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XULANE

NORELGESTROMIN AND ETHINYL ESTRADIOL

Manufacturer: Mylan Pharmaceuticals Inc.

Score: 148.0

Quick Summary

Norelgestromin and Ethinyl Estradiol transdermal system is a combined hormonal contraceptive indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2. The system delivers 150 mcg of norelgestromin and 35 mcg of ethinyl estradiol per day and is applied once a week for three weeks, followed by a patch-free week. The drug has several contraindications, including high risk of arterial or venous thromboembolic events, liver tumors, and pregnancy. Common adverse reactions include breast symptoms, nausea, headache, and application site disorder. The drug should not be used during pregnancy or breastfeeding, and its use in pediatric and geriatric populations requires special consideration.

Key Clinical Findings and Indications

  • Prevention of pregnancy in women with a BMI < 30 kg/m2
  • Combined hormonal contraceptive
  • Delivers 150 mcg of norelgestromin and 35 mcg of ethinyl estradiol per day

Important Safety Information

Warning

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use, and the risk of venous thromboembolic events may be greater in women with a BMI ≥ 30 kg/m2

Contraindications

  • High risk of arterial or venous thromboembolic events
  • Liver tumors or liver disease
  • Pregnancy
  • Current diagnosis of, or history of, breast cancer
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Adverse Reactions

  • Breast symptoms
  • Nausea
  • Headache
  • Application site disorder

Dosing Recommendations

General Guidance

No dose adjustments are recommended

Prevention of pregnancy

Adult Dose

One patch per week for three weeks, followed by a patch-free week

Pediatric Dose

Special Population Considerations

Pregnancy

  • The drug should not be used during pregnancy
  • If pregnancy occurs during use, the drug should be discontinued

Nursing Mothers

  • The effects of the drug on nursing mothers have not been evaluated
  • Advise the nursing mother to use other forms of contraception until she has completely weaned her child

Pediatric Use

  • Safety and efficacy have been established in women of reproductive age
  • Efficacy is expected to be the same for post-pubertal adolescents under the age of 18

Geriatric Use

  • The drug has not been studied in postmenopausal women
  • The drug is not indicated in this population

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