Norethisterone

Irregular menstrual bleeding patterns are common with progestin-only contraceptives; nonpharmacologic causes of abnormal bleeding should be ruled out.

The use of combination hormonal contraceptives has been associated with a slight increase in the frequency of breast cancer, however studies are not consistent. Data is insufficient to determine if progestin-only contraceptives also increase this risk. Norethindrone and norethindrone acetate are contraindicated in women with breast cancer.

If follicular development occurs following use for contraception, follicles may grow and enlarge beyond the size attained in a normal cycle. May be asymptomatic or can be associated with mild abdominal pain; surgical intervention is rarely required.

The possibility of ectopic pregnancy following use of a progestin-only contraceptive should be considered in patients with lower abdominal pain.

May have adverse effects on lipid metabolism; use caution in women with hyperlipidemias.

Norethindrone acetate: Discontinue if migraine, loss of vision, proptosis, diplopia, or other visual disturbances occur; discontinue permanently if papilledema or retinal vascular lesions are observed on examination. Disease-related concerns:

Norethindrone acetate: Risk factors for cardiovascular disorders include diabetes mellitus, hypercholesterolemia, hypertension, SLE, obesity, tobacco use, and/or history of venous thromboembolism (VTE). Risk factors should be managed appropriately.

Norethindrone acetate: Use with caution in patients with depression. Progestin only contraceptive tablets may be used in women with depression (Curtis 2016b).

May have adverse effects on glucose tolerance; use caution in women with diabetes. Progestin only contraceptive tablets may be used in women with diabetes (Curtis 2016b).

Norethindrone acetate: Use with caution in patients with diseases which may be exacerbated by fluid retention, including asthma, epilepsy, or cardiac or renal dysfunction.

Extremely rare hepatic adenomas and focal nodular hyperplasia resulting in fatal intra-abdominal hemorrhage have been reported in association with long-term combination oral contraceptive use. Data is insufficient to determine if progestin-only contraceptives also increase this risk. Use as a contraceptive is contraindicated in women with hepatic tumors.

Use with caution in patients with a history of migraine. Progestin-only contraceptive tablets may be used in women with a history of headache or migraine; new headaches or changes in headaches should be evaluated (Curtis 2016b). Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Not for use prior to menarche.

Progestin-only contraceptives may be used in women who smoke (Curtis 2016b). Because of an increased risk of cardiovascular disease, women using oral contraceptives should be strongly advised not to smoke. Other warnings/precautions:

Norethindrone: Progestin-only contraceptives contain less progestin than contained in estrogen/progestin–combined contraceptives. Risks associated with estrogen/progestin contraceptives should be considered for progestin-only products.

Progestin-only contraceptives do not protect against HIV infection or other sexually transmitted diseases.

The use of estrogens and/or progestins may change the results of some laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). The dose, route, and the specific estrogen/progestin influence these changes. In addition, personal risk factors (eg, cardiovascular disease, smoking, diabetes, age) also contribute to adverse events; use of specific products may be contraindicated in women with certain risk factors.