Product Elements:
Norethindrone norethindrone norethindrone norethindrone anhydrous lactose d&c yellow no. 10 fd&c yellow no. 6 povidone k30 starch, corn lactose monohydrate magnesium stearate yellow round flat lu;j22
Boxed Warning:
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. women who use oral contraceptives are strongly advised not to smoke.
Warning: cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. women who use oral contraceptives are strongly advised not to smoke.
Indications and Usage:
Indications and usage 1. indications progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. efficacy if used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. however, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. the following table lists the pregnancy rates for users of all major methods of contraception. 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. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year 3 1 among typical 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 initi
Read more...ate use of a method (not necessarily for the first time), and who use it perfectly (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). 1 0 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. method typical use 1 perfect use 2 ( 1 ) ( 2 ) ( 3 ) ( 4 ) chance 4 85 85 spermicides 5 26 6 40 periodic abstinence 25 63 calendar 9 ovulation method 3 sympto-thermal 6 2 post-ovulation 1 cap 7 parous women 40 26 42 nulliparous women 20 9 56 sponge parous women 40 20 42 nulliparous women 20 9 56 diaphragm 7 20 6 56 withdrawal 19 4 condom 8 female (reality) 21 5 56 male 14 3 61 pill 5 71 progestin only 0.5 combined 0.1 iuds progesterone t 2.0 1.5 81 copper t380a 0.8 0.6 78 lng 20 0.1 0.1 81 depo-provera ® 0.3 0.3 70 levonorgestrel implants (norplant ® ) 0.05 0.05 88 female sterilization 0.5 0.5 100 male sterilization 0.15 0.10 100 emergency contraceptive pills : treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 lactational amenorrhea method : lam is a highly effective, temporary method of contraception. 1 0 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.
Warnings:
Warnings cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. women who use oral contraceptives are strongly advised not to smoke. norethindrone 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
Read more... manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1. ectopic pregnancy the incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives. 2. delayed follicular atresia/ovarian cysts if follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. generally these enlarged follicles disappear spontaneously. often they are asymptomatic; in some cases they are associated with mild abdominal pain. rarely they may twist or rupture, requiring surgical intervention. 3. irregular genital bleeding irregular menstrual patterns are common among women using progestin-only oral contraceptives. if genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. if prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated. 4. carcinoma of the breast and reproductive organs some epidemiologic studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. these studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of pops similarly increase the risk. women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined. 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 benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the united states. rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. 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.
Dosage and Administration:
Dosage and administration to achieve maximum contraceptive effectiveness, norethindrone 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 patient labeling for detailed instructions.
Contraindications:
Contraindications 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
Adverse Reactions:
Adverse reactions 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.
Overdosage:
Overdosage there have been no reports of serious ill effects from overdosage, including ingestion by children.
Description:
Description each yellow norethindrone tablet usp 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 anhydrous, lactose monohydrate, corn starch, povidone and magnesium stearate. 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
Clinical Pharmacology:
Clinical pharmacology 1. mode of action norethindrone tablets progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle lh and fsh peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium. 2. pharmacokinetics absorption norethindrone is rapidly absorbed with maximum plasma concentrations occurring within 1 to 2 hours after norethindrone tablet administration (see table 1). 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 tablets administration. peak plasma concentrations occur approximately 1 hour after administration (mean t max 1.2 hours). the mean (sd) c max was 4816.8 (1532.6) pg/ml and
Read more...generally occurred within 1 hour (mean) of tablet administration, ranging from 0.5 to 2 hours. the mean (sd) c avg 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 norethindrone tablets administration. table 1: mean ± sd pharmacokinetic parameters following single dose administration of norethindrone tablets in 12 healthy female subjects under fasting conditions pharmacokinetic parameter norethindrone 0 . 35 mg t m a x (hr) 1.2 ± 0.5 c m a x (pg/ml) 4817 ± 1533 auc ( 0 - 4 8 ) (pg.h/ml) 21233 ± 6002 t 1 / 2 (h) 7.7 ± 0.5 the food effect on the rate and extent of norethindrone absorption after norethindrone tablet administration has not been evaluated. distribution following oral administration, norethindrone is 36% bound to sex hormone-binding globulin (shbg) and 61% bound to albumin. volume of distribution of norethindrone is approximately 4 l/kg. metabolism norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5% of a norethindrone dose is excreted unchanged; greater than 50% and 20-40% of a dose is excreted in urine and feces, respectively. the majority of metabolites in the circulation are sulfate, with glucuronides accounting for most of the urinary metabolites. excretion plasma clearance rate for norethindrone has been estimated to be approximately 600 l/day. norethindrone is excreted in both urine and feces, primarily as metabolites. the mean terminal elimination half-life of norethindrone following single dose administration of norethindrone tablet is approximately 8 hours. figure 1 mean sd norethindrone plasma concentrations following uforla administration
How Supplied:
How supplied norethindrone tablets usp containing 0.35 mg of norethindrone, are yellow coloured, round flat face beveled edge tablets debossed with "lu" on one side and "j22" on the other side. nnorethindrone tablets usp are available in a blister (ndc 68180-876-71) containing 28 tablets. three such blisters are packaged in a carton (ndc 68180-876-73). storage store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature].
Package Label Principal Display Panel:
Principal display panel norethindrone tablets usp 0.35 mg rx only ndc 68180-876-71 blister label: 28 tablets 28 day regimen www.birthcontrolhealth.com norethindrone tablets usp 0.35 mg rx only ndc 68180-876-73 carton label: 3 blisters, 28 tablets each 28 day regimen www.birthcontrolhealth.com norethindrone tablets usp 0.35 mg rx only ndc 68180-876-71 blister label: 28 tablets 28 day regimen norethindrone tablets usp 0.35 mg rx only ndc 68180-876-73 carton label: 3 blisters, 28 tablets each 28 day regimen