Aygestin

DRUG DESCRIPTION

Aygestin (norethindrone acetate tablets, USP) - 5 mg oral tablets. Aygestin (norethindrone) , (17-hydroxy-19-nor-17?-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.

Aygestin® (norethindrone acetate) Structural Formula Illustration

Aygestin (norethindrone) Tablets contain the following inactive ingredients: lactose, magnesium stearate, and microcrystalline cellulose.

What are the possible side effects of norethindrone?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • pain or swelling in one or both legs;
  • migraine headache;
  • swelling in...

Read All Potential Side Effects and See Pictures of Aygestin »

What are the precautions when taking norethindrone (Aygestin)?

Before taking norethindrone, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, history of bleeding in the brain, liver disease, history of cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), recent stroke or heart attack (within 1 year).

Before using this medication, tell your doctor or pharmacist your medical...

Read All Potential Precautions of Aygestin »


Aygestin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, dizziness, mood swings, trouble sleeping, weight gain/loss, acne, breast swelling/tenderness, change in sexual interest, unwanted hair growth, or hair loss may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these serious side effects occur: changes in vaginal bleeding (e.g., spotting, breakthrough bleeding, changes in menstrual flow, no menstrual bleeding), change in vaginal discharge, depression, swelling of the hands/feet, frequent/burning/painful urination, yellowing eyes/skin, dark patches on the skin or face (melasma).

This medication may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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 taking norethindrone, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, history of bleeding in the brain, liver disease, history of cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), recent stroke or heart attack (within 1 year).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps/cancer or blood clots), obesity, heart disease (e.g., past heart attacks, coronary artery disease, congestive heart failure), high blood pressure, lupus, seizures, migraine headaches, asthma, kidney problems, high blood levels of cholesterol/fats, depression, diabetes, strokes.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.

Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.

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

This medication must not be used during pregnancy because it may harm an unborn baby, especially during the first 4 months of pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.

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


Aygestin Patient Information Including Side Effects

Brand Names: Aygestin, Camila, Errin, Jolivette, Nora-Be, Nor-QD, Ortho Micronor

Generic Name: norethindrone (Pronunciation: nor eth IN drone)

  • What is norethindrone (Aygestin)?
  • What are the possible side effects of norethindrone?
  • What is the most important information I should know about norethindrone?
  • What should I discuss with my healthcare provider before using norethindrone?
  • How should I take norethindrone?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking norethindrone?
  • What other drugs will affect norethindrone?
  • Where can I get more information?

What is norethindrone (Aygestin)?

Norethindrone is a form of progesterone, a female hormone. Norethindrone prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

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.

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

What are the possible side effects of norethindrone?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • pain or swelling in one or both legs;
  • migraine headache;
  • swelling in your hands or feet, rapid weight gain;
  • symptoms of depression (sleep problems, weakness, mood changes);
  • severe pelvic pain;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, bloating, stomach cramps;
  • breast pain, swelling, or tenderness;
  • dizziness;
  • freckles or darkening of facial skin;
  • increased acne or hair growth;
  • changes in weight;
  • vaginal itching or discharge;
  • skin itching or rash;
  • changes in your menstrual periods, decreased sex drive; or
  • mild headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about norethindrone?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, breast cancer, abnormal vaginal bleeding, liver disease, or if you have recently had an incomplete miscarriage or abortion.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

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

Related Drug Centers
  • Ortho Micronor
  • Aygestin
  • Nor-QD


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