May 27, 2017
Recommended Topic Related To:

Menostar

"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.

The committee voted 12-9 against continued marketing of the drug, citing"...

A A A

Menostar

Menostar
(estradiol) Transdermal System




WARNING

ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed, persis tent or recurring abnormal genital bleeding [see WARNINGS AND PRECAUTIONS].

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and Clinical Studies].

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other forms of estrogens.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration cons is tent with treatment goals and risks for the individual woman.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plusprogestin therapy should not be used for the prevention of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

The WHI estrogen plusprogestin sub study reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyproges terone acetate (MPA) [2.5 mg], relative to placebo [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger pos tmenopaus al women [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and Clinical Studies].

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration cons is tent with treatment goals and risks for the individual woman.

DRUG DESCRIPTION

Menostar (estradiol transdermal system) is designed to provide nominal in vivo delivery of 14 mcg of estradiol per day continuously upon application to intact skin. The period of use is 7 days. The transdermal system has a contact surface area of 3.25 cm², and contains 1 mg of estradiol USP.

Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17▀diol. It has an empirical formula of C18H24O2 and molecular weight of 272.38. The structural formula is:

Meno star (estradiol) Structural Formula Illustration

The Menostar transdermal system comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are:

  1. A translucent polyethylene film.
  2. An acrylate adhesive matrix containing estradiol USP.
  3. A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the transdermal system can be used.

The three layers of Menostar transdermal system -  Illustration

The active component of the transdermal system is estradiol. The remaining components of the transdermal system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive.

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 a serious side effect such as:

  • 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 severe headache, sudden vision changes, problems with speech or balance;
  • sudden cough, wheezing, rapid breathing, coughing up...

Read All Potential Side Effects and See Pictures of Menostar »

Last reviewed on RxList: 12/28/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Healthy Bones

Get tips and advances in treatment.