Norethindrone

DEA Class; Rx

Common Brand Names; Camila, Errin, Heather, Jencycla, Jolivette, Lyza, Nor QD, Nora-BE, norethisterone, Norhisterone, Deblitane, Sharobel

Oral synthetic progestin with moderate androgenic and slight estrogenic activity relative to other progestins; norethindrone acetate a prodrug of norethindrone
Used as progestin-only (‘mini pill’) contraceptive and found in some combination oral contraceptives
Also used for hormonal imbalance (e.g., secondary amenorrhea, dysfunctional uterine bleeding, or endometriosis); in combination products for hormone replacement for postmenopausal women

Progestin only oral contraceptive

Documented hypersensitivity

Liver disease or impairment

Undiagnosed abnormal vaginal bleeding

Pregnancy

History, suspected, or known malignancy of the breast

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

Use caution in 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 associated with retinal vascular lesions (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.

Follicles may enlarge beyond size of the one in normal cycle; enlarged follicle may be asymptomatic or may be associated with mild abdominal pain; surgical intervention rarely needed

Rare hepatic adenomas and focal modular hyperplasia, resulting in fatal intra-abdominal hemorrhage reported with therapy

Irregular menstrual bleeding is common with progestin only contraceptives; rule out nonpharmacologic causes of abnormal bleeding

Ectopic pregnancy should be considered in patients that use progestin only contraceptive and experience lower abdominal pain

Discontinue 4 week before major surgery or prolonged immobilization.

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

May have adverse effect on lipid metabolism; use caution in women with hyperlipidemia

Not for use prior to menarche

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

Discontinue if migraine, proptosis, diplopia, or other visual disturbances occur; discontinue permanently if papilledema or retinal vascular lesions are observed on examination

Pregnancy Category: X

Lactation: Excreted in breast milk; use caution