Ethynodiol diacetate and ethinyl estradiol
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Overview
Ethynodiol diacetate and ethinyl estradiol is a hormone that is FDA approved for the prophylaxis of indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.. Common adverse reactions include thrombophlebitis and thrombosis, arterial thromboembolism, Pulmonary embolism, Myocardial infarction and coronary thrombosis, Cerebral hemorrhage, Cerebral thrombosishypertension, gallbladder disease, benign and malignant liver tumors, and other hepatic lesions.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Zovia 1/35E and Zovia 1/50E are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Zovia 1/50E, which contain 50 mcg of estrogen, should not be used unless medically indicated.
- Oral contraceptives are highly effective.
- 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.
- DOsage
- To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals of 24 hours.
- 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.
Zovia 1/35E-28 Zovia 1/50E-28 Dosage Schedules
- The Zovia 1/35E-28 and Zovia 1/50E-28 tablet dispensers contain 21 colored 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 pink or pink) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (light pink or pink) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (light pink or pink) 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 or three courses of tablet-taking. In the event of spotting or breakthrough bleeding organic causes should be borne in mind.
- 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.
- 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.
- Post-treatment cycles after the first one, however, are usually typical for the individual woman prior to taking tablets.
- 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; 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 Zovia 1/35E-28 or Zovia 1/50E-28 are missed, the Zovia 1/35E-28 or Zovia 1/50E-28 schedule should be resumed on the eighth day after the last colored 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ethynodiol diacetate and ethinyl estradiol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ethynodiol diacetate and ethinyl estradiol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ethynodiol diacetate and ethinyl estradiol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ethynodiol diacetate and ethinyl estradiol in pediatric patients.
Contraindications
Oral contraceptives should not be used in women who have 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
- Known or suspected carcinoma of the breast, or a history of this condition
- 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
Warnings
b. Thromboembolism.
An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established.17, 33-51 Case-control studies have estimated the relative risk to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease.34-37, 45, 46 Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases (subjects with no past history of venous thrombosis or varicose veins) and about 4.5 for new cases requiring hospitalization.42, 47, 48 The risk of venous thromboembolic disease associated with oral contraceptives is not related to duration of use.
A two- to seven-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives.38, 39 The relative risk of venous thrombosis in women who have predisposing conditions is about twice that of women without such medical conditions.43 If feasible, oral contraceptives should be discontinued at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated with an increased risk of thromboembolism, and also during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than 4 to 6 weeks after delivery in women who elect not to breast feed.
c. Cerebrovascular diseases.
Both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes) have been reported to be increased with oral contraceptive use,14, 17, 18, 34, 42, 46, 52-59 although, in general, the risk was greatest among older (over 35 years), hypertensive women who also smoked. Hypertension was reported to be a risk factor for both users and nonusers, for both types of strokes, while smoking increased the risk for hemorrhagic strokes.
In one large study,52 the relative risk for thrombotic stroke was reported as 9.5 times greater in users than in nonusers. It ranged from 3 for normotensive users to 14 for users with severe hypertension.54 The relative risk for hemorrhagic stroke was reported to be 1.2 for nonsmokers who used oral contraceptives, 1.9 to 2.6 for smokers who did not use oral contraceptives, 6.1 to 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users, and 25.7 for users with severe hypertension. The risk is also greater in older women and among smokers.
d. Dose-related risk of vascular disease with oral contraceptives.
A positive association has been reported between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease.41, 43, 53, 59-64 A decline in serum high density lipoproteins (HDL) has been reported with many progestogens.23-31 A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease.65 Because estrogens increase HDL-cholesterol, the net effect of an oral contraceptive depends on the balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptives. The amount of both steroids should be considered in the choice of an oral contraceptive.
Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen-progestogen combination, the dosage regimen prescribed should be one that contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. New acceptors of oral contraceptives should be started on preparations containing the lowest estrogen content that produces satisfactory results in the individual.
Products containing 50 mcg estrogen should be used only when medically indicated.
e. Persistence of risk of vascular disease.
There are three studies that have shown persistence of risk of vascular disease for users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persisted for at least 9 years for women 40-49 years old who had used oral contraceptives for 5 or more years, but this increased risk was not demonstrated in other age groups.16 Another American study reported former use of oral contraceptives was significantly associated with increased risk of subarachnoid hemorrhage.57 In another study, in Great Britain, the risk of developing non-rheumatic heart disease plus hypertension, subarachnoid hemorrhage, cerebral thrombosis, and transient ischemic attacks persisted for at least 6 years after discontinuation of oral contraceptives, although the excess risk was small.14, 18, 66 It should be noted that these studies were performed with oral contraceptive formulations containing 50 mcg or more of estrogens.
2. Estimates of mortality from contraceptive use. One study67 gathered data from a variety of sources that have estimated the mortality rates associated with different methods of contraception at different ages (Table 2). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that, with the exception of oral contraceptive users 35 and older who smoke and 40 or older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970’s, but not reported until 1983.67 However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling.
Because of these changes in practice and, also, because of some limited new data that suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed,48, 152 the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that, although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures that may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ethynodiol diacetate and ethinyl estradiol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ethynodiol diacetate and ethinyl estradiol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ethynodiol diacetate and ethinyl estradiol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol in geriatric settings.
Gender
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ethynodiol diacetate and ethinyl estradiol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ethynodiol diacetate and ethinyl estradiol in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Administration in the drug label.
Monitoring
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ethynodiol diacetate and ethinyl estradiol and IV administrations.
Overdosage
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Mechanism of Action in the drug label.
Structure
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol How Supplied in the drug label.
Storage
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ethynodiol diacetate and ethinyl estradiol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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