Alora

DRUG DESCRIPTION

Alora (estradiol transdermal system) is designed to deliver estradiol continuously and consistently over a 3 or 4-day interval upon application to intact skin. Four strengths of Alora (estradiol transdermal system) are available, having nominal in vivo delivery rates of 0.025, 0.05, 0.075, and 0.1 mg estradiol per day through skin of average permeability (inter-individual variation in skin permeability is approximately 20%). Alora (estradiol transdermal system) has contact surface areas of 9, 18, 27, and 36 cm2 and contains 0.77, 1.5, 2.3, and 3.1 mg of estradiol, USP, respectively. The composition of the estradiol transdermal systems per unit area is identical. Estradiol, USP is a white, crystalline powder that is chemically described as estra-1,3,5(10)-triene-3, 17?-diol, has an empirical formula of C18H24O2 and has molecular weight of 272.39. The structural formula is:

Alora (estradiol transdermal system) Structural Formula Illustration

Alora (estradiol transdermal system) consists of three layers. Proceeding from the polyethylene backing film as shown in the cross-sectional view below, the adhesive matrix drug reservoir that is in contact with the skin consists of estradiol, USP and sorbitan monooleate dissolved in an acrylic adhesive matrix. The polyester overlapped release liner protects the adhesive matrix during storage and is removed prior to application of the system to the skin.

Layers of Alora - Illustration

What are the possible side effects of estradiol transdermal?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in...

Read All Potential Side Effects and See Pictures of Alora

What are the precautions when taking estradiol transdermal system (Alora)?

Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity,...

Read All Potential Precautions of Alora


Alora Consumer (continued)

SIDE EFFECTS: See also Warning section.

Skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking an estrogen product. You may need to stop this medication for a time or take special precautions.

If you are going to have an MRI test, notify testing personnel that you are using this patch. Serious burns may occur during MRI tests because of the aluminum contained in some brands of these patches. Check with your pharmacist or testing personnel whether your specific brand of patch should be removed just before the MRI test or consult your doctor for specific instructions.

This drug may cause blotchy, dark areas of the skin on the face (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

Children may be more sensitive to the side effects of this drug. It may affect their growth/development. Discuss the possible effects of this medication with the doctor, and monitor your child's growth periodically.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.


Alora Patient Information Including Side Effects

Brand Names: Alora, Climara, Estraderm, Estradiol Patch, Menostar, Vivelle, Vivelle-Dot

Generic Name: estradiol transdermal (Pronunciation: ess tra DYE ol tranz DERM al)

  • What is estradiol transdermal (Alora)?
  • What are the possible side effects of estradiol transdermal?
  • What is the most important information I should know about estradiol transdermal?
  • What should I discuss with my healthcare provider before using estradiol transdermal?
  • How should I use estradiol transdermal?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using estradiol transdermal?
  • What other drugs will affect estradiol transdermal?
  • Where can I get more information?

What is estradiol transdermal (Alora)?

Estradiol is a form of estrogen, a female sex hormone the regulates many processes in the body.

Estradiol transdermal skin patches are used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol transdermal also reduces urgency or irritation of urination.

Estradiol skin patches are also used to treat ovarian disorders, infertility, and abnormal vaginal bleeding. Some estradiol skin patches are used to prevent postmenopausal osteoporosis. Transdermal skin patches release the drug slowly, and it is absorbed through your skin.

Estradiol transdermal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of estradiol transdermal?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in your lower leg;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes); or
  • a lump in your breast.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;
  • swollen breasts;
  • acne or skin color changes;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • migraine headaches or dizziness;
  • vaginal pain, dryness, or discomfort;
  • swelling of your ankles or feet;
  • depression; or
  • changes in your menstrual periods, break-through bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about estradiol transdermal?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a bleeding disorder, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol transdermal.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol transdermal.

Related Drug Centers
  • Alora
  • Vivelle-Dot
  • Menostar


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