Norethindrone/Ethinyl Estradiol/Ferrous Fumarate

Brands

DEA Class; Rx

Common Brand Names; Generess Fe, Nexesta Fe, Kaitlib Fe, Zenchent Fe, Layolis FE, Wymzya FE

  • Estrogens/Progestins; 
  • Contraceptives, Oral
 

Combined oral contraceptive (COC) containing a synthetic estrogen and norethindrone acetate, a progestin with moderate androgenic and slight estrogenic activity
Ferrous fumarate tablets provide a small amount of iron supplement during menses but no significant therapeutic value
Used for routine contraception in adolescent and adult premenopausal females; some products are additionally approved for acne treatment in these populations
All COCs contain a boxed warning regarding the increased risk for thromboembolism in women who smoke

Indicated for routine contraception.

For the treatment of moderate acne vulgaris related to sebum overproduction in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
For the treatment or adjuvant treatment of amenorrhea, abnormal uterine bleeding (dysfunctional uterine bleeding), hirsutism, hypermenorrhea, or polycystic ovary syndrome related to hypoestrogenic or hyperandrogenic conditions in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and have been evaluated for causes of the condition.
For the treatment of endometriosis to induce endometrial involution to a ‘resting’ phase and reduce the size and growth of endometrial tissue in females with no contraindications to hormonal contraceptives, have achieved menarche and who desire contraception.

Documented hypersensitivity

Active or history of breast cancer

Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

Estrogen-dependent neoplasia

Liver disease, liver tumors

Undiagnosed abnormal vaginal bleeding

Uncontrolled hypertension

Diabetes mellitus with vascular involvement

Jaundice with prior oral contraceptive use

  • Edema
  • Weakness
  • Anorexia
  • Amenorrhea
  • Breakthrough bleeding
  • Change in menstrual flow
  • Spotting
  • Deep vein thrombosis
  • Thrombophlebitis
  • Depression
  • Dizziness
  • Headache
  • Nervousness
  • Somnolence
  • Breast tenderness
  • Galactorrhea
  • Abdominal pain
  • Nausea
  • Vomiting
  • Weight change
  • Cholestatic jaundice

Acitretin inhibits contraceptive efficacy of norethindrone preparations

Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

Discontinue 4 week before major surgery or prolonged immobilization

Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)

Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk; woman’s risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity

Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk

Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use

Pregnancy Category: X

Lactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)

Adults

1 tablet/day PO.

Geriatric

Not indicated.

Adolescents

1 tablet/day PO.

Children

Not indicated in prepubescent females.

Norethindrone/ethinyl estradiol/ferrous fumarate

tablet

  • 0.4mg/35mcg (21 tabs) plus 75mg Fe (7 chewable tabs) (Nexesta Fe, Zenchent Fe, Wymzya Fe)
  • 0.8mg/25mcg (24 tabs) plus 75mg Fe (4 chewable tabs) (Generess Fe, Kaitlib Fe, Layolis Fe)
Drugs Generic
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