Aviane

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 back-up 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 back-up 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 back-up 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 back-up 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, implant, or intrauterine system (IUS), the patient should be advised to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days of the first pack.
• If spotting or breakthrough bleeding occurs If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen.
• This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.
• Risk of pregnancy if tablets are missed While there is little likelihood of ovulation occurring if only one or two orange tablets are missed, the possibility of ovulation increases with each successive day that scheduled orange tablets are missed.
• Although the occurrence of pregnancy is unlikely if Aviane is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered.
• If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken.
• If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.
• The risk of pregnancy increases with each active (orange) tablet missed.
• For additional patient instructions regarding missed tablets, see the WHAT TO DO
• IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.
• Use after pregnancy, abortion or miscarriage Aviane may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see C ONTRAINDICATIONS , WARNINGS , and PRECAUTIONS concerning thromboembolic disease).
• The patient should be advised to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days.
• Aviane may be initiated immediately after a first trimester abortion or miscarriage.
• Instruct the patient to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days, unless starting Aviane on the day of surgical abortion.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

15. Geriatric Use Aviane has not been studied in women over 65 years of age and is not indicated in this population.

Quoted from the official label, section “Geriatric Use”.

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.
• 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 2).
• 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:
• Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives 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.
• The following adverse reactions associated with the use of oral CHCs were identified in clinical studies or postmarketing reports.
• Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
• Additional adverse reactions that have been reported include the following:
• Eye disorder:
• intolerance to contact lenses, steepening of corneal curvature Gastrointestinal disorders:
• Abdominal bloating, vomiting General disorders and administration site conditions:
• Edema, fluid retention Hepatobiliary disorders:
• Cholestatic jaundice Psychiatric disorders:
• Change in libido, mood changes Reproductive system and breast disorders:
• Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding Skin and subcutaneous tissue disorders:
• Acne, melasma Vascular disorders:
• Budd-Chiari syndrome, aggravation of varicose veins To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions. 1

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

• Aviane ® (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC:
• 0555-9045-58) 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.
• Brands listed are the registered trademarks of their respective owners.
• Teva Pharmaceuticals USA, Inc.
• North Wales, PA 19454 Rev.
• F 7/2024

Quoted from the official label, section “How Supplied”.

What is in it

• 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.
• 296.40 Description: Levonorgestrel Structure Description: Ethinyl Estradiol Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Levonorgestrel and Ethinyl Estradiol