Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
FDA Drug Information • Also known as: Aurovela 24 Fe, Aurovela Fe, Aurovela Fe 1/20, Charlotte 24Fe, Finzala, Gemmily, Hailey 24 Fe,...
- Brand Names
- Aurovela 24 Fe, Aurovela Fe, Aurovela Fe 1/20, Charlotte 24Fe, Finzala, Gemmily, Hailey 24 Fe, Hailey Fe 1.5/30, Hailey Fe 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Junel Fe 24, Junel Fe 28 Day, Loestrin Fe 28 Day, Melodetta 24 Fe, Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate, Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate, Oshih, Tarina 24 Fe, Tarina Fe 1/20 Eq, Taytulla
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Hailey ® Fe 1.5/30, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS ).
Description
DESCRIPTION Hailey ® Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is a progestogen-estrogen combination. Hailey Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP): provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light green to green tablet, for oral administration, contains 1.5 mg norethindrone acetate, USP [(17α)-17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one] and 30 mcg ethinyl estradiol, USP [19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol]. The tablets also contain the following inactive ingredients: acacia, corn starch, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, lactose monohydrate, magnesium stearate, sucrose, and talc. The structural formulas are as follows: Norethindrone Acetate, USP Ethinyl Estradiol, USP Each brown to dark brown tablet for oral administration contains ferrous fumarate, acacia, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose, and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. norstructure eestructure
What Is Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate Used For?
INDICATIONS AND USAGE Hailey Fe 1.5/30 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 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected* Typical ** (No contraception) (85) (85) Oral contraceptives 3 Combined 0.1 N/A*** progestin only 0.5 N/A*** Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 Vaginal Sponge nulliparous 9 20 parous 20 40 Implant 0.05 0.05 Injection: depot medroxyprogesterone acetate 0.3 0.3 IUD progesterone T 1.5 2 copper T 380A 0.6 0.8 LNg 20 0.1 0.1 Condom without spermicides female 5 21 male 3 14 Cervical Cap with spermicidal cream or jelly nulliparous 9 20 parous 26 40 Periodic abstinence (all methods) 1 to 9 25 Withdrawal 4 19 Female sterilization 0.5 0.5 Male sterilization 0.1 0.15 Adapted from RA Hatcher et al, Reference 7. *The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. **This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ***N/A-Data not available.
Dosage and Administration
DOSAGE AND ADMINISTRATION The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets. Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 28-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Hailey Fe 1.5/30 should be taken exactly as directed and at intervals not exceeding 24 hours. Hailey Fe 1.5/30 provides a continuous administration regimen consisting of 21 light green to green tablets of Hailey Fe 1.5/30 and 7 brown to dark brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no “off-tablet days.” A. Sunday-Start Regimen: The patient begins taking the first light green to green tablet from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When the menstrual flow begins on Sunday, the first light green to green tablet is taken on the same day. The patient takes one light green to green tablet daily for 21 days. The last light green to green tablet in the dispenser will be taken on a Saturday. Upon completion of all 21 light green to green tablets, and without interruption, the patient takes one brown to dark brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday light green to green tablet in the top row. Adhering to this regimen of one light green to green tablet daily for 21 days, followed without interruption by one brown to dark brown tablet daily for seven days, the patient will start all subsequent cycles on a Sunday. B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one light green to green tablet daily, beginning with...
Side Effects (Adverse Reactions)
ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
Warnings and Precautions
WARNINGS The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, 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 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 ratio 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 difference 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 (adapted from References 8 and 9 with the author’s permission). For further information, the reader is referred to a text on epidemiological methods. 1. Thromboembolic Disorders and Other Vascular Problems a. Myocardial infarction An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six (10 to 16). The risk is very low under the age of 30. Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases (17). Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Table II) among women who use oral contraceptives. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity (19). In particular, some progestogens are known to decrease HDL cholesterol and cause...
Drug Interactions
7. Drug Interactions
Contraindications
CONTRAINDICATIONS Oral contraceptives are contraindicated in women who currently have the following conditions:
Pregnancy and Breastfeeding
10. Pregnancy Discontinue Hailey Fe 1.5/30 if pregnancy occurs because there is no reason to use COCs in pregnancy. See WARNINGS section.
11. Lactation Small amounts of oral contraceptive steroids have been identified in human milk, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.
Overdosage
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.
How Supplied
HOW SUPPLIED Hailey ® Fe 1.5/30 is available in dispensers (blisters), each containing 21 light green to green tablets and 7 brown to dark brown tablets.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.