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Email Address. Log In. Remember Me. Forgot password? Back to log in. In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small.

However, both studies were performed with oral contraceptive formulations containing 50 mcg or higher of estrogens. Estimates of Mortality from Contraceptive Use.

One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages TABLE III.

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 and older who do not smoke, mortality associated with all methods of birth control is less than that associated with childbirth.

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 which 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 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 which 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.

Adapted from H. Ory, Family Planning Perspectives, 15 : 57 to 63, Carcinoma of the Reproductive Organs and Breasts. Numerous epidemiological studies have examined the association between the use of oral contraceptives and the incidence of breast and cervical cancer.

The risk of having breast cancer diagnosed may be slightly increased among current and recent users of combination oral contraceptives.

However, this excess risk appears to decrease over time after combination oral contraceptive discontinuation and by 10 years after cessation the increased risk disappears.

Some studies report an increased risk with duration of use while other studies do not and no consistent relationships have been found with dose or type of steroid.

Some studies have reported a small increase in risk for women who first use combination oral contraceptives at a younger age. Breast cancers diagnosed in current or previous OC users tend to be less clinically advanced than in nonusers.

Women with known or suspected carcinoma of the breast or personal history of breast cancer should not use oral contraceptives because breast cancer is usually a hormonally-sensitive tumor.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer 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 combination oral contraceptive use and breast and cervical cancers, a cause-and-effect relationship has not been established.

Hepatic Neoplasia. Benign hepatic adenomas are associated with oral-contraceptive use, although the incidence of these benign tumors is rare in the United States.

Indirect calculations have estimated the attributable risk to be in the range of 3. Rupture of rare, benign, hepatic adenomas may cause death through intra abdominal hemorrhage.

However, these cancers are extremely rare in the U. There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives that may lead to partial or complete loss of vision.

Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions.

Appropriate diagnostic and therapeutic measures should be undertaken immediately. Extensive epidemiological studies have revealed no increased risk of birth defects in infants born to women who have used oral contraceptives prior to 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.

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.

Oral-contraceptive use should be discontinued if pregnancy is confirmed. Gallbladder Disease. Combination oral contraceptives may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women.

Earlier studies have 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 hormonal doses of estrogens and progestogens.

Carbohydrate and Lipid Metabolic Effects. Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users.

Oral contraceptives containing greater than 75 mcg of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance.

Progestogens increase insulin secretion and create insulin resistance, this 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.

A small proportion of women will have persistent hypertriglyceridemia while on the pill. 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 continued use.

Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing quantities of progestogens.

Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception.

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.

The onset or exacerbation of migraine or development of headache with 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.

The type and dose of progestogen may be important. If bleeding persists or recurs, 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 pathology has been excluded, time 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 possibly with anovulation , especially when such a condition was preexistent.

Ectopic Pregnancy. Ectopic as well as intrauterine pregnancy may occur in contraceptive failures. Physical Examination and Follow-Up. A periodic personal and family medical history and complete physical examination are appropriate for all women, 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 diagnostic 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.

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. A small proportion of women will have adverse lipid changes while taking oral contraceptives.

Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias. Persistent hypertriglyceridemia may occur in a small population of combination oral contraceptive users.

Elevations of plasma triglycerides may lead to pancreatitis and other complications. If jaundice develops in any woman receiving such drugs, the medication should be discontinued.

Steroid hormones may be poorly metabolized in patients with impaired liver function. 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 which might be aggravated by fluid retention.

Emotional Disorders. Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related.

Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

Drug Interactions. Changes in Contraceptive Effectiveness Associated with Coadministration of Other Products: Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids.

This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil.

In such cases a back-up nonhormonal method of birth control should be considered. Several cases of contraceptive failure and breakthrough bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and other penicillins, and tetracyclines.

However, clinical pharmacology studies investigating drug interactions between combined oral contraceptives and these antibiotics have reported inconsistent results.

Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes increase and decrease in the plasma levels of the estrogen and progestin have been noted in some cases.

The safety and efficacy of oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

Herbal products containing St. John's Wort Hypericum perforatum may induce hepatic enzymes cytochrome P and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids.

This may also result in breakthrough bleeding. Ascorbic acid and acetaminophen increase the bioavailability of ethinyl estradiol since these drugs act as competitive inhibitors for sulfation of ethinyl estradiol in the gastrointestinal wall, a known pathway of elimination for ethinyl estradiol.

CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole, and troleandomycin may increase plasma hormone levels.

Troleandomycin may also increase the risk of intrahepatic cholestasis during coadministration with combination oral contraceptives.

Combination hormonal contraceptives containing some synthetic estrogens eg, ethinyl estradiol may inhibit the metabolism of other compounds. In-creased plasma concentrations of cyclosporin, prednisolone and other corticosteroids, and theophylline have been reported with concomitant administration of oral contraceptives.

Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid, due to induction of conjugation particularly glucuronidation , have been noted when these drugs were administered with oral contraceptives.

The prescribing information of concomitant medications should be consulted to identify potential interactions. Interactions with Laboratory Tests.

Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:.

Increased thyroid-binding globulin TBG leading to increased circulating total thyroid hormone, as measured by protein-bound iodine PBI , T 4 by column or by radioimmunoassay.

Other binding proteins may be elevated in serum i. Free or biologically active hormone concentrations are unchanged.

Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.

Serum folate levels may be depressed by oral-contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

Pregnancy Category X. Nursing Mothers. In addition, combination 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 combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Safety and efficacy of levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol before menarche is not indicated. Levonorgestrel and ethinyl estradiol has not been studied in women over 65 years of age and is not indicated in this population.

Information for the Patient. An increased risk of the following serious adverse reactions see WARNINGS section for additional information has been associated with the use of oral contraceptives:.

Thromboembolic and thrombotic disorders and other vascular problems including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis , carcinoma of the reproductive organs and breasts, hepatic neoplasia including hepatic adenomas or benign liver tumors , ocular lesions including retinal vascular thrombosis , gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related alphabetically listed :.

The following adverse reactions have been reported in users of oral contraceptives:. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.

The dosage of Delyla is one white tablet daily for 21 consecutive days, followed by one yellow inert tablet daily for 7 consecutive days, according to the prescribed schedule.

It is recommended that Delyla be taken at the same time each day. The blister should be kept in the wallet supplied to avoid possible fading of the pills.

If the pills fade, patients should continue to take them as directed. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should be instructed to begin taking Delyla on either the first Sunday after the onset of menstruation Sunday Start or on Day 1 of menstruation Day 1 Start.

The patient is instructed to begin taking Delyla on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet white is taken that day.

One white tablet should be taken daily for 21 consecutive days, followed by one yellow inert tablet daily for 7 consecutive days.

Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started.

During the first cycle, contraceptive reliance should not be placed on Delyla until a white tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days.

During the first cycle of medication, the patient is instructed to begin taking Delyla during the first 24 hours of her period day one of her menstrual cycle.

If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Delyla tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Delyla tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during 7 days.

After the first cycle of use. The patient begins her next and all subsequent courses of tablets on the day after taking her last yellow tablet.

She should follow the same dosing schedule: 21 days on white tablets followed by 7 days on yellow tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

Switching from another hormonal method of contraception. When the patient is switching from a 21—day regimen of tablets, she should wait 7 days after her last tablet before she starts Delyla.

She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21—day regimen.

When the patient is switching from a day regimen of tablets, she should start her first pack of Delyla on the day after her last tablet. She should not wait any days between packs.

The patient may switch any day from a progestin-only pill and should begin Delyla the next day. If switching from an implant or injection, the patient should start Delyla on the day of implant removal or, if using an injection, the day the next injection would be due.

In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

If spotting or breakthrough bleeding occurs. If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen.

This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Risk of pregnancy if tablets are missed. While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.

Although the occurrence of pregnancy is unlikely if Delyla is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered.

If the patient has not adhered to the prescribed schedule missed one or more tablets or started taking them on a day later than she should have , the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. The risk of pregnancy increases with each active white tablet missed.

Use after pregnancy, abortion or miscarriage. The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking.

Delyla may be initiated immediately after a first trimester abortion or miscarriage. If the patient starts Delyla immediately, back-up contraception is not needed.

Brief Summary Patient Package Insert. This product like all oral contraceptives is intended to prevent pregnancy.

For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.

For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death.

The risks associated with taking oral contraceptives increase significantly if you:. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

Although cardiovascular disease risks may be increased with oral-contraceptive use after age 40 in healthy, nonsmoking women, there are also greater potential health risks associated with pregnancy in older women.

Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses.

These side effects, especially nausea and vomiting, may subside within the first three months of use.

The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill:.

Blood clots in the legs thrombophlebitis and lungs pulmonary embolism , blockage or rupture of a blood vessel in the brain stroke , blockage of blood vessels in the heart heart attack and angina pectoris or other organs of the body.

As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Women with migraine also may be at increased risk of stroke with pill use.

Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer.

However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills.

Notify your health-care provider if you notice any unusual physical disturbances while taking the pill.

In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, herbal preparations containing St.

Various studies give conflicting reports on the relationship between breast cancer and oral contraceptive use. Oral contraceptive use may slightly increase your chance of having breast cancer diagnosed, particularly if you started using hormonal contraceptives at a younger age.

After you stop using hormonal contraceptives, the chances of having breast cancer diagnosed begin to go down and disappear 10 years after stopping use of the pill.

It is not known whether this slightly increased risk of having breast cancer diagnosed is caused by the pill. It may be that women taking the pill were examined more often, so that breast cancer was more likely to be detected.

You should have regular breast examinations by a health-care provider and examine your own breasts monthly.

Tell your health-care provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram.

Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormone sensitive tumor.

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.

Taking the pill provides some important noncontraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

Be sure to discuss any medical condition you may have with your health-care provider. Your health-care provider will take a medical and family history before prescribing oral contraceptives and will examine you.

The physical examination may be delayed to another time if you request it and the health-care provider believes that it is appropriate to postpone it.

You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your health-care provider.

If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.

If you feel sick to your stomach, do not stop taking Delyla. The problem will usually go away. 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 back-up nonhormonal method such as condoms or spermicide until you check with your health-care provider. It is important to take it at about the same time every day.

You have a choice of which day to start taking your first pack of pills. Decide with your health-care provider which is the best day for you.

Pick a time of day which will be easy to remember. Pick the day label strip that starts with the first day of your period.

Place this day label strip over the area that has the days of the week starting with Sunday pre-printed on the blister pack. Note: if the first day of your period is a Sunday, you can skip step 1.

You will not need to use a back-up nonhormonal method of birth control, since you are starting the pill at the beginning of your period.

If your period begins on Sunday, start the pack that same day. Use a nonhormonal method of birth control such as condoms or spermicide as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday 7 days.

Take one pill at the same time every day until the pack is empty. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach nausea.

Do not skip pills even if you do not have sex very often. Do not wait any days between packs. If your previous brand had 21 pills: Wait 7 days to start taking Delyla.

You will probably have your period during that week. 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 a nonhormonal birth-control method such as condoms or spermicide as a back-up for those 7 days.

Take 2 pills on the day you remember and 2 pills the next day. Then take 1 pill a day until you finish the pack. If you are a Day 1 Starter :.

If you are a Sunday Starter :. 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 health-care provider because you might be pregnant.

If you are a Sunday Starter:. Keep taking 1 pill each day until the pack is empty. You do not need a back-up nonhormonal birth-control method if you start your next pack on time.

If you do not wish to become pregnant after stopping the pill speak to your health-care provider about another method of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill.

It will tell you how to use the pill properly so that it will be as effective as possible. However, 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. The chance of becoming pregnant increases with each missed pill during each day cycle of use.

In comparison, average 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 have any of the following conditions:. Tell your health-care provider if you have had any of these conditions.

Your health-care provider can recommend another method of birth control. Tell your health-care provider if you or any family member has ever had:.

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