Vivelle (Transdermal)

Estradiol transdermal gel, spot, and spray are utilized to treat modest to extreme signs and symptoms of menopause (eg, feelings of warmth in the face, neck, and chest, or abrupt solid sensations of heat and sweating [warm flashes] in ladies with a womb. It is additionally used to treat modifications in and around the vagina (eg, vaginal dry skin, itching, and burning) brought on by reduced estrogen levels or menopause. This medicine is additionally used to deal with certain problems in women before menopause if their ovaries do not make adequate estrogens naturally, and avoid osteoporosis after menopause.

Estradiol is an estrogen hormonal agent. The hormone from the patch, gel, and spray is taken in via your skin right into your body.

This medicine is offered only with your physician's prescription.

It is extremely important that your physician examine your progress at routine check outs to see to it this medicine is working correctly and does not create undesirable results. These visits might be every 3 to 6 months. Pelvic test, bust examination, and mammogram (breast x-ray) may be needed to look for unwanted results, unless your physician informs you or else. Be sure to keep all visits.

It is unlikely that a postmenopausal lady might become pregnant. Yet, you need to know that using this medicine while you are expecting could harm your coming infant. If you assume you have conceived while using the medication, inform your doctor as soon as possible.

Using this medication may boost your danger for having embolism, strokes, or cardiac arrest. This danger may proceed also after you quit making use of the medicine. Your risk for these severe troubles is even higher if you have hypertension, high cholesterol in your blood, diabetic issues, or if you are obese or smoke cigarettes. Get in touch with your doctor immediately if you experience confusion, difficulty talking, double vision, frustrations, a failure to relocate arms, legs or facial muscle, or a lack of ability to speak.

Utilizing this medication over a long period of time may increase your danger of breast cancer, endometrial cancer, or uterine cancer. Do not utilize this medicine if you have actually had your uterus (womb) removed (hysterectomy). Check with your doctor immediately if you experience abnormal genital bleeding.

Utilizing this medicine may increase your risk of dementia, particularly in ladies 65 years old and older.

Using this medicine may raise your risk for gallbladder illness. Talk with your doctor concerning this danger.

Tell the clinical doctor or dental professional in charge that you are utilizing this medication prior to any type of type of surgical procedure (including oral surgery) or first aid. Your doctor will decide whether you ought to proceed using this medicine. This medicine might likewise impact the results of specific medical tests.

Check with your medical professional quickly if extreme frustration or sudden loss of vision or any kind of other adjustment in vision happens while you are utilizing this medicine. Your physician might want you to have your eyes examined by an ophthalmologist (optometrist).

This medication may cause a serious sort of allergy, including anaphylaxis, which can be lethal and needs immediate medical interest. Call your doctor right away if you have a breakout, itching, hoarseness, problem breathing, trouble ingesting, or any kind of swelling of your hands, face, or mouth while you are utilizing this medication.

Get in touch with your child's physician as soon as possible if your child begins to have nipple or breast swelling or tenderness in women, or augmentation of the breasts in men. Your kid may have been revealed to this medicine.

Do not allow your animals to lick or touch the arm where this medication was applied. Small pets might be delicate to this medication. Call your animal's vet if your pet dog begins to have nipple or bust enlargement, swelling of the vulva, or any type of signs of disease.

Do not take other medicines or drink grapefruit juice unless you review it with your physician. This consists of prescription or nonprescription (over-the-counter [OTC] medications and natural (eg, St. John's wort) or vitamin supplements.

In making a decision to use a medication, the threats of taking the medication has to be considered versus the excellent it will certainly do. This is a decision you and your doctor will make. For this medication, the following should be taken into consideration:

Allergies

Inform your doctor if you have ever had any kind of unusual or allergy to this medicine or any other medicines. Additionally tell your healthcare expert if you have any kind of various other kinds of allergies, such as to foods, dyes, chemicals, or pets. For non-prescription products, checked out the tag or package active ingredients carefully.

Pediatric

Use estradiol transdermal patch, gel, and spray is not suggested in the pediatric population. Safety and effectiveness have not been established.

Geriatric

Although suitable studies on the connection old to the results of estradiol transdermal spot, gel, and spray have not been done in the geriatric population, no geriatric-specific troubles have been documented to date. However, senior patients are most likely to have breast cancer, stroke, or dementia, which might need caution in individuals obtaining estradiol transdermal spot, gel and spray.

Breast Feeding

There are no appropriate researches in ladies for identifying infant threat when using this medication during breastfeeding. Weigh the potential benefits versus the possible threats prior to taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines ought to not be used together at all, in various other cases 2 various medications may be used with each other also if an interaction could occur. In these situations, your medical professional may want to alter the dosage, or various other safety measures may be essential. When you are taking this medicine, it is specifically important that your health care expert know if you are taking any one of the medications listed here. The following communications have been selected on the basis of their prospective significance and are not always all-encompassing.

Using this medicine with any one of the following medications is not recommended. Your physician may determine not to treat you with this medication or transform a few of the other medications you take.

• Tranexamic Acid

Using this medication with any of the following medicines is generally not advised, yet might be needed in some cases. If both medicines are prescribed together, your doctor might alter the dose or just how typically you use one or both of the medications.

• Abametapir
• Amifampridine
• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Bosentan
• Bupropion
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Colesevelam
• Conivaptan
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fedratinib
• Fexinidazole
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Griseofulvin
• Guar Gum
• Isotretinoin
• Itraconazole
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lorlatinib
• Lumacaftor
• Mavacamten
• Meropenem
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Netupitant
• Nevirapine
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Penicillin G.
• Penicillin G Procaine.
• Penicillin V.
• Phenobarbital.
• Phenylbutazone.
• Phenytoin.
• Pitolisant.
• Pixantrone.
• Prednisolone.
• Prednisone.
• Primidone.
• Rifabutin.
• Rifampin.
• Rifapentine.
• Ritonavir.
• Rufinamide.
• Secobarbital.
• Somatrogon-ghla.
• St John's Wort.
• Sugammadex.
• Sultamicillin.
• Tazemetostat.
• Telaprevir.
• Tetracycline.
• Theophylline.
• Ticarcillin.
• Tigecycline.
• Tirzepatide.
• Tizanidine.
• Topiramate.
• Ulipristal.
• Valproic Acid.

Using this medicine with any one of the adhering to medicines may trigger a boosted danger of particular adverse effects, but utilizing both medications might be the very best treatment for you. If both medications are prescribed together, your doctor might alter the dose or just how typically you make use of one or both of the medicines.

• Atazanavir.
• Diazepam.
• Ginseng.
• Lamotrigine.
• Levothyroxine.
• Licorice.
• Lorazepam.
• Selegiline.
• Tacrine.
• Temazepam.
• Tipranavir.
• Triazolam.
• Troleandomycin.
• Voriconazole.
• Warfarin.

Interactions with Food/Tobacco/Alcohol.

Specific medicines ought to not be made use of at or around the time of consuming food or eating specific types of food given that interactions may happen. Utilizing alcohol or cigarette with specific medications might additionally cause interactions to happen. The adhering to interactions have been picked on the basis of their prospective significance and are not always complete.

Using this medicine with any of the adhering to might cause a raised threat of specific negative effects but may be unavoidable sometimes. If made use of together, your medical professional might transform the dose or exactly how frequently you utilize this medicine, or provide you unique directions concerning using food, alcohol, or cigarette.

• Caffeine.

Other Medical Problems.

The visibility of other clinical issues may impact the use of this medicine. Ensure you inform your physician if you have any other clinical problems, especially:.

• Abnormal or unusual genital blood loss or.
• Blood clots (eg, deep capillary apoplexy, lung embolism), active or history of or.
• Breast cancer cells, understood or suspected, or history of or.
• Dementia or.
• Heart assault, active or recent (within the past 12 months) or.
• Heart or blood vessel disease or.
• Liver illness or.
• Protein C, healthy protein S shortage, or antithrombin deficiency, or various other understood blood clotting conditions or.
• Stroke, energetic or current (within the past 12 months) or.
• Surgery with a long period of inactivity or.
• Tumors (estrogen-dependent), recognized or presumed-- 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 condition or.
• Hereditary angioedema (swelling of the face, lips, tongue, or throat) or.
• Hypercalcemia (high calcium in the blood) or.
• Hypertension (hypertension) or.
• Hypertriglyceridemia (high triglycerides or fats in the blood) or.
• Hypocalcemia (low calcium in the blood), extreme or.
• Hypothyroidism (an underactive thyroid) or.
• Jaundice during pregnancy or from using hormone treatment in the past or.
• Kidney illness or.
• Liver growths or.
• Migraine migraine or.
• Obesity or.
• Porphyria (an enzyme problem) or.
• Systemic lupus erythematosus (SLE)-- Use with caution. May make these problems worse.

Together with its needed results, a medicine might trigger some unwanted effects. Although not every one of these adverse effects might occur, if they do occur they might require medical attention.

Get in touch with your medical professional quickly if any of the complying with side effects take place:

Occurrence not recognized

• Acid or sour stomach
• anxiousness
• backache
• burping
• blistering, peeling, or loosening of the skin
• bloating
• blurred vision
• bust tenderness, enlargement, discomfort, or discharge
• adjustment in genital discharge
• modifications in skin shade
• changes in vision
• upper body pain, discomfort, or tightness
• cools
• clay-colored feceses
• clear or bloody discharge from the nipple area
• complication
• irregularity
• cough
• darkening of the pee
• looseness of the bowels
• trouble with swallowing
• dimpling of the breast skin
• lightheadedness or faintness
• dual vision
• fainting
• quick heart beat
• fever
• fluid-filled skin blisters
• complete or bloated sensation or pressure in the belly
• headache
• migraine, severe and pain
• heartburn
• hives, itching, skin breakout
• indigestion
• inverted nipple
• uneven heart beat
• itching of the vaginal canal or genital location
• joint or muscular tissue discomfort
• huge, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex body organs
• light feceses
• anorexia nervosa
• loss of bladder control
• swelling in the bust or under the arm
• migraine headache
• state of mind or psychological adjustments
• muscular tissue aches in the hands, arms, feet, legs, or face
• muscle convulsion or jerking of all extremities
• queasiness
• noisy breathing
• pins and needles and tingling around the mouth, fingertips, or feet
• discomfort during intercourse
• pain in the ankle joints or knees
• discomfort or discomfort in the arms, jaw, back, or neck
• pain or feeling of stress in the hips
• pain, inflammation, or swelling in the arm, foot, or leg
• agonizing, red swellings under the skin, mainly on the legs
• pains in the tummy, side, or abdominal area, potentially emitting to the back
• persistent crusting or scaling of the nipple
• inadequate insight and judgment
• issues with memory or speech
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• redness or swelling of the breast
• seizures
• level of sensitivity to the sun
• skin slimness
• aching on the skin of the bust that does not recover
• aching throat
• sores, ulcers, or white spots in the mouth or on the lips
• tummy cramps, pain, upset, discomfort, or swelling
• sudden loss of consciousness
• unexpected difficulty breathing
• sweating
• thick, white vaginal discharge with no odor or with a light smell
• trembling
• trouble identifying items
• trouble believing and planning
• trouble walking
• unanticipated or excess milk circulation from the breasts
• undesirable breath smell
• uncommon tiredness or weakness
• uncommonly heavy or unforeseen menstruation bleeding
• genital bleeding or spotting
• throwing up
• vomiting of blood
• yellow eyes or skin

Some adverse effects might happen that normally do not need medical focus. These negative effects might vanish throughout therapy as your body adapts to the medication. Also, your health care specialist might be able to tell you about ways to prevent or minimize several of these negative effects. Talk to your healthcare expert if any of the following adverse effects proceed or are aggravating or if you have any type of inquiries regarding them:

Much less typical

• Back discomfort
• difficulty with moving
• muscle mass aches, discomfort, or stiffness
• stale or dripping nose

Incidence not known

• Decreased rate of interest in sexual intercourse
• hefty bleeding
• boosted hair development, especially on the face
• boosted in sex-related capability, desire, drive, or efficiency
• increased interest in sexual intercourse
• impatience
• leg aches
• loss in sexual ability, desire, drive, or performance
• loss of scalp hair
• psychological depression
• mood disruptions
• patchy brown or dark brownish staining of the skin
• inflammation of the skin
• twitching, unrestrained movements of the tongue, lips, face, arms, or legs
• weight changes

Other side impacts not provided may likewise occur in some people. If you discover any kind of various other effects, talk to your health care expert.

Call your doctor for clinical guidance about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Alora
• Climara
• Divigel
• Elestrin
• Esclim
• Estraderm
• Estrasorb
• EstroGel
• Evamist
• Menostar
• Minivelle
• 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

Readily Available Dosage Forms:

• Patch, Extended Release
• Gel/Jelly
• Spray

Restorative Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

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 and patients instructions. 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 patch:

• Wash your hands with soap and water before and after you use this medicine.
• Carefully tear open the pouch when you are ready to put the patch on your skin. Do not cut it.
• Peel off the backing from the patch and apply the patch to a clean, dry, and hair-free area of the lower stomach or upper buttock area. This area must be free of powder, oil, or lotion for the patch to stick on to your skin.
• Press the patch firmly in place with your hand for about 10 seconds.
• Do not apply the patch on the breast or over any skin folds. Do not apply the patch on oily, broken, burned, or irritated skin, or areas with skin conditions (eg, birth marks, tattoos). Avoid applying the patch on the waistline or other places where tight clothing may rub it off.
• Wear the patch at all times until it is time to put on a new patch. Do not expose it to the sun for long periods of time.
• When replacing your patch, make sure to apply the new patch to a different area of your lower abdomen. Wait at least 1 week before applying a patch to the same area.
• When changing a patch, slowly peel it off from your skin. If you have any patch adhesive left on your skin, allow it to dry for 15 minutes and gently rub the sticky area with oil or lotion to remove it. It is best to change your patch on the same days of each week to help you remember.
• You may take a bath, shower, or swim while using this medicine. Doing so will not affect the patch.
• If a patch falls off, just put it back on a different area. If the patch does not stick completely, put on a new patch but continue to follow your original schedule for changing your patch.
• To throw away a used patch: Fold the patch in half with the sticky side together and place it in a sturdy child-proof container. Throw this container in the trash away from children and pets. Do not flush the patch down the toilet.

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 to open wounds, cuts, abrasions, or rashes. 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 massage or 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 56 sprays even though the bottle may not be fully empty. You may not get the correct dose.
• Apply sunscreen at least 1 hour before applying Evamist®.

To use the gel:

• The gel form of this medicine comes in a pump. Each time you press the pump you will get the same amount of medication. You may need to prime the pump by pumping 5 times (EstroGel®) or 10 times (Elestrin™) the first time you use it. Follow the patient instructions for the container you use. After you prime the pump, do not press the pump more than 1 time each time you use it.
• Apply the gel to clean, dry, and unbroken skin. Apply EstroGel® after your bath or shower. If you go swimming. try to leave as much time as possible between using EstroGel® and going swimming. Spread the gel as thinly as possible over the entire area on the inside and outside of your upper arm from your wrist to your shoulder area. Do not apply the medicine directly to your breasts or in or around your vagina. Do not massage or rub in EstroGel®.
• Do not allow others to come in contact with the area of skin where you applied the gel for at least 1 hour after you use the medicine. Do not allow others to apply the gel for you. Allow the medicine to dry for at least 5 minutes before you get dressed.
• Do not use EstroGel® for more than 30 doses even the canister may not be fully empty. You may not get the correct dose.
• Apply sunscreen at least 25 minutes after using the gel. Avoid applying sunscreen on the same application site for 7 days or more.

The gel and spray contain alcohol and are 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 hot flashes and other symptoms caused by menopause: For transdermal dosage form (gel): Adults— Elestrin™: Apply one dose (0.87 grams) of the gel to the upper arm once a day. Your doctor may adjust your dose as needed. EstroGel®: Apply one dose (1.25 grams) of the gel to the arm once a day. Your doctor may adjust your dose as needed. Children—Use is not recommended. For transdermal dosage form (patch): Adults— Climara®: At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttocks area once a week. Your doctor may adjust your dose as needed. Minivelle® and Vivelle-Dot®: At first, apply one patch (0.0375 milligrams (mg)) to the lower stomach or upper buttocks area 2 times a week (every 3 to 4 days). Your doctor may adjust your dose as needed. Children—Use is not recommended. For transdermal dosage form (spray): 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.
• For prevention of osteoporosis after menopause:For transdermal dosage form (patch): Adults— Climara®: At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttock area once a week. Your doctor may adjust your dose as needed. Minivelle® and Vivelle-Dot®: At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttock area 2 times a week (every 3 to 4 days). Your doctor may adjust your dose as needed. Children—Use is not recommended.
• For the treatment of low estrogen levels:For transdermal dosage form (patch): Adults—At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttock area once a week. Your doctor may adjust your dose as needed. Children—Use is not recommended.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a 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 patches at room temperature in a closed container, away from heat, moisture, and direct light.

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.