07.11.2014

Lutera and pregnancy chances

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
No specific investigation of the absolute bioavailability of Lutera in humans has been conducted.
Based on the pharmacokinetic study with Lutera, there are no apparent differences in pharmacokinetic parameters among women of different races. No formal studies have evaluated the effect of hepatic disease on the disposition of Lutera. Interactions between ethinyl estradiol and other drugs have been reported in the literature.
In a clinical trial with Lutera, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. An increased risk of venous thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke. A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease. Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. 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 1989. Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives. 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.
Extensive epidemiological studies have revealed no increased risk of birth defects in 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. Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. 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.
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.
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. A periodic history and physical examination are appropriate for all women, including women using oral contraceptives. 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.
Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin.
Sex-hormone binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels remain unchanged. 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. To achieve maximum contraceptive effectiveness, Lutera® must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Lutera is one white tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days, according to the prescribed schedule.
During the first cycle of medication, the patient is instructed to begin taking Lutera on the first Sunday after the onset of menstruation.
During the first cycle of medication, the patient is instructed to begin taking Lutera during the first 24 hours of her period (day one of her menstrual cycle). When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Lutera. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. Any woman who considers using oral contraceptives (the birth-control pill or the pill) should understand the benefits and risks of using this form of birth control.
Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives and can be fatal.
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. Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart).
All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. 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. 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. 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. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.


Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism.
The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion.
Levonorgestrel and its metabolites are primarily excreted in the urine (40% to 68%) and about 16% to 48% are excreted in feces.
Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.
This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes. The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined.
This risk is primarily in smokers or women with other underlying risk factors for coronary-artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.
Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and nonsmokers over the age of 40 (Table III) among women who use oral contraceptives.
In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deepvein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease.
Hypertension was found to be a risk factor for both users and non-users, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes. These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure.
The Committee concluded that although cardiovascular disease risks may be increased with oral-contraceptive use after age 40 in healthy non-smoking 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.
The overwhelming evidence in the literature suggests that use of oral contraceptives is not associated with an increase in the risk of developing breast cancer, regardless of the age and parity of first use or with most of the marketed brands and doses. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy (see CONTRAINDICATIONS).
Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
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.
If women with hypertension elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued.
The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin, and possibly with griseofulvin, ampicillin, and tetracyclines.
This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using another method of birth control until she has taken a white tablet daily for 7 consecutive days. 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. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage 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. Your health-care provider will take a medical and family history before prescribing oral contraceptives and will examine you.
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. 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. For example, you should not take the pill if you are pregnant or think you may be pregnant. 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.
You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease.
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. 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 100,000 women, depending on age). An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral-contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%.


Levels of Cytochrome P450 (CYP3A) vary widely among individuals and can explain the variation in rates of ethinyl estradiol 2-hydroxylation. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization. If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. The Cancer and Steroid Hormone (CASH) study also showed no latent effect on the risk of breast cancer for at least a decade following long-term use.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. 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. 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. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests.
These side effects, especially nausea and vomiting, may subside within the first three months of use.
As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.
In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, may decrease oral contraceptive effectiveness. 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. 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.
Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.
You should also not take oral contraceptives soon after delivery of a baby or a midtrimester pregnancy termination. In addition, a possible but not definite association has been found with the pill and liver cancers in two studies in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, except for those women over the age of 40, when the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. Observed levonorgestrel concentrations increased from day 1 (single dose) to days 6 and 21 (multiple doses) by 34% and 96%, respectively (Figure 1).
Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.
Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and undergoes enterohepatic circulation. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral-contraceptive users and non-users. The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped. Since the immediate post-partum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breast-feed, or a midtrimester pregnancy termination. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogen used in the contraceptive. 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.
A few studies have shown a slightly increased relative risk of developing breast cancer, although the methodology of these studies, which included differences in examination of users and nonusers and differences in age at start of use, has been questioned. 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.
When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Lutera on the day after her last tablet.
Although the occurrence of pregnancy is unlikely if Lutera is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. However, this leaflet is not a replacement for a careful discussion between you and your health-care provider. 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. Unbound levonorgestrel concentrations increased from day 1 to days 6 and 21 by 25% and 83%, respectively. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives. If Lutera tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Lutera tablets until after the first 7 consecutive days of administration.
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 before the medication is resumed.
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 possibility of ovulation and conception prior to initiation of medication should be considered.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.



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