Aviane Levonorgestrel and Ethinyl Estradiol Kit, 1 pouch — NDC 63187-889-28 (Billing 63187-0889-28)
This is a package of 1 pouch of Aviane Levonorgestrel and Ethinyl Estradiol Kit from Proficient Rx LP, marketed since Apr 2001 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 030986
- GCN: 11534
- GPI-14 (Medi-Span): 25990002400305
- HICL (First Databank): 001460
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 242297
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Estrogen class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It prevents pregnancy. It is a combined hormonal birth control with an estrogen and a progestin. It comes as daily tablets or as the weekly Twirla patch.
- With tablets, you take one at the same time every day, no more than 24 hours apart. With the Twirla patch, you wear one patch for a week, three weeks in a row, then take a patch-fr...
- Headache, nausea, acne, breast tenderness, mood changes, and irregular bleeding are the common ones. Bleeding changes often settle with time. Call your doctor if they persist.
- Get help for chest pain, sudden shortness of breath, leg swelling or pain, vision loss, or severe new headaches. These can signal a blood clot or stroke. Also report yellowing of y...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2595 | $0.26 / 1 kit |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63187-0889-28 You're viewing this Main listing | 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 2017-08-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levonorgestrel And Ethinyl Estradiol 00378-6550-53 | Mylan | 3 pouches | $0.113 | AB | Discontinued | — |
| Altavera 70700-0116-85 | Xiromed, | 1 kit | $0.114 | AB | Availability likely | — |
| Ayuna 65862-0848-88 | Aurobindo | 3 pouches | $0.114 | AB | Availability likely | — |
| Chateal EQ 50102-0230-23 | Afaxys | 3 pouches | $0.114 | AB | Availability likely | — |
| Marlissa 68462-0388-29 | Glenmark | 1 kit | $0.114 | AB | Availability likely | — |
| Kurvelo 68180-0844-73 | Lupin | 63 tablets | $0.114 | AB | Availability likely | — |
| Portia 00555-9020-58 | Teva | 6 pouches | $0.114 | — | Availability likely | — |
| Daysee 68180-0846-13 | Lupin | 2 pouches | $0.125 | AB | Availability likely | — |
| Levora 51862-0097-06 | Mayne | 1 kit | $0.145 | AB | Discontinued | — |
| Levonorgestrel And Ethinyl Estradiol 00378-7287-53 | Mylan | 3 pouches | $0.151 | AB1 | Availability likely | — |
| Lutera 51862-0028-06 | Mayne | 1 kit | $0.152 | AB1 | Discontinued | — |
| Lessina 00555-9014-67 | Teva | 3 pouches | $0.154 | — | Availability likely | — |
| Aubra EQ 50102-0220-23 | Afaxys | 3 pouches | $0.154 | AB1 | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0854-73 | Lupin | 1 kit | $0.154 | AB1 | Availability likely | — |
| Aviane 00555-9045-58 | Teva | 6 pouches | $0.154 | — | Availability likely | — |
| Vienva 70700-0118-85 | Xiromed, | 1 kit | $0.154 | AB1 | Availability likely | — |
| Falmina 16714-0359-01 | Northstar | 1 packet | $0.154 | AB1 | Availability likely | — |
| Sronyx 51862-0545-06 | Mayne | 1 kit | $0.174 | AB2 | Discontinued | — |
| Introvale 70700-0117-87 | Xiromed, | 1 kit | $0.184 | AB | FDA listed | — |
| Afirmelle 65862-0849-88 | Aurobindo | 3 pouches | $0.225 | AB1 | FDA listed | — |
| Iclevia 65862-0865-83 | Aurobindo | 3 pouches | $0.227 | AB | FDA listed | — |
| Setlakin 16714-0366-03 | Northstar | 3 pouches | $0.227 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0843-13 | Lupin | 1 kit | $0.227 | AB | Availability likely | — |
| levonorgestrel and ethinyl estradiol 68462-0672-95 | Glenmark | 3 pouches | $0.227 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 | Lupin | 2 pouches | $0.239 | AB | Availability likely | — |
| Levonest 16714-0340-01 | Northstar | 1 packet | $0.324 | AB | Availability likely | — |
| Levonorgestrel and Ethinyl Estradiol 68180-0857-73 | Lupin | 1 kit | $0.324 | AB | Availability likely | — |
| Tyblume 00642-7471-01 | Exeltis | 1 kit | $0.828 | — | Availability likely | — |
| levonorgestrel and ethinyl estradiol 42192-0623-03 | Acella | 1 kit | $3.445 | AB3 | Availability likely | — |
| Levonest 50090-2505-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Kurvelo 50090-6374-00 | A-S | 21 tablets | — | AB | FDA listed | — |
| Altavera 63629-2343-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Lutera 55741-0005-06 | Dr. | 1 kit | — | AB1 | FDA listed | — |
| Balcoltra 75854-0602-02 | Avion | 1 kit | — | AB3 | FDA listed | — |
| Vienva Tm 50090-5580-00 | A-S | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 79929-0003-07 | Naari | 1 kit | — | AB | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 60505-4898-08 | Apotex | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 60505-4899-08 | Apotex | 1 kit | — | AB | FDA listed | — |
| Vienva TM 63629-2344-01 | Bryant | 1 kit | — | AB1 | FDA listed | — |
| Levonorgestrel and Ethinyl Estradiol 79929-0004-07 | Naari | 1 kit | — | AB1 | FDA listed | — |
| Avianethis 63187-0889-28 | Proficient | 1 pouch | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Aviane (levonorgestrel and ethinyl estradiol 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. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.
The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE II: 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. 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
Method (1) Typical Use 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. (2) Perfect Use 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. (3) (4) Chance 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. 85 85 Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film.
26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-Ovulation 1 Cap With spermicidal cream or jelly. Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Withdrawal 19 4 Condom Without spermicides.
Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only
0.5 Combined
0.1IUD Progesterone T 2 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Levonorgestrel Implants (Norplant ® ) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.1 100 Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel 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%.
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 and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets.
Lactati… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Aviane (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Aviane - 28 is one orange tablet daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Aviane - 28 tablets be taken at the same time each day.
The dispenser should be kept in the wallet supplied to avoid possible fading of the pills. If the pills fade, patients should continue to take them as directed. During The First Cycle Of Use The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient should be instructed to begin taking Aviane on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start). Sunday Start The patient is instructed to begin taking Aviane - 28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (orange) is taken that day.
One orange tablet should be taken daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Aviane - 28 until an orange tablet has been taken daily for 7 consecutive days, and a nonhormonal backup method of birth control should be used during those 7 days.
Day 1 Start During the first cycle of medication, the patient is instructed to begin taking Aviane - 28 during the first 24 hours of her period (day one of her menstrual cycle). One orange tablet should be taken daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started.
If medication is begun on day one of the menstrual cycle, no backup contraception is necessary. If Aviane - 28 tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Aviane - 28 tablets until after the first 7 consecutive days of administration, and a nonhormonal backup method of birth control should be used during those 7 days. After the First Cycle of Use The patient begins her next and all subsequent courses of tablets on the day after taking her last light-green tablet.
She should follow the same dosing schedule: 21 days on orange tablets followed by 7 days on light-green tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal backup method of birth control until she has taken an orange tablet daily for 7 consecutive days. Switching from Another Hormonal Method of Contraception When the patient is switching from a 21 day regimen of tablets, she should wait 7 days after her last tablet before she starts Aviane.
She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21 day regimen. When the patient is switching from a 28 day regimen of tablets, she should start her first pack of Aviane on the day after her last tablet.
She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Aviane the next day. If switching from an implant or injection, the patient should start Aviane on the day of implant removal or, if using an injection, the day the next injection would be due.
In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal backup method of birth control for the first 7 days… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Combination oral contraceptives should not be used in women with any of the following conditions: 1. Thrombophlebitis or thromboembolic disorders 2. A history of deep-vein thrombophlebitis or thromboembolic disorders 3.
Cerebrovascular or coronary artery disease (current or past history) 4. Valvular heart disease with thrombogenic complications 5. Thrombogenic rhythm disorders 6.
Hereditary or acquired thrombophilias 7. Major surgery with prolonged immobilization 8. Diabetes with vascular involvement 9.
Headaches with focal neurological symptoms 10. Uncontrolled hypertension 11. Known or suspected carcinoma of the breast or personal history of breast cancer 12.
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia 13. Undiagnosed abnormal genital bleeding 14. Cholestatic jaundice of pregnancy or jaundice with prior pill use 15.
Hepatic adenomas or carcinomas, or active liver disease 16. Known or suspected pregnancy 17. Hypersensitivity to any of the components of Aviane 18.
Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS , Error! Hyperlink reference not valid. ).
⚠️ Warnings ▾
WARNINGS Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives: Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed): 1. Acne 2. Amenorrhea 3.
Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms 4. Breast changes: tenderness, pain, enlargement, secretion 5. Budd-Chiari syndrome 6.
Cervical erosion and secretion, change in 7. Cholestatic jaundice 8. Chorea, exacerbation of 9.
Colitis 10. Contact lenses, intolerance to 11. Corneal curvature (steepening), change in 12.
Dizziness 13. Edema/fluid retention 14. Erythema multiforme 15.
Erythema nodosum 16. Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating) 17. Hirsutism 18.
Infertility after discontinuation of treatment, temporary 19. Lactation, diminution in, when given immediately postpartum 20. Libido, change in 21.
Melasma/chloasma which may persist 22. Menstrual flow, change in 23. Mood changes, including depression 24.
Nausea 25. Nervousness 26. Pancreatitis 27.
Porphyria, exacerbation of 28. Rash (allergic) 29. Scalp hair, loss of 30.
Serum folate levels, decrease in 31. Spotting 32. Systemic lupus erythematosus, exacerbation of 33.
Unscheduled bleeding 34. Vaginitis, including candidiasis 35. Varicose veins, aggravation of 36.
Vomiting 37. Weight or appetite (increase or decrease), change in The following adverse reactions have been reported in users of oral contraceptives: 1. Cataracts 2.
Cystitis-like syndrome 3. Dysmenorrhea 4. Hemolytic uremic syndrome 5.
Hemorrhagic eruption 6. Optic neuritis, which may lead to partial or complete loss of vision 7. Premenstrual syndrome 8.
Renal function, impaired
🧒 Pediatric Use ▾
14. Pediatric Use Safety and efficacy of Aviane tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of Aviane before menarche is not indicated.
🧓 Geriatric Use ▾
15. Geriatric Use Aviane has not been studied in women over 65 years of age and is not indicated in this population.
🆘 Overdosage ▾
OVERDOSAGE Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mode of Action Combination 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 the endometrium (which reduce the likelihood of implantation). Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of Aviane in humans has been conducted.
However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%. After a single dose of Aviane to 22 women under fasting conditions, maximum serum concentrations of levonorgestrel are 2.8 ± 0.9 ng/mL (mean ± SD) at 1.6 ± 0.9 hours.
At steady state, attained from day 19 onwards, maximum levonorgestrel concentrations of 6 ± 2.7 ng/mL are reached at 1.5 ± 0.5 hours after the daily dose. The minimum serum levels of levonorgestrel at steady state are 1.9 ± 1 ng/mL. Observed levonorgestrel concentrations increased from day 1 (single dose) to days 6 and 21 (multiple doses) by 34% and 96%, respectively ( Figure I ).
Unbound levonorgestrel concentrations increased from day 1 to days 6 and 21 by 25% and 83%, respectively. The kinetics of total levonorgestrel are nonlinear due to an increase in binding of levonorgestrel to sex hormone binding globulin (SHBG), which is attributed to increased SHBG levels that are induced by the daily administration of ethinyl estradiol. Following a single dose, maximum serum concentrations of ethinyl estradiol of 62 ± 21 pg/mL are reached at 1.5 ± 0.5 hours.
At steady state, attained from at least day 6 onwards, maximum concentrations of ethinyl estradiol were 77 ± 30 pg/mL and were reached at 1.3 ± 0.7 hours after the daily dose. The minimum serum levels of ethinyl estradiol at steady state are 10.5 ± 5.1 pg/mL. Ethinyl estradiol concentrations did not increase from days 1 to 6, but did increase by 19% from days 1 to 21 ( Figure I ).
Figure I: Mean (SE) Levonorgestrel and Ethinyl Estradiol Serum Concentrations in 22 Subjects Receiving 100 mcg Levonorgestrel and 20 mcg Ethinyl Estradiol TABLE I provides a summary of levonorgestrel and ethinyl estradiol pharmacokinetic parameters. TABLE I: MEAN (SD) PHARMACOKINETIC PARAMETERS OF AVIANE OVER A 21 DAY DOSING PERIOD Levonorgestrel C max T max AUC CL/F Vλz/F SHBG Day ng/mL h ng•h/mL mL/h/kg L/kg nmol/L 1 2.75 (0.88) 1.6 (0.9) 35.2 (12.8) 53.7 (20.8) 2.66 (1.09) 57 (18) 6 4.52 (1.79) 1.5 (0.7) 46 (18.8) 40.8 (14.5) 2.05 (0.86) 81 (25) 21 6 (2.65) 1.5 (0.5) 68.3 (32.5) 28.4 (10.3) 1.43 (0.62) 93 (40) Unbound Levonorgestrel pg/mL h pg•h/mL L/h/kg L/kg fu% 1 51.2 (12.9) 1.6 (0.9) 654 (201) 2.79 (0.97) 135.9 (41.8) 1.92 (0.3) 6 77.9 (22) 1.5 (0.7) 794 (240) 2.24 (0.59) 112.4 (40.5) 1.80 (0.24) 21 103.6 (36.9) 1.5 (0.5) 1177 (452) 1.57 (0.49) 78.6 (29.7) 1.78 (0.19) Ethinyl Estradiol pg/mL h pg•h/mL mL/h/kg L/kg 1 62 (20.5) 1.5 (0.5) 653 (227) 567 (204) 14.3 (3.7) 6 76.7 (29.9) 1.3 (0.7) 604 (231) 610 (196) 15.5 (4) 21 82.3 (33.2) 1.4 (0.6) 776 (308) 486 (179) 12.4 (4.1) Figure 1 Distribution Levonorgestrel in serum is primarily bound to SHBG.
Ethinyl estradiol is about 97% bound to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Metabolism Levonorgestrel The most important metabolic pathway occurs in the reduction of the Δ4-3-oxo group and hydroxylation at positions 2α, 1β, and 16β, followed by conjugation.
Most of the metabolites that circulate in the blood are sulfates of 3α,5β-tetrahydro-levonorgestrel, while excretion occurs predominantly in the form of glucuronides. Some of the parent levonorgestrel also circula… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Aviane ® (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with dp on one side and 016 on the other side.
Each light-green tablet is round and debossed with dp on one side and 519 on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
REFERENCES AVAILABLE UPON REQUEST. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. B 4/2017
📋 Description ▾
DESCRIPTION 21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α -pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide.
7 light-green, inert tablets each containing: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no.
6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Levonorgestrel, USP C 21 H 28 O 2 M.W. 312.45 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W.
296.4 Description: Levonorgestrel Structure Description: Ethinyl Estradiol Structure
⚠️ Precautions ▾
PRECAUTIONS 1. General Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. 2.
Physical Examination and Follow-Up A periodic personal and family medical history and complete physical examination are appropriate for all women, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, including cervical cytology, and relevant laboratory tests.
In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. 3.
Lipid Disorders Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult (see WARNINGS, 1 a , 1 d , and 9 ). A small proportion of women will have adverse lipid changes while taking oral contraceptives.
Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias. Persistent hypertriglyceridemia may occur in a small population of combination oral contraceptive users. Elevations of plasma triglycerides may lead to pancreatitis and other complications.
4. Liver Function If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.
5. Fluid Retention Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
6. Emotional Disorders Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
7. Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. 8.
Gastrointestinal Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations. 9. Drug Interactions Changes in Contraceptive Effectiveness Associated with Coadministration of Other Products Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids.
This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil. In such cases a backup nonhormonal method of birth control should be considered.
Several cases of contraceptive failure and breakthrough bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and other penicillins, and tetracyclines. However, clinical pharmacology studies investigating drug interactions between combined oral contraceptives and these antibiotics have reported inconsistent results. Several of the anti-HIV protease inhibitors have been studied with coadministration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and pr… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of Aviane in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%.
After a single dose of Aviane to 22 women under fasting conditions, maximum serum concentrations of levonorgestrel are 2.8 ± 0.9 ng/mL (mean ± SD) at 1.6 ± 0.9 hours. At steady state, attained from day 19 onwards, maximum levonorgestrel concentrations of 6 ± 2.7 ng/mL are reached at 1.5 ± 0.5 hours after the daily dose. The minimum serum levels of levonorgestrel at steady state are 1.9 ± 1 ng/mL.
Observed levonorgestrel concentrations increased from day 1 (single dose) to days 6 and 21 (multiple doses) by 34% and 96%, respectively ( Figure I ). Unbound levonorgestrel concentrations increased from day 1 to days 6 and 21 by 25% and 83%, respectively. The kinetics of total levonorgestrel are nonlinear due to an increase in binding of levonorgestrel to sex hormone binding globulin (SHBG), which is attributed to increased SHBG levels that are induced by the daily administration of ethinyl estradiol.
Following a single dose, maximum serum concentrations of ethinyl estradiol of 62 ± 21 pg/mL are reached at 1.5 ± 0.5 hours. At steady state, attained from at least day 6 onwards, maximum concentrations of ethinyl estradiol were 77 ± 30 pg/mL and were reached at 1.3 ± 0.7 hours after the daily dose. The minimum serum levels of ethinyl estradiol at steady state are 10.5 ± 5.1 pg/mL.
Ethinyl estradiol concentrations did not increase from days 1 to 6, but did increase by 19% from days 1 to 21 ( Figure I ). Figure I: Mean (SE) Levonorgestrel and Ethinyl Estradiol Serum Concentrations in 22 Subjects Receiving 100 mcg Levonorgestrel and 20 mcg Ethinyl Estradiol TABLE I provides a summary of levonorgestrel and ethinyl estradiol pharmacokinetic parameters. TABLE I: MEAN (SD) PHARMACOKINETIC PARAMETERS OF AVIANE OVER A 21 DAY DOSING PERIOD Levonorgestrel C max T max AUC CL/F Vλz/F SHBG Day ng/mL h ng•h/mL mL/h/kg L/kg nmol/L 1 2.75 (0.88) 1.6 (0.9) 35.2 (12.8) 53.7 (20.8) 2.66 (1.09) 57 (18) 6 4.52 (1.79) 1.5 (0.7) 46 (18.8) 40.8 (14.5) 2.05 (0.86) 81 (25) 21 6 (2.65) 1.5 (0.5) 68.3 (32.5) 28.4 (10.3) 1.43 (0.62) 93 (40) Unbound Levonorgestrel pg/mL h pg•h/mL L/h/kg L/kg fu% 1 51.2 (12.9) 1.6 (0.9) 654 (201) 2.79 (0.97) 135.9 (41.8) 1.92 (0.3) 6 77.9 (22) 1.5 (0.7) 794 (240) 2.24 (0.59) 112.4 (40.5) 1.80 (0.24) 21 103.6 (36.9) 1.5 (0.5) 1177 (452) 1.57 (0.49) 78.6 (29.7) 1.78 (0.19) Ethinyl Estradiol pg/mL h pg•h/mL mL/h/kg L/kg 1 62 (20.5) 1.5 (0.5) 653 (227) 567 (204) 14.3 (3.7) 6 76.7 (29.9) 1.3 (0.7) 604 (231) 610 (196) 15.5 (4) 21 82.3 (33.2) 1.4 (0.6) 776 (308) 486 (179) 12.4 (4.1) Figure 1 Distribution Levonorgestrel in serum is primarily bound to SHBG.
Ethinyl estradiol is about 97% bound to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Metabolism Levonorgestrel The most important metabolic pathway occurs in the reduction of the Δ4-3-oxo group and hydroxylation at positions 2α, 1β, and 16β, followed by conjugation.
Most of the metabolites that circulate in the blood are sulfates of 3α,5β-tetrahydro-levonorgestrel, while excretion occurs predominantly in the form of glucuronides. Some of the parent levonorgestrel also circulates as 17β-sulfate. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.
Ethinyl Estradiol Cytochrome P450 enzymes (CYP3A4) in the liver are responsible for the 2-hydroxylation that is the major oxidative reaction. The 2-hydroxy metabolite… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel Aviane® (levonorgestrel and ethinyl estradiol tablets USP) 28 Tablets Each NDC 63187-889-28 28 Tablets Each Aviane® (levonorgestrel and ethinyl estradiol tablets USP) 0.10 mg/0.02 mg Contains 28 tablets. Twenty-one orange tablets, each containing 0.10 mg levonorgestrel, USP with 0.02 mg ethinyl estradiol, USP and seven light-green inert tablets. Rx only SHAPING WOMEN’S HEALTH® 63187-889-28
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