Kelnor 1/35 Ethynodiol Diacetate and Ethinyl Estradiol Kit, 6 pouches — NDC 0555-9064-58 (Billing 00555-9064-58)
This is a package of 6 pouches of Kelnor 1/35 Ethynodiol Diacetate and Ethinyl Estradiol Kit from Teva Pharmaceuticals USA, Inc., marketed since Jun 2005 and currently FDA-listed; retail pharmacies pay about $0.3790 per pouche (NADAC). It is this product's only package size.
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): 003308
- GCN: 11490
- GPI-14 (Medi-Span): 25990002200310
- HICL (First Databank): 001456
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 310228
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 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 Progestin class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and ethynodiol diacetate (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work mainly by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Read the full MedlinePlus article ↗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 1, 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.379 | $2.27 / 6 kit |
| Medicaid paysCMS SDUD · 12 mo | $0.4622 | $2.77 / 6 kit |
| Medicare drug plans payPart D · Q2 2026 | $0.4948 | $2.97 / 6 kit |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 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 |
|---|---|---|---|---|
| 00555-9064-58 You're viewing this Main listing | 6 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 2005-06-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Kelnor 1/35this 00555-9064-58 | Teva | 6 pouches | $0.379 | AB | Availability likely | — |
| Valtya 1/35 70700-0304-85 | Xiromed | 3 pouches | $0.379 | AB | Availability likely | — |
| Ethynodiol Diacetate And Ethinyl Estradiol 00378-7307-53 | Mylan | 3 pouches | $0.382 | AB | Availability likely | +1% |
| Valtya 1/50 70700-0305-85 | Xiromed | 3 pouches | $0.738 | AB | Availability likely | +95% |
| Ethynodiol Diacetate And Ethinyl Estradiol 00378-7306-53 | Mylan | 3 pouches | $0.738 | AB | Availability likely | +95% |
| Kelnor 1/35 50090-2191-00 | A-S | 1 kit | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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 Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 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 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
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 adverse effects on the heart and blood vessels 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 Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets) 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR.
UNITED STATES. % of Women Experiencing an Unintended Pregnancy Within the First Year of Use % of Women Continuing Use at One Year 1 Method (1) Typical Use 2 (2) Perfect Use 3 (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal 6 2 Post-ovulation 1 Withdrawal 19 4 Cap 7 Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm 7 20 6 56 Condom 8 Female (Reality ® ) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only
0.5 Combined
0.1IUD Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Injection (Depo-Provera ® ) 0.3 0.3 70 Implant (Norplant ® and Norplant-2 ® ) 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.1 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 Source: Trussell J, Contraceptive efficacy.
In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition . New York, NY: Irvington Publishers, 1998, in press. 1 1.
Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 4.
The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6.
Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly.
8. Without spermicides. 9.
The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral ® (1 dose is 2 white pills), Alesse ® (1 dose is 5 pink pills), Nordette ® or Levlen ® (1 dose is 2 light-orange pills), Lo/Ovral ® (1 dose is 4 white pills), Triphasil ® or Tri-Levlen ® (1 dose is 4 yellow pills). 10.
However, to maintain effective protection against pregnancy,… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals of 24 hours. IMPORTANT: If the Sunday start schedule is selected, the patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle. The possibility of ovulation and conception prior to initiation of use should be considered.
Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets) Dosage Schedule The Kelnor 1/35 (28 Day Regimen) tablet dispenser contains 21 light yellow active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 white placebo tablets. Days of the week are printed above the tablets, starting with Sunday on the left. 28 Day Schedule For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (light yellow) is then taken on Day 1.
For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (light yellow) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (light yellow) is taken each day at the same time for 21 days. Then the white tablets are taken for 7 days, whether bleeding has stopped or not.
After all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day. Special Notes Spotting, Breakthrough Bleeding, or Nausea If spotting (bleeding insufficient to require a pad), breakthrough bleeding (heavier bleeding similar to a menstrual flow), or nausea occurs the patient should continue taking her tablets as directed. The incidence of spotting, breakthrough bleeding or nausea is minimal, most frequently occurring in the first cycle.
Ordinarily spotting or breakthrough bleeding will stop within a week. Usually the patient will begin to cycle regularly within two to three courses of tablet-taking. In the event of spotting or breakthrough bleeding organic causes should be borne in mind.
(See WARNINGS , No. 12 .) Missed Menstrual Periods Withdrawal flow will normally occur 2 or 3 days after the last active tablet is taken. Failure of withdrawal bleeding ordinarily does not mean that the patient is pregnant, providing the dosage schedule has been correctly followed.
(See WARNINGS , No. 7 .) 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. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
The first intermenstrual interval after discontinuing the tablets is usually prolonged; consequently, a patient for whom a 28 day cycle is usual might not begin to menstruate for 35 days or longer. Ovulation in such prolonged cycles will occur correspondingly later in the cycle. Posttreatment cycles after the first one, however, are usually typical for the individual woman prior to taking tablets.
(See WARNINGS , No. 12 .) Missed Tablets If a woman misses taking one active tablet, the missed tablet should be taken as soon as it is remembered. In addition, the next tablet should be taken at the usual time.
If two consecutive active tablets are missed in week 1 or week 2 of the dispenser, the dosage should be doubled for the next 2 days. The regular schedule should then be resumed, but an additional method of protection must be used as backup for the next 7 days if she has sex during that time or she may become pregnant. If two consecutive active tablets are missed in week 3 of the dispenser or three consecutive active tablets are missed during any of the first 3 weeks of the dispenser, direct the patient to do one of the following: Day 1 Starters should discard the rest of the dispenser and begin a new dispenser that same day; Su… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Kelnor 1/35 is contraindicated in females who are known to have or develop the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular disease, myocardial infarction, or coronary artery disease, or a past history of these conditions Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive Known or suspected carcinoma of the female reproductive organs or suspected estrogen-dependent neoplasia, or a history of these conditions Undiagnosed abnormal genital bleeding History of cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use Past or present, benign or malignant liver tumors 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 ).
⚠️ 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 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 thromboembolism, thrombotic and hemorrhagic stroke, myocardial infarction, liver tumors or other liver lesions, and gallbladder disease. The risk of morbidity and mortality increases significantly in the presence of other risk factors such as hypertension, hyperlipidemia, obesity, and diabetes mellitus. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these and other risks.
The information contained herein is principally based on studies carried out in patients who used oral contraceptives with formulations containing higher amounts of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lesser amounts of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective case-control studies and prospective cohort studies.
Case-control studies provide an estimate of the relative risk of a disease, which is defined as the ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk (or odds ratio) does not provide information about the actual clinical occurrence of a disease. Cohort studies provide a measure of both the relative risk and the attributable risk.
The latter is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence or incidence of a disease in the subject population. 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 associated with oral contraceptive use.
2-21 This increased risk is primarily in smokers or in women with other underlying risk factors for coronary artery disease such as hypertension, obesity, diabetes, and hypercholesterolemia. The relative risk for myocardial infarction in current oral contraceptive users has been estimated to be 2 to 6. The risk is very low under the age of 30.
However, there is the possibility of a risk of cardiovascular disease even in very young women who take oral contraceptives. Smoking in combination with oral contraceptive use has been reported to contribute substantially to the risk of myocardial infarction in women in their mid-thirties or older, with smoking accounting for the majority of excess cases. 22 Mortality rates associated with circulatory disease have been shown to increase substantially in smokers, especially in those 35 years of age and older among women who use oral contraceptives (see Figure 1 , Table 2 ).
Figure 1. Circulatory disease mortality rates per 100,000 woman-years by age, smoking status, and oral contraceptive use. 14 Oral contraceptives may compound the effects of well-known cardiovascular risk factors such as hypertension, diabetes, hyperlipidemias, hypercholesterolemia, age, cigarette smoking, and obesity.
In particular, some progestogens decrease HDL cholesterol 23-31 and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. 32 Oral contraceptives have been shown to increase blood pressure among some users (see WARNINGS , No. 10 ).
Similar effects on risk factors have been associated with an increased risk of heart disease. Figure 1 b. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contracepti… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 ( Figure 2 ). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs ( Figure 2 ). One of these studies reported no association between breast cancer risk and COC use.
The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 2: Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ): Thrombophlebitis and thrombosis Arterial thromboembolism Pulmonary embolism Myocardial infarction and coronary thrombosis Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Benign and malignant liver tumors, and other hepatic lesions There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis Neuro-ocular lesions (e.g., retinal thrombosis and optic neuritis) 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 during or after use Temporary infertility after discontinuation of use Edema Chloasma or melasma, which may persist Breast changes: tenderness, enlargement, secretion Change in weight (increase or decrease) Change in cervical erosion or 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 or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Premenstrual 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 Acne Changes in libido Colitis Budd-Chiari syndrome Endocervical hyperplasia or ectropion 1
🔄 Drug Interactions ▾
7. Drug Interactions Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested for barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines.
Administration of troglitazone concomitantly with a combination oral contraceptive (estrogen and progestin) reduced the plasma concentrations of both hormones by approximately 30%. This could result in loss of contraceptive efficacy. Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Kelnor 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 ).
🔄 Drug / Laboratory Test Interactions ▾
8. Laboratory Test Interactions 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 III; increased platelet aggregability. b) 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. c) Other binding proteins may be elevated in the serum. d) Sex-steroid 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 and phospholipids may be increased. f) Glucose tolerance may be decreased. g) Serum folate levels may be depressed.
This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives. h) Increased sulfobromophthalein and other abnormalities in liver function tests may occur. i) Plasma levels of trace minerals may be altered. j) Response to the metyrapone test may be reduced.
🤰 Pregnancy ▾
10. Pregnancy Teratogenic Effects (See CONTRAINDICATIONS and WARNINGS .)
🧒 Pediatric Use ▾
12. Pediatric Use Safety and efficacy of Kelnor has 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. 180, 181 Overdosage may cause nausea, and withdrawal bleeding may occur in females.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation) may also contribute to contraceptive effectiveness.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is packaged in cartons of six blister card dispensers. Each blister card dispenser contains 21 light yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 14 on the other side and 7 white, round, flat-faced, beveled-edge, unscored placebo tablets, debossed with stylized b on one side and 143 on the other side. Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 0.035 mg of ethinyl estradiol, USP.
Each white tablet contains inert ingredients. Available in cartons of six blisters NDC 0555-9064-58 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
📋 Description ▾
DESCRIPTION Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone.
Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows: Ethynodiol Diacetate, USP C 24 H 32 O 4 M.W.
384.51 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Ethynodiol Diacetate structural formula Ethinyl Estradiol structural formula
💬 Information for Patients ▾
INFORMATION FOR THE PATIENT See patient labeling printed below.
⚠️ Precautions ▾
PRECAUTIONS 1. 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.
2. Lipid Disorders 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.
3. Liver Function If jaundice develops in any woman receiving oral contraceptives, they should be discontinued. Steroids may be poorly metabolized in patients with impaired liver function and should be administered with caution in such patients.
Cholestatic jaundice has been reported after combined treatment with oral contraceptives and troleandomycin. Hepatotoxicity following a combination of oral contraceptives and cyclosporine has also been reported. 4.
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 that might be aggravated by fluid retention, such as convulsive disorders, migraine syndrome, asthma, or cardiac, hepatic, or renal dysfunction. 5.
Emotional Disorders Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. 6. Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
7. Drug Interactions Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested for barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines.
Administration of troglitazone concomitantly with a combination oral contraceptive (estrogen and progestin) reduced the plasma concentrations of both hormones by approximately 30%. This could result in loss of contraceptive efficacy. Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Kelnor 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 ).
8. Laboratory Test Interactions 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 III; increased platelet aggregability. b) 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. c) Other binding proteins may be elevated in the serum. d) Sex-steroid 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 and phospholipids may be increased. f) Glucose tolerance may be decreased. g) Serum folate levels may be depressed.
This may be of clinical significance if a woman becomes pregnant shortly aft… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
11. Nursing Mothers Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers 141-143 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
9. Carcinogenesis See WARNINGS .
📚 References ▾
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New York, NY, 1998. 1a. Physicians' Desk Reference.
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Mann JI, et al. Br Med J. 1976;2(Aug 21):445.
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Layde P, et al. Lancet. 1981;1(March 7):541.
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1981;88(Aug):838. 16. Slone D, et al.
N Engl J Med. 1981;305(Aug 20):420. 17.
Ramcharan S, et al. The Walnut Creek Contraceptive Drug Study. Vol 3.
US Govt Ptg Off; 1981; and J Reprod Med. 1980;25(Dec):346. 18.
Layde PM, et al. J R Coll Gen Pract. 1983;33(Feb):75.
19. Rosenberg L, et al. JAMA.
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A… [Excerpted — this section continues on DailyMed.]
📄 Patient Package Insert ▾
BRIEF SUMMARY OF PATIENT WARNINGS This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels 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. In the detailed leaflet, "What You Should Know About Oral Contraceptives," which you have received, the risks and benefits of oral contraceptives are discussed in much more detail.
That leaflet also provides information on other forms of contraception. Please take time to read it carefully for it may have been recently revised. If you have any questions or problems regarding this information, contact your doctor.
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. However, forgetting to take pills considerably increases the chances of pregnancy.
For most women, oral contraceptives are free of serious or unpleasant side effects. However, oral contraceptive use is associated with certain serious diseases or conditions that can cause severe disability or death, though rarely. 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, or have high blood pressure, diabetes, high cholesterol, or are overweight, or have or have had clotting disorders, heart attack, stroke, angina pectoris (chest pains on exertion), cancer of the breast or sex organs, jaundice (yellowing of the skin or whites of the eyes), or malignant (cancerous) or benign (noncancerous) liver tumors. Women should not use oral contraceptives if they suspect they are pregnant or if they have unexplained vaginal bleeding.
Most side effects of the pill are not serious. The most common effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.
Proper use of oral contraceptives requires that they be taken under your doctor's continuing supervision, because they can be associated with serious side effects. 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, and that certain of the risks may persist after use of the pill has been discontinued: Blood clots in the legs, arms, lungs, heart (heart attack), eyes, abdomen, or elsewhere in the body.
As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Stroke, due to a blood clot, or to bleeding in the brain (hemorrhage) as a result of bursting of a blood vessel. Stroke can lead to paralysis in all or part of the body, or to death.
Liver tumors, which may rupture and cause severe bleeding and death. A possible, but not definite, association has also been found with the pill and liver cancer. However, with or without use of the pill, liver cancers are extremely rare in the United States.
High blood pressure, although blood pressure ordinarily, but not always, returns to original levels when the pill is stopped. Gallbladder disease, which might require surgery. The symptoms associated with these serious side effects are discussed in the d… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel, Part 1 of 2 NDC 0555-9064-58 6 Blister Card Dispensers, 28 Tablets Each 28 DAY REGIMEN Kelnor® 1/35 (ethynodiol diacetate and ethinyl estradiol tablets USP) Contains 6 blister cards, each containing 28 tablets. Each light yellow tablet contains 1 mg ethynodiol diacetate, USP and 35 mcg ethinyl estradiol, USP. Each white tablet contains inert ingredients. Rx only SHAPING WOMEN’S HEALTH® 1
Package/Label Display Panel, Part 2 of 2 2
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