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. Table 1. Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States. Emergency Contraceptive Pills : Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.
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).
Lactational Amenorrhea Method : LAM is a highly effective, temporary method of contraception. 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. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition.
New York NY: Irvington Publishers, 1998, in press. 1 % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method (1) Typical use 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.
(2) Perfect use 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. (3) (4) Chance 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.
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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. 85 85 Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film. 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-ovulation 1 Withdrawal 19 4 Cap With spermicidal cream or jelly.
Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm 20 6 56 Condom Without spermicides. Female (Reality ® ) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only
0.5 Combined
0.1 IUD Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Injection (Depo-Provera) 0.3 0.3 70 Implant (Norplant and Norplant-2) 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.1 100
Contraindications
Ethynodiol diacetate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop 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
Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
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).
Warnings and precautions
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 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 use. 14 Adapted from Layde and Beral. 14 Oral contraceptives may compound the effects of well-known cardiovascular risk factors such as hypertension, diabetes, hyperlipidemias, hypercholesterolemia, age, cigarette smoking, and obesity. In particular, some progestogens decrease HDL cholesterol 23-31 and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. 32 Oral contraceptives have been shown to increase blood pressure among some users (see WARNING No. 9 ).
Similar effects on risk factors have been associated with an increased risk of heart disease. Graph 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 con
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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 Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 2. Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. Figure 2. Risk of Breast Cancer with Combined Oral Contraceptive Use
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