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ethynodiol diacetate and ethinyl estradiol
Overview
What is ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg.
The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor- 17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.
The structural formulas are as follows:
Therapeutic class: Oral contraceptive.
What does ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL look like?
What are the available doses of ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
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What should I talk to my health care provider before I take ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
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How should I use ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg 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 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.
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 The possibility of ovulation and conception prior to initiation of use should be considered.
Dosage Schedules
Each ethynodiol diacetate and ethinyl estradiol tablet dispenser contains 21 light orange colored active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 green placebo tablets.
Days of the week are printed above the tablets, starting with Sunday on the left.
28-Day Schedule:
Special notes
Spotting, breakthrough bleeding, or nausea.
WARNING
Missed menstrual periods.
WARNING
If the patient has 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. Post-treatment cycles after the first one, however, are usually typical for the individual woman prior to taking tablets. (See
.)
Missed tablets.
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; Sunday Starters should continue to take 1 tablet daily until Sunday, discard the rest of the dispenser and begin a new dispenser that same day. The patient may not have a period this month; however, if she has missed two consecutive periods, pregnancy should be ruled out. An additional method of protection must be used as a backup for the next 7 days after the tablets are missed if she has sex during that time or she may become pregnant.
While there is little likelihood of ovulation if only one active tablet is missed, the possibility of spotting or breakthrough bleeding is increased and should be expected if two or more successive active tablets are missed. However, the possibility of ovulation increases with each successive day that scheduled active tablets are missed.
If one or more placebo tablets of ethynodiol diacetate and ethinyl estradiol tablets are missed, the ethynodiol diacetate and ethinyl estradiol tablets schedule should be resumed on the eighth day after the last light orange tablet was taken. Omission of placebo tablets in the 28-tablet courses does not increase the possibility of conception provided that this schedule is followed.
What interacts with ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
- Oral contraceptives should not be used in women who have the following conditions:
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- •
- •
- •
- •
- •
- •
- •
- •
- RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).
What are the warnings of ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
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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 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 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
2. Estimates of mortality from contraceptive use
Array
| No fertility control methods | 7 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 |
| Oral contraceptives | ||||||
| nonsmoker | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 |
| smoker | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 | 117.2 |
| IUD | 0.8 | 0.8 | 1 | 1 | 1.4 | 1.4 |
| Condom | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 | 0.4 |
| Diaphragm/Spermicide | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 | 2.8 |
| Periodic abstinence | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 | 3.6 |
3. Carcinoma of the breast and reproductive organs
Array
4. Hepatic neoplasia
Array
5. Ocular lesions
There have been reports of retinal thrombosis and other ocular lesions associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained, gradual or sudden, partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or any evidence of retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.
6. Oral contraceptive use before or during pregnancy
Array
7. Gallbladder disease
Earlier studies reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower doses of estrogens and progestogens.
8. Carbohydrate and lipid metabolic effects
Array
9. Elevated blood pressure
Array
10. Headache
The onset or exacerbation of migraine or the development of headache of a new pattern that is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.
11. Bleeding irregularities
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If a pathologic basis has been excluded, time alone or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.
What are the precautions of ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
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 ethynodiol diacetate and ethinyl estradiol with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see , ).
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 by column or by radioimmunoassay. Free T resin uptake is decreased, reflecting the elevated TBG; free Tconcentration 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.
9. Carcinogenesis
10. Pregnancy.
11. 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.
12. Pediatric use
Safety and efficacy of Ethynodiol Diacetate 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.
13. Venereal diseases
Oral contraceptives are of no value in the prevention or treatment of venereal disease. The prevalence of cervical and in oral contraceptive users is increased several-fold. It should not be assumed that oral contraceptives afford protection against pelvic inflammatory disease from chlamydia. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
14. General
a. The pathologist should be advised of oral contraceptive therapy when relevant specimens are submitted.
b. Treatment with oral contraceptives may mask the onset of the climacteric. (See regarding risks in this age group.)
What are the side effects of ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ):
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
What should I look out for while using ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
Oral contraceptives should not be used in women who have the following conditions:
What might happen if I take too much ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
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.
NON-CONTRACEPTIVE HEALTH BENEFITS
The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies that largely utilized oral contraceptive formulations containing estrogen doses exceeding 35 mcg of ethinyl estradiol or 50 mcg of mestranol.
Effects on menses:
Effects related to inhibition of ovulation:
Effects from long-term use:
How should I store and handle ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
Each light orange ethynodiol diacetate and ethinyl estradiol tablet USP, 1 mg/35 mcg is round in shape, unscored and debossed with on one side and plain on the other side and contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol.Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are packaged in cartons of three (NDC 0378-7307-53) tablet dispensers. Each dispenser contains 21 light orange tablets and 7 green placebo tablets. (Placebo tablets are debossed with on one side and plain on the other side.)Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Each light orange ethynodiol diacetate and ethinyl estradiol tablet USP, 1 mg/35 mcg is round in shape, unscored and debossed with on one side and plain on the other side and contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol.Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are packaged in cartons of three (NDC 0378-7307-53) tablet dispensers. Each dispenser contains 21 light orange tablets and 7 green placebo tablets. (Placebo tablets are debossed with on one side and plain on the other side.)Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Each light orange ethynodiol diacetate and ethinyl estradiol tablet USP, 1 mg/35 mcg is round in shape, unscored and debossed with on one side and plain on the other side and contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol.Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are packaged in cartons of three (NDC 0378-7307-53) tablet dispensers. Each dispenser contains 21 light orange tablets and 7 green placebo tablets. (Placebo tablets are debossed with on one side and plain on the other side.)Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Clinical Information
Chemical Structure
No Image foundClinical 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.
Non-Clinical Toxicology
Oral contraceptives should not be used in women who have the following conditions: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 ethynodiol diacetate and ethinyl estradiol with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see , ).
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 by column or by radioimmunoassay. Free T resin uptake is decreased, reflecting the elevated TBG; free Tconcentration 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.
9. Carcinogenesis
10. Pregnancy.
11. 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.
12. Pediatric use
Safety and efficacy of Ethynodiol Diacetate 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.
13. Venereal diseases
Oral contraceptives are of no value in the prevention or treatment of venereal disease. The prevalence of cervical and in oral contraceptive users is increased several-fold. It should not be assumed that oral contraceptives afford protection against pelvic inflammatory disease from chlamydia. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
14. General
a. The pathologist should be advised of oral contraceptive therapy when relevant specimens are submitted.
b. Treatment with oral contraceptives may mask the onset of the climacteric. (See regarding risks in this age group.)
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ):
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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