Esclim Transdermal

Generic Name: estradiol (Transdermal route)

es-tra-DYE-ol

Transdermal route(Emulsion)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .

Transdermal route(Patch, Extended Release)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible.

Transdermal route(Gel/Jelly)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .

Transdermal route(Spray)

Unopposed estrogens increase the risk of endometrial cancer. Adding a progestin will reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogen alone have been 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) using estrogens combined with progestins have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported in women receiving estrogen alone or estrogen combined with progestins. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible. Breast budding and breast masses in prepubertal females and gynecomastia and breast masses in prepubertal males have been reported following unintentional secondary exposure. Patients should strictly adhere to recommended instructions for use .

Commonly used brand name(s)

In the U.S.

• Alora


• Climara


• Divigel


• Elestrin


• Esclim


• Estraderm


• Estrasorb


• EstroGel


• Evamist


• Menostar


• Vivelle


• Vivelle-Dot

In Canada

• Estradot Transdermal


• Estradot Transdermal Therapeutic System


• Estradot Transdermal Therapeutic System


• Oesclim


• Rhoxal-Estradiol Derm 50


• Rhoxal-Estradiol Derm 75


• Roxal-Estradiol Derm 100


• Vivelle 100 Mcg


• Vivelle 25 Mcg


• Vivelle 37.5 Mcg

Available Dosage Forms:

• Patch, Extended Release


• Gel/Jelly


• Spray


• Emulsion

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

Uses For Esclim

Estradiol transdermal spray is used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen.

Estradiol is an estrogen hormone. The hormone from the spray is absorbed through your skin into your body. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes") in women during menopause.

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

Before Using Esclim

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.

Pediatric

Use of estradiol transdermal spray is not indicated in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of estradiol transdermal spray 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 estradiol transdermal spray.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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.

Interactions with 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 receiving 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.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

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.

• Alprazolam


• Amoxicillin


• Ampicillin


• Amprenavir


• Aprepitant


• Atazanavir


• Bacampicillin


• Betamethasone


• Bexarotene


• Bosentan


• Carbamazepine


• Clarithromycin


• Colesevelam


• Cyclosporine


• Darunavir


• Delavirdine


• Doxycycline


• Efavirenz


• Etravirine


• Fosamprenavir


• Fosaprepitant


• Fosphenytoin


• Ginseng


• Griseofulvin


• Itraconazole


• Ketoconazole


• Lamotrigine


• Levothyroxine


• Licorice


• Minocycline


• Modafinil


• Mycophenolate Mofetil


• Mycophenolic Acid


• Nelfinavir


• Nevirapine


• Oxcarbazepine


• Oxytetracycline


• Phenobarbital


• Phenytoin


• Pioglitazone


• Prednisolone


• Primidone


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rosuvastatin


• Rufinamide


• Selegiline


• St John's Wort


• Tacrine


• Telaprevir


• Tetracycline


• Tipranavir


• Topiramate


• Troglitazone


• Troleandomycin


• Voriconazole


• Warfarin

Interactions with Food/Tobacco/Alcohol

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• Grapefruit Juice

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 recent (within the past 12 months) or


• Liver disease or


• Stroke, active or recent (within the past 12 months) 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


• Heart disease 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 estradiol

This section provides information on the proper use of a number of products that contain estradiol. It may not be specific to Esclim. Please read with care.

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 is for use on the skin only. Do not get it in your eyes, nose, mouth, breast, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

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

Wash your hands with soap and water before and after using this medicine.

To use the spray:

• The spray form of this medicine comes in an applicator that delivers a measured amount of estradiol to the skin with each spray. When using a new spray applicator, prime the pump by holding the spray upright and pumping 3 times. Priming is only necessary the first time you use a new spray applicator; do not prime again.


• Apply the medicine to clean, dry, and unbroken skin on the inside of the forearm between the elbow and the wrist. Do not apply the medicine directly to your breasts or in or around the vagina.


• Allow the medicine to dry for at least 2 minutes before dressing, and at least 1 hour before washing.


• If your doctor tells you to increase your dose, move the applicator to an area of the skin next to your previous application site, before applying the second or third spray.


• Do not rub Evamist® spray into your skin.


• Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid being close with your child, wear clothes with long sleeves to cover the application site.


• If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.


• Do not allow your pets to lick or touch the arm where the medicine was sprayed.


• Always place the protective cover back on the applicator of the spray.


• Do not use the applicator for more than 75 sprays.


• Apply sunscreen at least 1 hour before applying Evamist®.

The spray contains alcohol and is flammable. Avoid using it near an open flame or while smoking.

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 transdermal dosage form (spray):
  
  • For hot flashes and other symptoms caused by menopause:
    
    • Adults—At first, one spray once a day, usually in the morning. Your doctor may adjust your dose as needed.
    
    
    • 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.

Do not use Evamist® spray if it has been more than 12 hours since you missed your last dose.

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 Esclim

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.

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 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.

This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.

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).

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 this medicine.

Do not allow your pets to lick or touch the arm where this medicine 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.

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.

Do not take other medicines or drink grapefruit juice unless you discuss it with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Esclim Side Effects

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:

Incidence not known

• Abdominal or stomach cramps or pain


• acid or sour stomach


• anxiety


• backache


• belching


• blistering, peeling, or loosening of the skin


• bloating


• blurred vision


• breast tenderness, enlargement, pain, or discharge


• change in vaginal discharge


• changes in skin color


• changes in vision


• chest pain or discomfort


• chills


• clay-colored stools


• clear or bloody discharge from the nipple


• confusion


• constipation


• convulsions


• cough


• darkening of the urine


• diarrhea


• difficulty with breathing


• difficulty with swallowing


• dimpling of the breast skin


• dizziness or lightheadedness


• double vision


• fainting


• fast heartbeat


• fever


• fluid-filled skin blisters


• full or bloated feeling or pressure in the stomach


• headache


• headache, severe and throbbing


• heartburn


• hives


• indigestion


• inverted nipple


• irregular heartbeats


• itching of the skin


• itching of the vagina or genital area


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• loss of bladder control


• lump in the breast or under the arm


• migraine headache


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle spasm or jerking of all extremities


• nausea


• noisy breathing


• numbness and tingling around the mouth, fingertips, or feet


• pain during sexual intercourse


• 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, redness, or swelling in the arm, foot, or leg


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


• 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


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


• rash


• red, irritated eyes


• redness or swelling of the breast


• sensitivity to the sun


• shortness of breath


• skin thinness


• 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 shortness of breath or troubled breathing


• sweating


• swelling


• swelling of the abdominal or stomach area


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


• tightness in the chest


• tremor


• trouble recognizing objects


• trouble thinking and planning


• trouble walking


• unexpected or excess milk flow from the breasts


• unpleasant breath odor


• unusual tiredness or weakness


• unusually heavy or unexpected menstrual bleeding


• vaginal bleeding or spotting


• 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:

Less common

• Back pain


• difficulty with moving


• muscle aches


• muscle pain or stiffness


• stuffy or runny nose

Incidence not known

• Decreased interest in sexual intercourse


• 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


• leg cramps


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


• loss of scalp hair


• mental depression


• mood disturbances


• patchy brown or dark brown discoloration of the skin


• redness of the skin


• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs


• 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.

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