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norethindrone

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Overview

What is Nor QD?

Each yellow Nor-QD tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include D&C Yellow No. 10, FD&C Yellow No. 6, lactose, magnesium stearate, povidone, and starch.

The chemical name for norethindrone is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows:

Therapeutic class = oral contraceptive.



What does Nor QD look like?



What are the available doses of Nor QD?

Sorry No records found.

What should I talk to my health care provider before I take Nor QD?

Sorry No records found

How should I use Nor QD?

1. Indications.

2. Efficacy.

Emergency Contraceptive Pills:

Lactational Amenorrhea Method:

temporary

Source: Trussell, J, Contraceptive Efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.

To achieve maximum contraceptive effectiveness, Nor-QD must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See for detailed instructions.


What interacts with Nor QD?


  • Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:

    • Known or suspected pregnancy
    • Known or suspected carcinoma of the breast
    • Undiagnosed abnormal genital bleeding
    • Hypersensitivity to any component of this product
    • Benign or malignant liver tumors
    • Acute liver disease



What are the warnings of Nor QD?

Studies from Britain and the U.S. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

Nor-QD does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.

The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.

1. Ectopic pregnancy.

2. Delayed follicular atresia/Ovarian cysts.

3. Irregular genital bleeding.

4. Carcinoma of the breast and reproductive organs.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

5. Hepatic neoplasia.

Studies from Britain and the U.S. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.


What are the precautions of Nor QD?

1. General.

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

2. Physical examination and followup.

It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.

3. Carbohydrate and lipid metabolism.

Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin, but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.

Lipid metabolism is occasionally affected in that HDL, HDL, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is no effect on total cholesterol, HDL, LDL, or VLDL.

4. Drug interactions.

Change in contraceptive effectiveness associated with co-administration of other products:

a. Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.

b. Several of the anti-HIV protease inhibitors have been studied with co-administration of oral contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of OC products may be affected with the co-administration of anti-HIV protease inhibitors. Health care providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

c. Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.

5. Interactions with laboratory tests.

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The following endocrine tests may be affected by progestin-only oral contraceptive use:

6. Carcinogenesis.

See section.

7. Pregnancy.

Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.

8. Nursing mothers.

Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1-6% of the levels of maternal plasma. However, isolated post-market cases of decreased milk production have been reported in POPs. Very rarely, adverse effects in the infant/child have been reported, including jaundice.

9. Fertility following discontinuation.

The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

10. Headache/Migraine.

If you have a headache or a worsening migraine headache with a new pattern that is recurrent, persistent, or severe, this requires discontinuation of oral contraceptives and evaluation of the cause.

11. Gastrointestinal.

Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.

12. Pediatric use.

Safety and efficacy of Nor-QD have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.


What are the side effects of Nor QD?

Menstrual irregularity is the most frequently reported side effect.

Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.

Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.

Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

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What should I look out for while using Nor QD?

Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:

Nor-QD does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.

The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.

1. Ectopic pregnancy.

2. Delayed follicular atresia/Ovarian cysts.

3. Irregular genital bleeding.

4. Carcinoma of the breast and reproductive organs.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

5. Hepatic neoplasia.

Studies from Britain and the U.S. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.


What might happen if I take too much Nor QD?

There have been no reports of serious ill effects from overdosage, including ingestion by children.


How should I store and handle Nor QD?

Store below 86°F (30°C).Nor-QD (norethindrone) tablets are available in 28-tablet dispensers.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

1. Mode of Action.

2. Pharmacokinetics.

Absorption:

Peak plasma concentrations occur approximately 1 hour after administration (mean T 1.2 hours). The mean (SD) C was 4816.8 (1532.6) pg/mL and generally occurred within 1 hour (mean) of tablet administration, ranging from 0.5 to 2 hours. The mean (SD) C was 885 (250) pg/mL, however, the mean concentration at 24 hrs was 130 (47) pg/mL.

Table 1 provides summary statistics of the pharmacokinetic parameters associated with single dose Nor-QD administration.

The food effect on the rate and extent of norethindrone absorption after Nor-QD administration has not been evaluated.

Distribution:

Metabolism:

Excretion:

Non-Clinical Toxicology
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:

Nor-QD does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.

The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.

1. Ectopic pregnancy.

2. Delayed follicular atresia/Ovarian cysts.

3. Irregular genital bleeding.

4. Carcinoma of the breast and reproductive organs.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

5. Hepatic neoplasia.

Studies from Britain and the U.S. have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

Change in contraceptive effectiveness associated with co-administration of other products:

a. Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.

b. Several of the anti-HIV protease inhibitors have been studied with co-administration of oral contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of OC products may be affected with the co-administration of anti-HIV protease inhibitors. Health care providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

c. Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Menstrual irregularity is the most frequently reported side effect.

Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.

Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.

Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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