Ethynodiol Diacetate And Ethinyl Estradiol Tablets
FDA Drug Information • Also known as: Zovia 1/35
- Brand Names
- Zovia 1/35
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Zovia 1/35: Each pale pink tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, pregelatinized starch, vitamin e, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, povidone, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol/macrogol, lecithin (soya), FD&C Red #40 aluminum lake, FD&C Blue #1 aluminum lake, and FD&C yellow #6 aluminum lake. Each white tablet in the Zovia 1/35 package is a placebo containing no active ingredients and the inactive ingredients include lactose monohydrate, magnesium stearate, pregelatinized starch, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol. 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. 1 2
What Is Ethynodiol Diacetate And Ethinyl Estradiol Tablets Used For?
INDICATIONS AND USAGE Zovia 1/35 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. (A) 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. (B) 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. (C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. (D) 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. (E) Foams, creams, gels, vaginal suppositories, and vaginal film. (F) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. (G) With spermicidal cream or jelly. (H) Without spermicides. (I) 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). (J) However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. 14
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. Zovia 1/35 Dosage Schedules The Zovia 1/35 tablet dispensers contain 21 pale pink active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 white placebo (inactive) tablets . Days of the week are embossed on the plastic compact just 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 (pale pink) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (pale pink) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (pale 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. (See WARNING 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 WARNING 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. Post-treatment cycles after...
Side Effects (Adverse Reactions)
ADVERSE REACTIONS 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
Warnings and Precautions
WARNINGS 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 casecontrol 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...
Contraindications
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 ● 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 )
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.
How Supplied
HOW SUPPLIED Zovia 1/35: Each pale pink Zovia 1/35 tablet is round, biconvex, unscored, debossed with X1 on one side and contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol. Zovia 1/35 is packaged in cartons of six (NDC 75907-087-62) tablet compact dispensers. Each compact dispenser contains 21 pale pink tablets and 7 white placebo tablets. Placebo tablets are round, biconvex and have a debossed P on one side and N on the other side. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.]
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.