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Levonorgestrel And Ethinyl Estradiol is a brand name for Levonorgestrel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are progestin/estrogen COC indicated for use by…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day. 1 ) Take tablets in the order directed on the blister pack. 1 How to Start Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are dispensed in a blister card [see How Supplied/Storage and Handling ( 16 )] .
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets may be started using either a Day 1 start or a Sunday start (see Table 1 ). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
2 How to Take Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets (orange active tablets and blue placebo tablets) are swallowed whole once a day Table 1: Instructions for Administration of Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.
Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product.
Tablet Color:
Levonorgestrel and ethinyl estradiol active tablets are orange (Day 1 to Day 21). Ferrous bisglycinate placebo tablets are blue (Day 22 to Day 28).
Day 1 Start:
Take first orange active tablet on the first day of menses. Take subsequent orange active tablets once daily at the same time each day for a total of 21 days. Take one blue placebo tablet daily for 7 days and at the same time of day that active tablets were taken.
e. on the day after taking the last inactive tablet).
Sunday Start:
Take first active tablet on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle pack of levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
02 mg tablets, a total of 1477 healthy women of child-bearing potential were enrolled and had 7870 cycles of exposure. Of these, 792 subjects had completed 6 cycles of treatment. The women ranged in age from 17 to 49 years and 87% were Caucasian.
Common Adverse Reactions (≥ 2% of women): headache (14%) metrorrhagia (8%) dysmenorrhea (7%) nausea (7%) abdominal pain (4%) breast pain (4%) emotional lability (3%) acne (3%) depression (2%) amenorrhea (2%) vaginal moniliasis (2%) At the time of the report, 133 (9%) subjects had withdrawn from the study due to adverse events.
The most frequent were due to headache and metrorrhagia (1% each). Other adverse events occurring in < 1% of those who discontinued included amenorrhea, depression, emotional lability, hypertension, acne, menorrhagia, nausea, hypercholesterolemia, weight gain, dysmenorrhea, and flatulence.
All other reasons for discontinuation were reported by 3 or fewer subjects. 12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use.
33 with current or recent use. 4 with more than 8-10 years of COC use. RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. 02 mg tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorder: chest pain, dyspnea, palpitations Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea General disorders and administration site conditions: chest pain, fatigue, pain, malaise, injection site pain or erythema, feeling abnormal, pyrexia, condition aggravated, asthenia Immune system disorders: hypersensitivity reactions, including pruritus, rash, urticaria,erythema Injury, poisoning, and procedural complications: i njury Investigations: weight decreased Musculoskeletal and connective tissue disorders: pain in extremity, arthralgia, back pain,muscle spasm Nervous system disorders: headache, migraine, dizziness, hypoesthesia, paresthesia Psychiatric disorders: depression, insomnia, anxiety Reproductive system and breast disorders: metrorrhagia, menorrhagia, hot flush, vaginal hemorrhage Respiratory, thoracic, and mediastinal disorders: nasopharyngitis, cough Sleep disorders and disturbances: somnolence Vascular disorders: deep vein thrombosis, pulmonary embolism 1
5 WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems : Stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery.
Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. 2 ) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if blood pressure rises significantly.
4 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
6 ) Headache: Evaluate significant change in headaches and discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if indicated. 7 ) Bleeding Irregularities and Amenorrhea: Evaluate irregular bleeding or amenorrhea.
8 ) This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 1 Thrombotic Disorders and Other Vascular Problems Stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
Stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets 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 the following prolonged immobilization.
4 CONTRAINDICATIONS Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic disease.
1 )] . 1 )] . 1 )] . 1 )] . 1 )] . 1 )] . 4 )] . 6 )] . 7 )] . 7 )] . 2 )]. 8 )] . 1 )] . 11 )] . Hypersensitivity to any of the components. 3 )]. A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Breast cancer ( 4 ) Hypersensitivity of any of the components ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Take subsequent orange tablets once daily at the same time each day for a total of 21 days. Take one blue placebo tablet daily for the following 7 days and at the same time of day that active tablets were taken. , on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets from another hormonal contraceptive Start on the same day that a new pack of the previous hormonal contraceptive would have started. Switching from another contraceptive method to levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets Start levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets: Transdermal patch On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms or spermicide) is needed for the first seven days of the first cycle pack.
Implant On the day of removal Starting Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets may be started immediately.
An additional method of contraception is not needed if levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are started within 5 days after termination of the pregnancy. If levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle pack of levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets.
Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets following the instructions in Table 1 for Day 1 or Sunday start, as desired.
If using Sunday start, use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle pack of levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets.
] Starting Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets following the instructions in Table 1 for women not currently using hormonal contraception.
If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets. 2 ), and FDA-Approved Patient Labeling ] .
3 Missed Tablets Table 2: Instructions for Missed Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets If one orange active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.
If two orange active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
If two orange tablets are missed in Week 3 or three or more orange active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start: Throw out the rest of pack and start a new pack that same day.
Sunday start:
Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling ] .
Start levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets 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 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 COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The 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.
2 Liver Disease Impaired Liver Function Do not use levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications ( 4 )] .
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 levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if jaundice develops.
Liver Tumors Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are contraindicated in women with benign and malignant liver tumors [see Contraindications ( 4 )] . Hepatic adenomas are associated with COC use.
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 risk of liver cancers in COC users is less than one case per million users.
3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/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 levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications ( 4 )] .
Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. 4 High Blood Pressure Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications ( 4 )] .
For women with well-controlled hypertension, monitor blood pressure and stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets 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 with extended duration of use.
The incidence of hypertension increases with increasing concentrations of progestin. 5 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. 6 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who take levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.
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.
7 Headache If a woman taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if indicated.
Consider discontinuation of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
8 Bleeding Irregularities and Amenorrhea Unscheduled Bleeding and Spotting Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, 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 contraceptive product. 02 mg tablets breakthrough bleeding and spotting was reported in 4% and 12% of cycles, respectively.
Breakthrough bleeding and spotting occurred together during 11% of the cycles. Amenorrhea and Oligomenorrhea Women who use levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets may experience amenorrhea. 6% of the evaluable cycles were amenorrheic.
Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was preexistent. If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. 9 FD&C Yellow No. 5 Allergic-type Reaction This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.
Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. 10 Depression Carefully observe women with a history of depression and discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if depression recurs to a serious degree.
11 Malignant Neoplasms Breast Cancer Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4)] .
Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer.
2)]. Cervical Cancer 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.
12 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.
13 Monitoring A woman who is taking COCs should have her blood pressure checked periodically with her healthcare provider. 14 Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
15 Chloasma Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.