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Zovia 1/35E-28
Overview
What is Zovia 1/35E-28?
Zovia 1/35E-28.
Zovia 1/50E-28.
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.
What does Zovia 1/35E-28 look like?
What are the available doses of Zovia 1/35E-28?
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What should I talk to my health care provider before I take Zovia 1/35E-28?
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How should I use Zovia 1/35E-28?
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. 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.
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
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:
Special notes
Spotting, breakthrough bleeding, or nausea.
Missed menstrual periods.
If the patient has 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. (See .)
Missed tablets.
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.
What interacts with Zovia 1/35E-28?
- 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 estrogendependent 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
What are the warnings of Zovia 1/35E-28?
Beta-adrenergic blockade in patients with Wolff-Parkinson-White syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker. In one case, this result was reported after an initial dose of 5 mg propranolol.
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 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 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.
b. Thromboembolism.
c. Cerebrovascular diseases.
d. Dose-related risk of vascular disease with oral contraceptives.
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. Another American study reported former use of oral contraceptives was significantly associated with increased risk of subarachnoid hemorrhage. 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. 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 study 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. 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, 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.
| * Deaths are birth-related | |||||||
| ** Deaths are method-related | |||||||
| Adapted from Ory. | |||||||
| No fertility control methods* | 7.0 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 | |
| Oral contraceptives | |||||||
| nonsmoker** | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 | |
| smoker** | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 | 117.2 | |
| IUD** | 0.8 | 0.8 | 1.0 | 1.0 | 1.4 | 1.4 | |
| Condom* | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 | 0.4 | |
| Diaphragm/Spermicide* | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 | 2.8 | |
| Periodic abstinence* | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 | 3.6 |
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. Other studies, however, have reported an increased risk overall, 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. These risks have been surveyed in two books and in review articles.
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. 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, 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. Rupture of benign, hepatic adenomas or other lesions may cause death through intra-abdominal 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. Diagnosis may prove difficult.
Studies from the U.S., Great Britain, and Italy 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. The majority of recent studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, 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. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. 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. This effect has been shown to be directly related to estrogen dose. Progestogens increase insulin secretion and create insulin resistance, the effect varying with different progestational agents. 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 WARNINGS and ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
9. Elevated blood pressure.
An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and with extended duration of use. Data from the Royal College of General Practitioners 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 disease 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, and there is no difference in the occurrence of hypertension among ever- and never-users.
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 preexistent.
What are the precautions of Zovia 1/35E-28?
1. Physical examination and follow-up.
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
2. Lipid disorders.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.
3. Liver function.
If jaundice develops in any woman receiving oral contraceptives, they should be discontinued. Steroids may be poorly metabolized in patients with impaired liver function and should be administered with caution in such patients. Cholestatic jaundice has been reported after combined treatment with oral contraceptives and troleandomycin. Hepatotoxicity following a combination of oral contraceptives and cyclosporine has also been reported.
4. Fluid retention.
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions that might be aggravated by fluid retention, such as convulsive disorders, migraine syndrome, asthma, or cardiac, hepatic, or renal dysfunction.
5. Emotional disorders.
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
6. Contact lenses.
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
7. 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.
8. Laboratory test interactions
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Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
9. Carcinogenesis
(See .)
10. Pregnancy
Pregnancy Category X.
CONTRAINDICATIONS
WARNINGS
11. Nursing mothers.
Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers 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.
12. 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.
13. Venereal diseases.
Oral contraceptives are of no value in the prevention or treatment of venereal disease. The prevalence of cervical and in oral contraceptive users is increased several-fold. It should not be assumed that oral contraceptives afford protection against pelvic inflammatory disease from chlamydia. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
14. General
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What are the side effects of Zovia 1/35E-28?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ):
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
What should I look out for while using Zovia 1/35E-28?
Oral contraceptives should not be used in women who have the following conditions:
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 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 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.
What might happen if I take too much Zovia 1/35E-28?
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. 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.
Effects on menses:
Effects related to inhibition of ovulation:
Effects from long-term use:
How should I store and handle Zovia 1/35E-28?
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Zovia 1/35E:WATSON 383Zovia 1/35E-28 is packaged in tablets dispensers of 28 (NDC 54868-4240-0). Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Zovia 1/50E:WATSON 384Zovia 1/50E-28 is packaged in tablet dispensers of 28 (NDC 54868-4778-0). Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Store at controlled room temperature 15°-30°C (59°-86°F).Zovia 1/35E:WATSON 383Zovia 1/35E-28 is packaged in tablets dispensers of 28 (NDC 54868-4240-0). Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Zovia 1/50E:WATSON 384Zovia 1/50E-28 is packaged in tablet dispensers of 28 (NDC 54868-4778-0). Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Store at controlled room temperature 15°-30°C (59°-86°F).Zovia 1/35E:WATSON 383Zovia 1/35E-28 is packaged in tablets dispensers of 28 (NDC 54868-4240-0). Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Zovia 1/50E:WATSON 384Zovia 1/50E-28 is packaged in tablet dispensers of 28 (NDC 54868-4778-0). Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Store at controlled room temperature 15°-30°C (59°-86°F).Zovia 1/35E:WATSON 383Zovia 1/35E-28 is packaged in tablets dispensers of 28 (NDC 54868-4240-0). Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Zovia 1/50E:WATSON 384Zovia 1/50E-28 is packaged in tablet dispensers of 28 (NDC 54868-4778-0). Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Store at controlled room temperature 15°-30°C (59°-86°F).Zovia 1/35E:WATSON 383Zovia 1/35E-28 is packaged in tablets dispensers of 28 (NDC 54868-4240-0). Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Zovia 1/50E:WATSON 384Zovia 1/50E-28 is packaged in tablet dispensers of 28 (NDC 54868-4778-0). Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Store at controlled room temperature 15°-30°C (59°-86°F).Zovia 1/35E:WATSON 383Zovia 1/35E-28 is packaged in tablets dispensers of 28 (NDC 54868-4240-0). Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Zovia 1/50E:WATSON 384Zovia 1/50E-28 is packaged in tablet dispensers of 28 (NDC 54868-4778-0). Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Store at controlled room temperature 15°-30°C (59°-86°F).Zovia 1/35E:WATSON 383Zovia 1/35E-28 is packaged in tablets dispensers of 28 (NDC 54868-4240-0). Each dispenser contains 21 light pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Zovia 1/50E:WATSON 384Zovia 1/50E-28 is packaged in tablet dispensers of 28 (NDC 54868-4778-0). Each dispenser contains 21 pink tablets and 7 white placebo tablets. (Placebo tablets have a debossed on one side and on the other side.)Store at controlled room temperature 15°-30°C (59°-86°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation) may also contribute to contraceptive effectiveness.
Non-Clinical Toxicology
Oral contraceptives should not be used in women who have the following conditions: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 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 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.
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.
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ):
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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