Norethindrone Acetate

Norethindrone Acetate is a prescription medication used to treat the symptoms of Amenorrhea, Uterine Bleeding, and Endometriosis.

• Norethindrone Acetate is available under the following different brand names: Aygestin, Norlutate

Common side effects of Norethindrone Acetate include:

• irregular vaginal bleeding or spotting,
• headache,
• breast pain or swelling,
• stomach pain,
• bloating,
• nausea,
• vomiting,
• hair loss,
• depressed mood,
• trouble sleeping,
• weight gain, and
• vaginal itching or discharge

Serious side effects of Norethindrone Acetate include:

• sudden vision loss,
• bulging eyes,
• severe headache,
• swelling,
• rapid weight gain,
• unusual vaginal bleeding,
• missed menstrual periods,
• pelvic pain (especially on one side),
• breast lump,
• light-headedness,
• increased thirst,
• increased urination,
• loss of appetite,
• stomach pain (upper right side),
• dark urine,
• yellowing of the skin or eyes (jaundice),
• sudden numbness or weakness,
• problems with vision or speech,
• chest pain,
• shortness of breath, and
• swelling or redness in an arm or leg

Rare side effects of Norethindrone Acetate include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

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

• 5 mg

Amenorrhea or Uterine Bleeding

Adult dosage

• 2.5-10 mg/day orally for 5-10 days during the latter part of the cycle
• Expect withdrawal bleeding within 3-7 days after stopping norethindrone

Endometriosis

Adult dosage

• 5 mg orally once a day for 14 days, may increase by 2.5 mg up to 15 mg/day for 6-9 months

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 Acetate has severe interactions with no other drugs.
• Norethindrone Acetate has serious interactions with at least 22 other drugs.
• Norethindrone Acetate has moderate interactions with at least 23 other drugs.
• Norethindrone Acetate has minor interactions with no other drugs.

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 your products. 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
• Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease, cerebral apoplexy
• Known, suspected, or history of breast cancer; estrogen-dependent neoplasia, liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Diabetes mellitus with vascular involvement
• As a diagnostic test for pregnancy

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Norethindrone acetate is 2 times as potent as norethindrone
• Patients with risk factors for arterial vascular disease (.g, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (.g, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately
• 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 (.g, migraine, asthma, epilepsy).
• Discontinue if the following develop jaundice, any signs of VTE, migraine with unusual severity, significant blood pressure increase, and increased risk of thromboembolic complications after surgery.
• Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine; if examination reveals papilledema or retinal vascular lesions, medication should be discontinued
• The drug may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunctions, may require careful observation
• In cases of breakthrough bleeding, and in all cases of irregular bleeding per vagina nonfunctional causes should be borne in mind; in cases of undiagnosed vaginal bleeding, adequate diagnostic measures indicated
• Patients who have a history of clinical depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree
• Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism; the choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified; women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy
• 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
• Not for use before menarche
• Discontinue 4 weeks before major surgery or prolonged immobilization. Patients on warfarin, and oral anticoagulants (increase in anticoagulant dose may be warranted).
• 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, and 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.

Pregnancy and Lactation

• Do not use it in pregnancy.

Lactation

• Excreted in breast milk; use caution