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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

CLIMARA Patch (2017)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Bayer HealthCare Pharmaceuticals Inc.

Λέξεις κλειδιά

50419-454 50419-456 50419-451 50419-459 50419-453 50419-452

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1. Indications and Usage

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause <u>Limitation of Use:</u> When prescribing ...

2. Dosage and Administration

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a ...

3. Dosage Forms and Strengths

Climara (estradiol transdermal system), 0.025 mg per day—each 6.5 cm² system contains 2 mg of estradiol. Climara (estradiol transdermal system), 0.0375 mg per day—each 9.375 cm² system contains 2.85 mg ...

4. Contraindications

Climara is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding Known, suspected, or history of breast cancer Known or suspected estrogen-dependent neoplasia ...

5. Warnings and Precautions

5.1 Cardiovascular Disorders An increased risk of stroke and DVT has been reported with estrogen-alone therapy. An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin ...

6. Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders <em>[see Boxed Warning, and 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 the Climara transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it ...

7. Drug Interactions

7.1 Metabolic 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 ...

8.1. Pregnancy

Climara should not be used during pregnancy <em>[see Contraindications (4)]</em>. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and ...

8.3. Nursing Mothers

Climara should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified ...

8.4. Pediatric Use

Climara is not indicated in children. Clinical studies have not been conducted in the pediatric population.

8.5. Geriatric Use

There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Climara to determine whether those over 65 years of age differ from younger subjects in their response to ...

8.6. Renal Impairment

In postmenopausal women with end stage renal disease (ESRD) receiving maintenance hemodialysis, total estradiol serum levels are higher than in normal subjects at baseline and following oral doses of estradiol. ...

8.7. Hepatic Impairment

Estrogens may be poorly metabolized in patients with impaired liver function and should be administered with caution.

10. Overdosage

Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding in women. Treatment of overdose consists of discontinuation of Climara ...

11. Description

Climara (estradiol transdermal system), is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm²) systems are available to provide nominal ...

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

There are no pharmacodynamic data for Climara.

12.3. Pharmacokinetics

Absorption Transdermal administration of Climara produces mean serum concentrations of estradiol comparable to those produced by premenopausal women in the early follicular phase of the ovulatory cycle. ...

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 Vasomotor Symptoms A study of 214 women 25 to 74 years of age met the qualification criteria and were randomly assigned to one of the three treatment groups: 72 to the 0.05 mg estradiol ...

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

Climara (estradiol transdermal system), 0.025 mg per day — each 6.5 cm² system contains 2 mg of estradiol USP Individual Carton of 4 systems NDC 50419-454-04 Climara (estradiol transdermal system), 0.0375 ...

16.2. Storage and Handling

Store at 20°C to 25°C (66°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

See FDA-approved patient labeling (Patient Information and Instructions for Use) Vaginal Bleeding Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider ...

BOXED WARNING SECTION

<b>WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA</b> <b><u>Estrogen-Alone Therapy</u></b> <b>Endometrial Cancer</b> <b>There is an increased risk of endometrial ...