• ear congestion or pain
• excess air or gas in the stomach or intestines
• fear
• feeling of warmth
• feeling sad or empty
• frequent urge to urinate
• general feeling of discomfort or illness
• headache, severe and throbbing
• increased clear or white vaginal discharge
• irritability
• itching of the vaginal, rectal or genital areas
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• mild dizziness
• neck pain
• nervousness
• pain
• pain during sexual intercourse
• painful or difficult urination
• pain or tenderness around the eyes and cheekbones
• passing gas
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• skin irritation or redness where skin patch was worn
• shivering
• sleeplessness
• sneezing
• sore mouth or tongue
• stuffy nose
• sudden sweating
• tender, swollen glands in the neck
• thick, white vaginal discharge with no odor or with a mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• unable to sleep
• voice changes

• Blemishes on the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning or stinging of the skin
• diarrhea (mild)
• difficulty with moving
• dizziness (mild)
• increased hair growth, especially on the face
• lower abdominal or stomach pain or pressure
• mood or mental changes
• muscle stiffness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pimples
• pounding in the ears
• problems in wearing contact lenses
• slow heartbeat
• tooth or gum pain
• unusual decrease in sexual desire (in males)
• unusual increase in sexual desire (in females)
• white or brownish vaginal discharge

• Abnormal turning out of cervix
• changes in appetite
• dull ache or feeling of pressure or heaviness in the legs
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• irritability
• large amount of triglyceride in the blood
• leg cramps
• patchy brown or dark brown discoloration of the skin
• poor insight and judgment
• problems with memory or speech
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of the scalp hair in some people.

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.