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 E-Gen-C:
Store E-Gen-C 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 E-Gen-C out of the reach of children and away from pets.
Overdose of E-Gen-C in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting, sudden/unusual vaginal bleeding.
Notes
Do not share this medication with others.
Keep all regular medical and laboratory appointments. You should have regular complete physical exams which include laboratory and medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) to monitor your progress and check for side effects. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Consult your doctor for more details.
Missed Dose
Refer to the product package information for advice on missed doses. You may need to use back-up birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.
If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.
Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
What should I avoid while taking E-Gen-C?
Do not smoke while using Ethinyl Estradiol (E-Gen-C) and Levonorgestrel (E-Gen-C), especially if you are older than 35 years of age.
Grapefruit may interact with Ethinyl Estradiol (E-Gen-C) and Levonorgestrel (E-Gen-C) 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.
E-Gen-C warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Thrombotic Disorders and Other Vascular Problems
Stop E-Gen-C if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop E-Gen-C if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop E-Gen-C 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 E-Gen-C 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 E-Gen-C 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 E-Gen-C.
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 E-Gen-C. 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 E-Gen-C 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 E-Gen-C if jaundice develops.
Liver Tumors
E-Gen-C 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 (E-Gen-C)-containing medications, such as COCs. Discontinue E-Gen-C prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. E-Gen-C can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
High Blood Pressure
E-Gen-C is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. For women with well-controlled hypertension, monitor blood pressure and stop E-Gen-C 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 E-Gen-C. 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 E-Gen-C develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue E-Gen-C if indicated.
Consider discontinuation of E-Gen-C 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 E-Gen-C, 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 E-Gen-C, 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 E-Gen-C (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 E-Gen-C subjects, compared to subjects on the comparator 28-day cycle regimen, discontinued prematurely for unacceptable bleeding (7.7% [E-Gen-C] 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.
Table 3: Number of Unscheduled Bleeding and/or Spotting Days per 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 E-Gen-C and the 28-day cycle treatment groups.
Table 4: Percentage of Subjects with Unscheduled Bleeding and/or Spotting
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 E-Gen-C subjects and days 1 to 21 of a 28 day cycle over 4 cycles in the 28-day dosing regimen.
E-Gen-C
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 E-Gen-C subjects and subjects on the 28-day cycle regimen.
Amenorrhea and Oligomenorrhea
Women who are not pregnant and use E-Gen-C 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 E-Gen-C 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 E-Gen-C 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 E-Gen-C has been reported. Carefully observe women with a history of depression and discontinue E-Gen-C if severe depression recurs.
Carcinoma of the Breast and Cervix
E-Gen-C 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 E-Gen-C.
What should I discuss with my healthcare provider before taking E-Gen-C?
Some medical conditions may interact with E-Gen-C. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
if you have a history of diabetes or high blood sugar, gallbladder problems, migraines or severe or persistent headaches, heart problems, high blood pressure, high blood cholesterol or lipid levels, kidney or liver problems, blood or bleeding problems, blood in the urine, mental or mood problems (eg, depression), lupus, high blood calcium levels, chorea (jerky, involuntary movements of the face, arms, or legs), varicose veins, yellowing of the eyes or skin, pancreas problems, or seizures
if you are overweight, have swelling problems, you have not yet had your first menstrual period, or you smoke or use tobacco
if you are older than 40 years old
Some MEDICINES MAY INTERACT with E-Gen-C. Tell your health care provider if you are taking any other medicines, especially any of the following:
Troleandomycin because the risk of serious liver problems may be increased
Acetaminophen, ascorbic acid (vitamin C), or atorvastatin because they may increase the risk of E-Gen-C's side effects
Azole antifungals (eg, ketoconazole) because they may decrease E-Gen-C's effectiveness or increase the risk of E-Gen-C's side effects
Aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, ampicillin), phenylbutazone, primidone, rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease E-Gen-C's effectiveness, resulting in breakthrough bleeding or pregnancy
Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, theophylline, or tizanidine because the risk of their side effects may be increased by E-Gen-C
Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by E-Gen-C
Clofibric acid, lamotrigine, morphine, salicylic acid, or temazepam because their effectiveness may be decreased by E-Gen-C
This may not be a complete list of all interactions that may occur. Ask your health care provider if E-Gen-C may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
E-Gen-C precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Thrombotic Disorders and Other Vascular Problems
Stop E-Gen-C if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop E-Gen-C if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop E-Gen-C 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 E-Gen-C 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 E-Gen-C 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 E-Gen-C.
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 E-Gen-C. 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 E-Gen-C 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 E-Gen-C if jaundice develops.
Liver Tumors
E-Gen-C 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 (E-Gen-C)-containing medications, such as COCs. Discontinue E-Gen-C prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. E-Gen-C can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
High Blood Pressure
E-Gen-C is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. For women with well-controlled hypertension, monitor blood pressure and stop E-Gen-C 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 E-Gen-C. 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 E-Gen-C develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue E-Gen-C if indicated.
Consider discontinuation of E-Gen-C 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 E-Gen-C, 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 E-Gen-C, 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 E-Gen-C (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 E-Gen-C subjects, compared to subjects on the comparator 28-day cycle regimen, discontinued prematurely for unacceptable bleeding (7.7% [E-Gen-C] 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.
Table 3: Number of Unscheduled Bleeding and/or Spotting Days per 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 E-Gen-C and the 28-day cycle treatment groups.
Table 4: Percentage of Subjects with Unscheduled Bleeding and/or Spotting
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 E-Gen-C subjects and days 1 to 21 of a 28 day cycle over 4 cycles in the 28-day dosing regimen.
E-Gen-C
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 E-Gen-C subjects and subjects on the 28-day cycle regimen.
Amenorrhea and Oligomenorrhea
Women who are not pregnant and use E-Gen-C 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 E-Gen-C 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 E-Gen-C 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 E-Gen-C has been reported. Carefully observe women with a history of depression and discontinue E-Gen-C if severe depression recurs.
Carcinoma of the Breast and Cervix
E-Gen-C 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 E-Gen-C.
What happens if I miss a dose of E-Gen-C?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Follow the patient instructions provided in your E-Gen-C 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 E-Gen-C 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).