Esme 28 combination is used to prevent pregnancy in women who can get pregnant with a BMI less than 30 kilograms (kg) per square meter (m2). It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control patches. Discuss your options for birth control with your doctor.
Esme 28 will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
Esme 28 is available only with your doctor's prescription.
Esme 28 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.
Esme 28 tablets USP 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 One Year3
Typical Use1 (2)
Perfect Use2 (3)
Levonorgestrel (Esme 28)
Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or Levonorgestrel (Esme 28) 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 0.05 mg of ethinyl estradiol and 0.50 mg of norgestrel 1 dose is 2 tablets; for tablets containing 0.02 mg of ethinyl estradiol and 0.1 mg of Levonorgestrel (Esme 28) 1 dose is 5 tablets; for tablets containing 0.03 mg of ethinyl estradiol and 0.15 mg of Levonorgestrel (Esme 28) 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 Esme 28 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 Esme 28 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 Esme 28 (n=323) or the cyclic comparator of 0.1 mg Levonorgestrel (Esme 28) and 0.02 mg ethinyl estradiol (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 Esme 28 pill packs and 2,886 cyclic comparator pill packs. There was one pregnancy in the Esme 28 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 Esme 28, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled bleeding and spotting.
Esme 28 description
Each tablet contains Levonorgestrel (Esme 28) 100 mcg and Ethinylestradiol (Esme 28) 20 mcg.
Esme 28 is a combined oral contraceptive (COC) tablet containing the synthetic progestin, Levonorgestrel (Esme 28) and the synthetic estrogen, Ethinylestradiol (Esme 28).
Levonorgestrel (Esme 28) is (-)-13-ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Its chemical formula is C21H28O2. It has a molecular weight of 312.45 and a melting point of 232-239°C.
Levonorgestrel (Esme 28) is a white, odorless crystalline powder. It is practically insoluble in water, slightly soluble in alcohol, acetone, ether and soluble in chloroform.
Ethinylestradiol (Esme 28) is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Its chemical formula is C20H24O2. It has a molecular weight of 296.41 and a melting point of 181-185°C.
Ethinylestradiol (Esme 28) 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.
Esme 28 dosage
The recommended dose for the prevention of pregnancy and the treatment of acne is the same.
To achieve maximum contraceptive effectiveness, Esme 28 must be administered as directed and at the same time everyday, preferably after the evening meal or at bedtime.
How to Take Esme 28: Tablets 1-21 contain active ingredients (active tablets).
Tablets must be taken in the order directed on the package every day at about the same time. One tablet is to be taken daily for 21 consecutive days, followed by a 7-day tablet-free interval. Each subsequent pack is started on the day after the tablet-free interval. A withdrawal bleed usually starts on days 2-3 after the last active tablet and may not have finished before the next pack is started.
How to Start Esme 28: No Hormonal Contraceptive Use Within the Preceding Month: Tablet-taking should start on day 1 of the woman's natural menstrual cycle (ie, the first day of menstrual bleeding). Starting on days 2-7 of the menstrual cycle (eg, Sunday start) is allowed; however, a nonhormonal back-up method of birth control (eg, condoms, spermicide) is recommended during the first 7 days of Esme 28 use.
Switching from Another Combined
Oral Contraceptive (COC):
Preferably, Esme 28 use should begin the day after the last active tablet of the previous COC pack has been taken but no later than the day following the usual tablet-free or inactive tablet interval of the previous COC.
Switching from a Progestin-Only Method of Birth Control [Pill, Implant, Intrauterine Device (IUD), injection]: The user may discontinue use of a progestin-only pill on any day and should start use of Esme 28 the following day. Esme 28 use should begin on the same day that a progestin-only implant or a progestin-only IUD is removed or on the day that the next progestin-only injection is scheduled.
In each of these situations, the user should be advised to use a nonhormonal back-up method of birth control during the first 7 days of Esme 28 use.
Following First-Trimester Abortion: Start Esme 28 immediately. Additional contraceptive measures are not needed.
Postpartum: Since the immediate postpartum period is associated with an increased risk of thromboembolism, Esme 28 use should begin no sooner than the 28th postpartum day following either delivery in a nonlactating woman or second-trimester abortion. The woman should be advised to use a nonhormonal back-up method of birth control during the first 7 days of Esme 28 use. However, if intercourse has already occurred, pregnancy must be ruled out before Esme 28 use is begun; otherwise, the woman must wait until her first menstrual period before beginning Esme 28 use.
How to Delay a Period: To delay a menstrual period, the user should skip the tablet-free interval and immediately begin a new pack of Esme 28. The delay may be continued for as long as desired up until all tablets in the new pack are taken. During the delay, the user may experience breakthrough bleeding or spotting. Regular intake of Esme 28 should be resumed after the usual 7-day tablet-free interval.
Management of Missed Tablets: Contraceptive protection may be reduced if active tablets are missed, particularly if the missing of tablets extends the tablet-free interval.
If one active tablet is missed but is remembered within 12 hours of the usual dose, it should be taken as soon as it is remembered. Subsequent tablets should be taken at the usual time.
If one active tablet is missed and is remembered more than 12 hours after the usual dose or if two or more active tablets are missed, contraceptive protection may be reduced. The last missed tablet should be taken as soon as it is remembered, which may result in the user taking two tablets on the same day. Subsequent tablets should be taken at the usual time. A nonhormonal back-up method of birth control must be used for the next 7 days.
If the user takes the last active tablet before the 7-day interval during which use of a nonhormonal back-up method of birth control is required has ended, the user must begin a new pack immediately; there should be no tablet-free interval between packs. This prevents an extended break in the tablet-taking interval, thereby reducing the risk of escape ovulation. The user is unlikely to have a withdrawal bleed until all tablets in the new pack are taken, although spotting or breakthrough bleeding may be experienced on tablet-taking days. If the user does not have a withdrawal bleed after all tablets in the new pack are taken, pregnancy must be ruled out before tablet-taking is resumed.
Advice in Case of Vomiting and/or Diarrhea: If vomiting or diarrhea occurs within 4 hours after tablet-taking, tablet absorption may be incomplete. The user must take the needed active tablet(s) from a back-up pack.
Always inform the prescriber which medicines or herbal products that the patient is using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that the patient uses Esme 28. The healthcare providers can tell if the patient needs to take additional contraceptive precautions (eg, condoms) and if so, for how long.
Some medicines can make Esme 28 less effective in preventing pregnancy or can cause unexpected bleeding.
These include medicines used for the treatment of epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine) and tuberculosis (eg, rifampicin) or HIV infections (ritonavir) or other infectious disease (eg, griseofulvin, ampicillin, tetracycline) to increase intestinal motility (eg, metoclopramide) and the herbal remedy St. John's wort.
If the patient wants to use herbal products containing St. John 's wort while she is already using Esme 28, consult the doctor first.
Esme 28 may decrease efficacy of other medicines eg, medicines containing cyclosporine or the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).
Ask the doctor or pharmacist for advice before taking any medicine.
Laboratory Tests: If the patient needs blood test, inform the doctor or the laboratory staff that she is taking Esme 28, because oral contraceptives can affect the results of some tests.
Hypersensitivity to any of the components of Esme 28; current or history of deep vein thrombosis and thromboembolism; hepatic adenomas or carcinomas, active liver disease, as long as liver function has not returned to normal; known or suspected carcinoma of the breast or other known or suspected estrogen-dependent neoplasia; disorders of lipometabolism; thrombogenic rhythm disorders and thrombogenic valvulopathies; sickle-cell anemia; diabetes with vascular involvement; undiagnosed vaginal bleeding; known or suspected pregnancy; cerebrovascular or coronary artery disease; uncontrolled hypertension; hereditary or acquired thrombophilias; headache with focal neurological symptoms such as aura; pancreatitis associated with severe hypertriglyceridemia (current or history).
Reasons for the Immediate Discontinuation of Esme 28: Occurrence for the first time of migrainous headaches or the more frequent occurrence of unusually severe headaches; acute disturbances of vision, hearing or speech; first symptoms of thrombophlebitis or thromboembolism (eg, unusual pain in or swelling of the legs, stabbing pain on breathing or coughing for no apparent reason); feeling of pain or tightness in the chest; six weeks before planned operations or during prolonged periods of immobilization; development of jaundice (cholestasis), hepatitis or generalized pruritus; increase in epileptic seizures; significant rise in blood pressure; onset of severe clinical depression; severe upper abdominal pain or liver enlargement.
Use in Pregnancy: If pregnancy occurs during treatment with combined oral contraceptives (COCs), further intake should be discontinued. There is no conclusive evidence that the estrogen and progestin contained in the COC will damage the developing child if conception accidentally occurs during COC use.
Use in Lactation: Small amounts of contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. Lactation may be affected by COCs, as COCs may reduce the quantity and change the composition of breast milk.
The use of COCs is generally not recommended until the nursing mother has completely weaned her child.
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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