Ethynodiol diacetate and ethinyl estradiol

Ethynodiol diacetate and ethinyl estradiol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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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.

This image is provided by the National Library of Medicine.

• 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

This image is provided by the National Library of Medicine.

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.

This image is provided by the National Library of Medicine.

3. Carcinoma of the breast and reproductive organs. Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. While there are conflicting reports, many studies suggest that the use of oral contraceptives is not associated with an overall increase in the risk of developing breast cancer.17,40,68–78 Other studies, however, have reported an increased risk overall,153–155 or in certain subgroups. In these studies, increased risk has been associated with long duration of use, use beginning at a young age, use before the first term pregnancy, use by those who had an early menarche, those who had a positive family history of breast cancer, or in nulliparas.79–102,151,156–162 These risks have been surveyed in two books163–164 and in review articles.85,99,153,165–167

Some studies suggested that oral contraceptive use was associated with an increase in the risk of cervical intraepithelial neoplasia, dysplasia, erosion, carcinoma, or microglandular dysplasia in some populations of women.17, 50, 103-115 However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause and effect relationship has not been established.

4. Hepatic neoplasia. Benign hepatic adenomas and other hepatic lesions have been associated with oral contraceptive use,116-121 although the incidence of such benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases per 100,000 for users, a risk that increases after 4 or more years of use.120 Rupture of benign, hepatic adenomas or other lesions may cause death through intraabdominal hemorrhage. Therefore, such lesions should be considered in women presenting with abdominal pain and tenderness, abdominal mass, or shock. About one quarter of the cases presented because of abdominal masses; up to one half had signs and symptoms of acute intraperitoneal hemorrhage.121 Diagnosis may prove difficult.

Studies from the U.S.,122, 150 Great Britain,123, 124 and Italy125 have shown an increased risk of hepatocellular carcinoma in long-term (>8 years; relative risk of 7-20) oral contraceptive users. However, these cancers are rare in the United States, and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than 1 per 1,000,000 users.

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. Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.126, 129 The majority of recent studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned,126, 129 when the pill is taken inadvertently during early pregnancy.

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and further use of oral contraceptives should be withheld until pregnancy has been ruled out. Oral contraceptive use should be discontinued if pregnancy is confirmed.

7. Gallbladder disease. Earlier studies reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens.40, 42, 53, 70 More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.130-132 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. Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users.32 This effect has been shown to be directly related to estrogen dose.133 Progestogens increase insulin secretion and create insulin resistance, the effect varying with different progestational agents.32, 134 However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.

Some women may have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS1A and 1D), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.23-31, 135, 136

9. Elevated blood pressure. An increase in blood pressure has been reported in women taking oral contraceptives50, 53, 137-139 and this increase is more likely in older oral contraceptive users137 and with extended duration of use.53 Data from the Royal College of General Practitioners138 and subsequent randomized trials have shown that the incidence of hypertension increases with increasing concentrations of progestogens.

Women with a history of hypertension or hypertension-related disease, or renal disease139 should be encouraged to use another method of contraception. If such women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives,137 and there is no difference in the occurrence of hypertension among ever- and never-users.140

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.

Adverse Reactions

Clinical Trials Experience

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives:

• 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

Postmarketing Experience

There is limited information regarding Ethynodiol diacetate and ethinyl estradiol Postmarketing Experience in the drug label.

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.

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

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers141-143 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.

Pediatric Use

Safety and efficacy of Zovia 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.

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

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.

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.148, 149

Effects on menses:

Increased menstrual cycle regularity

Decreased blood loss and decreased risk of iron-deficiency anemia

Decreased frequency of dysmenorrhea

Effects related to inhibition of ovulation:

Decreased risk of functional ovarian cysts

Decreased risk of ectopic pregnancies

Effects from long-term use:

Decreased risk of fibroadenomas and fibrocystic disease of the breast

Decreased risk of acute pelvic inflammatory disease

Decreased risk of endometrial cancer

Decreased risk of ovarian cancer

Decreased risk of uterine fibroids

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

This image is provided by the National Library of Medicine.

Zovia 1/35E-28. Each light pink tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Zovia 1/35E-28 package is a placebo containing no active ingredients and the inactive ingredients include lactose (anhydrous), magnesium stearate and microcrystalline cellulose.

Zovia 1/50E-28. Each pink tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Zovia 1/50E-28 package is a placebo containing no active ingredients, and the inactive ingredients include lactose (anhydrous), magnesium stearate and microcrystalline cellulose.

The chemical name for ethynodiol diacetate is 19-Nor-17a-pregn-4-en-20-yne-3b,17-diol diacetate, and for ethinyl estradiol it is 19-Nor-17a-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.

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

Zovia 1/35E: Each light pink Zovia 1/35E tablet is round in shape, unscored, debossed with WATSON 383 and contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol.

Zovia 1/35E-28 is packaged in cartons of three (NDC 52544-383-31) and six (NDC 52544-383-28) tablet dispensers. Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed WATSON on one side and P on the other side.)

Zovia 1/50E: Each pink Zovia 1/50E tablet is round in shape, unscored, debossed with WATSON 384 and contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol.

Zovia 1/50E-28 is packaged in cartons of three (NDC 52544-384-31) and six (NDC 52544-384-28) tablet dispensers. Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed WATSON on one side and P on the other side.)

Storage

Store at 20°-25°C (68°-77°F).

Images

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Patient Counseling Information

WHAT YOU SHOULD KNOW ABOUT ORAL CONTRACEPTIVES

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

INTRODUCTION

You should not use Zovia 1/50E, which contains higher doses of estrogen than other oral contraceptives, unless specifically recommended by your health care provider.

It is important that any woman who considers using an oral contraceptive understand the risks involved. Although the oral contraceptives have important advantages over other methods of contraception, they have certain risks that no other method has. Only you and your physician can decide whether the advantages are worth these risks. This leaflet will tell you about the most important risks. It will explain how you can help your doctor prescribe the pill as safely as possible by telling him/her about yourself and being alert for the earliest signs of trouble. And it will tell you how to use the pill properly so that it will be as effective as possible. THERE IS MORE DETAILED INFORMATION AVAILABLE IN THE LEAFLET PREPARED FOR DOCTORS. Your pharmacist can show you a copy; you may need your doctor’s help in understanding parts of it.

This leaflet is not a replacement for a careful discussion between you and your health care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your health care provider’s advice with regard to regular check-ups while you are on the pill.

If you do not have any of the conditions listed below and are thinking about using oral contraceptives, to help you decide, you need information about the advantages and risks of oral contraceptives and of other contraceptive methods as well. This leaflet describes the advantages and risks of oral contraceptives. Except for sterilization, the intrauterine device (IUD), and abortion, which have their own specific risks, the only risks of other methods are those due to pregnancy should the method fail. Your doctor can answer questions you may have with respect to other methods of contraception, and further questions you may have on oral contraceptives after reading this leaflet.

WHAT ARE ORAL CONTRACEPTIVES?

The most common type of oral contraceptive, often simply called “the pill,” is a combination of estrogen and progestogen, the two kinds of female hormones. The amount of estrogen and progestogen can vary, but the amount of estrogen is more important because both the effectiveness and some of the dangers of the pill have been related to the amount of estrogen. The pill works principally by preventing release of an egg from the ovary during the cycle in which the pills are taken.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

The pill is one of the most effective methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually about 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

In comparison, typical failure rates for other methods of birth control during the first year of use are as follows:

This image is provided by the National Library of Medicine.

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

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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