ENSKYCE desogestrel and ethinyl estradiol Kit, 3 pouches
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Progestin class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and desogestrel (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.163 | $0.49 / 3 kit |
| Medicaid paysCMS SDUD · 12 mo | $0.3551 | $1.07 / 3 kit |
| Medicare drug plans payPart D · Q2 2026 | $0.2501 | $0.75 / 3 kit |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Reclipsen 28 Day 00093-3304-16 | Teva | 6 pouches | $0.138 | AB | Availability likely | save 16% |
| Apri 28 Day 00555-9043-58 | Teva | 6 pouches | $0.138 | AB | Availability likely | save 16% |
| Isibloom 70700-0113-85 | Xiromed, | 1 kit | $0.138 | AB | Availability likely | save 16% |
| Enskyce 68180-0739-73 | Lupin | 21 tablets | $0.138 | AB | Availability likely | save 16% |
| Cyred EQ 50102-0254-23 | Afaxys | 3 pouches | $0.138 | AB | Availability likely | save 16% |
| Juleber 16714-0464-01 | Northstar | 1 packet | $0.138 | AB | Availability likely | save 16% |
| Volnea 70700-0122-85 | Xiromed, | 1 kit | $0.161 | AB | Availability likely | save 1% |
| Desogestrel and Ethinyl Estradiol 51862-0514-01 | Mayne | 1 packet | $0.163 | AB | FDA listed | — |
| Enskycethis 68180-0891-73 | Lupin | 3 pouches | $0.163 | AB | FDA listed | — |
| Velivet Triphasic Regimen 00555-9051-67 | Teva | 3 pouches | $0.524 | AB | Availability likely | +222% |
| Volnea 63629-2449-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Apri 28 Day 50090-2481-00 | A-S | 1 kit | — | AB | FDA listed | — |
| desogestrel and ethinyl estradiol 60505-4896-01 | Apotex | 21 tablets | — | AB | FDA listed | — |
| Averi 75854-0604-01 | Avion | 1 kit | — | — | Discontinued | — |
| Kalliga 65862-0887-88 | Aurobindo | 3 pouches | — | AB | FDA listed | — |
| desogestrel and ethinyl estradiol 79929-0006-07 | Naari | 1 kit | — | AB | FDA listed | — |
| Isibloom 63629-2333-01 | Bryant | 1 kit | — | AB | Discontinued | — |
| Desogestrel and Ethinyl Estradiol 31722-0540-33 | Camber | 6 pouches | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68180-0891-73 You're viewing this | 3 POUCH in 1 CARTON (68180-891-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 2020-02-08 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Enskyce™ (desogestrel and ethinyl estradiol tablets USP), should not be used by women who are over 35 years of age and smoke.
Do not use Enskyce if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination oral contraceptives, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Do not use Enskyce if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination oral contraceptives, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
Some women should not use the pill. For example, you should not take the pill if you have any of the following conditions: A history of heart attack or stroke Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes A history of blood clots in the deep veins of your legs An inherited problem that makes your blood clot more than normal Chest pain (angina pectoris) Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina Unexplained vaginal bleeding (until a diagnosis is reached by your healthcare professional) Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill Liver tumor (benign or cancerous) If you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood. Known or suspected pregnancy If you plan to have surgery with prolonged bed rest Tell your healthcare professional if you have ever had any of these conditions. Your healthcare professional can recommend another method of birth control.
Do not use Enskyce if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination oral contraceptives, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Enskyce Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception.
The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Enskyce, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported.
This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. TABLE 1: 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 Year 1 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 4 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 5 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.
1 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2 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. 3 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.
4 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 brands of oral contraceptives to be safe and effective for emergency contraception: Ovral ® (1 dose is 2 white pills), Alesse ® (1 dose is 5 pink pills), Nordette ® or Levlen ® (1 dose is 4 yellow pills). 5 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.
6 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.
7 Foams, creams, gels, vaginal suppositories, and vaginal film. 8 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 9 With spermicidal cream or jelly.
1 0 Without spermicides. Method ( 1 ) Typical Use 2 ( 2 ) Perfect Use 3 ( 3 ) ( 4 ) Chance 6 85 85 Spermicides 7 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 8 2 Post-Ovulation 1 Withdrawal 19 4 Cap 9 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 9 20 6 56 Condom 1 0 Female (Reality ® ) 21 5 56 Ma…
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Enskyce must be taken exactly as directed and at intervals not exceeding 24 hours. Enskyce is available in the blister which is preset for a Sunday Start. Day 1 Start is also provided.
Day 1 Start The dosage of Enskyce for the initial cycle of therapy is one light orange "active" tablet administered daily from the 1 st day through the 21 st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1". Tablets are taken without interruption as follows: One light orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a light orange "active" tablet is taken the next day.
The use of Enskyce for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease.
See also ( PRECAUTIONS , Nursing Mothers). If the patient starts on Enskyce postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
If the patient misses one (1) light orange "active" tablet in Weeks 1, 2, or 3, the light orange "active" tablet should be taken as soon as she remembers. If the patient misses two (2) light orange "active" tablets in Week 1 or Week 2, the patient should take two (2) light orange "active" tablets the day she remembers and two (2) light orange "active" tablets the next day; and then continue taking one (1) light orange "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills.
If the patient misses two (2) light orange "active" tablets in the third week or misses three (3) or more light orange "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. Sunday Start When taking Enskyce, the first light orange "active" tablet should be taken on the first Sunday after menstruation begins.
If the period begins on Sunday, the first light orange "active" tablet is taken on that day. If switching directly from another oral contraceptive, the first light orange "active" tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One light orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days.
After 28 tablets have been taken, a new course is started and a light orange "active" tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. The use of Enskyce for contraception may be initiated 4 weeks postpartum.
When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also ( PRECAUTIONS , Nursing Mothers) .
If the patient starts on Enskyce postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (…
⛔ Contraindications ▾
CONTRAINDICATIONS Enskyce is contraindicated in females who are known to have or develop the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Known thrombophilic conditions Cerebral vascular or coronary artery disease (current or history) Valvular heart disease with complications Persistent blood pressure values of ≥160 mm Hg systolic or ≥100 mg Hg diastolic 102 Diabetes with vascular involvement Headaches with focal neurological symptoms Major surgery with prolonged immobilization Current diagnosis of, or history of, breast cancer, which may be hormonesensitive Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Acute or chronic hepatocellular disease with abnormal liver function Hepatic adenomas or carcinomas Known or suspected pregnancy Hypersensitivity to any component of this product Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see section 5 in WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).
⚠️ Warnings ▾
WARNINGS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Enskyce, should not be used by women who are over 35 years of age and smoke.
Contains color additives including FD&C Yellow No. 6. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.
The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today.
The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers.
The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs.
2 and 3 with the author's permission). For further information, the reader is referred to a text on epidemiological methods. 1.
Thromboembolic Disorder and Other Vascular Problems a. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease.
2,3,19-24 Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization. 25 The risk of thromboembolic disease associated with oral contraceptives gradually disappears after combined oral contraceptive (COC) use is stopped. 2 VTE risk is highest in the first year of use and when restarting hormonal contraception after a break of four weeks or longer.
Several epidemiologic studies indicate that third generation oral contraceptives, including those containing desogestrel, are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives. In general, these studies indicate an approximate 2-fold increased risk, which corresponds to an additional 1-2 cases of venous thromboembolism per 10,000 women-years of use. However, data from additional studies have not shown this 2-fold increase in risk.
A two- to four-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives. 9 The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. 26 If feasible, oral contraceptives should be discontinued at l…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2). 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.
The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 2: Risk of Breast Cancer with Combined Oral Contraceptive 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.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ). Thrombophlebitis and venous thrombosis with or without embolism Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives Mesenteric thrombosis Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea Vomiting Gastrointestinal symptoms (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Temporary infertility after discontinuation of treatment Edema Melasma which may persist Breast changes: tenderness, enlargement, secretion Change in weight (increase or decrease) Change in cervical erosion and secretion Diminution in lactation when given immediately postpartum Cholestatic jaundice Migraine Allergic reaction, including rash, urticaria, and angioedema Mental depression Reduced tolerance to carbohydrates Vaginal candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted: Pre-menstrual syndrome Cataracts Changes in appetite Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Vaginitis Porphyria Impaired renal function Hemolytic uremic syndrome Acne Changes in libido Colitis Budd-Chiari Syndrome Figure 2: Risk of Breast Cancer with Combined Oral Contraceptive Use
🆘 Overdosage ▾
OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. NON-CONTRACEPTIVE HEALTH BENEFITS The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
73-78 Effects on menses: increased menstrual cycle regularity decreased blood loss and decreased incidence of iron deficiency anemia decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: decreased incidence of functional ovarian cysts decreased incidence of ectopic pregnancies Effects from long-term use: decreased incidence of fibroadenomas and fibrocystic disease of the breast decreased incidence of acute pelvic inflammatory disease decreased incidence of endometrial cancer decreased incidence of ovarian cancer
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacodynamics Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus, which increase the difficulty of sperm entry into the uterus, and changes in the endometrium which reduce the likelihood of implantation. Receptor binding studies, as well as studies in animals, have shown that 3-keto-desogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity.
91,92 The relevance of this latter finding in humans is unknown. Pharmacokinetics Desogestrel is rapidly and almost completely absorbed and converted into 3-keto-desogestrel, its biologically active metabolite. Following oral administration, the relative bioavailability of desogestrel, as measured by serum levels of 3-keto-desogestrel, is approximately 84%.
In the third cycle of use after a single dose of Enskyce, maximum concentrations of 3-keto-desogestrel of 2,805 ± 1,203 pg/mL (mean ± SD) are reached at 1.4 ± 0.8 hours. The area under the curve (AUC 0-∞ ) is 33,858 ± 11,043 pg/mL·hr after a single dose. At steady state, attained from at least day 19 onwards, maximum concentrations of 5,840 ± 1,667 pg/mL are reached at 1.4 ± 0.9 hours.
The minimum plasma levels of 3-keto-desogestrel at steady state are 1,400 ± 560 pg/mL. The AUC 0-24 , at steady state is 52,299 ± 17,878 pg/mL·hr. The mean AUC 0-∞ for 3-keto-desogestrel at single dose is significantly lower than the mean AUC 0-24 at steady state.
This indicates that the kinetics of 3-keto-desogestrel are non-linear due to an increase in binding of 3-keto-desogestrel to sex hormone-binding globulin in the cycle, attributed to increased sex hormone-binding globulin levels which are induced by the daily administration of ethinyl estradiol. Sex hormone-binding globulin levels increased significantly in the third treatment cycle from day 1 (150 ± 64 nmol/L) to day 21 (230 ± 59 nmol/L). The elimination half-life for 3-keto-desogestrel is approximately 38 ± 20 hours at steady state.
In addition to 3-keto-desogestrel, other phase I metabolites are 3α-OH-desogestrel, 3β-OH-desogestrel, and 3α-OH-5α-H-desogestrel. These other metabolites are not known to have any pharmacologic effects, and are further converted in part by conjugation (phase II metabolism) into polar metabolites, mainly sulfates and glucuronides. Ethinyl estradiol is rapidly and almost completely absorbed.
In the third cycle of use after a single dose of Enskyce, the relative bioavailability is approximately 83%. In the third cycle of use after a single dose of Enskyce, maximum concentrations of ethinyl estradiol of 95 ± 34 pg/mL are reached at 1.5 ± 0.8 hours. The AUC 0-∞ is 1,471± 268 pg/mL·hr after a single dose.
At steady state, attained from at least day 19 onwards, maximum ethinyl estradiol concentrations of 141 ± 48 pg/mL are reached at about 1.4 ± 0.7 hours. The minimum serum levels of ethinyl estradiol at steady state are 24 ± 8.3 pg/mL. The AUC 0-24 at steady state is 1,117 ± 302 pg/mL·hr.
The mean AUC 0-∞ for ethinyl estradiol following a single dose during treatment cycle 3 does not significantly differ from the mean AUC 0-24 at steady state. This finding indicates linear kinetics for ethinyl estradiol. The elimination half-life is 26 ± 6.8 hours at steady state.
Ethinyl estradiol is subject to a significant degree of presystemic conjugation (phase II metabolism). Ethinyl estradiol escaping gut wall conjugation undergoes phase I metabolism and hepatic conjugation (phase II metabolism). Major phase I metabolites are 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol.
Sulfate and glucuronide conjugates of both ethinyl estradiol and phase I metabolites, which are excreted in bile, can undergo enterohepatic circulation.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Enskyce Tablets are available in a blister (NDC 68180-891-71) containing 28 tablets packed in a pouch (NDC 68180-891-71). Such three pouches are packaged in a carton (NDC 68180-891-73). Each blister contains 28 film-coated tablets in the following order: • Each of the 21 light orange, round, biconvex, film-coated tablet contains 0.15 mg of desogestrel and 0.03 mg of ethinyl estradiol USP and is debossed with "L" on one side and "J7" on the other side. • Each of the 7 green coloured, round, biconvex film-coated tablet contains inert ingredients and is debossed with "LU" on one side and "L22" on the other side.
STORAGE: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Enskyce ™ (desogestrel and ethinyl estradiol tablets USP) provide an oral contraceptive regimen of 21 light orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include colloidal silicon dioxide, corn starch, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, and vitamin E.
Each green tablet contains the following inactive ingredients: corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue #2/ Indigo Carmine Aluminium Lake, FD&C Yellow #6/ Sunset Yellow FCF Aluminium Lake, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide. Enskyce meets USP Dissolution Test 2.
Desogestrel and Ethinyl Estradiol Structure
💬 Information for Patients ▾
INFORMATION FOR PATIENTS See Patient Labeling printed below.