Your activity: 148 p.v.
your limit has been reached. plz Donate us to allow your ip full access, Email: sshnevis@outlook.com

Norethindrone: Pediatric drug information

Norethindrone: Pediatric drug information
(For additional information see "Norethindrone: Drug information" and see "Norethindrone: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Aygestin;
  • Camila;
  • Deblitane;
  • Errin;
  • Heather;
  • Incassia;
  • Jencycla;
  • Jolivette [DSC];
  • Lyleq;
  • Lyza;
  • Nora-BE;
  • Norlyda [DSC];
  • Norlyroc;
  • Ortho Micronor [DSC];
  • Sharobel;
  • Tulana [DSC]
Brand Names: Canada
  • Jencycla;
  • Micronor [DSC];
  • Movisse;
  • Norlutate
Therapeutic Category
  • Contraceptive, Oral;
  • Contraceptive, Progestin Only;
  • Progestin
Dosing: Pediatric
Abnormal uterine bleeding and amenorrhea

Abnormal uterine bleeding and amenorrhea (secondary): Postmenarche females: Limited data in postmenarche children: Norethindrone acetate: Oral: 2.5 to 10 mg once daily for 5 to 12 days each month; most pediatric experts suggest 5 mg once daily for 12 days per month (Kliegman 2011; Kliegman 2016). Secretory transformation of the endometrium will occur when adequately primed with endogenous or exogenous estrogen. Withdrawal bleeding may be expected within 3 to 7 days after discontinuing norethindrone acetate.

Contraception

Contraception: Postmenarche adolescent females: Norethindrone: Oral: 0.35 mg once daily every day (no missed days)

Initial dose: Start on first day of menstrual period or the day after a miscarriage or abortion. If switching from a combined oral contraceptive, begin the day after finishing the last active combined tablet.

Missed dose: Take as soon as remembered. A back-up method of contraception should be used for 48 hours if dose is taken ≥3 hours late.

Additional contraception dosing considerations (CDC [Curtis 2016a]):

Initiation of therapy: May be started at any time in the menstrual cycle once it is determined that the female is not pregnant. Back-up contraception is not needed if started within 5 days of onset of menstruation. If started >5 days after the onset of menstruation or at any time in a female experiencing amenorrhea (not postpartum), back up contraception should be used for 2 days.

Switching from a different contraceptive to a progestin-only contraceptive: May be started at any time if it is determined that the female is not pregnant. Unless the female abstains from sexual intercourse, a back-up method of contraception is needed if it has been >5 days since menstrual bleeding has begun. When an additional method of contraception is needed, consider continuing the woman’s previous method for 2 days after starting the progestin-only contraceptive.

Switching from an IUD to a progestin-only contraceptive: Continue the IUD for at least 2 days after the progestin-only contraceptive is started or advise the female to abstain from sexual intercourse or use a barrier contraceptive for 7 days before removing the IUD. Alternately, an emergency contraceptive may be used at the time of IUD removal.

Endometriosis

Endometriosis: Postmenarche females ≥10 years: Limited data in children 10 to 12 years (Kaser 2012): Norethindrone acetate: Oral: 5 mg once daily for 14 days; increase at increments of 2.5 mg/day every 2 weeks to reach target maintenance of 15 mg/day; continue for 6 to 9 months or until breakthrough bleeding demands temporary termination

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, use is contraindicated in patients with hepatic tumors or impairment.

Dosing: Adult

(For additional information see "Norethindrone: Drug information")

Note: Norethindrone (NET) is used for progestin-only contraception. Norethindrone acetate (NETA) is a prodrug of NET used in treatment of abnormal uterine bleeding, amenorrhea, and endometriosis. NET and NETA have different dosing, warnings, and precautions; confirm appropriate formulation before prescribing. International considerations: Different preparations (with different dosing and indications) are available outside of the United States.

Abnormal uterine bleeding, nonacute

Abnormal uterine bleeding, nonacute (alternative agent): Note: Dosing not intended for management of acute abnormal bleeding (ie, excessively heavy or prolonged bleeding that requires urgent evaluation). Alternative for patients who cannot or choose not to use preferred agents (eg, estrogen-progestin contraceptives, levonorgestrel IUD) (Kaunitz 2022).

Oral: Norethindrone acetate (NETA): 5 to 15 mg per day in 1 to 3 divided doses; adjust dose at 1- to 3-month intervals within this range to the lowest effective dose to control bleeding and minimize adverse reactions (ACOG 2019; Kaunitz 2022). Note: Continuous therapy is preferred in most patients due to increased efficacy and patient adherence; however, for patients who do not desire contraception, cyclic therapy (eg, administration only on days 5 to 26 of the menstrual cycle) may be preferred (Abu Hashim 2012; Bofill Rodriguez 2019; Irvine 1998; Kaunitz 2022; Lethaby 2019; Ramalho 2021).

Contraception

Contraception: Oral: Norethindrone (NET): 0.35 mg once daily in the order presented in the blister pack (no missed days).

Initial dose: Start on first day of menstrual period or the day after a miscarriage or abortion. If switching from a combined oral contraceptive, begin the day after finishing the last active combined tablet.

Missed dose: Take as soon as remembered. A back up method of contraception should be used for 48 hours if dose is taken ≥3 hours late.

Additional contraception dosing considerations (CDC [Curtis 2016a]):

Initiation of therapy: May be started at any time in the menstrual cycle once it is determined that the patient is not pregnant. Back-up contraception is not needed if started within 5 days of onset of menstruation. If started >5 days after the onset of menstruation or at any time in a patient experiencing amenorrhea (not postpartum), back up contraception should be used for 2 days.

Switching from a different contraceptive to a progestin-only contraceptive: May be started at any time if it is determined that the patient is not pregnant. Unless the patient abstains from sexual intercourse, a backup method of contraception is needed if it has been >5 days since menstrual bleeding has begun. When an additional method of contraception is needed, consider continuing the patient's previous method for 2 days after starting the progestin-only contraceptive.

Switching from an IUD to a progestin-only contraceptive: Continue the IUD for at least 2 days after the progestin-only contraceptive is started or advise the patient to abstain from sexual intercourse or use a barrier contraceptive for 7 days before removing the IUD. Alternately, an emergency contraceptive may be used at the time of IUD removal.

Endometriosis

Endometriosis: Oral: Norethindrone acetate (NETA): 5 mg/day for 14 days; increase at increments of 2.5 mg/day every 2 weeks to reach 15 mg/day; continue for 6 to 9 months or until breakthrough bleeding demands temporary termination.

Estrogen therapy-associated endometrial hyperplasia, prevention

Estrogen therapy-associated endometrial hyperplasia, prevention (alternative agent):

Note: Indicated in patients with a uterus receiving estrogen therapy (eg, for secondary amenorrhea) (ES [Gordon 2017]). Discontinue when estrogen therapy is discontinued.

Oral: Norethindrone acetate (NETA): 5 to 10 mg/day for 10 to 14 days (Ackerman 2022; manufacturer's labeling).

Secondary amenorrhea, diagnostic aid

Secondary amenorrhea, diagnostic aid ("progestin challenge") (alternative agent): Oral: Norethindrone acetate (NETA): 5 mg daily for 5 to 10 days (Gordon 2017). Note: Withdrawal bleeding may be expected during therapy or within 3 to 7 days after cessation of therapy; absence of withdrawal bleeding suggests low endometrial estrogen exposure and/or uterine or outflow tract abnormality (Gordon 2017; manufacturer's labeling).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, use is contraindicated in patients with hepatic tumors or impairment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Camila: 0.35 mg [DSC]

Camila: 0.35 mg [contains corn starch, fd&c red #40(allura red ac)aluminum lake]

Deblitane: 0.35 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]

Errin: 0.35 mg [contains corn starch, quinoline (d&c yellow #10) aluminum lake]

Heather: 0.35 mg [contains fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]

Incassia: 0.35 mg [contains corn starch, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]

Jencycla: 0.35 mg [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10)]

Jolivette: 0.35 mg [DSC]

Lyleq: 0.35 mg [contains corn starch, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]

Lyza: 0.35 mg [contains corn starch, quinoline yellow (d&c yellow #10)]

Nora-BE: 0.35 mg

Norlyda: 0.35 mg [DSC]

Norlyroc: 0.35 mg

Ortho Micronor: 0.35 mg [DSC] [contains corn starch, quinoline (d&c yellow #10) aluminum lake]

Sharobel: 0.35 mg [contains fd&c blue #1 (brill blue) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, soybean lecithin]

Tulana: 0.35 mg [DSC] [contains corn starch, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]

Generic: 0.35 mg

Tablet, Oral, as acetate:

Aygestin: 5 mg [scored]

Generic: 5 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Jencycla: 0.35 mg [contains fd&c blue #1 (brill blue) aluminum lake, quinoline (d&c yellow #10) aluminum lake]

Micronor: 0.35 mg [DSC] [contains quinoline yellow (d&c yellow #10)]

Movisse: 0.35 mg [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10)]

Tablet, Oral, as acetate:

Norlutate: 5 mg [contains corn starch, quinoline yellow (d&c yellow #10)]

Administration: Pediatric

Oral: Administer at the same time each day

When used for the prevention of pregnancy, a back-up method of contraception should be used for 48 hours if dose is missed or taken ≥3 hours late. If vomiting or severe diarrhea occur within 3 hours of taking a dose, take another dose as soon as possible, then continue taking one dose daily and use a backup method of contraception (or avoid sexual intercourse) until 2 days after vomiting or diarrhea have resolved. Emergency contraception should be considered in the event of unprotected intercourse (CDC 2013).

Administration: Adult

Ora l: For oral administration. Administer at the same time each day.

When used for the prevention of pregnancy, a backup method of contraception should be used for 48 hours if dose is missed or taken ≥3 hours late. If vomiting or severe diarrhea occur within 3 hours of taking a dose, take another dose as soon as possible, then continue taking one dose daily and use a backup method of contraception (or avoid sexual intercourse) until 2 days after vomiting or diarrhea have resolved. Emergency contraception should be considered in the event of unprotected intercourse (CDC [Curtis 2016a]).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016).

Storage/Stability

Store at controlled room temperature.

Use

Norethindrone: Prevention of pregnancy (FDA approved in postmenarche pediatric and adult females); Note: Not indicated for emergency contraception.

Norethindrone acetate: Treatment of amenorrhea, endometriosis, and abnormal uterine bleeding (FDA approved in postmenarche pediatric and adult females)

Medication Safety Issues
Sound-alike/look-alike issues:

Micronor may be confused with miconazole, Micronase

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

International issues:

Norethindrone (NET) and norethindrone acetate (NETA) may both be available as 5 mg tablets outside of the United States; these products are not equivalent and have different dosing and indications; confirm appropriate formulation before prescribing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Cardiovascular: Cerebral embolism, cerebral thrombosis, deep vein thrombosis, edema, pulmonary embolism, retinal thrombosis

Central nervous system: Depression, dizziness, fatigue, headache, insomnia, migraine, emotional lability, nervousness

Dermatologic: Acne vulgaris, alopecia, chloasma, pruritus, skin rash, urticaria

Endocrine & metabolic: Amenorrhea, hirsutism, hypermenorrhea, menstrual disease, weight gain

Gastrointestinal: Abdominal pain, nausea, vomiting

Genitourinary: Breakthrough bleeding, breast hypertrophy, breast tenderness, cervical erosion, change in cervical secretions, decreased lactation, genital discharge, mastalgia, spotting, vaginal hemorrhage

Hypersensitivity: Anaphylaxis, hypersensitivity

Hepatic: Cholestatic jaundice, hepatitis, abnormal hepatic function tests

Neuromuscular & skeletal: Arm pain, leg pain

Ophthalmic: Optic neuritis (with or without vision loss)

Contraindications

Hypersensitivity to norethindrone or any component of the formulation; breast cancer (known, suspected, or history of); undiagnosed abnormal genital bleeding; pregnancy.

Norethindrone (NET): Additional contraindications: Benign or malignant liver tumors; acute liver disease.

Norethindrone acetate (NETA):

Additional contraindications: Deep vein thrombosis or pulmonary embolism (current or history of); active or recent history of arterial thromboembolic disease (eg, stroke, myocardial infarction); hepatic impairment or disease; as a diagnostic test for pregnancy.

Additional contraindications in Canadian labeling: Estrogen or progestin dependent malignant tumor; partial or complete vision loss due to ophthalmic vascular disease; missed abortion.

Warnings/Precautions

Concerns related to adverse effects:

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

• Delayed follicular atresia/ovarian cysts: 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.

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

• Hepatic adenomas or carcinomas: Use of combination hormonal contraceptives is associated with hepatic adenomas (rare); rupture may cause fatal intra-abdominal hemorrhage. Long-term use may be associated with an increased risk of hepatocellular carcinoma (rare). Data are insufficient to determine if progestin-only contraceptives also increase this risk.

• Lipid effects: May have adverse effects on lipid metabolism; use caution in patients with hyperlipidemias.

• Visual abnormalities: Norethindrone acetate (NETA): 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:

• Breast cancer: In patients at risk for breast cancer due to family history or susceptibility genes (BRCA1, BRCA2), it is unclear if combination hormonal contraceptives increase the risk for breast cancer and there are insufficient data specific to progestin-only contraceptives. However, breast cancer is a hormonal-sensitive tumor and the prognosis for patients with a current or recent history of breast cancer may be worse with hormonal contraceptive use (CDC [Curtis 2016b]; SGO/ASRM [Chen 2019]).

• Cardiovascular disease: Norethindrone acetate (NETA): 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.

• Depression: Norethindrone acetate (NETA): Use with caution in patients with depression. Progestin-only contraceptive tablets may be used in patients with depression (CDC [Curtis 2016b]).

• Diabetes: May have adverse effects on glucose tolerance; use caution in patients with diabetes. Progestin-only contraceptive tablets may be used in patients with diabetes (CDC [Curtis 2016b]).

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

• Migraine: Use with caution in patients with a history of migraine. Progestin-only contraceptive tablets may be used in patients with a history of headache or migraine; new headaches or changes in headaches should be evaluated (CDC [Curtis 2016b]).

Special populations:

• Smoking: Progestin-only contraceptives may be used in patients who smoke (CDC [Curtis 2016b]). Because of an increased risk of cardiovascular disease, patients using oral contraceptives should be strongly advised not to smoke.

Other warnings/precautions:

• Appropriate use: Norethindrone (NET): Progestin-only contraceptives contain less progestogen than contained in estrogen/progestogen–combined contraceptives. Risks associated with estrogen/progestogen contraceptives should be considered for progestin-only products.

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

Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program

Albiglutide: Norethindrone may diminish the therapeutic effect of Albiglutide. Albiglutide may increase the serum concentration of Norethindrone. Risk C: Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Aprepitant: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration with aprepitant, and to continue back-up contraception for 28 days after discontinuing aprepitant to ensure contraceptive reliability. Risk D: Consider therapy modification

Asparaginase Products: Hormonal Contraceptives may enhance the thrombogenic effect of Asparaginase Products. Management: Consider discontinuing hormonal contraceptives and using an alternative contraceptive method in patients treated with asparaginase products. Risk D: Consider therapy modification

Asunaprevir: May decrease the serum concentration of Hormonal Contraceptives. Management: Use of a high-dose oral contraceptive (at least 30 mcg of ethinyl estradiol combined with norethindrone) is recommended when combined with asunaprevir. Consider an additional barrier method when other forms of contraception are used with asunaprevir. Risk D: Consider therapy modification

Atazanavir: May decrease the serum concentration of Hormonal Contraceptives. Specifically, atazanavir/ritonavir may decrease concentrations of estrogens. Atazanavir may increase the serum concentration of Hormonal Contraceptives. Specifically, atazanavir alone may increase concentrations of estrogens and atazanavir alone or boosted may increase concentrations of progestins. Management: Dose adjustment of hormonal contraceptives or use of alternative or additional nonhormonal contraceptive may be needed when combined with atazanavir. See full interact monograph for details. Atazanavir/cobicistat with drospirenone is contraindicated. Risk D: Consider therapy modification

Brigatinib: May decrease the serum concentration of Hormonal Contraceptives. Management: Use a non-hormonal contraceptive during brigatinib use and for at least 4 months after the last brigatinib dose. Males with partners of reproductive potential should use contraception during treatment with brigatinib and for 3 months after brigatinib use. Risk D: Consider therapy modification

Carfilzomib: Hormonal Contraceptives may enhance the thrombogenic effect of Carfilzomib. Management: Consider alternative, non-hormonal methods of contraception in patients requiring therapy with carfilzomib, especially patients using carfilzomib in combination with dexamethasone, lenalidomide plus dexamethasone, or daratumumab plus dexamethasone. Risk D: Consider therapy modification

Cladribine: May diminish the therapeutic effect of Hormonal Contraceptives. Management: In females of reproductive potential using systemically acting hormonal contraceptives, add a barrier method during cladribine dosing and for at least 4 weeks after the last dose in each treatment course Risk D: Consider therapy modification

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Cobicistat: May decrease the serum concentration of Hormonal Contraceptives. Specifically, cobicistat may decrease serum concentrations of estrogens. Cobicistat may increase the serum concentration of Hormonal Contraceptives. Specifically, cobicistat may increase serum concentrations of progestins. Management: Use alternative or additional nonhormonal forms of contraception when estrogen-containing hormonal contraceptives are combined with cobicistat. Progestin-only contraceptives can be used without back up, but monitor for progestin toxicities. Risk D: Consider therapy modification

Colesevelam: May decrease the serum concentration of Norethindrone. Management: Oral contraceptives containing ethinyl estradiol and norethindrone should be administered at least 4 hours before colesevelam. Risk D: Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a moderate CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider therapy modification

CYP3A4 Inducers (Strong): May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a strong CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider therapy modification

CYP3A4 Inducers (Weak): May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a weak CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Hormonal Contraceptives. Risk C: Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Efavirenz: May decrease the serum concentration of Hormonal Contraceptives. Management: Use a back-up method during coadministration, and to continue back-up contraception for 12 weeks after stopping efavirenz to ensure contraceptive reliability. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Risk D: Consider therapy modification

Elagolix: Hormonal Contraceptives may diminish the therapeutic effect of Elagolix. Specifically, estrogen-containing hormonal contraceptives may diminish the therapeutic effects of elagolix. Elagolix may increase the serum concentration of Hormonal Contraceptives. Specifically, concentrations of ethinyl estradiol may be increased with elagolix therapy. Elagolix may decrease the serum concentration of Hormonal Contraceptives. Specifically, concentrations of progestins may be decreased with elagolix therapy. Management: Use an alternative, nonhormonal contraceptive during treatment with elagolix and for at least 28 days following discontinuation of elagolix treatment. Use of elagolix 200 mg twice daily with an estrogen-containing hormonal contraceptive is not recommended Risk D: Consider therapy modification

Elexacaftor, Tezacaftor, and Ivacaftor: Hormonal Contraceptives may enhance the adverse/toxic effect of Elexacaftor, Tezacaftor, and Ivacaftor. Specifically, the risk for rash may be increased. Risk C: Monitor therapy

Encorafenib: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination

Etravirine: May decrease the serum concentration of Hormonal Contraceptives. Specifically, progestin concentrations may decrease. Etravirine may increase the serum concentration of Hormonal Contraceptives. Specifically, estrogen concentrations may increase. Risk C: Monitor therapy

Exenatide: Hormonal Contraceptives may diminish the therapeutic effect of Exenatide. Exenatide may decrease the serum concentration of Hormonal Contraceptives. Management: Administer oral hormonal contraceptives at least one hour prior to exenatide. Monitor blood glucose more frequently when patients treated with exenatide initiate therapy with a hormonal contraceptive. Increases in exenatide doses may be needed. Risk D: Consider therapy modification

Felbamate: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing felbamate to ensure contraceptive reliability. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Flibanserin: Hormonal Contraceptives may increase the serum concentration of Flibanserin. Risk C: Monitor therapy

Fosaprepitant: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration with fosaprepitant, and to continue back-up contraception for 28 days after discontinuing fosaprepitant to ensure contraceptive reliability. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Griseofulvin: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing griseofulvin to ensure contraceptive reliability. Risk D: Consider therapy modification

Interleukin-6 (IL-6) Inhibiting Therapies: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy

Ivosidenib: May decrease the serum concentration of Hormonal Contraceptives. Management: Consider alternative methods of contraception (ie, non-hormonal) in patients receiving ivosidenib. Risk D: Consider therapy modification

Ixazomib: May decrease the serum concentration of Hormonal Contraceptives. More specifically, use of ixazomib with dexamethasone may decrease the serum concentrations of hormonal contraceptives. Management: Patients of reproductive potential should use a non-hormonal contraceptive method during treatment with ixazomib and for at least 90 days after the last ixazomib dose. Risk D: Consider therapy modification

LamoTRIgine: May decrease the serum concentration of Progestins (Oral Contraceptive [mini-pill]). Risk C: Monitor therapy

Lixisenatide: Hormonal Contraceptives may diminish the therapeutic effect of Lixisenatide. Lixisenatide may decrease the serum concentration of Hormonal Contraceptives. Management: Administer oral hormonal contraceptives 1 hour before or at least 11 hours after administration of lixisenatide. Additionally, monitor blood glucose more frequently when patients treated with lixisenatide initiate therapy with a hormonal contraceptive. Risk D: Consider therapy modification

Mavacamten: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative contraceptive that is not sensitive to CYP3A4 induction or a back-up method during coadministration, and to continue back-up contraception for 4 months after stopping mavacamten to ensure contraceptive reliability. Risk D: Consider therapy modification

MetyraPONE: Progestins may diminish the diagnostic effect of MetyraPONE. Management: Consider alternatives to the use of the metyrapone test in patients taking progestins. Risk D: Consider therapy modification

MiFEPRIStone: May diminish the therapeutic effect of Hormonal Contraceptives. Management: Nonhormonal contraception should be used during, and for 4 weeks following, mifepristone treatment for hyperglycemia due to Cushing syndrome. If used for pregnancy termination, hormonal contraceptives can be used after pregnancy expulsion is confirmed. Risk D: Consider therapy modification

Mobocertinib: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination

Mycophenolate: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients of childbearing potential who are taking hormonal contraceptives should use an additional form of barrier contraception during treatment with mycophenolate and for 6 weeks after mycophenolate discontinuation. Risk D: Consider therapy modification

Nirmatrelvir and Ritonavir: May decrease the serum concentration of Hormonal Contraceptives. Specifically, nirmatrelvir and ritonavir may decrease concentrations of estrogens. Nirmatrelvir and Ritonavir may increase the serum concentration of Hormonal Contraceptives. Specifically, nirmatrelvir and ritonavir may increase concentrations of progestins. Management: Use additional nonhormonal forms of contraception (back-up method) when estrogen-containing hormonal contraceptives are combined with nirmatrelvir/ritonavir. Progestin-only contraceptives can be used without back-up, but monitor for progestin toxicities. Risk D: Consider therapy modification

Octreotide: May decrease the serum concentration of Hormonal Contraceptives. Management: Women should use an alternative non-hormonal method of contraception or a back-up method when octreotide is combined with hormonal contraceptives. Risk D: Consider therapy modification

Olutasidenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Avoid use of olutasidenib with sensitive or narrow therapeutic index CYP3A4 substrates when possible. If concurrent use with olutasidenib is unavoidable, monitor closely for evidence of decreased concentrations of the CYP3A4 substrates. Risk D: Consider therapy modification

OXcarbazepine: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing oxcarbazepine to ensure contraceptive reliability. Risk D: Consider therapy modification

Perampanel: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients should use an alternative, nonhormonal-based form of contraception during the concurrent use of perampanel and for 1 month after discontinuing perampanel. Risk D: Consider therapy modification

Pexidartinib: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination

Pitolisant: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with pitolisant and for at least 21 days after discontinuation of pitolisant treatment. Risk D: Consider therapy modification

Protease Inhibitors: May decrease the serum concentration of Hormonal Contraceptives. Specifically, protease inhibitors may decrease concentrations of estrogens. Protease Inhibitors may increase the serum concentration of Hormonal Contraceptives. Specifically, protease inhibitors may increase concentrations of progestins. Management: Use alternative or additional nonhormonal forms of contraception when estrogen-containing hormonal contraceptives are combined with protease inhibitors. Progestin-only contraceptives can be used without back up, but monitor for progestin toxicities. Risk D: Consider therapy modification

Retinoic Acid Derivatives: May diminish the therapeutic effect of Progestins (Contraceptive). Retinoic Acid Derivatives may decrease the serum concentration of Progestins (Contraceptive). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Microdosed progesterone-only preparations (ie, minipills that do not contain estrogen) are considered an inadequate method of contraception. Risk D: Consider therapy modification

Sugammadex: May diminish the therapeutic effect of Hormonal Contraceptives. Management: Patients receiving any hormonal contraceptive (oral or non-oral) should use an additional, nonhormonal contraceptive method during and for 7 days following sugammadex treatment. Risk D: Consider therapy modification

Taurursodiol: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination

Tazemetostat: May decrease the serum concentration of Hormonal Contraceptives. Management: Individuals of childbearing potential should use a non-hormonal contraceptive method during treatment with tazemetostat and for 6 months after. Males with partners of childbearing potential should use contraception during treatment and for 3 months after. Risk D: Consider therapy modification

Tetrahydrocannabinol and Cannabidiol: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients taking hormonal contraceptives should use an additional, non-hormonal contraceptive or reliable barrier method during treatment with tetrahydrocannabinol and cannabidiol buccal spray. Risk D: Consider therapy modification

Thalidomide: Hormonal Contraceptives may enhance the thrombogenic effect of Thalidomide. Risk C: Monitor therapy

Tirzepatide: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients using oral hormonal contraceptives should switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after initiation of tirzepatide and for 4 weeks after each dose escalation of tirzepatide. Risk D: Consider therapy modification

Topiramate: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing topiramate to ensure contraceptive reliability. Risk D: Consider therapy modification

Tranexamic Acid: Hormonal Contraceptives may enhance the thrombogenic effect of Tranexamic Acid. Risk X: Avoid combination

Ulipristal: May diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Risk X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Hormonal Contraceptives may increase the serum concentration of Vitamin K Antagonists. Hormonal Contraceptives may decrease the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Voriconazole: Hormonal Contraceptives may increase the serum concentration of Voriconazole. Voriconazole may increase the serum concentration of Hormonal Contraceptives. Risk C: Monitor therapy

Reproductive Considerations

Norethindrone (NET): Progestin-only contraceptives may be started immediately postpartum (CDC [Curtis 2016a]; CDC [Curtis 2016b]). A rapid return to fertility occurs when progestin-only contraceptives are discontinued.

All available forms of contraception, including norethindrone (NET), can be considered for patients on gender affirming testosterone therapy after evaluating patient preferences and medical conditions (eg, risk for venous thromboembolism) (Bonnington 2020; Krempasky 2020).

Norethindrone acetate (NETA): The contraceptive dose of norethindrone acetate is not known. Barrier contraception is recommended to prevent unintended pregnancy (eg, when treating endometriosis) (Kaser 2012). Pregnancy should be excluded prior to inducing withdrawal bleeding with norethindrone acetate (NETA) when evaluating patients for secondary amenorrhea (ES [Gordon 2017]).

Pregnancy Considerations

First trimester exposure of progestins may cause genital abnormalities including hypospadias in male infants and mild virilization of external female genitalia. Changes in external genitalia have been reported in female infants exposed to norethindrone acetate (NETA) (Fine 1963). Significant adverse events related to growth and development have not been observed following use of oral progestins in contraceptive doses (limited studies). Use is contraindicated during pregnancy.

Monitoring Parameters

Norethindrone: Contraception: Assessment of pregnancy status (prior to therapy); weight (optional; BMI at baseline may be helpful to monitor changes during therapy); assess potential health status changes at routine visits (Curtis 2016a). Evaluate pregnancy status if 2 consecutive menstrual cycles are missed, or if the menstrual cycle is delayed and ≥1 pill was taken late or missed in a cycle in which intercourse occurred without a back-up method of contraception.

Norethindrone acetate: Monitor patient for vision changes; signs or symptoms of depression; glycemic control in patients with diabetes; lipid profiles in patients being treated for hyperlipidemias.

Regardless of indication, adequate diagnostic measures, including endometrial sampling, if indicated, should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding. Pathologist should be informed of therapy when submitting endometrial tissue for histologic evaluation.

Mechanism of Action

Once absorbed, systemic disposition of norethindrone acetate (NETA) and norethindrone (NET) is the same.

NET is used in preparations for progestin-only contraception. NET suppresses ovulation, thickens cervical mucus (which inhibits sperm penetration), alters follicle-stimulating hormone (FSH) and luteinizing hormone (LH) concentrations, slows the movement of ovum through the fallopian tubes, and alters the endometrium.

Progestogens, such as NETA in the doses used for abnormal uterine bleeding, amenorrhea, and endometriosis, lead to atrophy of the endometrial tissue. They may also suppress new growth and implantation. Pain associated with endometriosis is decreased. When treating endometriosis, NETA may be used in combination with gonadotropin-releasing hormone agonists to decrease side effects from hypoestrogenism (ASRM 2014).

Pharmacokinetics (Adult data unless noted)

Absorption: Oral: Rapidly absorbed

Distribution: Vd: 4 L/kg

Protein binding: 61% to albumin; 36% to sex hormone-binding globulin (SHBG); SHBG capacity affected by plasma ethinyl estradiol levels (Orme 1983)

Metabolism: Oral: Norethindrone acetate (NETA) is deacetylated to norethindrone; norethindrone undergoes hepatic reduction and conjugation; orally administered norethindrone is subject to first-pass effect (Orme 1983). In addition to forming glucuronide and sulfide conjugates, norethindrone is also metabolized to ethinyl estradiol (Kuhnz 1997; Orme 1983).

Bioavailability: 64% (Orme 1983)

Half-life elimination: ~8 to 9 hours

Time to peak: ~2 hours (varies by dose and use of concomitant estrogen (Orme 1983)

Excretion: Urine (>50% as metabolites); feces (20% to 40% as metabolites)

Pricing: US

Tablets (Aygestin Oral)

5 mg (per each): $7.28

Tablets (Camila Oral)

0.35 mg (per each): $1.32

Tablets (Deblitane Oral)

0.35 mg (per each): $1.32

Tablets (Errin Oral)

0.35 mg (per each): $1.32

Tablets (Heather Oral)

0.35 mg (per each): $1.32

Tablets (Incassia Oral)

0.35 mg (per each): $1.32

Tablets (Jencycla Oral)

0.35 mg (per each): $1.32

Tablets (Lyleq Oral)

0.35 mg (per each): $1.32

Tablets (Lyza Oral)

0.35 mg (per each): $1.32

Tablets (Nora-BE Oral)

0.35 mg (per each): $1.32

Tablets (Norethindrone Acetate Oral)

5 mg (per each): $2.65

Tablets (Norethindrone Oral)

0.35 mg (per each): $1.32

Tablets (Norlyroc Oral)

0.35 mg (per each): $3.96

Tablets (Sharobel Oral)

0.35 mg (per each): $1.32

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Aminor (AE, BH, CY, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);
  • Conludag (BE, BG, NO);
  • Ethinor (BD);
  • Locilan (AU);
  • Menogia (BD);
  • Menoral-S (LK);
  • Micronor (AE, AU, BF, BJ, BR, CI, CY, ET, GB, GH, GM, GN, IE, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW);
  • Micronovum (CH, DE);
  • Mini-PE (DK);
  • Norcolut (BB, BM, BS, BZ, EE, GY, HK, HU, JM, MY, PR, SR, TT, UA);
  • Norcutin (MY, SG);
  • Nordron (TW);
  • Norelut (HK);
  • Norestin (BR);
  • Noret (AR);
  • Noretone (ZW);
  • Norgest (LK);
  • Noriday (AE, BF, BH, BJ, CI, ET, GB, GH, GM, GN, IE, KE, LR, MA, ML, MR, MU, MW, MY, NE, NG, NZ, QA, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);
  • Noriday 28 (AU);
  • Norina (TW);
  • Noristerat (DE, MX);
  • Norlut-N (LK);
  • Ortho-Novum (MX);
  • Primolut (PK);
  • Primolut N (AE, BB, BD, BF, BH, BJ, BM, BS, BZ, CH, CI, CL, CY, DE, ET, FI, GB, GH, GM, GN, GY, IE, IL, IQ, IR, IS, JM, JO, JP, KE, KR, KW, LB, LR, LY, MA, ML, MR, MT, MU, MW, NE, NG, NL, NO, OM, PH, PK, PL, PR, QA, SA, SC, SD, SG, SL, SN, SR, SY, TH, TN, TR, TT, TZ, UG, YE, ZA, ZM, ZW);
  • Primolut Nor (AR, BE, BG, CR, CZ, DO, EC, EG, GR, GT, HN, IT, LU, NI, PA, PT, PY, RU, SE, SI, SV, UY);
  • Primolut-N (KR, LK);
  • Primolut-Nor (ES, UA);
  • Primolutin (DE);
  • Regamen (ID);
  • Renorcyl (BD);
  • Rontril (BD);
  • Shiton (TW);
  • Steron (TH);
  • Styptin 5 (IN);
  • Sunolut (MY);
  • Utovlan (GB);
  • Villfull (TW)


For country code abbreviations (show table)
  1. Abu Hashim H, Alsherbini W, Bazeed M. Contraceptive vaginal ring treatment of heavy menstrual bleeding: a randomized controlled trial with norethisterone. Contraception. 2012;85(3):246-252. doi:10.1016/j.contraception.2011.07.012 [PubMed 22067765]
  2. Ackerman KE, Misra M. Functional hypothalamic amenorrhea: Evaluation and management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 8, 2022.
  3. Ackerman KE, Singhal V, Slattery M, et al. Effects of estrogen replacement on bone geometry and microarchitecture in adolescent and young adult oligoamenorrheic athletes: a randomized trial. J Bone Miner Res. 2020;35(2):248-260. doi:10.1002/jbmr.3887 [PubMed 31603998]
  4. American College of Obstetricians and Gynecologists’ Committee on Adolescent Health Care. Committee Opinion No. 668: Menstrual manipulation for adolescents with physical and developmental disabilities. Obstet Gynecol. 2016;128(2):e20-e25. doi:10.1097/AOG.0000000000001585 [PubMed 27454732]
  5. American College of Obstetricians and Gynecologists (ACOG). ACOG Committee Opinion No. 785: ACOG screening and management of bleeding disorders in adolescents with heavy menstrual bleeding. Obstet Gynecol. 2019;134(3):e71-e83. doi:10.1097/AOG.0000000000003411 [PubMed 31441825]
  6. Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. [PubMed 27060684]
  7. Aygestin (norethindrone acetate) [prescribing information]. North Wales, PA: Teva Women's Health; October 2015.
  8. Betrabet SS, Shikary ZK, Toddywalla VS, Toddywalla SP, Patel D, Saxena BN. ICMR Task Force Study on hormonal contraception. Transfer of norethisterone (NET) and levonorgestrel (LNG) from a single tablet into the infant's circulation through the mother's milk. Contraception. 1987;35(6):517-522. [PubMed 3117488]
  9. Bhaskar A, Schulze PE, Acksteiner B, Laumas KR. Quantitative analysis of norethindrone in milk using deuterated carrier and gas chromatography-mass spectrometry. J Steroid Biochem. 1979;11(3):1323-1328. [PubMed 513753]
  10. Bofill Rodriguez M, Lethaby A, Farquhar C. Non-steroidal anti-inflammatory drugs for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019;9(9):CD000400. doi: 10.1002/14651858.CD000400.pub4. PMID: 31535715; PMCID: PMC6751587. [PubMed 31535715]
  11. Bonnington A, Dianat S, Kerns J, et al. Society of Family Planning clinical recommendations: contraceptive counseling for transgender and gender diverse people who were female sex assigned at birth. Contraception. 2020;102(2):70-82. doi:10.1016/j.contraception.2020.04.001 [PubMed 32304766]
  12. Camila (norethindrone) [prescribing information]. North Wales, PA: Teva Pharmaceuticals; October 2015.
  13. Carswell JM, Roberts SA. Induction and maintenance of amenorrhea in transmasculine and nonbinary adolescents. Transgend Health. 2017;2(1):195-201. doi:10.1089/trgh.2017.0021 [PubMed 29142910]
  14. Centers for Disease Control and Prevention (CDC). U.S. Selected Practice Recommendations for Contraceptive Use, 2013: adapted from the World Health Organization selected practice recommendations for contraceptive use, 2nd edition. MMWR Recomm Rep. 2013 Jun;62(RR-05):1-60. [PubMed 23784109]
  15. Chen LM, Blank SV, Burton E, Glass K, Penick E, Woodard T. Reproductive and hormonal considerations in women at increased risk for hereditary gynecologic cancers: Society of Gynecologic Oncology and American Society for Reproductive Medicine evidence-based review. Fertil Steril. 2019;112(6):1034-1042. doi:10.1016/j.fertnstert.2019.07.1349 [PubMed 31606136]
  16. Curtis KM, Jatlaoui TC, Tepper NK, et al. US selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016a;65(4):1‐66. doi:10.15585/mmwr.rr6504a1 [PubMed 27467319]
  17. Curtis KM, Tepper NK, Jatlaoui TC, et al. US medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep. 2016b;65(3):1‐103. doi:10.15585/mmwr.rr6503a1 [PubMed 27467196]
  18. Damm T, Lamvu G, Carrillo J, Ouyang C, Feranec J. Continuous vs. cyclic combined hormonal contraceptives for treatment of dysmenorrhea: a systematic review. Contracept X. 2019;1:100002. doi:10.1016/j.conx.2019.100002 [PubMed 32550522]
  19. Deblitane (norethindrone) [prescribing information]. Memphis, TN: Northstar Rx; March 2014.
  20. Fine E, Levin HM, McConnell EL Jr. Masculinization of female infants associated with norethindrone acetate. Obstet Gynecol. 1963;22:210-213. [PubMed 14043272]
  21. Fotherby K, Towobola O, Muggeridge J, Elder MG. Norethisterone levels in maternal serum and milk after intramuscular injection of norethisterone oenanthate as a contraceptive. Contraception. 1983;28(5):405-411. [PubMed 6673900]
  22. Gordon CM, Ackerman KE, Berga SL, et al. Functional hypothalamic amenorrhea: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2017;102(5):1413-1439. doi:10.1210/jc.2017-00131 [PubMed 28368518]
  23. Heather (norethindrone) [prescribing information]. Mahwah, NJ: Glenmark Pharmaceuticals Inc USA; August 2021.
  24. Incassia (norethindrone) [prescribing information]. East Windsor, NJ: Aurobindo Pharma USA Inc; August 2021.
  25. Irvine GA, Campbell-Brown MB, Lumsden MA, Heikkilä A, Walker JJ, Cameron IT. Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia. Br J Obstet Gynaecol. 1998;105(6):592-598. doi:10.1111/j.1471-0528.1998.tb10172.x [PubMed 9647148]
  26. Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126. [PubMed 10891521]
  27. Jencycla (norethindrone) [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; April 2020.
  28. Jencycla (norethindrone) [product monograph]. Boucherville, Quebec, Canada: Sandoz Canada Inc; June 2018.
  29. Jolivette (norethindrone) [prescribing information]. Corona, CA: Watson Pharma; August 2014.
  30. Kaser DJ, Missmer SA, Berry KF, Laufer MR. Use of norethindrone acetate alone for postoperative suppression of endometriosis symptoms. J Pediatr Adolesc Gynecol. 2012;25(2):105-108. [PubMed 22154396]
  31. Kaunitz AM. Abnormal uterine bleeding in nonpregnant reproductive-age patients: management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 29, 2022.
  32. Kirkham YA, Ornstein MP, Aggarwal A, McQuillan S. No. 313-menstrual suppression in special circumstances. J Obstet Gynaecol Can. 2019;41(2):e7-e17. doi:10.1016/j.jogc.2018.11.030 [PubMed 30638562]
  33. Kliegman RM, Behrman RE, Jenson HB, et al, eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007.
  34. Kliegman RM, Stanton BMD, St. Geme J, Schor NF, eds. Nelson' s Textbook of Pediatrics. 20th ed. Philadelphia, PA: Saunders Elsevier; 2016.
  35. Koetsawang S, Nukulkarn P, Fotherby K, Shrimanker K, Mangalam M, Towobola K. Transfer of contraceptive steroids in milk of women using long-acting gestagens. Contraception. 1982;25(4):321-331. [PubMed 6213373]
  36. Krempasky C, Harris M, Abern L, Grimstad F. Contraception across the transmasculine spectrum. Am J Obstet Gynecol. 2020;222(2):134-143. doi:10.1016/j.ajog.2019.07.043 [PubMed 31394072]
  37. Kuhnz W, Heuner A, Hümpel M, Seifert W, Michaelis K. In vivo conversion of norethisterone and norethisterone acetate to ethinyl etradiol in postmenopausal women. Contraception. 1997;56(6):379-385. [PubMed 9494772]
  38. Lethaby A, Wise MR, Weterings MA, Bofill Rodriguez M, Brown J. Combined hormonal contraceptives for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019;2(2):CD000154. doi:10.1002/14651858.CD000154.pub3 [PubMed 30742315]
  39. Lyza (norethindrone) [prescribing information]. Charleston, SC: Afaxys Pharma LLC; June 2017.
  40. Micronor (norethindrone) [product monograph]. Toronto, Ontario, Canada: Janssen; February 2018.
  41. Movisse (norethindrone) tablets, USP [product monograph]. Etobicoke, Ontario, Canada: Mylan Pharmaceuticals ULC; August 2022.
  42. Nora-BE (norethindrone) [prescribing information]. Parsippany, NJ: Watson Pharma; July 2011.
  43. Norethindrone acetate tablets [prescribing information]. Orlando, FL: Ingenus Pharmaceuticals LLC; May 2019.
  44. Norlutate (norethindrone acetate) [product monograph]. Montreal, Quebec, Canada: Erfa Canada; November 2010.
  45. Norlyroc (norethindrone) [prescribing information]. North Brunswick, NJ: Ohm Laboratories Inc; February 2014.
  46. Nor-QD (norethindrone) [prescribing information]. Parsippany, NJ: Watson Pharma; July 2011.
  47. Orme ML, Back DJ, Breckenridge AM. Clinical pharmacokinetics of oral contraceptive steroids. Clin Pharmacokinet. 1983;8(2):95-136. [PubMed 6342899]
  48. Ortho Micronor (norethindrone) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals Inc; November 2021.
  49. Practice Committee of the American Society for Reproductive Medicine (ASRM). Treatment of pelvic pain associated with endometriosis: a committee opinion. Fertil Steril. 2014;101(4):927-935. [PubMed 24630080]
  50. Pradhan S, Gomez-Lobo V. Hormonal contraceptives, intrauterine devices, gonadotropin-releasing hormone analogues and testosterone: menstrual suppression in special adolescent populations. J Pediatr Adolesc Gynecol. 2019;32(5S):S23-S29. doi:10.1016/j.jpag.2019.04.007 [PubMed 30980941]
  51. Ramalho I, Leite H, Águas F. Abnormal uterine bleeding in adolescents: a multidisciplinary approach. Acta Med Port. 2021;34(4):291-297. doi:10.20344/amp.12829 [PubMed 34214420]
  52. Sahlberg BL The characterization of sulphated metabolites of norethindrone in human milk after oral administration of contraceptive steroids. J Steroid Biochem. 1987;26(4):481-485. [PubMed 3586665]
  53. Saxena BN, Shrimanker K, Grudzinskas JG. Levels of contraceptive seroids in breast milk and plasma of lactating women. Contraception. 1977;16(6):605-613. [PubMed 606500]
  54. Sharobel (norethindrone) [prescribing information]. Memphis, TN: Northstar Rx; March 2014.
  55. Toddywalla VS, Mehta S, Virkar KD, Saxena BN. Release of 19-nor-testosterone type of contraceptive steroids through different drug delivery systems into serum and breast milk of lactating women. Contraception. 1980;21(3):217-223. [PubMed 7389350]
  56. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed December 29, 2016.
Topic 12652 Version 391.0