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Alora .05mg/24 Hour Patch 8 By Actavis Pharma

Image 0 of Alora .05mg/24 Hour Patch 8 By Actavis PharmaImage 1 of Alora .05mg/24 Hour Patch 8 By Actavis Pharma

Alora .05mg/24 Hour Patch 8 By Actavis Pharma

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Alora .05mg/24 Hour Patch 8 By Actavis Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3292075/RXB10025726/RXA452785
Size : 8
Selling UoM : EA
NDC: 52544-0471-08
UPC Barcode : 352544471083Supplier: 0050000680 ACTAVIS PHARMA INC/BRAND
Supplier Material : 047108
Generic Code : 003202 ESTRADIOL TRANSDERM PATCH TDSW 0.05MG/24
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Bra

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Product Description.:

Transdermal system , translucent , clear , rectangular (rounded end) rect

Color/Shape: Translucent: rectangular
Inscription: Alora 0.05mg/day estradiol
Orange Book Rating: BX

Continuous Delivery for Twice Weekly Dosing

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. (See WARNINGS, Malignant neoplasms, Endrometrial cancer.)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with and without progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular disorders and 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. (See CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.)

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. (See CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)

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.

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