Esro G is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). Esro G also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Esro G is used as contraception to prevent pregnancy. There are many brands and forms of this medicine available. Not all brands are listed on this leaflet.
Esro G may also be used for purposes not listed in this medication guide.
Esro G indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Esro G is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Table 2: Percentage of Women Experiencing an Unintended Pregnancy During The First Year of Typical Use and The First Year of Perfect Use of Contraception and The Percentage Continuing Use at The End of the First Year. United States.
% of Women Experiencing an Unintended Pregnancy
within the First Year of Use
% of Women
Continuing Use at
Typical Use1 (2)
Perfect Use2 (3)
Levonorgestrel (Esro G)
Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing Ethinyl estradiol (Esro G) and norgestrel or Levonorgestrel (Esro G) are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10
Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.
Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
Foams, creams, gels, vaginal suppositories, and vaginal film.
Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
With spermicidal cream or jelly.
The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of Ethinyl estradiol (Esro G) and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of Ethinyl estradiol (Esro G) and 100 mcg of Levonorgestrel (Esro G) 1 dose is 5 tablets; for tablets containing 30 mcg of Ethinyl estradiol (Esro G) and 150 mcg of Levonorgestrel (Esro G) 1 dose is 4 tablets.
However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.
The efficacy and safety of Esro G were studied in 2 one-year clinical trials of subjects age 18-49. There were no exclusions for body mass index (BMI), weight, or bleeding history.
The primary efficacy and safety study (313-NA) was a one-year open-label clinical trial that treated 2,134 subjects in North America. Of these subjects 1,213 (56.8%) discontinued prematurely, including 102 (4.8%) discontinued by the Sponsor for early study closure. The mean weight of subjects in this study was 70.38 kg. The efficacy of Esro G was assessed by the number of pregnancies that occurred after the onset of treatment and within 14 days of the last dose. Among subjects 35 years or less, there were 23 pregnancies (4 of these occurred during the interval 1 to 14 days after the last day of pill use) during 12,572 28-day pill packs of use. The resulting total Pearl Index was 2.38 (95% CI: 1.51, 3.57) and the one-year life table pregnancy rate was 2.39 (95% CI: 1.57, 3.62). Pill pack cycles during which subjects used back-up contraception or were not sexually active were not included in these calculations. Among women 35 years or less who took the pills completely as directed, there were 15 pregnancies (method failures) resulting in a Pearl Index of 1.55 (95% CI: 0.87, 2.56) and the one-year life table pregnancy rate was 1.59 (95% CI: 0.95-2.67).
In a second supportive study conducted in Europe (315-EU), 641 subjects were randomized to Esro G (n=323) or the cyclic comparator of 100 mcg Levonorgestrel (Esro G) and 20 mcg Ethinyl estradiol (Esro G) (n=318). The mean weight of subjects in this study was 63.86 kg. The efficacy analysis among women 35 years or less included 2,756 Esro G pill packs and 2,886 cyclic comparator pill packs. There was one pregnancy in the Esro G group that occurred within 14 days following the last dose. There were three pregnancies in the cyclic comparator group.
Inhibition of Menses (Bleeding Profile)
The bleeding profile for subjects in Study 313-NA also was assessed. Women with a history of unscheduled bleeding and/or spotting were not excluded from the study.
In those subjects who provided complete bleeding data, the percentage of patients who were amenorrheic in a given cycle and remained amenorrheic through cycle 13 (cumulative amenorrhea rate) was determined (Figure 2).
Figure 2: Percentage of Subjects with Cumulative Amenorrhea for Each Pill Pack through Pill Pack 13
When prescribing Esro G, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled bleeding and spotting.
How should I use Esro G?
Use Esro G as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Esro G. Talk to your pharmacist if you have questions about this information.
Take Esro G by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Do not remove the tablet from the blister packaging until you are ready to take Esro G.
Begin taking Esro G during the first 24 hours of your period, unless your doctor tells you otherwise
If you are switching from another form of hormonal birth control to Esro G, be sure you know when you should start taking Esro G. Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to Esro G.
Try to take Esro G at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
For Esro G to be effective it must be taken every day. Do not skip doses, even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
If you vomit within 4 hours after taking Esro G, follow the directions for what to do if you miss a pill.
If you miss 1 dose of Esro G, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Esro G, read the extra patient information leaflet that comes with Esro G or contact your doctor for instructions. If you miss one or more doses of Esro G, you must use a backup form of birth control for 7 days after you start to take it again. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.
Ask your health care provider any questions you may have about how to use Esro G.
Uses of Esro G in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin (Levonorgestrel (Esro G)) and an estrogen (Ethinyl estradiol (Esro G)). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body.
Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne.
Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
How to use Esro G
Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.
It is very important to continue taking this medication exactly as prescribed by your doctor. Follow the package instructions to find the first tablet, start with the first tablet in the pack, and take them in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.
Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.
Begin taking this medication on the first Sunday following the beginning of your menstrual period. If your period begins on a Sunday, begin taking this medication on that day. Your pill pack contains 84 estrogen/progestin pills and 7 estrogen-only pills. Take one estrogen/progestin pill daily for 84 days in a row. The day after you finish all the combination pills, start taking one estrogen-only pill daily for 7 days in a row. You should have your period during the week you are taking the estrogen-only pills. The day after you take the last estrogen-only pill, start a new pack whether or not you have your period. If you do not get your period, consult your doctor.
If this is the first time you are using this medication, use an additional form of non-hormonal birth control (such as condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start on the first day of your period, you do not need to use back-up birth control the first week.
Ask your doctor or pharmacist about how to switch from other forms of hormonal birth control (such as patch, other birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.
Esro G description
Each tablet contains Levonorgestrel (Esro G) 150μg and Ethinyl estradiol (Esro G) 30 μg.
Ethinyl estradiol (Esro G) is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol.
Levonorgestrel (Esro G) is (-)-13-ethyl-17-hydroxy-18,19-dinor-17α-pregna-4-en-20-yn-3-one.
Ethinyl estradiol (Esro G) is a white to creamy white, odorless, crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils and aqueous solutions of alkali hydroxides.
Levonorgestrel (Esro G) is a white, crystalline powder that is very slightly soluble in water, slightly soluble in alcohol and acetone and soluble in chloroform.
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Take one tablet by mouth at the same time every day. The dosage of Esro G tablets is one white tablet containing Levonorgestrel (Esro G) and Ethinyl estradiol (Esro G) daily for 84 consecutive days, followed by one light blue Ethinyl estradiol (Esro G) tablet for 7 days. To achieve maximum contraceptive effectiveness, Esro G tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking Esro G tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first white tablet is taken that day. One white tablet should be taken daily for 84 consecutive days, followed by one light blue tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a white tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the light blue tablets are taken.
Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Esro G tablets, following the same schedule: 84 days taking a white tablet followed by 7 days taking a blue tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a white tablet daily for 7 consecutive days. If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
For patient instructions regarding missed pills, see FDA-Approved Patient Labeling.
For postpartum women who are not breastfeeding, start Esro G tablets no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Esro G tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a white tablet for 7 consecutive days.
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Interactions between Ethinyl estradiol (Esro G) and other substances may lead to decreased or increased serum Ethinyl estradiol (Esro G) concentrations, respectively.
Decreased Ethinyl estradiol (Esro G) serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the COC.
During concomitant use of Ethinyl estradiol (Esro G)-containing products and substances that may lead to decreased Ethinyl estradiol (Esro G) serum concentrations, it is recommended that a nonhormonal back-up method of birth control (eg, condoms and spermicide) be used in addition to the regular intake of Esro G. In the case of prolonged use of such substances, COCs should not be considered the primary contraceptive.
After discontinuation of substances that may lead to decreased Ethinyl estradiol (Esro G) serum concentrations, use of a nonhormonal back-up method is recommended for at least 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have lead to induction of hepatic microsomal enzymes, resulting in decreased Ethinyl estradiol (Esro G) serum concentrations. It may sometimes take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use and rate of elimination of the inducing substance.
Substances That May Decrease Serum Ethinyl estradiol (Esro G) Concentrations: Any substance that reduces gastrointestinal tract transit time and, therefore, Ethinyl estradiol (Esro G) absorption.
Substances that induce hepatic microsomal enzymes eg, rifampicin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil. Hypericum perforatum, also known as St. John's wort and ritonavir (possibly by induction of hepatic microsomal enzymes). Certain antibiotics (eg, ampicillin and other penicillins, tetracyclines), by a decrease of enterohepatic circulation of estrogens.
Substances That May Increase Serum Ethinyl estradiol (Esro G) Concentrations: Atorvastatin. Competitive inhibitors for sulfation in the gastrointestinal wall eg, as ascorbic acid (vitamin C) and paracetamol (acetaminophen). Substances that inhibit cytochrome P450 3A4 isoenzymes eg, indinavir, fluconazole and troleandomycin.
Troleandomycin may increase the risk of intrahepatic cholestasis during co-administration with COCs.
Ethinyl estradiol (Esro G) may interfere with the metabolism of other drugs by inhibiting hepatic microsomal enzymes, or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, plasma and tissue concentrations may either be increased (eg, cyclosporine, theophylline, corticosteroids) or decreased (eg, lamotrigine).
In patients treated with flunarizine, use of oral contraceptives has been reported to increase the risk of galactorrhea.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
Although ritonavir is an inhibitor of cytochrome P450 3A4, treatment with ritonavir has been shown to decrease Ethinyl estradiol (Esro G) serum concentrations.
Effects on Laboratory Parameters: The use of COCs may cause certain physiologic changes which may be reflected in the results of certain laboratory tests, including biochemical parameters of liver function (including a decrease in bilirubin and alkaline phosphatase, thyroid function (increased total T3 and T4 due to increased TBG, decreased free T3 resin uptake), adrenal function [increased plasma cortisol and cortisol binding globulin, decreased dehydroepiandrosterone sulfate (DHEAS)] and renal function (increased plasma creatinine and creatinine clearance); plasma levels of (carrier) proteins eg, corticosteroid-binding globulin and lipid/lipoprotein fractions; parameters of carbohydrate metabolism; parameters of coagulation and fibrinolysis; decreased serum folate levels.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Serious cardiovascular events and stroke
Adverse reactions commonly reported by COC users are:
Irregular uterine bleeding
Clinical Trial 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 the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The clinical trial that evaluated the safety and efficacy of Esro G was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of Esro G (345.14 woman-years of exposure).
Adverse Reactions Leading to Study Discontinuation: 14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation in the Esro G group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%).
Common Adverse Reactions (≥ 2% of women): headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%).
The following adverse reactions have been identified during post-approval use of Esro G. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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).
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