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. 

The active ingredient in Alora, estradiol, is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes is available as a transdermal patch and is usually applied twice a week. 

Common side effects of Alora include headache, breast pain, and brain tenderness.

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.

• Actavis Pharma, Inc.

• Watson Pharma, Inc.

Serious side effects have been reported with Alora. See the “Alora Precautions” section.

Common side effects of Alora include the following:

• headache
• breast pain or tenderness
• nausea
• vomiting
• constipation
• gas
• heartburn
• 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
• anxiety
• depression
• changes in mood
• change in sexual desire
• back, neck, or muscle pain
• runny nose or congestion
• cough
• 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delaviridine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate)
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Alora drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Alora including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not use Alora if you:

• are allergic to Alora or to any of its ingredients
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• have a history of blood clots
• have liver disease
• are pregnant or possibly pregnant

Grapefruit and grapefruit juice may interact with Alora and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using Alora, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Alora or to any of its ingredients
• have or have ever had asthma
• have seizures
• have migraine headaches
• have endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body)
• have uterine fibroids (growths in the uterus that are not cancer)
• have or have had yellowing of the skin or eyes, especially during pregnancy or while you were using an estrogen product
• have very high or very low levels of calcium in your blood
• have porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system) or gallbladder, thyroid, pancreas, liver or kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Alora falls into category X. Alora should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while using Alora.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Estradiol has been detected in human breast milk. Estradiol can decrease the quality or quantity of breast milk. A choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Use Alora exactly as prescribed.

This medication is available as a transdermal patch. It is usually applied twice a week. 

Place the adhesive side of the Alora on a clean, dry area of skin. The recommended application site is the lower abdomen. In addition, the upper quadrant of the buttocks or outer aspect of the hip may be used. 

• Do not apply Alora to the breasts. 
• Rotate the application sites (with an interval of at least 1 week allowed between applications to a particular site)
• Make sure the selected area is not oily, damaged, or irritated.
• Avoid applying the patch to the waistline, since tight clothing may rub the patch off.
• Apply the patch immediately after opening the pouch and removing the protective liner. Make sure to press the patch firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges.

In the event that the patch should fall off, you can reaaply the same patch. If necessary, a new patch may be applied to another site. The original treatment schedule should be maintained.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Alora (estradiol) transdermal patche for the treatment of menopause symptoms or hypoestrogenism is 0.05 mg/day applied to the skin twice weekly.

The recommended starting dose of Alora (estradiol) transdermal patches for the prevention of postmenopausal osteoporosis is 0.025 mg/day applied to the skin twice weekly.

If you take use much Alora, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Alora is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Alora at 20-25°C (68-77°F).
• Keep this and all medicines out of the reach of children.

Warning: Estrogens Increase the Risk of Endometrial Cancer. 

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is currently no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose.

CARDIOVASCULAR AND OTHER RISKS 

Estrogens with and without progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.