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norethindrone
Overview
What is Norlyda?
Each white NORLYDA (norethindrone tablet, USP) provides a continuous oral contraceptive regimen of 0.35 mg norethindrone, USP daily, and the inactive ingredients include hydrogenated cottonseed oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, talc, and titanium dioxide.
Norethindrone, USP is a white to creamy white, odorless, crystalline powder practically insoluble in water; soluble in chloroform and in dioxane; sparingly soluble in alcohol; slightly soluble in ether.
The chemical name for norethindrone is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows:
norethindrone
Therapeutic class = oral contraceptive.
What does Norlyda look like?
What are the available doses of Norlyda?
Sorry No records found.
What should I talk to my health care provider before I take Norlyda?
Sorry No records found
How should I use Norlyda?
1. Indications.
2. Efficacy.
Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.
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.
1. Among couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason.
2. Among couples who initiate use of a method (not necessarily for the first time), and who use it (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4. The percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7. With spermicidal cream or jelly.
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 yellow pills).
10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.
To achieve maximum contraceptive effectiveness, NORLYDA tablets 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 Norlyda?
- 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 Norlyda?
Carboplatin injection may cause fetal harm when administered to a pregnant woman. Carboplatin, USP has been shown to be embryotoxic and teratogenic in rats. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
NORLYDA tablets do 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.
What are the precautions of Norlyda?
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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.
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2. Physical Examination and Follow-Up
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.
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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.
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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.
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- Sex hormone-binding globulin (SHBG) concentrations may be decreased.
- Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).
5. Interactions with Laboratory Tests
The following endocrine tests may be affected by progestin-only oral contraceptive use:
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6. Carcinogenesis
See section.
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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.
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8. Nursing Mothers
Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1 to 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.
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9. Fertility following discontinuation
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.
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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.
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11. Gastrointestinal
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.
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12. Pediatric use
Safety and efficacy of norethindrone 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.
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INFORMATION FOR THE PATIENT
Safety and efficacy of norethindrone 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 Norlyda?
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1‑800-FDA-1088 or
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.
- 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.
What should I look out for while using Norlyda?
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:
NORLYDA tablets do 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.
What might happen if I take too much Norlyda?
There have been no reports of serious ill effects from overdosage, including ingestion by children.
How should I store and handle Norlyda?
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “” on one side and are supplied as follows:NDC 69238-1583-6 Blister Pack of 28 TabletsSTORAGEStore at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].Distributed by:Amneal Pharmaceuticals LLCBridgewater, NJ 08807Rev. 07-2016-00
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
1. Mode of Action.
2. Pharmacokinetics.
Norethindrone is rapidly absorbed with maximum plasma concentrations occurring within 1 to 2 hours after norethindrone tablets administration (see ). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first pass metabolism resulting in an absolute bioavailability of approximately 65%.
Figure 1: Mean ± SD Norethindrone Plasma Concentrations Following Norethindrone Administration.
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
Table 1: Mean ± SD Pharmacokinetic Parameters Following Single Dose Administration of Norethindrone in 12 Healthy Female Subjects Under Fasting Conditions
The food effect on the rate and extent of norethindrone absorption after norethindrone tablets administration has not been evaluated.
Distribution:
4 L/kg.
Metabolism:
Excretion:
Non-Clinical Toxicology
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:NORLYDA tablets do 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.
The renal effects of nephrotoxic compounds may be potentiated by carboplatin injection.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1‑800-FDA-1088 or
Array
www.fda.gov/medwatch
.
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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