Norethindrone

Norethindrone is a prescription medicine used as contraception to prevent pregnancy.

• Norethindrone is available under the following different brand names: Camila, Errin, Heather, Jencycla, Jolivette, Lyza, Nor QD, Nora-BE, norethisterone, Norhisterone, Deblitane, Sharobel

Common side effects of Norethindrone include:

• breast tenderness,
• increased hair growth, especially on the face,
• acne,
• weight gain,
• brown or blotchy spots on the skin,
• enlarged breasts,
• hair loss or thinning of the hair,
• mood swings,
• nervousness, and
• weight changes.

Serious side effects of Norethindrone include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• frequent and irregular bleeding,
• menstrual changes,
• abdominal pain,
• blindness,
• blurred vision,
• breast pain,
• vision changes,
• chills,
• clay-colored stools,
• confusion,
• cough,
• dark urine,
• itching,
• rash,
• irritability,
• loss of appetite,
• migraine headache,
• nausea,
• vomiting,
• numbness of the hands,
• dark urine,
• swelling of the eyelids or around the eyes, face, lips, or tongue,
• pain, redness, or swelling in the arm or leg,
• chest pain or pressure,
• diarrhea,
• difficulty with swallowing,
• chest pain or pressure,
• trouble concentrating,
• dizziness,
• double vision,
• eye pain,
• rapid heartbeat,
• trouble sleeping,
• depression,
• fever,
• tiredness,
• weakness,
• headache,
• unpleasant breath odor,
• upper right abdominal pain,
• vomiting blood, and
• yellowing of the skin and eyes (jaundice).

Rare side effects of Norethindrone include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 0.35mg

Contraception

Adult dosage

• 1 tablet (0.35mg) orally once daily
• Take at the same time each day; use additional contraception x48 hours if dose more than 3 hours late

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Norethindrone has severe interactions with the following drug:
  • mifepristone
• Norethindrone has serious interactions with at least 28 other drugs.
• Norethindrone has moderate interactions with at least 35 other drugs.
• Norethindrone has minor interactions with the following drugs: 
  • levoketoconazole
  • ribociclib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Liver disease or impairment
• Undiagnosed abnormal vaginal bleeding
• Pregnancy
• History, suspected, or known malignancy of the breast

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Norethindrone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Norethindrone?”

Cautions

• Use caution in the 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, significant blood pressure increase, severe depression, and increased risk of thromboembolic complications after surgery.
• Follicles may enlarge beyond the size of the one in the normal cycle; enlarged follicles may be asymptomatic or may be associated with mild abdominal pain; surgical intervention is rarely needed
• Rare hepatic adenomas and focal nodular 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 contraceptives and experience lower abdominal pain
• Discontinue 4 weeks before major surgery or prolonged immobilization.
• Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)
• May hurt lipid metabolism; use caution in women with hyperlipidemia
• Not for use before menarche
• Some studies link OCP use with an increased risk of breast cancer, whereas other studies have not shown a change in risk. A woman’s risk depends on conditions where naturally high hormone levels persist for long periods 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 the 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

Drug interaction overview

• Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease systemic concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding; counsel women to use an alternative non-hormonal method of contraception or a backup method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability
• Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort; interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure
• Coadministration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic concentrations of progestins, including Norethindrone
• Significant decreases in systemic concentrations of progestin have been noted in cases of coadministration with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (eg, boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (eg, nevirapine, efavirenz)
• In contrast, significant increases in systemic exposure of progestin have been noted in cases of co-administration with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine). These changes may be clinically relevant in some cases
• Hormonal contraceptives may affect the metabolism of other drugs; consequently, systemic concentrations may either increase (for example, cyclosporine) or decrease; consult the labeling of all concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations
• The effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing; therefore, if a woman wishes to use the drug after using ulipristal acetate, she should do so no sooner than 5 days after the intake of ulipristal acetate and she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period

Pregnancy and Lactation

• Do not use it in pregnancy. The risks involved outweigh the potential benefits. Safer alternatives exist.
• Lactation
  • Excreted in breast milk; use caution