Ethynodiol diacetate and ethinyl estradiol

{{DrugProjectFormSinglePage |authorTag=Kiran Singh, M.D. [1] |genericName=ethynodiol diacetate and ethinyl estradiol |aOrAn=a |drugClass=hormone |indicationType=prophylaxis |indication=indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. |adverseReactions=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 |blackBoxWarningTitle=TITLE |blackBoxWarningBody=Condition Name: (Content) |fdaLIADAdult=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.

|offLabelAdultGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Ethynodiol diacetate and ethinyl estradiol in adult patients. |offLabelAdultNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Ethynodiol diacetate and ethinyl estradiol in adult patients. |offLabelPedGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Ethynodiol diacetate and ethinyl estradiol in pediatric patients. |offLabelPedNoGuideSupport=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 |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. }} {{#subobject:

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