Norethindrone Acetate/Ethinyl Estradiol/Ferrous Fmarate

DEA Class; Rx

Common Brand Names; Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Lo Loestrin Fe, Lomedia 24 Fe, Lo Minastrin Fe, Estrostep Fe, Gildess Fe 1.5/30, Gildess Fe 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Junel Fe 24, Microgestin Fe 1.5/30, Microgestin Fe 1/20, Minastrin 24 FE, Tilia Fe, TriLegest Fe, Blisovi 24 Fe, Blisovi Fe 1.5/30, Blisovi Fe 1/20, Taytulla, Larin 24 FE, Larin FE 1/20, Larin FE 1.5/30, Melodetta 24 FE, Mibelas 24 FE, Tarina 24 FE, Tarina FE 1/20, Merzee

Indicated for routine contraception.

Liver tumors or liver disease

Undiagnosed abnormal uterine bleeding

Breast cancer or other estrogen-or progestin-sensitive cancer

Pregnancy

Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

Cholestatic jaundice of pregnancy or jaundice with prior pill 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
• Mood swings

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

If a thrombotic event occurs, stop at least 4 wk before through 2 wk after major surgery; start no earlier than 4 weeks after delivery, in women who are not breastfeeding

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

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

Steroid hormones may be poorly metabolized in patients with hepatic impairment; acute or chronic disturbances of liver function may necessitate discontinuation of combination oral contraceptive until markers of liver function return to normal and causation by combination oral contraceptive has been excluded

CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)

Monitor prediabetic and diabetic women taking eithinyl estradiol/ norethindrone; consider alternative contraceptive method for women with uncontrolled dyslipidemia

Evaluate significant change in headaches and discontinue therapy if indicated

Evaluate irregular bleeding or amenorrhea

If used in women with well-controlled hypertension, monitor blood pressure and stop therapy if blood pressure rises significantly

Discontinue hormonal therapy prior to starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with combination drug regimen

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema

Chloasma may occur with therapy, especially in women with a history of chloasma gravidarum; advise women with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while taking the drug

There is no use for contraception in pregnancy; therefore, drug should be discontinued during pregnancy

Small amounts of oral contraceptive steroids identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given in postpartum period may interfere with lactation by decreasing quantity and quality of breast milk