Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 06 November 2017

Indication(s)

INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are 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 I 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 I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD 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. % 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

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Advisory information

contraindications
CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions: •Thrombophlebitis or thromboembolic disorders •A past history of deep vein thrombophlebitis or thromboembolic disorders •Cerebral vascular or coronary artery disease •Known or suspected carcinoma of the breast •Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia •Undiagnosed abnormal genital bleeding •Cholestatic jaundice of pregnancy or jaundice with prior pill use •Hepatic adenomas or carcinomas •Known or suspected pregnancy •Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).
Special warnings and precautions
PRECAUTIONS 1. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 2. Physical Examination and Follow-Up It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. 3. Lipid Disorders Women who are being treated for hyperlipidemia 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. 4. Liver Function If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function. 5. Fluid Retention Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. 6. Emotional Disorders Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. 7. Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. 8. Drug Interactions Effects of Other Drugs on Oral Contraceptives (78) Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin. A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. Anticonvulsants: Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine, have been shown to increase the metabolism of ethinyl estradiol and/or norethindrone, which could result in a reduction in contraceptive effectiveness. Troglitazone: Administration of troglitazone with an oral contraceptive containing ethinyl estradiol and norethindrone reduced the plasma concentrations of both by approximately 30%, which could result in a reduction in contraceptive effectiveness. Antibiotics: Pregnancy while taking oral contraceptives has been reported when the oral contraceptives were administered with antimicrobials such as ampicillin, tetracycline, and griseofulvin. However, clinical pharmacokinetic studies have not demonstrated any consistent effect of antibiotics (other than rifampin) on plasma concentrations of synthetic steroids. Atorvastatin: Coadministration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively. Concomitant Use with HCV Combination Therapy: Liver Enzyme Elevation Do not co-administer Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT). Other: Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding has been suggested with phenylbutazone. Effects of Oral Contraceptives on Other Drugs Oral contraceptive combinations containing ethinyl estradiol may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives. In addition, oral contraceptives may induce the conjugation of other compounds. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid have been noted when these drugs were administered with oral contraceptives. 9. Interactions with Laboratory Tests Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: a.Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability. b.Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered. c.Other binding proteins may be elevated in serum. d.Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged. e.Triglycerides may be increased. f.Glucose tolerance may be decreased. g.Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives. 10. Carcinogenesis See WARNINGS section. 11. Pregnancy Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS sections. 12. Nursing Mothers Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers, 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. 13. Pediatric Use Safety and efficacy of norethindrone acetate and ethinyl estradiol tablets 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. INFORMATION FOR THE PATIENT See Patient Labeling.
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): •Thrombophlebitis •Arterial thromboembolism •Pulmonary embolism •Myocardial infarction •Cerebral hemorrhage •Cerebral thrombosis •Hypertension •Gallbladder disease •Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: •Mesenteric thrombosis •Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: •Nausea •Vomiting •Gastrointestinal symptoms (such as abdominal cramps and bloating) •Breakthrough bleeding •Spotting •Change in menstrual flow •Amenorrhea •Temporary infertility after discontinuation of treatment •Edema •Melasma which may persist •Breast changes: tenderness, enlargement, secretion •Change in weight (increase or decrease) •Change in cervical erosion and secretion •Diminution in lactation when given immediately postpartum •Cholestatic jaundice •Migraine •Rash (allergic) •Mental depression •Reduced tolerance to carbohydrates •Vaginal candidiasis •Change in corneal curvature (steepening) •Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: •Pre-menstrual syndrome •Cataracts •Changes in appetite •Cystitis-like syndrome •Headache •Nervousness •Dizziness •Hirsutism •Loss of scalp hair •Erythema multiforme •Erythema nodosum •Hemorrhagic eruption •Vaginitis •Porphyria •Impaired renal function •Hemolytic uremic syndrome •Budd-Chiari Syndrome •Acne •Changes in libido •Colitis

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION The tablet blister pack 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 blister above the first row of tablets. Note: Each blister card 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, norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be taken exactly as directed and at intervals not exceeding 24 hours. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provides a continuous administration regimen consisting of 21 white to off-white tablets of norethindrone acetate and ethinyl estradiol tablets and 7 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 white to off-white tablet from the top row of the blister (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first white to off-white tablet is taken on the same day. The patient takes one white to off-white tablet daily for 21 days. The last white to off-white tablet in the blister pack will be taken on a Saturday. Upon completion of all 21 white to off-white tablets, and without interruption, the patient takes one 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 white to off-white tablet in the top row. Adhering to this regimen of one white to off-white tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 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 blister card. She starts taking one white to off-white tablet daily, beginning with the first white to off-white tablet in the top row. After the last white to off-white tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last white to off-white tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the tablet blister. Following this regimen of 21 white to off-white tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course. Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule. Special Notes on Administration Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking white to off-white tablets, continue medication without interruption. If the patient forgets to take one or more white to off-white tablets, the following is suggested: One tablet is missed •take tablet as soon as remembered •take next tablet at the regular time Two consecutive tablets are missed (week 1 or week 2) •take two tablets as soon as remembered •take two tablets the next day •use another birth control method for seven days following the missed tablets Two consecutive tablets are missed (week 3) Sunday-Start Regimen: •take one tablet daily until Sunday •discard remaining tablets •start new pack of tablets immediately (Sunday) •use another birth control method for seven days following the missed tablets Day-1 Start Regimen: •discard remaining tablets •start new pack of tablets that same day •use another birth control method for seven days following the missed tablets Three (or more) consecutive tablets are missed Sunday-Start Regimen: •take one tablet daily until Sunday •discard remaining tablets •start new pack of tablets immediately (Sunday) •use another birth control method for seven days following the missed tablets Day-1 Start Regimen: •discard remaining tablets •start new pack of tablets that same day •use another birth control method for seven days following the missed tablets The possibility of ovulation occurring increases with each successive day that scheduled white to off-white tablets are missed. While there is little likelihood of ovulation occurring if only one white to off-white tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive white to off-white tablets are missed. If the patient forgets to take any of the seven brown tablets in week four, those brown tablets that were missed are discarded and one brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last white to off-white tablet was taken. In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet blister pack on the next Sunday or the first day (Day-1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered. Use of Oral Contraceptives in the Event of a Missed Menstrual Period 1.If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out. 2.If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.

More information

Category Value
Authorisation number ANDA202772
Orphan designation No
Product NDC 0378-7283
Date Last Revised 26-09-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1358763
Marketing authorisation holder Mylan Pharmaceuticals Inc.
Warnings Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.