Norethindrone

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Generic Name: Norethindrone Brand Name(s): Generics only. No brands available.

Uses

What is Norethindrone used for?

Norethindrone is used to prevent pregnancy. It is often referred to as the “mini-pill” because it does not contain any estrogen. Norethindrone (a form of progestin) is a hormone that prevents pregnancy by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also stops the release of an egg (ovulation) in about half of a woman’s menstrual cycles.

While the “mini-pill” is more effective than certain other methods of birth control (such as condoms, cervical cap, diaphragm), it is less effective than combination hormone (estrogen and progestin) birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. To reduce the risk of pregnancy, it is very important to take this medication exactly as prescribed.

Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How should I take Norethindrone?

Take this medication by mouth as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.

Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart.

It is best to begin taking this medication on the first day of your menstrual period. If you begin taking it on any other day, use an additional form of non-hormonal birth control (such as condoms, spermicide) for the first 48 hours to prevent pregnancy until the medication has enough time to work.

Continue taking one tablet every day. After taking the last tablet in a pack, start a new pack the next day. There is no break between packs, and you do not take any “reminder” tablets (tablets without medication). Your periods may be irregular, or heavier/lighter than usual. You may also have vaginal bleeding (spotting) between periods. Do not stop taking your pills if this happens.

Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual. If you miss a pill, or take it 3 or more hours later than usual, or have diarrhea, or vomit soon after taking a pill, use a back-up method of birth control (such as condoms, spermicide) every time you have sex for the next 48 hours.

Ask your doctor or pharmacist about how to switch from other forms of hormonal birth control (such as patch, other birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

How do I store Norethindrone?

Norethindrone is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Norethindrone in the bathroom or the freezer. There may be different brands of Norethindrone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Norethindrone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Norethindrone?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), low levels of “good” cholesterol (HDL), depression, diabetes, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), liver disease (including tumors), unexplained vaginal bleeding.

Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication may pass into breast milk in small amounts and have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Norethindrone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Norethindrone. Norethindrone is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Norethindrone?

Nausea, vomiting, headache, bloating, breast tenderness, or weight gain may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Norethindrone?

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain laboratory tests (such as sex hormone-binding globulin, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.

Norethindrone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Norethindrone?

Norethindrone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Norethindrone?

Norethindrone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Norethindrone.

What is the dose of Norethindrone for an adult?

Usual Adult Dose for Abnormal Uterine Bleeding

2.5 to 10 mg orally once a day

Duration of therapy: 5 to 10 days

Comments:

-This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.

-Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Amenorrhea

2.5 to 10 mg orally once a day

Duration of therapy: 5 to 10 days

Comments:

-This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.

-Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Contraception

0.35 mg orally once a day

Comment:

-This drug should be taken at the same time each day.

Use: Prevention of pregnancy

Usual Adult Dose for Endometriosis

Initial dose: 5 mg orally once a day for 2 weeks

-Maximum dose: 15 mg/day

Comments:

-The dose should be increased by 2.5 mg/day every 2 weeks until 15 mg is reached.

-Treatment may continue for 6 to 9 months OR until annoying breakthrough bleeding demands temporary termination.

Uses: Treatment of endometriosis

Liver Dose Adjustments

Mild to moderate liver dysfunction: Data not available

Severe liver dysfunction or disease: Contraindicated

Dose Adjustments

Oral Contraceptives:

-Switching from combined oral contraceptives (COC): This drug should be started the day after the last active COC pill is taken.

-Switching to a COC: Patients should take the first active pill on the first day of the menstrual period (even if this drug is not finished).

Other Comments

Administration advice:

-Starting treatment: Patients should begin treatment on the first day of the menstrual period OR the next day after a miscarriage or abortion. Patients who begin treatment on another day should use backup birth control methods for 2 to 7 days.

-Breastfeeding: Patients who are fully breastfeeding should begin treatment 6 weeks after delivery; patients who are partially breastfeeding may begin 3 weeks after delivery.

-Contraceptive missed dose(s): Patients should take the missed dose as soon as possible, then continue taking the same dose at the regular time PLUS a backup birth control method for 2 to 7 days.

-IM injection: The injection should be administered extremely slowly, deep into the gluteal muscles with at least a medium bore needle. The ampoule may be immersed in warm water to facilitate injection.

Storage requirements:

-IM injection: Protect from light.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

Monitoring:

-Liver function tests

-Unusual bleeding

-Abdominal pain

Patient advice:

-Patients should be told that this drug does not protect against HIV/AIDS infection and other sexually-transmitted diseases.

-If this drug is taken 3 or more hours late, patients should be instructed to use a backup birth control method for the next 48 hours (e.g., condom and spermicide).

-Patients should be counseled to take this drug at the same time each day, and to avoid interruption of treatment between pill pack use.

What is the dose of Norethindrone for a child?

Usual Pediatric Dose for Contraception

Postpubertal adolescents (under 16 years): 0.35 mg orally once a day

Comments:

-This drug should be used after menarche occurs.

-The dose should be taken at the same time each day.

Use: Prevention of pregnancy

Precautions

Safety and efficacy have not been established in patients before menarche.

How is Norethindrone available?

Norethindrone is available in the following dosage forms and strengths:

  • Oral tablet,
  • Compounding powder.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Norethindrone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: April 5, 2018 | Last Modified: April 5, 2018

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