aviane-28
Aviane-28 is a combination medicine containing Ethinyl Estradiol and Levonorgestrel.
Ethinyl Estradiol and Levonorgestrel · by Duramed Pharms Barr
Generic of Loseasonique
This is one strength of Aviane-21
The FDA label is the same for every strength in this family, so the full page — with all 2 strengths — lives on Aviane-21.
- Aviane-21Ethinyl Estradiol 0.02MG; Levonorgestrel 0.1MG
- Aviane-28 (this page)Ethinyl Estradiol 0.02MG; Levonorgestrel 0.1MG
Key facts
- Active ingredient
- Ethinyl Estradiol and Levonorgestrel
- Form
- Kit
- Strength
- Ethinyl Estradiol 0.02MG; Levonorgestrel 0.1MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Duramed Pharms Barr
- Half-life
- about 36 hours (36 ± 13 hours at steady state) (how long it stays in your system)
- FDA application
- ANDA075796
- FDA boxed warning
- Yes — see the boxed warning
What is Aviane-28?
From the FDA label: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
How to use
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…
Side effects
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.…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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.
Warnings
Important safety information
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.
Who should not take Aviane-28
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. ).
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Ethinyl Estradiol and Levonorgestrel stay in your body?
The elimination half-life of ethinyl estradiol and levonorgestrel is about 36 hours (36 ± 13 hours at steady state) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal elimination half-life stated directly for levonorgestrel; the label reports no active metabolite that outlasts the parent, and levonorgestrel is not a prodrug. The number comes from a levonorgestrel/ethinyl estradiol combination oral-contraceptive label (Aviane), where it is attributed specifically to the levonorgestrel component; the single-ingredient OTC emergency-contraceptive labels do not state a half-life. On populations: the label says no formal studies evaluated hepatic or renal impairment, but cautions that steroid hormones may be poorly metabolized in patients with impaired liver function; it notes no apparent pharmacokinetic differences across races, and states nothing about older adults.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Aviane (levonorgestrel and ethinyl estradiol) label — DailyMed, Clinical Pharmacology / Pharmacokinetics.
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- Is there a coupon or discount for Aviane-28?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Aviane-28. To pay less, Aviane-28 is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Aviane-28?
- Aviane-28 is marketed by Duramed Pharms Barr. You can see Duramed Pharms Barr's full profile, rating, and other products on pharmaranks.
- Is Aviane-28 a brand-name or generic drug?
- Aviane-28 is a generic medication; its active ingredient is Ethinyl Estradiol and Levonorgestrel. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Aviane-28 available over the counter?
- No. Aviane-28 is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Aviane-28 come in?
- Aviane-28 is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Aviane-28 FDA-registered?
- Aviane-28 is on record with the U.S. FDA under application number ANDA075796. You can verify this on its official FDA label.
- Is Aviane-28 safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Aviane-28. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Aviane-28?
- Aviane-28's side effects are taken directly from its FDA label. From the label: 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 withou… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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