Loestrin 24 Fe Information
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron)
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Description
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets.
Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each white tablet also contains the following inactive ingredients: acacia, lactose, magnesium stearate, starch, confectioner’s sugar, and talc.
Each brown tablet contains ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, and compressible sugar. The ferrous fumarate tablets do not serve any therapeutic purpose.
The structural formulas for the active hormones are:
Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]
Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Clinical Pharmacology
Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Pharmacokinetics
Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, because the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate and ethinyl estradiol are rapidly absorbed from Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol occurring 1 to 4 hours postdose. Both are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol.
The plasma norethindrone and ethinyl estradiol pharmacokinetics following single- and multiple-dose administrations of Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) tablets in 17 healthy female volunteers are provided in Figures 1 and 2, and Table 1.
Following multiple-dose administration of Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) tablets, mean maximum concentrations of norethindrone and ethinyl estradiol were increased by 95% and 27%, respectively, as compared to single-dose administration. Mean norethindrone and ethinyl estradiol exposures (AUC values) were increased by 164% and 51% respectively, as compared to single-dose administration of Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) tablets.
Steady-state with respect to norethindrone was reached by Day 17 and steady-state with respect to ethinyl estradiol was reached by Day 13.
Mean SHBG concentrations were increased by 150% from baseline (57.5 nmol/L) to 144 nmol/L at steady-state.
Effect of Food: Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) tablets may be administered without regard to meals. A single-dose administration of Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) tablet with food decreased the maximum concentration of norethindrone by 11% and increased the extent of absorption by 27% and decreased the maximum concentration of ethinyl estradiol by 30% but not the extent of absorption.
Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.
Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide. Sulfates are the major circulating conjugates of ethinyl estradiol and glucuronides predominate in urine. The primary oxidative metabolite is 2-hydroxy ethinyl estradiol, formed by the CYP3A4 isoform of cytochrome P450. Part of the first-pass metabolism of ethinyl estradiol is believed to occur in gastrointestinal mucosa. Ethinyl estradiol may undergo enterohepatic circulation.
Race.
Renal Insufficiency.
Hepatic Insufficiency.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Indications And Usage
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table 2 lists the typical unplanned pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Contraindications
Oral contraceptives should not be used in women who currently have the following conditions:
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Warnings
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
The use of oral contraceptives is associated with increased risk of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited thrombophilias, hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.
One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table 3).
These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risk. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth.
The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970s but not reported until 1983. However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling.
Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed, the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risk may be increased with oral contraceptive use after age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective and meets the individual patient needs.
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. Although the risk of breast cancer may be slightly increased among current users of oral contraceptives (RR = 1.24), this excess risk decreases over time after oral contraceptive discontinuation and by 10 years after cessation the increased risk disappears. The risk does not increase with duration of use, and no relationships have been found with dose or type of steroid. The patterns of risk are also similar regardless of a woman's reproductive history or her family breast cancer history. The subgroup for whom risk has been found to be significantly elevated is women who first used oral contraceptives before age 20, but because breast cancer is so rare at these young ages, the number of cases attributable to this early oral contraceptive use is extremely small. Breast cancers diagnosed in current or previous oral contraceptive users tend to be less advanced clinically than in never-users. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is a hormone-sensitive tumor.
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer 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.
In spite of many studies of the relationship between oral contraceptive use and breast cancer and cervical cancers, a cause-and-effect relationship has not been established.
Benign hepatic adenomas are associated with oral contraceptive use, although their occurrence is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy (see section).
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.
Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.
A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see and ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
Women with significant hypertension should not be started on hormonal contraceptives. An increase in blood pressure has been reported in women taking oral contraceptives, and this increase is more likely in older oral contraceptive users and with continued use. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing concentrations of progestogens.
Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued (see section). For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension among ever- and never-users.
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. If bleeding persists or recurs, nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem.
Absence of a withdrawal menses may also occur. In the event of amenorrhea for two cycles or more, pregnancy should be ruled out. In the clinical trial with Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) , 31-41% of the women using Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) did not have a withdrawal menses in at least one of 6 cycles of use.
Some women may experience post-pill amenorrhea or oligomenorrhea (possibly with anovulation), especially when such a condition was preexistent.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Precautions
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. (See ).
In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
Changes in contraceptive effectiveness associated with co-administration of other products:
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Information For The Patient
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Adverse Reactions
The most common adverse events reported by 2 - 6% of the 743 women using Loestrin 24 Fe were the following, in order of decreasing incidence: headache, vaginal candidiasis, upper respiratory infection, nausea, menstrual cramps, breast tenderness, sinusitis, vaginitis (bacterial), abnormal cervical smear, acne, urinary tract infection, mood swings, weight gain, vomiting, and metrorrhagia.
Among the 743 women using Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) , 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal bleeding (0.9%), nausea (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see section):
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related:
The following adverse reactions have been reported in users of oral contraceptives, and a causal association has been neither confirmed nor refuted:
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Overdosage
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Noncontraceptive Health Benefits
The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Effects on menses:
Effects related to inhibition of ovulation:
Effects from long-term use:
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Dosage And Administration
To achieve maximum contraceptive effectiveness, Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) should be taken exactly as directed and at intervals not exceeding 24 hours. Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) tablets may be administered without regard to meals.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) provides a regimen consisting of 24 white active tablets of Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) and 4 brown non-hormonal (placebo) tablets of ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.
The possibility of ovulation and conception prior to initiation of medication should be considered. The patient is instructed to begin taking Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start). If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days.
The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 24 days on white tablets—4 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.
When the patient is switching to Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) after completing a 21-day regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring, she should wait 7 days after her last tablet, patch, or ring before she starts Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) . She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching to Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) after completing a 28-day regimen of oral contraceptive tablets, she should start her first pack of Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) the next day. If switching from an implant or injection, the patient should start Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) on the day of implant removal or, if using an injection, the day the next injection would be due.
The patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.
See the “WHAT TO DO IF YOU MISS PILLS” section in the . Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy she begins taking the active white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. Therefore, the risk of pregnancy increases with each active (white) tablet missed.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) should be initiated no earlier than 28 days postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see , , and concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) may be initiated after a first-trimester abortion or miscarriage; if the patient starts Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) immediately, additional contraceptive measures are not needed.
For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the .
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) How Supplied
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Patient brief summary
Oral contraceptives, also known as "birth control pills" or "the pill", are taken to prevent pregnancy, and when taken correctly without missing any pills, have a failure rate of about 1% per year (1 pregnancy per 100 women per year of use). The typical failure rate of pill users is 5% (5 pregnancies per 100 women per year of use) when women who miss pills are included.
For the majority of women, oral contraceptives can be taken safely. But for some women oral contraceptive use is associated with certain serious medical problems that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you:
You should not take the pill if you are pregnant or have unexplained vaginal bleeding.
Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.
Most side effects of the pill are not serious. The most common are nausea, vomiting, bleeding or spotting between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may decrease or subside within the first three months of use.
The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill:
1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris), or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Women with migraine headaches also may be at increased risk of stroke when taking the pill.
2. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.
The symptoms associated with these serious side effects are discussed in the leaflet given to you with your supply of pills. Notify your healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, and herbal preparations containing St. John's Wort (hypericum perforatum), may decrease oral contraceptive effectiveness.
Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use the pill. This very small increase in the number of breast cancer diagnoses gradually disappears during the 10 years after stopping use of the pill. It is not known whether the difference is caused by the pill. It may be that women taking the pill are examined more often, so that breast cancer is more likely to be detected. You should have regular breast examinations by a healthcare provider and examine your own breasts monthly. Tell your healthcare provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use hormonal contraceptives because breast cancer is usually a hormone-sensitive tumor.
Some studies have found an increase in the incidence of cancer or precancerous lesions of the cervix in women who use the pill. However, this finding may be related to factors other than the use of the pill.
Taking the combination pill provides some important noncontraceptive health benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.
Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The DETAILED PATIENT INFORMATION leaflet gives you further information which you should read and discuss with your healthcare provider.
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Detailed Patient Package Insert
Any woman who considers using oral contraceptives (the “birth control pill” or “the pill”) should understand the benefits and risks of using this form of birth control.
Although oral contraceptives have important advantages over other methods of contraception, they have certain risks that no other method has, and some of these risks may continue after you have stopped using the oral contraceptive. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) properly so that it will be as effective as possible. However, this booklet is not a replacement for a careful discussion between you and your healthcare provider. You should discuss the information provided in this booklet with your healthcare provider, both when you first start taking the pill and during your revisits. You should also follow your healthcare provider’s advice with regard to regular check-ups while you are on Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) .
Oral contraceptives or “birth control pill” or “the pill” are used to prevent pregnancy and are more effective than most other nonsurgical methods of birth control. The chance of becoming pregnant is approximately 1% per year (1 pregnancy per 100 women per year of use) when the pills are taken correctly, and no pills are missed. Typical failure rates are 5% per year when women who miss pills are included. The chance of becoming pregnant increases with each missed "active" hormonal pill during a 28-day cycle.
In comparison, typical failure rates for other methods of birth control during the first year of use are as follows:
No birth control methods: 85%Vaginal sponge: 20 to 40%Cervical cap: 20 to 40%Spermicides alone: 26%Periodic abstinence: 25%Condom (female): 21%Diaphragm with spermicides: 20%Withdrawal: 19%Condom (male): 14%Female sterilization: less than 1% IUD: less than 1-2%Injectable progestogen: less than 1%Male sterilization: less than 1%Norplant system: less than 1%
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) Principal display panel - carton label mg/ mcg
(norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets)1 mg/20 mcg
28-DAY REGIMEN
Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron) provides 24 days of active therapy
This carton contains 5 pouches.Each pouch contains 1 blister card of 28 tablets.
Five PATIENT INSERTS are enclosed for your use when dispensing Loestrin 24 fe (Norethindrone acetate/ethinyl estradiol/iron)
Each white tablet contains norethindrone acetate, 1 mg;ethinyl estradiol, 20 mcg; each brown tablet containsferrous fumarate 75 mg; each blister card contains 24 white tablets and 4 brown tablets.
Usual Dosage--One tablet daily for 28 days as directedby the physician. See Package Insert for Full Prescribing Information.
This package is not child resistant.
Keep this and all drugs out of the reach of children.
Store at 25° C (77° F); excursions permitted to 15 - 30° C (59 - 86° F)[see USP Controlled Room Temperature].See bottom flap for lot number and expiration date.Ferrous fumarate tablets are not USP for dissolution and assay.
To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
