Site Tanzania: Roxal-Estradiol Derm 100 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)

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 Roxal-Estradiol Derm 100

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 Roxal-Estradiol Derm 100

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

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 Roxal-Estradiol Derm 100. 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 Roxal-Estradiol Derm 100

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.

Roxal-Estradiol Derm 100 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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Site Tanzania

Wednesday, October 5, 2016

Roxal-Estradiol Derm 100 Transdermal