Minivelle Oral, Parenteral, Topical application, Transdermal

Name: Minivelle Oral, Parenteral, Topical application, Transdermal

Commonly used brand name(s)

In the U.S.

  • Alora
  • Cenestin
  • Climara
  • Divigel
  • Elestrin
  • Emcyt
  • Enjuvia
  • Esclim
  • Estinyl
  • EstroGel
  • Evamist
  • Femtrace
  • Gynodiol
  • Menest
  • Menostar
  • Minivelle
  • Ogen .625
  • Ogen 1.25
  • Ogen 2.5
  • Premarin
  • Vivelle
  • Vivelle-Dot

In Canada

  • Estraderm
  • Estradot Transdermal
  • Estradot Transdermal Therapeutic System
  • Estradot Transdermal Therapeutic System
  • Estrogel
  • Oesclim
  • Rhoxal-Estradiol Derm 50
  • Rhoxal-Estradiol Derm 75
  • Roxal-Estradiol Derm 100
  • Vivelle 100 Mcg
  • Vivelle 25 Mcg

Available Dosage Forms:

  • Tablet
  • Cream
  • Patch, Extended Release
  • Gel/Jelly
  • Spray
  • Emulsion
  • Tablet, Enteric Coated
  • Capsule

Uses For Minivelle

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

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

Estrogens are prescribed for several reasons:

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

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

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

Estrogens are available only with your doctor's prescription.

Before Using Minivelle

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Geriatric

Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

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 taking any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

  • Dasabuvir
  • Ombitasvir
  • Paritaprevir
  • Ritonavir
  • Tranexamic Acid

Using medicines in this class 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.

  • Anagrelide
  • Aprepitant
  • Boceprevir
  • Bosentan
  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Conivaptan
  • Dabrafenib
  • Darunavir
  • Dasabuvir
  • Dexamethasone
  • Donepezil
  • Eliglustat
  • Enzalutamide
  • Fosphenytoin
  • Griseofulvin
  • Idelalisib
  • Isotretinoin
  • Lesinurad
  • Lixisenatide
  • Lumacaftor
  • Mitotane
  • Modafinil
  • Netupitant
  • Oxcarbazepine
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Phenytoin
  • Piperaquine
  • Pitolisant
  • Pixantrone
  • Prednisone
  • Rifabutin
  • Rifampin
  • St John's Wort
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Topiramate
  • Valproic Acid

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

For all patients

  • Asthma or
  • Calcium, too much or too little in blood or
  • Diabetes or
  • Epilepsy or seizures or
  • Heart problems or
  • Kidney problems or
  • Liver tumors, benign or
  • Lupus erythematosus, systemic or
  • Migraine headaches—Estrogens may worsen these conditions.
  • Blood clotting problems, or history of during previous estrogen therapy—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.
  • Breast cancer or
  • Bone cancer or
  • Cancer of the uterus or
  • Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.
  • Bulging eyes or
  • Double vision or
  • Migraine headache or
  • Vision changes, sudden onset including or
  • Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).
  • Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.
  • Endometriosis or
  • Gallbladder disease or gallstones, or history of or
  • High cholesterol or triglycerides, or history of or
  • Liver disease, or history of or
  • Pancreatitis (inflammation of pancreas) or
  • Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.
  • Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

For males treated for breast or prostate cancer:

  • Blood clots or
  • Heart or circulation disease or
  • Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Precautions While Using Minivelle

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

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

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

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

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

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

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

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

Minivelle Side Effects

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

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

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

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

More common
  • Breast pain (in females and males)
  • fast heartbeat
  • fever
  • hives
  • hoarseness
  • increased breast size (in females and males)
  • irritation of the skin
  • itching of the skin
  • joint pain, stiffness, or swelling
  • rash
  • redness of the skin
  • shortness of breath
  • swelling of the eyelids, face, lips, hands, or feet
  • swelling of the feet and lower legs
  • tightness in the chest
  • troubled breathing or swallowing
  • weight gain (rapid)
  • wheezing
Less common or rare
  • Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
  • chest pain
  • chills
  • cough
  • heavy non-menstrual vaginal bleeding
  • lumps in, or discharge from, breast (in females and males)
  • pains in the stomach, side, or abdomen
  • yellow eyes or skin
Rare - for males being treated for breast or prostate cancer only
  • Headache (sudden or severe)
  • loss of coordination (sudden)
  • loss of vision or change of vision (sudden)
  • pains in the chest, groin, or leg, especially in the calf of leg
  • shortness of breath (sudden and unexplained)
  • slurring of speech (sudden)
  • weakness or numbness in the arm or leg
Incidence not known
  • Abdominal or stomach bloating
  • abdominal or stomach cramps
  • acid or sour stomach
  • anxiety
  • backache
  • belching
  • blindness
  • blistering, peeling, or loosening of the skin
  • blue-yellow color blindness
  • blurred vision
  • change in vaginal discharge
  • changes in skin color
  • changes in vision
  • chest discomfort
  • clay-colored stools
  • clear or bloody discharge from nipple
  • confusion
  • constipation
  • convulsions
  • dark urine
  • decrease in the amount of urine
  • decreased vision
  • depression
  • diarrhea
  • difficulty with breathing
  • difficulty with speaking
  • dimpling of the breast skin
  • dizziness
  • double vision
  • dry mouth
  • eye pain
  • fainting
  • fluid-filled skin blisters
  • full feeling in upper abdomen or stomach
  • full or bloated feeling or pressure in the stomach
  • headache
  • heartburn
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • incoherent speech
  • increased urination
  • indigestion
  • inverted nipple
  • irregular heartbeats
  • light-colored stools
  • lightheadedness
  • loss of appetite
  • loss of bladder control
  • lump under the arm
  • metallic taste
  • migraine headache
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle pain
  • muscle spasm or jerking of all extremities
  • muscle weakness
  • nausea
  • noisy breathing
  • numbness or tingling of the hands, feet, or face
  • pain in the ankles or knees
  • pain or discomfort in the arms, jaw, back or neck
  • pain or feeling of pressure in the pelvis
  • pain, tenderness, swelling of the foot or leg
  • painful or tender cysts in the breasts
  • painful, red lumps under the skin, mostly on the legs
  • pains in the chest, groin, or legs, especially calves of the legs
  • partial or complete loss of vision in the eye
  • pelvic pain
  • persistent crusting or scaling of nipple
  • pinpoint red or purple spots on the skin
  • prominent superficial veins over affected area
  • red, irritated eyes
  • redness or swelling of the breast
  • sensitivity to the sun
  • severe headaches of sudden onset
  • skin thinness
  • skin warmth
  • slow speech
  • sore on the skin of the breast that does not heal
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach discomfort, upset, or pain
  • sudden loss of consciousness
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
  • swelling of the abdominal or stomach area
  • swelling of the fingers or hands
  • thirst
  • tremor
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abnormal growth filled with fluid or semisolid material
  • accidental injury
  • bladder pain
  • bloated full feeling
  • bloody or cloudy urine
  • body aches or pain
  • coating or white patches on tongue
  • congestion
  • cough producing mucus
  • decrease in amount of urine
  • difficult, burning, or painful urination
  • discouragement
  • dryness of the throat
  • ear congestion or pain
  • excess air or gas in the stomach or intestines
  • fear
  • feeling of warmth
  • feeling sad or empty
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache, severe and throbbing
  • increased clear or white vaginal discharge
  • irritability
  • itching of the vaginal, rectal or genital areas
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • mild dizziness
  • neck pain
  • nervousness
  • pain
  • pain during sexual intercourse
  • painful or difficult urination
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • skin irritation or redness where skin patch was worn
  • shivering
  • sleeplessness
  • sneezing
  • sore mouth or tongue
  • stuffy nose
  • sudden sweating
  • tender, swollen glands in the neck
  • thick, white vaginal discharge with no odor or with a mild odor
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • voice changes
Less common
  • Blemishes on the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning or stinging of the skin
  • diarrhea (mild)
  • difficulty with moving
  • dizziness (mild)
  • increased hair growth, especially on the face
  • lower abdominal or stomach pain or pressure
  • mood or mental changes
  • muscle stiffness
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pimples
  • pounding in the ears
  • problems in wearing contact lenses
  • slow heartbeat
  • tooth or gum pain
  • unusual decrease in sexual desire (in males)
  • unusual increase in sexual desire (in females)
  • white or brownish vaginal discharge
Incidence not known
  • Abnormal turning out of cervix
  • changes in appetite
  • dull ache or feeling of pressure or heaviness in the legs
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • irritability
  • large amount of triglyceride in the blood
  • leg cramps
  • patchy brown or dark brown discoloration of the skin
  • poor insight and judgment
  • problems with memory or speech
  • trouble recognizing objects
  • trouble thinking and planning
  • trouble walking
  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
  • unexpected or excess milk flow from the breasts

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

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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