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.

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.

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Do not use this medication if you are allergic to norethindrone, or if you have:

• a history of a stroke, blood clot, or circulation problems;
• breast cancer;
• abnormal vaginal bleeding; or
• if you have recently had an incomplete miscarriage or abortion.

Before using norethindrone, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely take norethindrone.

• high blood pressure or a history of heart disease;
• migraines;
• kidney disease;
• liver disease or liver cancer;
• a history of depression or mental illness;
• high cholesterol or triglycide (fatty acid) levels in your blood;
• asthma; or
• seizures or epilepsy.

Norethindrone can pass into breast milk. Make sure your doctor knows if you are breast-feeding a baby while taking this medication.

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

Cardiovascular Disorders

Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

Visual Abnormalities

Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Do not use this medication if you are allergic to norethindrone, or if you have:

• a history of a stroke, blood clot, or circulation problems;

• breast cancer;

• abnormal vaginal bleeding; or

• if you have recently had an incomplete miscarriage or abortion.

Before using norethindrone, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely take norethindrone.

• high blood pressure or a history of heart disease;

• migraines;

• kidney disease;

• liver disease or liver cancer;

• a history of depression or mental illness;

• high cholesterol or triglycide (fatty acid) levels in your blood;

• asthma; or

• seizures or epilepsy.

Norethindrone can pass into breast milk. Make sure your doctor knows if you are breast-feeding a baby while taking this medication.

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

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using norethindrone.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

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

Administration

Oral Administration

Administer orally once daily.b

Dosage

Available as norethindrone acetate; dosage expressed in terms of the salt.b

Individualize dosage according to the condition being treated and the therapeutic response of the patient.b

Adults

2.5–10 mg daily for 5–10 days.a b

To establish dosage cycle for the treatment of secondary amenorrhea or abnormal uterine bleeding, the menstrual cycle is usually considered to be 28 days.a The first day of bleeding is counted as the first day of the cycle.a

Begin norethindrone during the assumed latter half of the menstrual cycle to induce optimum secretory transformation of the endometrium that has been adequately primed with endogenous or exogenous estrogen.a b

Withdrawal bleeding usually occurs within 3–7 days after discontinuing therapy.a b Planned menstrual cycling may benefit patients with a history of recurrent episodes of uterine bleeding.a b

Initially, 5 mg daily for 14 consecutive days.a b Increase dosage by 2.5 mg daily at 14-day intervals until a maximum dosage of 15 mg daily is reached.a b Continue to administer daily (no cyclic drug-free periods) for 6–9 months.a b Temporarily interrupt therapy for annoying breakthrough bleeding.a b

Prescribing Limits

Adults

Maximum: 15 mg daily.a b

• Importance of reading the manufacturer’s patient information.a b

• Importance of advising patients of anticipated menstrual effects.b

• Importance of discontinuing therapy and contacting clinician if sudden partial or complete vision loss, blurred vision, bulging of the eyes, double vision, or migraine occurs.a b

• Importance of discontinuing therapy and contacting clinician if any symptoms of thromboembolic and thrombotic disorders occur.b

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b

• Importance of informing patients of other important precautionary information. b (See Cautions.)

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Very bad dizziness or passing out.
• Bulging eyes.
• Change in eyesight.
• Loss of eyesight.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Mood changes.
• Swelling in the feet or hands.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Aygestin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aygestin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Aygestin (norethindrone (hormone replacement therapy)).

Review Date: October 4, 2017

Aygestin (norethindrone acetate tablets USP) is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Aygestin (norethindrone acetate tablets USP) is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

See WARNINGS and PRECAUTIONS.

The following adverse reactions have been observed in women taking progestins:

• Cancer
• Endometriosis (Symptoms, Causes, Treatments, and Prognosis)

Animal reproduction studies have not been conducted with this drug. There are no controlled data from human pregnancy studies. Use during the first trimester of pregnancy may be associated with congenital malformations in male and female fetuses and virilization of the external genitalia of the female fetus. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated. AU TGA pregnancy category: D US FDA pregnancy category: X Comments: -If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. -Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.

LactMed Record Number

419

Last Revision Date

20170905

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.