Generic Name: levonorgestrel and ethinyl estradiol Dosage Form: tablets. Medically reviewed by Drugs. Last updated on Sep 1, Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive COC use.
This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Levora 0. Each white active tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.
Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation. Levora 0. COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. Cigarette smoking increases the risk of serious cardiovascular events from COC use. Use of COCs increases the risk of Colm non lavora thromboembolic events VTEssuch as deep vein thrombosis and pulmonary embolism.
While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period see Figure 1.
The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females, and for females in the postpartum period.
To put the risk of developing a VTE into perspective: If 10, females Colm non lavora are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE. Discontinue Levora 0. Acute liver test abnormalities may necessitate the discontinuation of COC use until the liver tests return to normal and COC causation has been excluded. COCs increase the risk of hepatic adenomas.
An estimate of the attributable risk is 3. Rupture of hepatic adenomas may cause Colm non lavora from abdominal hemorrhage. The attributable risk of liver cancers in COC users is less than one case per million users.
For all females, including those with well- controlled hypertension, monitor blood pressure at routine visits and stop Levora 0. An increase in Colm non lavora pressure has been reported in females using COCs, and this increase is more likely in older women with extended duration of use. The risk for cardiovascular disease and prevalence of risk factors for cardiovascular disease increase with age. Consider the presence of underlying risk factors that may increase the risk of cardiovascular disease or VTE, particularly before initiating a COC for women over 35 years, such as:.
Studies suggest an increased risk of developing gallbladder disease among COC users. Use of COCs may also worsen existing gallbladder disease.
Females with a history of pregnancy-related cholestasis may be at an increased risk for COC- related cholestasis. Carefully monitor prediabetic and diabetic females who are using Levora Colm non lavora. Consider alternative contraception for females with uncontrolled dyslipidemia. Females with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using Levora 0. If a woman using Levora 0.
Consider discontinuation of Levora 0. Females using Levora 0. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles, evaluate for causes Colm non lavora as pregnancy or malignancy.
In two clinical trials of Levora subjects reporting for a total of treatment cycles and subjects reporting for a total of treatment cyclesbreakthrough bleeding occurred in 6.
In the two trials, intermenstrual bleeding i. In one trial, 33 subjects out of 3. Females who use Levora 0. In two clinical trials of Levora, one including reported treatment cycles, Colm non lavora the other Colm non lavora reported treatment cycles, amenorrhea occurred in 1.
If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not Colm non lavora to the prescribed dosing schedule missed one or two active tablets or started taking them on a day later than she should haveconsider the possibility of pregnancy at the time of the first missed period and perform appropriate diagnostic measures. If the patient has adhered to the prescribed dosing Colm non lavora and misses Colm non lavora consecutive periods, rule out pregnancy.
After discontinuation of a COC, amenorrhea or oligomenorrhea may occur, especially if these conditions were pre-existent. Carefully observe females Colm non lavora a history of Colm non lavora and discontinue Levora 0. Data on the association of COCs with onset of depression or exacerbation of existing depression are limited. Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia.
There is controversy about the extent to which these findings are due to differences in sexual behavior Colm non lavora other factors. The estrogen component of Levora 0. The dose of replacement thyroid hormone or cortisol therapy may need to be increased. In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Chloasma may occur with Levora 0. Advise females with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while using Levora 0. Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
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. The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are Colm non lavora.
Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. Table 1 includes substances that demonstrated an important drug interaction with Levora 0.
Co-administration of atorvastatin Colm non lavora rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation.
Table 2 provides significant drug interaction information for drugs co-administered with Levora 0. The use of COCs may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Epidemiologic studies and meta- analyses have not found an increased risk of genital or nongenital Colm non lavora defects including cardiac anomalies and limb-reduction defects following exposure to COCs before conception or during early pregnancy.
In the U. COCs can reduce milk production Colm non lavora breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established.
When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. Colm non lavora developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for Levora 0. Safety and efficacy of Levora 0. Use of Levora 0. The following serious adverse reactions with the use of Colm non lavora are discussed elsewhere in the labeling:.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp Colm non lavora Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell Colm non lavora Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.
There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea. For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first Colm non lavora consecutive days of administration. Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take Levora 0.
The failure rate may increase when pills are missed or taken incorrectly. Instruct patients about the handling of missed doses e. If vomiting occurs within 3 to 4 hours after taking Levora 0.
In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. What is the most important information I should know about Levora 0.
Do not use Levora 0. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of clinical studies, about 1 to 5 out Colm non lavora women may get pregnant during the first year they use Levora 0. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Colm non lavora box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective Colm non lavora are at the top of the chart.
The box on the bottom of the chart shows the Colm non lavora of getting pregnant for women who do not use birth control and are trying to get pregnant.