Norelgestromin and Ethinly Estradiol

NORELGESTROMIN AND ETHINLY ESTRADIOL

Manufacturer: Amneal Pharmaceuticals NY LLC

Score: 148.0

Quick Summary

Norelgestromin and Ethinyl Estradiol is a transdermal contraceptive patch used for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m^2. It contains 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol. The patch is applied once a week for three weeks, followed by a patch-free week. It works by suppressing gonadotropins, inhibiting ovulation, and altering cervical mucus and the endometrium. The most common adverse reactions include breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding, and mood disorders. The patch is contraindicated in women with a BMI ≥ 30 kg/m^2, at high risk of arterial or venous thromboembolic events, and with certain medical conditions such as liver tumors, undiagnosed abnormal uterine bleeding, and pregnancy.

Key Clinical Findings and Indications

Prevention of pregnancy in women with a BMI < 30 kg/m^2
Suppression of gonadotropins
Inhibition of ovulation
Alteration of cervical mucus and the endometrium

Important Safety Information

Warning

Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use, and the patch is contraindicated in women over 35 years old who smoke.

Contraindications

BMI ≥ 30 kg/m^2
High risk of arterial or venous thromboembolic events
Liver tumors
Undiagnosed abnormal uterine bleeding
Pregnancy

Adverse Reactions

Breast symptoms
Nausea/vomiting
Headache
Application site disorder
Abdominal pain
Dysmenorrhea
Vaginal bleeding
Mood disorders

Dosing Recommendations

General Guidance

No dose adjustments are necessary for women with renal or hepatic impairment.

Prevention of pregnancy

Adult Dose

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

Pediatric Dose

Special Population Considerations

Pregnancy

The patch is contraindicated in pregnancy
There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy

Nursing Mothers

The effects of norelgestromin and ethinyl estradiol in nursing mothers have not been evaluated and are unknown
Estrogen-containing CHCs can reduce milk production in breastfeeding mothers

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 and for users 18 years and older