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Free E-newsletter Subscribe to Housecall Our general interest e-newsletter keeps you up to date on a wide variety of health topics. Sign up now. Because of their association with elevations in blood pressure, COCs should be used cautiously in patients with mild to moderate hypertension or kidney disease; use is contraindicated in patients with uncontrolled or severe hypertension or hypertension with vascular disease.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin. Blood pressure should be monitored closely in individuals with high blood pressure; discontinue ethynodiol diacetate; ethinyl estradiol if blood pressure rises significantly.
COCs may also cause fluid retention, and patients predisposed to complications from edema, such as those with renal disease or cardiac disease, should be closely monitored. Combined oral contraceptive COC containing a synthetic estrogen and ethynodiol diacetate, a progestin with moderate androgenic and slight estrogenic activity Used for routine contraception in adolescent and adult premenopausal females All COCs contain a boxed warning regarding the increased risk for thromboembolism in women who smoke.
Repeat dosage cycles begin on the eighth day after taking the last hormonally active tablet. Administration of most monophasic fixed-combination OCs begins on day 5 of the menstrual cycle or the first Sunday after or on which bleeding has started. However, some clinicians and manufacturers suggest that administration begins on day 1 of the menstrual cycle to decrease the risk of early ovulation.
If administration begins on day 1, spotting and breakthrough bleeding may be more common during the initial dosage cycle. Follow dose as for routine contraception. Improvement may not be noticeable for 2 to 4 months. Prolonged treatment may be needed to control condition. Treatment for 6 to 12 months may be required; OCs have limited utility when the underlying cause of the condition is not related to a hypoestrogenic or hyperandrogenic state.
Follow dose as for routine contraception; alternatively, the active tablets can be given continuously. Combined hormonal contraceptives can reduce endometriosis-associated dyspareunia, dysmenorrhea, and non-menstrual pelvic pain.
Treatment for 6 to 9 months may be needed to induce endometrial atrophy and reduce symptoms. Hormonal contraceptives are contraindicated for use in the presence of active liver disease or markedly impaired liver function. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Patients should be instructed to review the patient information leaflet that accompanies the ethynodiol diacetate; ethinyl estradiol prescription each time it is filled.
To minimize nausea, administer ethynodiol diacetate; ethinyl estradiol with or after the evening meal or at bedtime. Take at the same time each day to ensure maximum contraceptive efficacy. Some contraceptive packs contain 28 tablets. For most of these, 21 tablets contain active hormone and 7 contain either iron or inert ingredients, so that the daily dosage cycle can be continuous. This reduces the chance of missed doses.
The 7 extra tablets are taken at the end of the cycle. Administration instructions for patients: Instruct patient on risks and warnings associated with hormonal contraceptives. Missing ethynodiol diacetate; ethinyl estradiol pills can cause spotting or light bleeding. The length of time required for using a second method of contraception after drug initiation is slightly different for each manufacturer.
In general, a second, non-hormonal form of contraception should be used until active ethynodiol diacetate; ethinyl estradiol tablets have been taken for at least 7 consecutive days. Each manufacturer has slightly different recommendations for missed pills. Patients should be instructed to review the patient information leaflet that accompanies the prescription each time it is filled.
General recommendations for missed doses: If one ethynodiol diacetate; ethinyl estradiol dose is missed, the patient should take it as soon as she remembers and then take the next pill at the regular time as usual. It may be necessary to take 2 tablets in one day.
Some manufacturers recommend that a second method of non-hormonal contraception be used for at least 7 days after restarting the pills. If two doses in a row are missed, 2 tablets should be taken on both the day the missed doses are remembered and the following day.
The regular schedule should then be continued. A second method of non-hormonal contraception should be used for at least 7 days after restarting the pills.
If 3 doses or more in a row are missed, the patient should not take the missed pills. Recommendations for restarting the pills can be found in the patient information leaflet that accompanies the prescription each time it is filled. A second method of contraception should be used for at least 7 days after the pills are restarted. Use of ethynodiol diacetate; ethinyl estradiol, as with other contraceptive steroids, may result in clinical changes that influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
Specific laboratory test interference has not been reported. Ethynodiol diacetate; ethinyl estradiol, does not protect against human immunodeficiency virus HIV infection or other sexually transmitted disease.
Conversely, patients with known HIV infection or acquired immunodeficiency syndrome AIDS should be aware that the use of this combined oral hormonal contraceptive COC will not prevent the transmission of HIV or other diseases to their partner s. Surgery can increase the risk for thromboembolism from combined hormonal contraceptives.
If feasible, discontinue ethynodiol diacetate; ethinyl estradiol products at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following any prolonged immobilization. Because of the increased potential for embolic risk, combined oral contraceptives COCs containing ethynodiol diacetate; ethinyl estradiol are contraindicated in women who currently have diabetes mellitus and are over 35 years of age, diabetes mellitus with hypertension or with vascular disease or end-organ damage, or diabetes mellitus of greater than 20 years duration.
Patients with diabetes mellitus should be observed for changes in glucose tolerance when initiating or discontinuing COCs, since estrogens may exacerbate diabetes. Altered glucose tolerance secondary to decreased insulin sensitivity has been reported. Women who are being treated for dyslipidemia should be followed closely if they elect to use combined hormonal oral contraceptives COCs. Some progestogens may elevate LDL levels and may render the control of hyperlipidemia more difficult.
Females with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. The majority of studies have found no overall increase in the risk of developing breast cancer. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.
There is insufficient evidence to rule out the possibility that pills may cause such cancers. Taking the pill may provide some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, less risk of fibroids, pelvic infections, and noncancerous breast disease, and less risk of cancer of the ovary and of the lining of the uterus womb.
Be sure to discuss any medical condition you may have with your health care provider. He or she will take a medical and family history before prescribing oral contraceptives and will also examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be re-examined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information that you should read and discuss with 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. And it will tell you how to use the pill properly so that it will be as effective as possible.
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. 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. The pill is one of the most effective methods of birth control. 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:. Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions:. Tell your health care provider if you have ever had any of these conditions.
He or she can recommend a safer method of birth control. Tell your health care provider if you have or have had any of the following conditions, as he or she will want to watch them closely or they might cause him or her to suggest using another method of contraception:. Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives. Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives.
In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness, or have recently delivered a baby, you may be at risk of developing blood clots.
You should consult your doctor about stopping oral contraceptives 3 to 4 weeks before surgery and not taking oral contraceptives for 2 weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least 4 weeks after delivery if you are not breast feeding. If you are breast feeding, you should wait until you have weaned your child before using the pill.
The risk of circulatory disease in oral contraceptive users may be higher in users of high-dose pills and may be greater with longer duration of oral contraceptive use. In addition, some of these increased risks may continue for a number of years after stopping oral contraceptives. The risk of abnormal blood clotting increases with age in both users and nonusers of oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages.
For women aged 20 to 44 it is estimated that about 1 in 2, using oral contraceptives will be hospitalized each year because of abnormal clotting. Among nonusers in the same age group, about 1 in 20, would be hospitalized each year. For oral contraceptive users in general, it has been estimated that in women between the ages of 15 and 34, the risk of death due to a circulatory disorder is about 1 in 12, per years, whereas for nonusers the rate is about 1 in 50, per year.
In the age group 35 to 44, the risk is estimated to be about 1 in 2, per year for oral contraceptive users and about 1 in 10, per year for nonusers. Oral contraceptives may increase the tendency to develop strokes stoppage by blood clots or rupture of blood vessels of the brain and angina pectoris and heart attacks blockage of blood vessels of the heart.
Any of these conditions can cause death or permanent disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increases the chances of developing and dying of heart disease. Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens.
In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in several studies, in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods.
However, liver cancers are rare. There is conflict among studies regarding breast cancer and oral contraceptive use. Women who use oral contraceptives and have a strong family history of breast cancer or who have had breast nodules or abnormal mammograms should be closely followed by their doctors. All methods of birth control and pregnancy are associated with a risk of developing certain diseases that may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table.
In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy 7 to 26 deaths per , women, depending on age. Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per , women, compared to 28 associated with pregnancy at that age.
However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. The suggestion that women over 40 who don't smoke should not take oral contraceptives is based on information from older high-dose pills and on less selective use of pills than is practiced today.
An Advisory Committee of the FDA discussed this issue in and recommended that the benefits of oral contraceptive use by healthy, nonsmoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective. If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:. This is a slight staining between your menstrual periods that may not even require a pad.
Some women spot even though they take their pills exactly as directed. Many women spot although they have never taken the pills. Spotting does not mean that your ovaries are releasing an egg. Spotting may be the result of irregular pill-taking. Getting back on schedule will usually stop it.
If you should spot while taking the pills, you should not be alarmed, because spotting usually stops by itself within a few days. It seldom occurs after the first pill cycle. Consult your doctor if spotting persists for more than a few days or if it occurs after the second cycle.
Unexpected breakthrough bleeding. Unexpected breakthrough bleeding does not mean that your ovaries have released an egg. It seldom occurs, but when it does happen it is most common in the first pill cycle. It is a flow much like a regular period, requiring the use of a pad or tampon. If you experience breakthrough bleeding use a pad or tampon and continue with your schedule.
Usually your periods will become regular within a few cycles. Breakthrough bleeding will seldom bother you again. Consult your doctor or health care provider if breakthrough bleeding is heavy, does not stop within a week, or if it occurs after the second cycle. If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider. Oral contraceptives may cause edema fluid retention , with swelling of the fingers or ankles.
If you experience fluid retention, contact your doctor or health care provider. Some women develop high blood pressure while on the pill, which ordinarily, but not always, returns to the original levels when the pill is stopped.
High blood pressure predisposes one to strokes, heart attacks, kidney disease, and other diseases of the blood vessels. A spotty darkening of the skin is possible, particularly of the face.
This may persist after the pill is discontinued. Other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections.
Missed periods and use of oral contraceptives before or during early pregnancy. Occasionally women who are taking the pill miss periods. It has been reported to occur as frequently as several times each year in some women, depending on various factors such as age and prior history your doctor is the best source of information about this. The pill should not be used when you are pregnant or suspect you may be pregnant.
Very rarely, women who are using the pill as directed become pregnant. The likelihood of becoming pregnant is higher if you occasionally miss one or two pills. Therefore, if you miss a period you should consult your physician before continuing to take the pill. If you miss a period, especially if you have not taken the pill regularly, you should use an alternative method of contraception until pregnancy has been ruled out; if you have missed more than one pill at any time, you should immediately start using an additional method of contraception and complete your pill cycle.
There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor.
You should check with your doctor about risks to your unborn child of any medication taken during pregnancy. If you are breast feeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin jaundice and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk.
If possible, do not use oral contraceptives while breast feeding. You should use another method of contraception since breast feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast feed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely. If you are scheduled for any laboratory tests, tell your doctor you are taking birth control pills.
Certain blood tests may be affected by birth control pills. Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding.
Such drugs include rifampin, drugs used for epilepsy such as barbiturates for example, phenobarbital and phenytoin Dilantin is one brand of this drug , phenylbutazone Butazolidin is one brand , Rezulin troglitazone a hypoglycemic, and possibly certain antibiotics. You may need to use additional contraception when you take drugs that can make oral contraceptives less effective.
Oral contraceptives may have an influence upon the way other drugs act. Check with your doctor if you are taking any other drugs while you are on the pill. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
Use a backup method such as condoms, foam, or sponge until you check with your doctor or clinic. Your tablet dispenser consists of a case and a pill pack containing 28 pills. They are arranged in four numbered rows with the days of the week printed above them. The pill pack has 21 "active" pills with hormones- light orange to take for 3 weeks, followed by 1 week of reminder green pills without hormones.
To remove a pill press down on it with the flat of your finger. The pill will drop through a hole in the bottom of the dispenser. Repeat for Row 2, Row 3, and finally Row 4. Take all "active" pills light orange before starting Row 4.
You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. Take the first "active" pill light orange of the first pack during the first 24 hours of your period. You will not need to use a backup method of birth control, since you are starting the pill at the beginning of your period.
Take the first "active" pill light orange of the first pack on the Sunday after your period starts , even if you are still bleeding. If your period begins on Sunday, start the pack that same day. Use another method of birth control as a backup method if you have sex anytime from the Sunday you start your first pack until the next Sunday 7 days.
Condoms, foam, or the sponge are good backup methods of birth control. Do not wait any days between day packs. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. You MUST use another birth control method such as condoms, foam, or sponge as a backup for those 7 days. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
If you become pregnant you should discuss your pregnancy with your doctor. There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives.
It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs after stopping the pill. Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children.
Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health care provider, pharmacist or Poison Control Center. Your health care provider will take a medical and family history before prescribing oral contraceptives and will also examine you. You should be reexamined at least once a year. Certain health problems or conditions in your medical or family history may require that your health care provider see you more frequently while you are taking the pill.
Be sure to keep all appointments with your health care provider because this is a time to determine if there are early signs of side effects of oral contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills. It does not protect against transmission of HIV AIDS and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis.
In addition to preventing pregnancy, use of oral contraceptives may provide certain benefits. They are:. If you want more information about birth control pills, ask your doctor or pharmacist. They have a more technical leaflet called the Professional Labeling, which you may wish to read. The Professional Labeling is also published in a book entitled Physicians' Desk Reference, available in many book stores and public libraries.
The structural formulas are as follows:. 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. 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.
Thromboembolic disorders and other vascular problems a. Myocardial infarction An increased risk of myocardial infarction has been associated with oral contraceptive use.
Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. 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, although, in general, the risk was greatest among older over 35 years , hypertensive women who also smoked.
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. Products containing 50 mcg estrogen should be used only when medically indicated. Persistence of risk of vascular disease There are three studies that have shown persistence of risk of vascular disease for users of oral contraceptives.
Estimates of mortality from contraceptive use One study 67 gathered data from a variety of sources that have estimated the mortality rates associated with different methods of contraception at different ages Table 2.
Table 2. Annual number of birth-related or method-related deaths associated with control of fertility per , nonsterile women, by fertility control method according to age. 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.
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.
Ocular lesions There have been reports of retinal thrombosis and other ocular lesions associated with the use of oral contraceptives. 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.
Gallbladder disease Earlier studies reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. Carbohydrate and lipid metabolic effects Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. Elevated blood pressure An increase in blood pressure has been reported in women taking oral contraceptives 50, 53, and this increase is more likely in older oral contraceptive users and with extended duration of use.
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.
Bleeding irregularities Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. 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.
Lipid disorders Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Liver function If jaundice develops in any woman receiving oral contraceptives, they should be discontinued.
Fluid retention Oral contraceptives may cause some degree of fluid retention. Emotional disorders Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. Contact lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
Drug interactions Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. Laboratory test interactions Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: a.
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