- Alora uses
- Alora used to treat
- Alora is used to treat
- Alora effects of alora
- Alora side effects
- Alora treats
- Alora serious side effects
- Alora what is alora used for
- Alora drug
- Alora how alora works
- Alora dosage
- Alora dosage forms
- Alora tablet
- Alora effects of
- Alora 100 mg
- Alora adverse effects
Uses of Alora
Alora is a prescription medication used to treat symptoms of menopause including hot flashes and vaginal dryness. It is used to treat conditions in which a woman's ovaries do not produce enough estrogen naturally (hypoestrogenism). It is also used to help prevent osteoporosis after menopause.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Side Effects of Alora
Serious side effects have been reported with Alora. See the “Alora Precautions” section.
Common side effects of Alora include the following:
- breast pain or tenderness
- weight gain or loss
- hair loss
- redness or irritation of the skin that was covered by Alora
- swelling, redness, burning, irritation or itching of the vagina
- vaginal discharge
- painful menstrual periods
- changes in mood
- change in sexual desire
- back, neck, or muscle pain
- runny nose or congestion
- darkening of skin on face (may not go away even after you stop using Alora)
- unwanted hair growth
This is not a complete list of Alora side effects. Ask your doctor or pharmacist for more information.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I use Alora (estradiol transdermal)?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Apply the skin patch to clean, dry skin on your stomach or buttocks. Choose a different spot within these skin areas each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.
Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband.
If a patch falls off, try sticking it back into place. If it does not stick well, put on a new patch on a different skin area and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.
Some transdermal patches contain aluminum that may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.
Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estradiol transdermal.
Store at room temperature away from moisture and heat. Keep each patch in its pouch until you are ready to use it.
After removing a skin patch, fold it in half so it sticks together. Discard the folded patch in a place children and pets cannot get to.
Uses For Alora
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.
Read this PATIENT INFORMATION before you start using Alora (ah-LORE-ah) and read what you get each time you refill Alora. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT Alora (AN ESTROGEN HORMONE)?
What is Alora?
Alora is a patch that contains the estrogen hormone estradiol. When applied to the skin as directed below, the Alora patch releases estrogen through the skin into the abdomen.
What is Alora used for?
Alora is used after menopause to:
Reduce moderate or severe hot flashes.
Estrogens are hormones made by a woman’s ovaries. Between ages 45 and 55, the ovaries normally stop making estrogens. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”
When estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating (“hot flashes” or “hot flushes”). In some women the symptoms are mild and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Alora.
Treat moderate to severe dryness, itching, and burning in and around the vagina.
You and your healthcare provider should talk regularly about whether you still need treatment with Alora to control these problems. If you use Alora only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
Treat certain conditions in which a young woman’s ovaries do not produce enough estrogen naturally.
Help reduce your chances of getting osteoporosis (thin weak bones).
Osteoporosis from menopause is a thinning of the bones that makes them weaker and allows them to break more easily. If you use Alora only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.
Weight-bearing exercise like walking and running, and taking calcium and vitamin D supplements may lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your healthcare provider before starting them.
Who Should Not Use Alora
Do not use Alora if you:
Have unusual vaginal bleeding.
Currently have or have had certain cancers.
Estrogens may increase the risk of certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk to your healthcare provider about whether you should use Alora.
Had a stroke or heart attack in the past year.
Currently have or have had blood clots.
Currently have or have had liver problems.
Are allergic to Alora or any of the ingredients in it. See the end of this leaflet for a list of ingredients in Alora.
Think you may be pregnant.
Tell your healthcare provider:
If you are breastfeeding. The hormone in Alora may pass into your milk.
About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing); epilepsy (seizures); migraine; endometriosis; lupus; problems with your heart; liver; thyroid; kidneys; or have high calcium levels in your blood.
About all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Alora works. Alora may also affect how your other medicines work.
If you are going to have surgery or will be on bed rest. You may need to stop estrogens.
What Are the Possible Side Effects of Alora?
Less common but serious side effects include:
Cancer of the uterus
These are some of the warning signs of serious side effects:
Unusual vaginal bleeding
Dizziness and faintness
Changes in speech
Shortness of breath
Pains in your legs
Changes in vision
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.
Common side effects include:
Irregular vaginal bleeding or spotting
Stomach/abdominal cramps, bloating
Nausea and vomiting
Other side effects include:
High blood pressure
High blood sugar
Enlargement of benign tumors of the uterus (“fibroids”)
Vaginal yeast infection
These are not all the possible side effects of Alora. For more information, ask your healthcare provider or pharmacist.
What Can I Do to Lower My Chances of Getting a Serious Side Effect with Alora?
Talk with your healthcare provider regularly about whether you should continue using Alora.
If you have a uterus, talk to your healthcare provider right away about whether the addition of a progestin is right for you. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
See your healthcare provider right away if you get vaginal bleeding while using Alora.
Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
How should I use Alora?
Before you begin, read all the information in these 5 steps.
Step 1. Choose your schedule for twice-a-week application.
Put on a new patch twice a week. Use one of the schedules on the inside flap of the patch box.
For example, if you apply your first patch on Sunday, take that patch off on Wednesday and put on a new one. Stay on this schedule as long as you use Alora. To help remind yourself, mark the schedule on the inside flap of the patch box. Put a check next to the first day you apply the patch. When you change your patch, don’t put the new one in the same place. To help reduce the chance of skin redness or irritation, wait at least 1 week before you reuse a spot.
Step 2. Before you apply the patch make sure the skin at the spot is:
Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower).
Free of body powder or lotion.
Free of cuts, rashes, or any other skin problem.
Step 3. Choose a spot for the patch
Place the patch on the lower abdomen (below the panty line) when you first start using Alora.
As you get used to applying Alora, you may want to try the hips or buttocks to see which area works best for you.
Do not apply Alora to your breasts or any other parts of your body.
Step 4. How to apply the patch
Open the pouch that contains the patch.
Locate the notch on the top left or right corner of the pouch.
Hold the pouch at the notch and tear off the top edge. Do not cut the pouch with scissors, which might damage the patch inside.
Pull the patch out.
Apply one half of the patch to your skin.
Remove half of the liner, which covers the sticky surface of the patch. To find the liner, bend the patch in half. Then grab the clear straight edge of the liner and pull that piece off.
Without touching the sticky surface, press the sticky half of the patch onto your skin. (If you touch the sticky surface, the patch may not stay on as well.)
Rub the sticky half firmly to ensure full contact with your skin.
Apply the second half of the patch to your skin.
Bend the patch back over itself. Press down on the liner firmly.
Push the liner forward a little to loosen the edge.
Grab the loose edge at either corner and peel off the second piece of the liner. Try not to touch the sticky surface of the patch.
Press the entire patch firmly onto the skin with your finger tips.
Press for at least 10 seconds to make sure the patch will stay in place. Be sure all of it sticks to your skin, even around the edges.
To help the patch stay in place:
Try not to disturb the patch while putting on and removing clothes. It may help to place the patch where your underwear will cover it at all times.
Be careful while changing clothes, washing or drying off, so that you do not catch the patch with your clothes or the towel.
Try different sites on the lower abdomen, hips, or buttocks area to see what works well with your body and your clothing.
If the patch starts to lift, simply press it back in place.
Step 5. Removing the patch
Take off the old patch.
Fold it in half (sticky sides together) and throw it away out of the reach of children and pets.
The skin under the old patch may look pink, but the color should fade away soon. In some cases, the skin may itch or look red; this may last from a couple of hours to a couple of days. Most of the time this is minor, and goes away by itself. But if it bothers you a lot or lasts longer than a few days, call your healthcare provider.
For Best Results, Stay with Your Patch Program
- Replace your patch twice each week, on the 2 days you have chosen. Until it becomes a habit, try:
- Marking your schedule on the inside flap of the patch box;
- Marking the days on your calendar;
Linking the days you change your patch to other things that always happen on those days (e.g., an exercise class, meetings, etc.).
Handle each patch with care.
Make sure the skin is clean, dry, and free of lotion and powder.
Try to avoid touching the sticky surface when applying the patch.
Be careful while changing clothes, washing or drying off, so that you do not catch the patch with your clothes or the towel.
If the patch starts to lift, simply press it back in place.
Keep working with your healthcare provider, pharmacist, or other healthcare professional. Ask questions. If you have concerns, talk them over - don’t just stop using the patch on your own. Remember, it may take a little time and some experience to get accustomed to using a patch. Estrogens should be used only as long as needed. Start with the lowest dose and talk to your healthcare provider about how well that dose is working for you. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with Alora.
Get your refills of the Alora patch before your supply runs out.
How should I store Alora?
Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Do not store patches outside of their pouches. Apply the patch as soon as you take it out of the protective pouch.
Discard used Alora in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.
General Information about the safe and effective use of Alora
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Alora for conditions for which it was not prescribed. Your healthcare provider has prescribed this drug for you and you alone. Do not give the drug to anyone else. It may harm them. Keep Alora out of the reach of children.
This leaflet provides a summary of the most important information about Alora. If you would like more information, talk with your healthcare provider. You can ask for information about Alora that is written for health professionals.
What are the ingredients in Alora?
Each patch contains estradiol, USP as the active component. Inactive components of each patch include sorbitan monooleate, NF; acrylic adhesive; polyethylene film; and siliconized polyester film.
Keep out of reach of children.
For all medical inquiries contact:
Parsippany, NJ 07054
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Content Updated: August 2014
For the Consumer
Applies to estradiol: vaginal cream, vaginal insert extended release, vaginal tablet
Other dosage forms:
- transdermal emulsion, transdermal gel/jelly, transdermal patch extended release, transdermal spray
Along with its needed effects, estradiol (the active ingredient contained in Alora) 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 while taking estradiol:Less common
- Vaginal yeast infection
- Change in vaginal discharge
- clear or bloody discharge from the nipple
- decrease in the amount of urine
- dimpling of the breast skin
- fast heartbeat
- hives, itching, or rash
- inverted nipple
- joint pain, stiffness, or swelling
- lump in the breast or under the arm
- noisy, rattling breathing
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- persistent crusting or scaling of the nipple
- redness of the skin
- redness or swelling of the breast
- sore on the skin of the breast that does not heal
- swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
- tightness in the chest
- troubled breathing at rest
- troubled breathing or swallowing
- vaginal bleeding
Get emergency help immediately if any of the following symptoms of overdose occur while taking estradiol:Symptoms of overdose
- Abdominal or stomach pain
- nausea or vomiting
- tenderness of the breasts
- unusual tiredness or weakness
Some side effects of estradiol 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
- Back pain
- itching or pain of the vagina or genital area
- thick, white vaginal discharge with mild or no odor
- weight gain
- Body aches or pain
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- Feeling sad or empty
- headache, severe and throbbing
- lack of appetite
- trouble concentrating
- trouble sleeping
Estradiol Levels and Effects while Breastfeeding
Summary of Use during Lactation
Limited information on the use of estradiol during breastfeeding indicates that the route of administration and dosage form have influences on the amount transferred into breastmilk. Vaginal administration results in measurable amounts in milk, but transdermal patches do not. Maternal doses of up to 200 mcg daily transdermally do not increase estradiol or estriol in breastfed infants or cause any adverse effects in breastfed infants. Vaginal administration results in unpredictable peak times for estradiol in breastmilk, so timing of the dose with respect to breastfeeding is probably not useful.
A case report of inadequate milk production and inadequate infant weight gain was possibly caused by transdermal estradiol initiated on the first day postpartum, but 2 small studies found no such effect when the drug was initiated after lactation was well established.
Maternal Levels. Six women who were 6 or more months postpartum were given a vaginal suppository containing 50 or 100 mg of estradiol. In 3 of the 6 women, peak milk levels occurred 3 hours after the dose. In 2 others, the peak level occurred 7 hours after the dose and in the sixth, the peak occurred 11 hours after the dose. Peak milk levels were about 100 ng/L in 4 women, in one it was 300 ng/L and in the sixth, it was 1000 ng/L.
Twenty-one women who were 20 weeks postpartum and breastfeeding their infants were randomized to receive a transdermal patch that released estradiol 50 mcg (n = 7), 75 mcg (n = 5) or 100 mcg (n = 6) daily or placebo (n = 4) for 2 weeks. Breastmilk and serum samples were collected at the beginning and end of the study. Serum estradiol levels increased slightly from baseline, but the differences were not statistically significant; serum levels were in the range of 25 to 45 ng/L. Estradiol was undetectable (<6.8 ng/L) in all breastmilk samples.
Infant Levels. Six nursing mothers received transdermal estradiol as part of a study comparing estradiol to sertraline and placebo for postpartum depression. The mothers received estradiol dosages between 50 and 200 mcg daily (mean 133 mcg daily) at the time of serum level analysis at 4 and 8 weeks of therapy. Four of the 6 infants were exclusively breastfed and the other two were more than 50% breastfed. All infants had undetectable (<2.5 ng/L) serum estriol concentrations and 4 of the 6 had undetectable (<2.5 ng/L) serum estradiol concentrations. The other two had estradiol concentrations of 7 and 7.1 ng/L. The serum estriol and estradiol concentrations were not significantly different from breastfed infants in the placebo or sertraline arms of the study. No correlation was found between maternal and infant serum concentrations of estriol or estradiol.
Effects in Breastfed Infants
A mother who had severe postpartum depression with 2 previous infants was prescribed a transdermal estradiol patch that released 50 mcg daily beginning on day 1 postpartum to prevent recurrence of depression. At 11 days of age, the infant was jaundiced and had gained only 60 grams since birth. With more frequent nursing, weight gain improved, but remained inadequate until day 28 when the estradiol was discontinued. The infant then experienced above average weight gain through day 66 postpartum. The delayed and reduced weight gain was possibly caused by estradiol.
Six nursing mothers received transdermal estradiol as part of a study comparing estradiol to sertraline and placebo for postpartum depression. The mothers received estradiol dosages between 50 and 200 mcg daily (mean 133 mcg daily) at the time of serum level analysis at 4 and 8 weeks of therapy. Four of the 6 infants were exclusively breastfed and the other two were more than 50% breastfed. There was no difference in infant length, weight, and head circumference nor in the average daily gains in any of these parameters between treatments.
Effects on Lactation and Breastmilk
Thirteen women who were 12 weeks postpartum and fully breastfeeding their infants were given a transdermal patch that released 100 mcg of estradiol daily. The average number of breast feeds per day did not change significantly during 3 days of patch application.
Nineteen women who were 6 weeks postpartum, using a barrier contraceptive method and breastfeeding their infants were randomized to transdermal patches that released estradiol 50 mcg daily or placebo patches for 12 weeks. An additional control group received no patches. The number of breast feeds per day decreased in all groups over the course of the study, but there were no important differences among the groups.
A retrospective cohort study compared 371 women who received high-dose estrogen (either 3 mg of diethylstilbestrol or 150 mcg of ethinyl estradiol daily) during adolescence for adult height reduction to 409 women who did not receive estrogen. No difference in breastfeeding duration was found between the two groups, indicating that high-dose estrogen during adolescence has no effect on later breastfeeding.
Alternate Drugs to Consider
1. Nilsson S, Nygren KG, Johansson ED. Transfer of estradiol to human milk. Am J Obstet Gynecol. 1978;132:653-7. PMID: 717472
2. Perheentupa A, Ruokonen A, Tapanainen JS. Transdermal estradiol treatment suppresses serum gonadotropins during lactation without transfer into breast milk. Fertil Steril. 2004;82:903-7. PMID: 15482766
3. Pinheiro E, Bogen DL, Hoxha D, Wisner KL. Transdermal estradiol treatment during breastfeeding: maternal and infant serum concentrations. Arch Womens Ment Health. 2016;19:409-13. PMID: 25956588
4. Ball DE, Morrison P. Oestrogen transdermal patches for post partum depression in lactating mothers--a case report. Central Afr J Med. 1999;45:68-70. PMID: 10565065
5. Illingworth PJ, Seaton JEV et al. Low dose transdermal oestradiol suppresses gonadotrophin secretion in breast-feeding women. Hum Reprod. 1995;10:1671-7. PMID: 8582959
6. Perheentupa A, Critchley HOD, Illingworth PJ et al. Enhanced sensitivity to steroid-negative feedback during breast-feeding: low-dose estradiol (transdermal estradiol supplementation) suppresses gonadotropins and ovarian activity assessed by inhibin B. J Clin Endocrinol Metab. 2000;85:4280-6. PMID: 11095468
7. Jordan HL, Bruinsma FJ, Thomson RJ et al. Adolescent exposure to high-dose estrogen and subsequent effects on lactation. Reprod Toxicol. 2007;24:397-402. PMID: 17531440
LactMed Record Number
Last Revision Date
Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.