Norethindrone 0.35 Mg Tablet

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.

Norethindrone – Uses, Side Effects, and More

This medication 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.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 to use Norethindrone

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, ask your doctor or pharmacist.

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.

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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.

Side Effects

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 last or get worse, 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 this medication has been prescribed because your doctor 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, trouble speaking, 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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to norethindrone; or to other progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 passes into breast milk. Consult your doctor before breast-feeding.

Norethindrone

Generic name: norethindrone [ nor-eth-IN-drone ]
Brand names: Aygestin, Camila, Errin, Jolivette, Nora-Be, . show all 17 brands Ortho Micronor, Nor-QD, Heather, Jencycla, Norlyroc, Deblitane, Sharobel, Lyza, Norlyda, Tulana, Incassia, Lyleq
Dosage form: oral tablet (0.35 mg; 5 mg)
Drug classes: Contraceptives, Progestins

Medically reviewed by Drugs.com on Feb 8, 2023. Written by Cerner Multum.

What is norethindrone?

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Norethindrone is used for birth control (contraception) to prevent pregnancy.

Norethindrone is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

Not all brands of norethindrone are for the same uses. Some brands are for use only as contraception. Others are for use in treating endometriosis or vaginal bleeding disorders. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

Norethindrone may also be used for other purposes not listed in this medication guide.

Warnings

You should not use this medicine if you you have: undiagnosed vaginal bleeding, breast cancer, liver disease, or a liver tumor. You may not be able to take norethindrone if you have ever had a heart attack, a stroke, or blood clot.

Do not use if you are pregnant or trying to become pregnant.

In some cases, you should not take norethindrone if you are nursing.

Before taking this medicine

You should not use norethindrone if you are allergic to it, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or a liver tumor;
• breast cancer; or
• a history of blood clots in your brain, eyes, lungs, or legs.

Do not use norethindrone if you are pregnant or trying to become pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant.

Ask your doctor about using norethindrone while you are breast-feeding. In some cases, you should not take norethindrone if you are nursing.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• liver disease;
• depression;
• migraine headaches;
• diabetes;
• high cholesterol or triglycerides;
• uterine fibroid tumors;
• epilepsy;
• kidney disease;
• asthma; or
• if you smoke.

Do not give this medicine to a child without medical advice.

How should I take norethindrone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Carefully follow your doctor’s dosing instructions about when to start taking norethindrone for contraception if you are switching from a combination birth control pill (estrogen and progestin).

If you take norethindrone for contraception: Take one pill every day, no more than 24 hours apart. You may get pregnant if you do not take one pill daily.

You may need to use back-up birth control (such as condoms with spermicide) if you are sick with vomiting or diarrhea, or if you are 3 or more hours late in taking your daily dose.

If you take norethindrone for menstrual disorders or abnormal vaginal bleeding: You will most likely take the medicine for only 5 to 10 days. Vaginal bleeding will occur 3 to 7 days after your last dose.

If you take norethindrone for endometriosis: Norethindrone is usually taken daily long-term for several months. Your doctor may occasionally change your dose.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Report any unusual vaginal bleeding right away.

Norethindrone can affect the results of certain medical tests. Tell any doctor who treats you that you are using norethindrone.

Store this medication at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Call your doctor for instructions, or follow the patient instructions provided with your medicine.

Missing a birth control pill increases your risk of becoming pregnant. If you are more than 3 hours late for your dose, take the medicine as soon as you remember and use back-up birth control for at least 48 hours. Take your next pill at the regularly scheduled time and continue on your regular dosing schedule.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of norethindrone is not expected to be dangerous.

What should I avoid while taking norethindrone?

Do not use estrogen medication unless your doctor tells you to.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while taking norethindrone for contraception.

Norethindrone will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Norethindrone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Norethindrone may cause serious side effects. Call your doctor at once if you have:

• sudden vision loss, bulging eyes, or severe headache;
• swelling, rapid weight gain;
• unusual vaginal bleeding;
• missed menstrual periods;
• pelvic pain (especially on one side);
• a breast lump;
• a light-headed feeling, like you might pass out;
• increased thirst, increased urination;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot–sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg.

Common side effects of norethindrone may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Norethindrone dosing information

Usual Adult Dose for Abnormal Uterine Bleeding:

2.5 to 10 mg orally once a day
Duration of therapy: 5 to 10 days

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

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

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

Uses: Treatment of endometriosis

Usual Pediatric Dose for Contraception:

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

Use: Prevention of pregnancy

What other drugs will affect norethindrone?

Some drugs can make norethindrone less effective, which may result in unintended pregnancy if you use norethindrone for contraception. Tell your doctor about all your other medicines, especially:

• St. John’s wort;
• medicine to treat an infection (antibiotics or antifungal medicine);
• medicine to treat tuberculosis;
• medicine to treat HIV or AIDS; or
• seizure medication.

This list is not complete. Other drugs may affect norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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