Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate Kit — NDC 63187-890-28 (Billing 63187-0890-28)
This is a package of Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate Kit from Proficient Rx LP, marketed since Sep 2003 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 63187-890-28 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63187 labeler · 890 product · 28 package
- Package marketed since
- Aug 1, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0363187890285
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003300
- GCN: 68101
- GPI-14 (Medi-Span): 25990003610320
- HICL (First Databank): 001454
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 259176
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Iron bivalent, oral preparations class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63187-0890-28 You're viewing this Main listing | 6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK | 2017-08-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hailey 24 Fe 68462-0731-29 | Glenmark | 1 kit | $0.175 | AB | Availability likely | — |
| Gemmily 70700-0152-85 | Xiromed, | 1 kit | $0.962 | AB | Availability likely | — |
| Taytulla 00023-5862-30 | Allergan, | 1 kit | $8.975 | AB | Availability likely | — |
| Junel Fe 1.5/30this 63187-0890-28 | Proficient | 1 kit | — | AB | FDA listed | — |
| Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate 69238-1686-03 | Amneal | 1 kit | — | — | FDA listed | — |
| Junel Fe 1/20 68788-6832-02 | Preferred | 1 kit | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
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- Zonisamide 100 mg Capsule NDC 63187-897-30
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 are strongly advised not to smoke.
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 are strongly advised not to smoke.
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 are strongly advised not to smoke.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Junel ® 21 and Junel ® Fe 28 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. % of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected 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.
Typical 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. (No contraception) (85) (85) Oral contraceptives combined progestin only 0.1 0.5 3 N/A N/A--Data not available 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 parous 9 20 20 40 Implant 0.05
0.05Injection: depot medroxyprogesterone acetate 0.3
0.3IUD progesterone T copper T 380A LNg 20 1.5 0.6 0.1 2.0 0.8
0.1Condom without spermicides female male 5 3 21 14 Cervical Cap with spermicidal cream or jelly nulliparous parous 9 26 20 40 Periodic abstinence (all methods) 1 to 9 25 Withdrawal 4 19 Female sterilization 0.5
0.5Male sterilization 0.10 0.15
⏱️ 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 either three or 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 days of the week stickers 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 days of the week sticker 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 21 Day Dosage Regimen To achieve maximum contraceptive effectiveness, Junel ® 21 must be taken exactly as directed and at intervals not exceeding 24 hours. Junel ® 21 provides the patient with a convenient tablet schedule of “3 weeks on --1 week off”.
Two dosage regimens are described, one of which may be more convenient or suitable than the other for an individual patient. For the initial cycle of therapy, the patient begins her tablets according to the Day 1 Start or Sunday-Start regimen. With either regimen, the patient takes one tablet daily for 21 consecutive days followed by one week of no tablets.
1. Sunday Start Regimen: The patient begins taking tablets from the top row on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first tablet is taken on the same day.
The last tablet in the dispenser will then be taken on a Saturday, followed by no tablets for a week (7 days). For all subsequent cycles, the patient then begins a new 21-tablet regimen on the eighth day, Sunday, after taking her last tablet. Following this regimen, of 21 days on--7 days off, the patient will start all subsequent cycles on a Sunday.
2. Day 1 Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive days of the week sticker that corresponds to her starting day over the preprinted days on the blister card.
She starts taking one tablet daily, beginning with the first tablet in the top row. The patient completes her 21-tablet regimen when she has taken the last tablet in the tablet dispenser. She will then take no tablets for a week (7 days).
For all subsequent cycles, the patient begins a new 21-tablet regimen on the eighth day after taking her last tablet, again starting with the first tablet in the top row after placing the appropriate days of the week sticker over the preprinted days on the tablet dispenser. Following this regimen of 21 days on--7 days off, the patient will start all subsequent cycles on the same day of the week as the first course. Likewise, the interval of no tablets will always start on the same day of the week.
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 discontinuing medication.
If spotting occurs while on the usual regimen of one tablet daily, the patient should continue medication without interruption. If a patient forgets to take one or more 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 m… [Excerpted — this section continues on DailyMed.]
⛔ 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
⚠️ Warnings ▾
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 are strongly advised not to smoke.
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 (10-16). 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 glucose intolerance, while estrogens may create a state of hyperinsulinism (20-24).
Oral contraceptives have been shown to increase blood pressure among users (see section 9 in WARNINGS). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Table II b. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein… [Excerpted — this section continues on DailyMed.]
🤒 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
🔄 Drug Interactions ▾
8. Drug Interactions
🔄 Drug / Laboratory Test Interactions ▾
9. Interactions with Laboratory Tests Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: 1. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine induced platelet aggregability.
2. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein bound iodine (PBI), T 4 by column or by radioimmunoassay. Free T 3 resin uptake is decreased, reflecting the elevated TBG; free T 4 concentration is unaltered.
3. Other binding proteins may be elevated in serum. 4.
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. 5. Triglycerides may be increased.
6. Glucose tolerance may be decreased. 7.
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.
🤰 Pregnancy ▾
11. Pregnancy Pregnancy Category X: See CONTRAINDICATIONS and WARNINGS sections.
🧒 Pediatric Use ▾
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.
🆘 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.
🧬 Clinical Pharmacology ▾
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). Pharmacokinetics The pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets have not been characterized; however, the following pharmacokinetic information regarding norethindrone acetate and ethinyl estradiol is taken from the literature.
Absorption Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, since the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone (1). Norethindrone acetate and ethinyl estradiol are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol (1-3). Distribution Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg (1-3).
Plasma protein binding of both steroids is extensive (>95%); norethindrone binds to both albumin and sex hormone binding globulin, whereas ethinyl estradiol binds only to albumin (4). Metabolism 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 (5).
A small amount of norethindrone acetate is metabolically converted to ethinyl estradiol. 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 (6).
Excretion Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites (5,6). Plasma clearance values for norethindrone and ethinyl estradiol are similar (approximately
0.4L/hr/kg) (1-3). Special Population Race The effect of race on the disposition of norethindrone acetate and ethinyl estradiol tablets has not been evaluated. Renal Insufficiency The effect of renal disease on the disposition of norethindrone acetate and ethinyl estradiol tablets has not been evaluated.
In premenopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma ethinyl estradiol concentrations were higher and norethindrone concentrations were unchanged compared to concentrations in premenopausal women with normal renal function. Hepatic Insufficiency The effect of hepatic disease on the disposition of norethindrone acetate and ethinyl estradiol tablets has not been evaluated. However, ethinyl estradiol and norethindrone may be poorly metabolized in patients with impaired liver function.
Drug-Drug Interactions Numerous drug-drug interactions have been reported for oral contraceptives. A summary of these is found under PRECAUTIONS, Drug Interactions.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Junel ® Fe 1.5/30 (28 Tablets) (norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg tablets, USP, and ferrous fumarate tablets) are packaged in cartons of six blister cards. Each card contains 21 pink, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 978 on the other side and 7 brown, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 247 on the other side. Each brown tablet contains 75 mg ferrous fumarate.
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. (NDC 63187-890-28) . Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION: Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 1.5/30: Each 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 yellow tablet contains norethindrone acetate (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized starch.
Each pink tablet contains norethindrone acetate (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized starch.
Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. C22H28O3 M.W. 340.46 C20H24O2 M.W.
296.40 Norethindrone Acetate Structural Formula Ethinyl Estradiol Structural Formula
💬 Information for Patients ▾
INFORMATION FOR THE PATIENT See patient labeling printed below.
⚠️ 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 griseofluvin.
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. 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, morph… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
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.
🧬 Pharmacokinetics ▾
Pharmacokinetics The pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets have not been characterized; however, the following pharmacokinetic information regarding norethindrone acetate and ethinyl estradiol is taken from the literature.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
10. Carcinogenesis See WARNINGS section.
📚 References ▾
REFERENCES 1. Back DJ, Breckenridge AM, Crawford FE, Mclver M, Orme ML’E, Rowe PH and Smith E: Kinetics of norethindrone in women II. Singledose kinetics.
Clin Pharmacol Ther 1978;24:448-453. 2. Humpel M, Nieuwober B, Wendt H and Speck U: Investigations of pharmacokinetics of ethinyl estradiol to specific consideration of a possible first pass effect in women.
Contraception 1979;19:421-432. 3. Back DJ, Breckenridge AM, Crawford FE, Maclver M, Orme ML’E, Rowe PH and Watts MJ.
An investigation of the pharmacokinetics of ethynylestradiol in women using radioimmunoassay. Contraception 1979;20:263-273. 4.
Hammond GL, Lahteenmaki PLA, Lahteenmaki P and Luukkainen T. Distribution and percentages of non-protein bound contraceptive steroids in human serum. J Steriod Biochem 1982;17:375-380.
5. Fotherby K. Pharmacokinetics and metabolism of progestins in humans, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press, Ltd., New York, 1994, 99-126.
6. Goldzieher JW. Pharmacokinetics and metabolism of ethynyl estrogens, in Pharmacology of the contraceptive steroids, Goldzieher JW, Fotherby K (eds), Raven Press Ltd., New York, 1994: 127-151.
7. Hatcher RA, et al. 1998.
Contraceptive Technology, Sixteenth Edition. New York: Irvington Publishers. 8.
Stadel, B.V.: Oral contraceptives and cardiovascular disease. (Pt. 1).
New England Journal of Medicine , 305:612-618, 1981. 9. Stadel, B.V.: Oral contraceptives and cardiovascular disease.
(Pt. 2). New England Journal of Medicine , 305:672-677, 1981.
10. Adam, S.A., and M. Thorogood: Oral contraception and myocardial infarction revisited: The effects of new preparations and prescribing patterns.
Brit. J. Obstet. and Gynec. , 88:838-845, 1981.
11. Mann, J.I., and W.H. Inman: Oral contraceptives and death from myocardial infarction.
Brit. Med. J. , 2(5965):245-248, 1975.
12. Mann, J.I., M.P. Vessey, M.
Thorogood, and R. Doll: Myocardial infarction in young women with special reference to oral contraceptive practice. Brit.
Med. J. , 2(5956):241-245, 1975. 13.
Royal College of General Practitioners' Oral Contraception Study: Further analyses of mortality in oral contraceptive users. Lancet , 1:541-546, 1981. 14.
Slone, D., S. Shapiro, D.W. Kaufman, L.
Rosenberg, O.S. Miettinen, and P.D. Stolley: Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives.
N.E.J.M. , 305:420-424, 1981. 15. Vessey, M.P.: Female hormones and vascular disease: An epidemiological overview.
Brit. J. Fam.
Plann. , 6:1-12, 1980. 16. Russell-Briefel, R.G., T.M.
Ezzati, R. Fulwood, J.A. Perlman, and R.S.
Murphy: Cardiovascular risk status and oral contraceptive use, United States, 1976-80. Preventive Medicine , 15:352-362, 1986. 17.
Goldbaum, G.M., J.S. Kendrick, G.C. Hogelin, and E.M.
Gentry: The relative impact of smoking and oral contraceptive use on women in the United States. J.A.M.A. , 258:1339-1342, 1987. 18.
Layde, P.M., and V. Beral: Further analyses of mortality in oral contraceptive users: Royal College General Practitioners' Oral Contraception Study. (Table 5) Lancet , 1:541-546, 1981.
19. Knopp, R.H.: Arteriosclerosis risk: The roles of oral contraceptives and postmenopausal estrogens. J. of Reprod.
Med. , 31(9)(Supplement): 913-921, 1986. 20. Krauss, R.M., S.
Roy, D.R. Mishell, J. Casagrande, and M.C.
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Wahl, P., C. Walden, R. Knopp, J.
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Wynn, V., and R. Niththyananthan: The effect of progestin in combined oral contraceptives on serum lipids with special reference to high-density lipoproteins. Am.
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Wynn, V., and I. Godsland: Effects of oral contraceptives on carbohy… [Excerpted — this section continues on DailyMed.]
📄 Patient Package Insert ▾
BRIEF SUMMARY PATIENT PACKAGE INSERT Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects.
However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability.
The risks associated with taking oral contraceptives increase significantly if you: • Smoke • Have high blood pressure, diabetes, high cholesterol • Have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. 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 are strongly advised not to smoke. Most side effects of the pill are not serious.
The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea, vomiting, and breakthrough bleeding may 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 are young.
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.
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 detailed leaflet given to you with your supply of pills. Notify your doctor or health care 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, may decrease oral contraceptive effectiveness. Most of the studies to date on breast cancer and pill use have found no increase in the risk of developing breast cancer, although some studies have reported an increased risk of developing breast cancer in certain groups of women. However, some studies have found an increase in the risk of developing cancer of the cervix in women taking the pill, but this finding may be related to differences in sexual behavior or other factors not related to use of the pill.
Therefore, there is insufficient evidence to rule out the possibility that the pill may cause cancer of the breast or cervix. Taking the pill provides some important non-contraceptive 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 discus… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Junel ® Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*) Foil Pouch Text NDC 63187-890-28 Junel ® Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*) Each pink tablet contains norethindrone acetate, 1.5 mg; ethinyl estradiol, 30 mcg. Each brown tablet contains ferrous fumarate, USP, 75 mg. Each tablet dispenser contains 21 pink tablets and 7 brown tablets. *Ferrous fumarate tablets are not USP for dissolution and assay.
28 DAY REGIMEN THIS PRODUCT(LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only 63187-890-28
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