Norethindrone Acetate

Contraindications

• Known or suspected pregnancy.b Not effective for any purpose during pregnancy.b

• Undiagnosed vaginal bleeding.a b

• Known or suspected breast cancer; history of breast cancer.a b

• Active DVT or pulmonary embolism; history of DVT or pulmonary embolism.b

• Active or recent (within past year) arterial thromboembolic disease (e.g., stroke, MI).b

• Liver disease or dysfunction.a b

• Use as a pregnancy test.a b

• Known hypersensitivity to norethindrone acetate or any ingredient in the formulation.a b

Warnings/Precautions

Warnings

Appropriately manage risk factors for cardiovascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, obesity) and/or venous thromboembolism (e.g., personal or family history of venous thromboembolism, obesity, systemic lupus erythematosus).b (See Contraindications under Cautions.)

If unexplained, sudden or gradual, partial or complete loss of vision; proptosis or diplopia; papilledema; migraine; or retinal vascular lesions occur, discontinue and initiate appropriate diagnostic and therapeutic measures.a b Do not reinitiate therapy if ocular examination reveals evidence of papilledema or retinal vascular lesions.a b

Potential adverse effects on the fetus when administered within the first 4 months of pregnancy (masculinization of the female fetus, hypospadias in male neonates, low birth weight).a b (See Contraindications under Cautions.)

General Precautions

May cause some degree of fluid retention.b Use with caution and careful monitoring in patients with conditions (e.g., asthma, seizure disorders, migraine headache, cardiac or renal impairment) that might be aggravated by fluid retention.a b

Possible breakthrough or irregular vaginal bleeding.a b Perform adequate diagnostic tests in patients with undiagnosed vaginal bleeding.a b

Possible depression.a b Exercise caution in women with a history of depression; discontinue if severe depression recurs during use.a b

Physical examination prior to initiation of therapy advised.a Physical examination should include special attention to the breasts and pelvic organs and should include a Papanicolaou test (Pap smear) and relevant laboratory tests.a

Possible adverse effects on carbohydrate and lipid metabolism.b Choice of progestin, dosage, and regimen may minimize metabolic adverse effects; further study needed to clarify this issue.b Monitor patients with hyperlipidemia or diabetes mellitus carefully.b

When used in combination with an estrogen, consider the cautions, precautions, and contraindications associated with estrogens.a

Specific Populations

Category X.b (See Contraindications and also Fetal/Neonatal Morbidity and Mortality, under Cautions.)

Progestins are distributed into milk;a b caution advised.b

Safety and efficacy not established.b

Contraindicated in patients with liver disease or dysfunction.a b

Common Adverse Effects

Menstrual abnormalities (amenorrhea; frequent, irregular, prolonged, or infrequent bleeding), nausea, weight changes, breast changes (tenderness, enlargement, secretion), headache.b

Absorption

Bioavailability

Rapidly deacetylated to norethindrone.b Peak plasma concentration of norethindrone achieved in 2 hours.b

Distribution

Extent

Distributed into human milk.a b

Plasma Protein Binding

61% to albumin and 36% to sex hormone binding globulin (SHBG).b

Elimination

Metabolism

Metabolized by reduction, followed by glucuronide and sulfate conjugation.b

Elimination Route

Excreted in urine and feces, mainly as metabolites.b

Half-life

Single dose: 8.51 hours.b

Storage

Oral

20–25°C.a b

Norethindrone Acetate tablets, USP - 5 mg oral tablets.

Norethindrone Acetate tablets, USP, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white to creamy white, odorless, crystalline powder.

Norethindrone Acetate tablets, USP contain the following inactive ingredients: anhydrous lactose, magnesium stearate, methylene chloride, and microcrystalline cellulose.

Meets USP Dissolution Test 2.

Norethindrone Acetate Tablets, USP
 
Norethindrone Acetate tablets, USP  are 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. Norethindrone Acetate tablets, USP  are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Norethindrone Acetate Tablets

Therapy with Norethindrone Acetate tablets must be adapted to the specific indications and therapeutic response of the individual patient.

Secondary Amenorrhea, Abnormal Uterine Bleeding due to Hormonal Imbalance in the Absence of Organic Pathology

2.5 to 10 mg Norethindrone Acetate tablets may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Norethindrone Acetate tablets therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Norethindrone Acetate tablets.

Endometriosis

Initial daily dosage of 5 mg Norethindrone Acetate tablets for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Norethindrone Acetate tablets is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

Norethindrone Acetate Tablets, USP

(nor eth' in drone as' e tate)

Read this PATIENT INFORMATION before you start taking Norethindrone Acetate tablets and read what you get each time you refill Norethindrone Acetate tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition.
 
What is the most important information I should know about Norethindrone Acetate (A Progestin Hormone) tablets?

• Do not use Norethindrone Acetate tablets if you are pregnant, breastfeeding or are trying to conceive.
• Do not use Norethindrone Acetate tablets if you have had a previous blood clot, stroke, or heart attack.
• Do not use Norethindrone Acetate tablets if you are postmenopausal.

What are Norethindrone Acetate tablets?

Norethindrone Acetate tablets are similar to the progesterone hormones naturally produced by the body. Your healthcare provider may provide Norethindrone Acetate tablets as individual tablets.

What are Norethindrone Acetate tablets used for?

Norethindrone Acetate tablets are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), the treatment of endometriosis, and the treatment of irregular menstrual periods due to hormone imbalance.

Who should not take Norethindrone Acetate tablets?

You should not take Norethindrone Acetate tablets if you are postmenopausal, pregnant or breast­feeding.

You should not take Norethindrone Acetate tablets if you have the following conditions: 

• Known or suspected pregnancy. Norethindrone Acetate tablets are not indicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take Norethindrone Acetate tablets during the first 4 months of pregnancy (mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus). If you take Norethindrone Acetate tablets and later find out you were pregnant, talk with your healthcare provider right away.
• History of blood clots in the legs, lungs, eyes, brain, or elsewhere, or a past history of these conditions.
• Liver impairment or disease.
• Known or suspected cancer of the breast. If you have or had cancer of the breast, talk with your healthcare provider about whether you should take Norethindrone Acetate tablets.
• Undiagnosed vaginal bleeding.
• Hypersensitivity to Norethindrone Acetate tablets. See the end of this leaflet for a list of all of the ingredients in Norethindrone Acetate tablets.

What are the risks associated with Norethindrone Acetate tablets? 

• Risk to the Fetus:

Norethindrone Acetate tablets should not be used if you are pregnant. Norethindrone Acetate tablets are contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and congenital abnormalities in male and female babies. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy.

You should avoid using Norethindrone Acetate tablets during pregnancy. If you take Norethindrone Acetate tablets and later find you were pregnant when you took it, be sure to discuss this with your healthcare provider as soon as possible. 

• Abnormal Blood Clotting:

Use of progestational drugs, such as Norethindrone Acetate tablets, has been associated with changes in the blood-clotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), visual loss or blindness (by cutting off blood vessels in the eye), or other problems. Any of these conditions may cause death or serious long-term disability. Call your healthcare provider right away if you suspect you have any of these conditions. He or she may advise you to stop using the drug. 

• Eye Abnormalities:

Discontinue Norethindrone Acetate tablets and call your healthcare provider right away if you experience sudden partial or complete loss of vision, blurred vision, or sudden onset of bulging eyes, double vision, or migraine.

These are some of the warning signs of serious side effects with progestin therapy: 

• Breast lumps
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps/bloating
• Nausea and vomiting
• Hair loss

Other side effects include:

• High blood pressure
• Liver problems
• High blood sugar
• Fluid retention
• Enlargements of benign tumors of the uterus (“fibroids”)
• Vaginal yeast infections
• Mental depression

These are not all the possible side effects of progestin and/or estrogen therapy. For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of getting a serious side effect with Norethindrone Acetate tablets?

• Talk with your healthcare provider regularly about whether you should continue taking Norethindrone Acetate tablets.
• Have a breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart attacks.

General information about the safe and effective use of Norethindrone Acetate tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Norethindrone Acetate tablets for conditions for which it was not prescribed. Do not give Norethindrone Acetate tablets to other people, even if they have the same symptoms you have. They may harm them.

Keep Norethindrone Acetate tablets out of the reach of children.

This leaflet provides a summary of the most important information about progestin and/or estrogen therapy. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Norethindrone Acetate tablets that is written for health professionals.

What are the ingredients in Norethindrone Acetate tablets?
 Norethindrone Acetate tablets contain the following inactive ingredients: anhydrous lactose, magnesium stearate, methylene chloride, and microcrystalline cellulose.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India


Revised: 12/2016

NDC 65862-715-50
Norethindrone
Acetate Tablets, USP
5 mg
ORALLY ACTIVE PROGESTIN
PHARMACIST: Please dispense with
patient information leaflet provided
separately.
Rx only           50 Tablets
AUROBINDO