MENOSTAR Patch (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Bayer HealthCare Pharmaceuticals Inc.
Λέξεις κλειδιά
50419-455
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1. Indications and Usage
<b>Menostar is indicated for:</b> 1.1 Prevention of Postmenopausal Osteoporosis <u>Limitation of Use:</u> When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use ...
2. Dosage and Administration
Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally a woman without a uterus does not ...
3. Dosage Forms and Strengths
Menostar (estradiol transdermal system) 14 mcg per day each 3.25 cm² system contains 1 mg of estradiol.
4. Contraindications
Menostar is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding <em>[see Warnings and Precautions (5.2)]</em> Breast cancer or history of breast cancer ...
5. Warnings and Precautions
5.1 Cardiovascular Disorders Increased risks of stroke and DVT are reported with estrogen-alone therapy. Increased risks of PE, DVT, stroke and MI are reported with estrogen plus progestin therapy. Immediately ...
6. Adverse Reactions
The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders <em>[see Boxed Warning, Warnings and Precautions (5.1)]</em> Malignant Neoplasms <em>[see Boxed ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Climara and Menostar. Because these reactions are reported voluntarily from a population of uncertain size, it is not always ...
7. Drug Interactions
<em>In vitro</em> and <em>in vivo</em> studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug ...
8.1. Pregnancy
Risk Summary Menostar is not indicated for use in pregnancy. There are no data with the use of Menostar in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk ...
8.2. Lactation
Risk Summary Estrogens are present in human milk and can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. ...
8.4. Pediatric Use
Menostar is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.
8.5. Geriatric Use
A total of 417 postmenopausal women 61 to 79 years old, with an intact uterus, participated in the osteoporosis trial. More than 50 percent of women receiving study drug, were 65 years of age or older. ...
10. Overdosage
Overdosage of estrogen may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding in women. Treatment of overdose consists of discontinuation of Menostar ...
11. Description
Menostar (estradiol transdermal system) is designed to provide nominal <em>in vivo</em> delivery of 14 mcg of estradiol per day continuously upon application to intact skin. The period of use is 7 days. ...
12.1. Mechanism of Action
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic ...
12.2. Pharmacodynamics
Generally, a serum estrogen concentration does not predict an individual womans therapeutic response to Menostar nor her risk for adverse outcomes. Likewise, exposure comparisons across different estrogen ...
12.3. Pharmacokinetics
Absorption The bioavailability of estradiol following application of a Menostar transdermal system, relative to that of a transdermal system delivering 25 mcg per day, was investigated in 18 healthy postmenopausal ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
14. Clinical Studies
14.1 Effects on Bone Mineral Density in Postmenopausal Women The efficacy of Menostar in the prevention of postmenopausal osteoporosis was investigated in a 2-year double blind, placebo-controlled, multicenter ...
15. References
Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. <em>JAMA.</em> 2007;297:1465–1477. Hsia J, et al. Conjugated Equine Estrogens and ...
16.1. How Supplied
Menostar (estradiol transdermal system), 14 mcg per day — each 3.25 cm² system contains 1 mg of estradiol USP. Individual Carton of 4 systems NDC 50419-455-04. Manufactured for Bayer HealthCare Pharmaceuticals ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not store above 86°F (30°C). Do not store unpouched. Apply immediately upon removal from the protective ...
17. Patient Counseling Information
Advise women to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Vaginal Bleeding Inform postmenopausal women to report any vaginal bleeding to their healthcare provider ...