Estraderm 4 extended release patch

Estraderm (Novartis Pharmaceuticals), manufactured drug form of Estradiol, 4mg/patch estradiol extended release patch, NDC 0083-2310

Available in:

NDC Product ID:

  • 0083-2310

Manufacturer:

Manufactured drug form

Manufactured form of:

Label date:

  • Mar 30, 2007

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Spl Unclassified Section
  • No
  • 42229-5
  • Estrogens Increase The Risk Of Endometrial Cancer.
  • Yes
  • 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 no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant Neoplasms, Endometrial Cancer .) CARDIOVASCULAR AND OTHER RISKS Estrogens and 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). 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.) 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.
  • 34066-1
  • Description
  • No
  • 34089-3
  • Clinical Pharmacology
  • No
  • 34090-1
  • Indications And Usage
  • No
  • 34067-9
  • Contraindications
  • No
  • 34070-3
  • Warnings
  • No
  • 34071-1
  • Precautions
  • No
  • 42232-9
  • Adverse Reactions
  • No
  • 34084-4
  • Overdosage
  • No
  • 34088-5
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