What happens if I overdose Ethinyl estradiol/levonorgestrel?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include severe dizziness, nausea, or vomiting; stomach pain; unusual drowsiness or tiredness; unusual vaginal bleeding.
Proper storage of Ethinyl estradiol/levonorgestrel:
Store Ethinyl estradiol/levonorgestrel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ethinyl estradiol/levonorgestrel out of the reach of children and away from pets.
Overdose of Ethinyl estradiol/levonorgestrel in details
Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
NONCONTRACEPTIVE HEALTH BENEFITS
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 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Effects on menses:
- •
- Increased menstrual cycle regularity
- •
- Decreased blood loss and decreased incidence of iron-deficiency anemia
- •
- Decreased incidence of dysmenorrhea
Effects related to inhibition of ovulation:
- •
- Decreased incidence of functional ovarian cysts
- •
- Decreased incidence of ectopic pregnancies
Effects from long-term use:
- •
- Decreased incidence of fibroadenomas and fibrocystic disease of the breast
- •
- Decreased incidence of acute pelvic inflammatory disease
- •
- Decreased incidence of endometrial cancer
- •
- Decreased incidence of ovarian cancer
What should I avoid while taking Ethinyl estradiol/levonorgestrel?
Do not smoke while using Ethinyl estradiol/levonorgestrel, especially if you are older than 35 years of age.
Grapefruit may interact with Ethinyl estradiol/levonorgestrel and lead to unwanted side effects. Avoid the use of grapefruit products.
This medicine may cause darkening of your facial skin (chloasma), especially if you've ever had chloasma during a pregnancy. Avoid sunlight or tanning beds. Use sunscreen (SPF 30 or higher) when you are outdoors.
Avoid applying makeup, lotions, powders, or oils to the skin where you apply a skin patch.
Ethinyl estradiol/levonorgestrel warnings
Thrombotic Disorders and Other Vascular Problems
- Stop Ethinyl estradiol/levonorgestrel if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop Ethinyl estradiol/levonorgestrel if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
- If feasible, stop Ethinyl estradiol/levonorgestrel at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization.
- Start Ethinyl estradiol/levonorgestrel no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
- The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman - years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.
- Use of Ethinyl estradiol/levonorgestrel provides women with more hormonal exposure on a yearly basis than conventional monthly COCs containing the same strength synthetic estrogens and progestins (an additional 9 weeks of exposure per year). In the clinical trial, one case of pulmonary embolism was reported. Postmarketing adverse reactions of VTE have been reported in women who used Ethinyl estradiol/levonorgestrel.
- Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. Stroke has been reported in women associated with the use of Ethinyl estradiol/levonorgestrel. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
- Use COCs with caution in women with cardiovascular disease risk factors.
Liver Disease
Impaired Liver Function
Do not use Ethinyl estradiol/levonorgestrel in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue Ethinyl estradiol/levonorgestrel if jaundice develops.
Liver Tumors
Ethinyl estradiol/levonorgestrel is contraindicated in women with benign and malignant liver tumors. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.
Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment
During clinical trials with the Hepatitis C combination drug regimen that contains obmitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Ethinyl estradiol/levonorgestrel prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Ethinyl estradiol/levonorgestrel can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
High Blood Pressure
Ethinyl estradiol/levonorgestrel is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. For women with well-controlled hypertension, monitor blood pressure and stop Ethinyl estradiol/levonorgestrel if blood pressure rises significantly.
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.
Gallbladder Disease
Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease.
A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC-related cholestasis.
Carbohydrate and Lipid Metabolic Effects
Carefully monitor prediabetic and diabetic women who are taking Ethinyl estradiol/levonorgestrel. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
Headache
If a woman taking Ethinyl estradiol/levonorgestrel develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Ethinyl estradiol/levonorgestrel if indicated.
Consider discontinuation of Ethinyl estradiol/levonorgestrel in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
Bleeding Irregularities and Amenorrhea
Bleeding and/or spotting that occurs at any time while taking the first 84 tablets of each extended-cycle regimen is considered “unscheduled” bleeding/spotting. Bleeding that occurs during the time a woman takes the seven green inert tablets is considered “scheduled” bleeding.
Unscheduled and Scheduled Bleeding and Spotting
Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. If unscheduled bleeding persists or occurs after previously regular cycles on Ethinyl estradiol/levonorgestrel, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.
Before prescribing Ethinyl estradiol/levonorgestrel, advise the woman to weigh the convenience of fewer scheduled menses (4 per year instead of 13 per year) against the inconvenience of increased unscheduled bleeding and/or spotting.
The clinical trial of the efficacy of Ethinyl estradiol/levonorgestrel (91-day cycles) in preventing pregnancy also assessed scheduled and unscheduled bleeding. The participants in the study were composed primarily of women who had used oral contraceptives previously as opposed to new users. Women with a history of breakthrough bleeding/spotting ≥ 10 consecutive days on oral contraceptives were excluded from the study. More Ethinyl estradiol/levonorgestrel subjects, compared to subjects on the comparator 28-day cycle regimen, discontinued prematurely for unacceptable bleeding (7.7% [Ethinyl estradiol/levonorgestrel] vs. 1.8% [28-day cycle regimen]).
Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 3 below presents the number of days with unscheduled bleeding and/or spotting for each respective 91-day cycle.
| Q1=Quartile 1: 25% of women had ≤ this number of days of unscheduled bleeding/spotting Median: 50% of women had ≤ this number of days of unscheduled bleeding/spotting Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled bleeding/spotting | |||||
| Cycle (N) | Days of Unscheduled Bleeding and/or Spotting per 84-Day Interval | Median Days Per Subject- Month | |||
| Mean | Q1 | Median | Q3 | ||
| 1 (446) | 15.1 | 3.0 | 12 | 23.0 | 3.0 |
| 2 (368) | 11.6 | 2.0 | 6 | 17.5 | 1.5 |
| 3 (309) | 10.6 | 1.0 | 6 | 15.0 | 1.5 |
| 4 (282) | 8.8 | 1.0 | 4 | 14.0 | 1.0 |
Table 4 shows the percentages of women with ≥ 7 days and ≥ 20 days of unscheduled spotting and/or bleeding in the Ethinyl estradiol/levonorgestrel and the 28-day cycle treatment groups.
| Days of unscheduled bleeding and/or spotting | Percentage of Subjectsa | |
|---|---|---|
| a Based on spotting and/or bleeding on days 1 to 84 of a 91 day cycle in the Ethinyl estradiol/levonorgestrel subjects and days 1 to 21 of a 28 day cycle over 4 cycles in the 28-day dosing regimen. | ||
| Ethinyl estradiol/levonorgestrel | Cycle 1 (N=385) | Cycle 4 (N=261) |
| ≥ 7 days | 65% | 42% |
| ≥ 20 days | 35% | 15% |
| 28-day regimen | Cycles 1 to 4 (N=194) | Cycles 10 to 13 (N=158) |
| ≥ 7 days | 38% | 39% |
| ≥ 20 days | 6% | 4% |
Total days of bleeding and/or spotting (scheduled plus unscheduled) were similar over one year of treatment for Ethinyl estradiol/levonorgestrel subjects and subjects on the 28-day cycle regimen.
Amenorrhea and Oligomenorrhea
Women who are not pregnant and use Ethinyl estradiol/levonorgestrel may experience amenorrhea. Based on data from the clinical trial, amenorrhea occurred in approximately 0.8% of women during Cycle 1, 1.2% of women during Cycle 2, 3.7% of women during Cycle 3, and 3.4% of women during Cycle 4. Because women using Ethinyl estradiol/levonorgestrel will likely have scheduled bleeding only 4 times per year, rule out pregnancy at the time of any missed menstrual period.
Some women may experience amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was pre-existent.
COC Use Before or During Early Pregnancy
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Ethinyl estradiol/levonorgestrel use if pregnancy is confirmed.
Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy.
Depression
Depression associated with the use of Ethinyl estradiol/levonorgestrel has been reported. Carefully observe women with a history of depression and discontinue Ethinyl estradiol/levonorgestrel if severe depression recurs.
Carcinoma of the Breast and Cervix
- Ethinyl estradiol/levonorgestrel is contraindicated in women who currently have or have had breast cancer because breast cancer may be hormonally sensitive.
There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.
- Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
Effect on Binding Globulins
The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
Monitoring
A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated health care.
Hereditary Angioedema
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Chloasma
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to develop chloasma should avoid prolonged exposure to the sun or ultraviolet radiation while taking Ethinyl estradiol/levonorgestrel.
What should I discuss with my healthcare provider before taking Ethinyl estradiol/levonorgestrel?
Ethinyl estradiol/levonorgestrel can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking Ethinyl estradiol/levonorgestrel. You should not take Ethinyl estradiol/levonorgestrel if you have:
-
untreated or uncontrolled high blood pressure;
-
heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
-
a blood-clotting disorder or circulation problems;
-
problems with your eyes, kidneys or circulation caused by diabetes;
-
a history of hormone-related cancer such as breast or uterine cancer;
-
unusual vaginal bleeding that has not been checked by a doctor;
-
liver disease or liver cancer;
-
severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
-
a history of jaundice caused by pregnancy or birth control pills; or
-
if you smoke and are over 35 years old.
To make sure you can safely take Ethinyl estradiol/levonorgestrel, tell your doctor if you have any of these other conditions:
-
high blood pressure, varicose veins;
-
high cholesterol or triglycerides, or if you are overweight;
-
a history of depression;
-
underactive thyroid;
-
gallbladder disease;
-
diabetes;
-
seizures or epilepsy;
-
a history of irregular menstrual cycles;
-
tuberculosis; or
-
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
The hormones in Ethinyl estradiol/levonorgestrel (Ethinyl estradiol/levonorgestrel) can pass into breast milk and may harm a nursing baby. Ethinyl estradiol/levonorgestrel may also slow breast milk production. Do not Ethinyl estradiol/levonorgestrel use if you are breast feeding a baby.
Ethinyl estradiol/levonorgestrel precautions
Thrombotic Disorders and Other Vascular Problems
- Stop Ethinyl estradiol/levonorgestrel if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
- Stop Ethinyl estradiol/levonorgestrel if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
- If feasible, stop Ethinyl estradiol/levonorgestrel at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization.
- Start Ethinyl estradiol/levonorgestrel no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
- The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman - years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.
- Use of Ethinyl estradiol/levonorgestrel provides women with more hormonal exposure on a yearly basis than conventional monthly COCs containing the same strength synthetic estrogens and progestins (an additional 9 weeks of exposure per year). In the clinical trial, one case of pulmonary embolism was reported. Postmarketing adverse reactions of VTE have been reported in women who used Ethinyl estradiol/levonorgestrel.
- Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. Stroke has been reported in women associated with the use of Ethinyl estradiol/levonorgestrel. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
- Use COCs with caution in women with cardiovascular disease risk factors.
Liver Disease
Impaired Liver Function
Do not use Ethinyl estradiol/levonorgestrel in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue Ethinyl estradiol/levonorgestrel if jaundice develops.
Liver Tumors
Ethinyl estradiol/levonorgestrel is contraindicated in women with benign and malignant liver tumors. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.
Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment
During clinical trials with the Hepatitis C combination drug regimen that contains obmitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Ethinyl estradiol/levonorgestrel prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Ethinyl estradiol/levonorgestrel can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
High Blood Pressure
Ethinyl estradiol/levonorgestrel is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. For women with well-controlled hypertension, monitor blood pressure and stop Ethinyl estradiol/levonorgestrel if blood pressure rises significantly.
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.
Gallbladder Disease
Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease.
A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC-related cholestasis.
Carbohydrate and Lipid Metabolic Effects
Carefully monitor prediabetic and diabetic women who are taking Ethinyl estradiol/levonorgestrel. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
Headache
If a woman taking Ethinyl estradiol/levonorgestrel develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Ethinyl estradiol/levonorgestrel if indicated.
Consider discontinuation of Ethinyl estradiol/levonorgestrel in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
Bleeding Irregularities and Amenorrhea
Bleeding and/or spotting that occurs at any time while taking the first 84 tablets of each extended-cycle regimen is considered “unscheduled” bleeding/spotting. Bleeding that occurs during the time a woman takes the seven green inert tablets is considered “scheduled” bleeding.
Unscheduled and Scheduled Bleeding and Spotting
Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. If unscheduled bleeding persists or occurs after previously regular cycles on Ethinyl estradiol/levonorgestrel, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.
Before prescribing Ethinyl estradiol/levonorgestrel, advise the woman to weigh the convenience of fewer scheduled menses (4 per year instead of 13 per year) against the inconvenience of increased unscheduled bleeding and/or spotting.
The clinical trial of the efficacy of Ethinyl estradiol/levonorgestrel (91-day cycles) in preventing pregnancy also assessed scheduled and unscheduled bleeding. The participants in the study were composed primarily of women who had used oral contraceptives previously as opposed to new users. Women with a history of breakthrough bleeding/spotting ≥ 10 consecutive days on oral contraceptives were excluded from the study. More Ethinyl estradiol/levonorgestrel subjects, compared to subjects on the comparator 28-day cycle regimen, discontinued prematurely for unacceptable bleeding (7.7% [Ethinyl estradiol/levonorgestrel] vs. 1.8% [28-day cycle regimen]).
Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 3 below presents the number of days with unscheduled bleeding and/or spotting for each respective 91-day cycle.
| Q1=Quartile 1: 25% of women had ≤ this number of days of unscheduled bleeding/spotting Median: 50% of women had ≤ this number of days of unscheduled bleeding/spotting Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled bleeding/spotting | |||||
| Cycle (N) | Days of Unscheduled Bleeding and/or Spotting per 84-Day Interval | Median Days Per Subject- Month | |||
| Mean | Q1 | Median | Q3 | ||
| 1 (446) | 15.1 | 3.0 | 12 | 23.0 | 3.0 |
| 2 (368) | 11.6 | 2.0 | 6 | 17.5 | 1.5 |
| 3 (309) | 10.6 | 1.0 | 6 | 15.0 | 1.5 |
| 4 (282) | 8.8 | 1.0 | 4 | 14.0 | 1.0 |
Table 4 shows the percentages of women with ≥ 7 days and ≥ 20 days of unscheduled spotting and/or bleeding in the Ethinyl estradiol/levonorgestrel and the 28-day cycle treatment groups.
| Days of unscheduled bleeding and/or spotting | Percentage of Subjectsa | |
|---|---|---|
| a Based on spotting and/or bleeding on days 1 to 84 of a 91 day cycle in the Ethinyl estradiol/levonorgestrel subjects and days 1 to 21 of a 28 day cycle over 4 cycles in the 28-day dosing regimen. | ||
| Ethinyl estradiol/levonorgestrel | Cycle 1 (N=385) | Cycle 4 (N=261) |
| ≥ 7 days | 65% | 42% |
| ≥ 20 days | 35% | 15% |
| 28-day regimen | Cycles 1 to 4 (N=194) | Cycles 10 to 13 (N=158) |
| ≥ 7 days | 38% | 39% |
| ≥ 20 days | 6% | 4% |
Total days of bleeding and/or spotting (scheduled plus unscheduled) were similar over one year of treatment for Ethinyl estradiol/levonorgestrel subjects and subjects on the 28-day cycle regimen.
Amenorrhea and Oligomenorrhea
Women who are not pregnant and use Ethinyl estradiol/levonorgestrel may experience amenorrhea. Based on data from the clinical trial, amenorrhea occurred in approximately 0.8% of women during Cycle 1, 1.2% of women during Cycle 2, 3.7% of women during Cycle 3, and 3.4% of women during Cycle 4. Because women using Ethinyl estradiol/levonorgestrel will likely have scheduled bleeding only 4 times per year, rule out pregnancy at the time of any missed menstrual period.
Some women may experience amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was pre-existent.
COC Use Before or During Early Pregnancy
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Ethinyl estradiol/levonorgestrel use if pregnancy is confirmed.
Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy.
Depression
Depression associated with the use of Ethinyl estradiol/levonorgestrel has been reported. Carefully observe women with a history of depression and discontinue Ethinyl estradiol/levonorgestrel if severe depression recurs.
Carcinoma of the Breast and Cervix
- Ethinyl estradiol/levonorgestrel is contraindicated in women who currently have or have had breast cancer because breast cancer may be hormonally sensitive.
There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.
- Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
Effect on Binding Globulins
The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
Monitoring
A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated health care.
Hereditary Angioedema
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Chloasma
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to develop chloasma should avoid prolonged exposure to the sun or ultraviolet radiation while taking Ethinyl estradiol/levonorgestrel.
What happens if I miss a dose of Ethinyl estradiol/levonorgestrel?
Follow the patient instructions provided in your Ethinyl estradiol/levonorgestrel packet. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.
If you miss one active Ethinyl estradiol/levonorgestrel pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.
If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.
If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.
If you miss three active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.
If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.
If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.
References
- DailyMed. "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ESTRADIOL; LEVONORGESTREL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "ethinyl estradiol". http://www.drugbank.ca/drugs/DB00977 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
