Norethindrone Acetate and Ethinyl Estradiol

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS

Manufacturer: Xiromed, LLC

Score: 143.0

Quick Summary

Norethindrone Acetate and Ethinyl Estradiol is a combination oral contraceptive used to prevent pregnancy in females of reproductive age. The drug works by suppressing ovulation and has several key clinical findings and indications, including the prevention of pregnancy and the treatment of menstrual disorders. However, it has several important safety considerations, including contraindications for women over 35 who smoke, those with a high risk of thrombotic events, and those with liver tumors or disease. The recommended dosing is one tablet per day, with considerations for special populations such as pregnant women, nursing mothers, and pediatric and geriatric patients.

Key Clinical Findings and Indications

Prevention of pregnancy
Treatment of menstrual disorders
Indicated for use in females of reproductive age

Important Safety Information

Warning

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use

Contraindications

Women over 35 who smoke
High risk of thrombotic events
Liver tumors or disease
Undiagnosed abnormal uterine bleeding
Pregnancy
Breast cancer or other estrogen- or progestin-sensitive cancer
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Adverse Reactions

Irregular uterine bleeding
Nausea
Breast tenderness
Headache
Vaginal candidiasis
Menstrual cramps
Bacterial vaginitis
Abnormal cervical smear
Acne
Mood swings
Weight gain

Dosing Recommendations

General Guidance

None specified

Prevention of pregnancy

Adult Dose

One tablet per day, taken at the same time every day

Pediatric Dose

Special Population Considerations

Pregnancy

There is no use for contraception in pregnancy; therefore, the drug should be discontinued during pregnancy
Epidemiologic studies have not found an increased risk of genital or nongenital birth defects following exposure to COCs before conception or during early pregnancy

Nursing Mothers

Contraceptive hormones and/or metabolites are present in human milk
COCs can reduce milk production in breastfeeding mothers
Advise the nursing mother to use other forms of contraception until she has weaned her child

Pediatric Use

Safety and efficacy have been established in women of reproductive age
Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older
Use before menarche is not indicated