Vivelle-Dot (Transdermal)

Estradiol transdermal gel, patch, and spray are used to treat modest to severe signs and symptoms of menopause (eg, feelings of warmth in the face, neck, and breast, or abrupt strong feelings of heat and sweating [warm flashes] in women with an uterus. It is also used to treat modifications in and around the vaginal area (eg, genital dry skin, itching, and burning) triggered by low estrogen degrees or menopause. This medicine is also utilized to treat certain problems in women before menopause if their ovaries do not make adequate estrogens naturally, and protect against osteoporosis after menopause.

Estradiol is an estrogen hormonal agent. The hormonal agent from the spot, gel, and spray is soaked up through your skin into your body.

This medication is readily available only with your medical professional's prescription.

It is really important that your physician inspect your progression at regular check outs to make sure this medication is working properly and does not create unwanted effects. These visits might be every 3 to 6 months. Pelvic test, bust exam, and mammogram (breast x-ray) may be needed to look for unwanted effects, unless your physician tells you or else. Make certain to maintain all visits.

It is not likely that a postmenopausal female might become pregnant. However, you must understand that utilizing this medication while you are expecting can hurt your coming child. If you think you have become pregnant while making use of the medicine, tell your physician immediately.

Using this medication might enhance your threat for having embolism, strokes, or cardiovascular disease. This risk may continue also after you quit making use of the medication. Your danger for these significant troubles is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Get in touch with your medical professional instantly if you experience complication, problem talking, double vision, headaches, a failure to move arms, legs or face muscle mass, or a failure to speak.

Utilizing this medication over an extended period of time might enhance your danger of bust cancer, endometrial cancer cells, or uterine cancer. Do not utilize this medication if you have had your womb (womb) removed (hysterectomy). Contact your medical professional promptly if you experience irregular genital bleeding.

Utilizing this medication may enhance your threat of mental deterioration, particularly in women 65 years old and older.

Using this medicine may raise your threat for gallbladder disease. Talk with your doctor concerning this threat.

Tell the clinical physician or dental professional accountable that you are utilizing this medication before any kind of sort of surgery (consisting of oral surgery) or emergency treatment. Your physician will determine whether you must continue using this medicine. This medication might also influence the outcomes of specific medical examinations.

Get in touch with your doctor instantly if serious frustration or sudden loss of vision or any type of other modification in vision takes place while you are using this medication. Your doctor might desire you to have your eyes inspected by an ophthalmologist (eye doctor).

This medicine may trigger a significant type of allergy, consisting of anaphylaxis, which can be lethal and needs immediate clinical focus. Call your doctor immediately if you have a breakout, itching, hoarseness, difficulty breathing, trouble ingesting, or any type of swelling of your hands, face, or mouth while you are using this medicine.

Get in touch with your child's doctor today if your kid starts to have nipple or bust swelling or tenderness in females, or augmentation of the breasts in males. Your kid may have been revealed to this medicine.

Do not enable your pet dogs to lick or touch the arm where this medicine was applied. Small animals may be delicate to this medication. Call your pet dog's vet if your pet begins to have nipple area or breast augmentation, swelling of the vulva, or any type of indicators of health problem.

Do not take various other medicines or consume alcohol grapefruit juice unless you discuss it with your medical professional. This includes prescription or nonprescription (over-the-counter [OTC] medicines and natural (eg, St. John's wort) or vitamin supplements.

In making a decision to utilize a medication, the threats of taking the medication should be weighed against the good it will certainly do. This is a decision you and your doctor will certainly make. For this medicine, the following ought to be considered:

Allergies

Tell your medical professional if you have actually ever before had any kind of unusual or allergic reaction to this medicine or any various other medicines. Likewise tell your healthcare specialist if you have any various other kinds of allergic reactions, such as to foods, dyes, preservatives, or animals. For non-prescription items, read the label or plan active ingredients carefully.

Pediatric

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

Geriatric

Although ideal studies on the relationship of age to the impacts of estradiol transdermal patch, gel, and spray have not been carried out in the senior citizen population, no geriatric-specific problems have actually been documented to day. Nevertheless, senior individuals are more probable to have bust cancer, stroke, or mental deterioration, which might need care in patients receiving estradiol transdermal spot, gel and spray.

Breast Feeding

There are no adequate studies in females for identifying baby danger when using this medication throughout breastfeeding. Evaluate the prospective advantages versus the possible threats before taking this medicine while breastfeeding.

Interactions with Medicines

Although certain medicines must not be utilized together in all, in other situations 2 various medicines may be used together even if an interaction could take place. In these situations, your doctor might intend to transform the dose, or various other preventative measures might be necessary. When you are taking this medicine, it is especially vital that your healthcare expert understand if you are taking any of the medications listed here. The following interactions have actually been chosen on the basis of their possible value and are not necessarily all-inclusive.

Utilizing this medication with any of the complying with medicines is not advised. Your medical professional may decide not to treat you with this drug or transform several of the various other medications you take.

• Tranexamic Acid

Utilizing this medication with any one of the complying with medicines is generally not recommended, however might be required in some cases. If both medicines are recommended together, your physician may change the dosage or how frequently you make use of 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.

Utilizing this medicine with any one of the following medications may create a boosted risk of particular side effects, but utilizing both medicines might be the best treatment for you. If both medicines are recommended together, your doctor might change the dose or just how often you utilize one or both of the medications.

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

Interactions with Food/Tobacco/Alcohol.

Particular medications must not be utilized at or around the time of eating food or consuming particular types of food because interactions might take place. Using alcohol or cigarette with particular medicines may also trigger interactions to happen. The complying with interactions have been selected on the basis of their prospective significance and are not always all-encompassing.

Utilizing this medicine with any one of the adhering to might cause a boosted threat of specific adverse effects yet might be inevitable sometimes. If used together, your physician might transform the dose or how frequently you use this medication, or provide you unique directions regarding using food, alcohol, or cigarette.

• Caffeine.

Other Medical Problems.

The visibility of other clinical problems may influence using this medication. See to it you tell your doctor if you have any various other clinical issues, particularly:.

• Abnormal or unusual vaginal bleeding or.
• Blood embolisms (eg, deep blood vessel apoplexy, lung embolism), energetic or background of or.
• Breast cancer cells, known or believed, or history of or.
• Dementia or.
• Heart assault, active or recent (within the past 12 months) or.
• Heart or blood vessel illness or.
• Liver disease or.
• Protein C, healthy protein S deficiency, or antithrombin shortage, or various other known blood clotting conditions or.
• Stroke, active or current (within the past 12 months) or.
• Surgery with a long period of inactivity or.
• Tumors (estrogen-dependent), recognized or believed-- Should not be used in individuals with these conditions.

• Asthma or.
• Cancer, background of or.
• Diabetes or.
• Edema (liquid 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), serious or.
• Hypothyroidism (an underactive thyroid) or.
• Jaundice during pregnancy or from using hormone treatment in the past or.
• Kidney disease or.
• Liver growths or.
• Migraine headache or.
• Obesity or.
• Porphyria (an enzyme issue) or.
• Systemic lupus erythematosus (SLE)-- Use with caution. May make these problems even worse.

Together with its needed impacts, a medication might create some unwanted results. Although not all of these negative effects may occur, if they do occur they might need clinical attention.

Contact your medical professional immediately if any of the complying with adverse effects happen:

Occurrence not understood

• Acid or sour belly
• stress and anxiety
• backache
• burping
• blistering, peeling, or loosening of the skin
• bloating
• blurred vision
• breast tenderness, enlargement, discomfort, or discharge
• change in genital discharge
• adjustments in skin color
• changes in vision
• breast pain, pain, or tightness
• chills
• clay-colored feceses
• clear or bloody discharge from the nipple
• complication
• irregularity
• coughing
• darkening of the urine
• diarrhea
• trouble with swallowing
• dimpling of the breast skin
• lightheadedness or lightheadedness
• double vision
• fainting
• quick heartbeat
• high temperature
• fluid-filled skin sores
• complete or bloated sensation or pressure in the belly
• headache
• frustration, severe and pain
• heartburn
• hives, itching, skin breakout
• indigestion
• inverted nipple area
• irregular heart beat
• irritation of the vaginal area 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 stools
• anorexia nervosa
• loss of bladder control
• lump in the bust or under the arm
• migraine frustration
• mood or psychological adjustments
• muscular tissue pains in the hands, arms, feet, legs, or face
• muscle mass convulsion or jerking of all extremities
• queasiness
• noisy breathing
• numbness and prickling around the mouth, fingertips, or feet
• discomfort throughout sexual intercourse
• pain in the ankles or knees
• pain or discomfort in the arms, jaw, back, or neck
• discomfort or feeling of pressure in the pelvis
• discomfort, redness, or swelling in the arm, foot, or leg
• unpleasant, red swellings under the skin, mainly on the legs
• pains in the belly, side, or abdomen, possibly emitting to the back
• relentless crusting or scaling of the nipple
• poor understanding and judgment
• issues with memory or speech
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, aggravated eyes
• inflammation or swelling of the breast
• seizures
• sensitivity to the sun
• skin thinness
• sore on the skin of the bust that does not heal
• sore throat
• sores, abscess, or white areas in the mouth or on the lips
• stomach pains, discomfort, distressed, pain, or swelling
• sudden loss of awareness
• unexpected problem breathing
• sweating
• thick, white genital discharge without any smell or with a moderate smell
• trembling
• trouble acknowledging items
• difficulty assuming and intending
• difficulty walking
• unexpected or excess milk circulation from the breasts
• unpleasant breath odor
• uncommon exhaustion or weak point
• abnormally heavy or unexpected menstrual bleeding
• genital blood loss or finding
• vomiting
• vomiting of blood
• yellow eyes or skin

Some side effects might happen that generally do not need clinical interest. These side effects might vanish during treatment as your body gets used to the medication. Likewise, your health care specialist may be able to tell you about methods to stop or reduce some of these side effects. Contact your healthcare expert if any one of the following adverse effects continue or are irritating or if you have any kind of concerns regarding them:

Less typical

• Back discomfort
• difficulty with moving
• muscle aches, pain, or stiffness
• stuffy or drippy nose

Occurrence not known

• Decreased interest in sexual relations
• hefty bleeding
• enhanced hair growth, especially on the face
• enhanced in sex-related capacity, desire, drive, or efficiency
• enhanced passion in sexual relations
• irritability
• leg aches
• loss in sex-related ability, wish, drive, or efficiency
• loss of scalp hair
• psychological anxiety
• mood disruptions
• irregular brown or dark brown discoloration of the skin
• soreness of the skin
• twitching, uncontrolled motions of the tongue, lips, face, arms, or legs
• weight adjustments

Opposite effects not detailed might additionally happen in some patients. If you see any type of other impacts, talk to your medical care expert.

Call your doctor for clinical recommendations concerning 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

Available Dosage Forms:

• Patch, Extended Release
• Gel/Jelly
• Spray

Therapeutic 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.