Aviane
Levonorgestrel and Ethinyl Estradiol · KIT · Teva Pharmaceuticals USA, Inc.
Aviane is a kit containing levonorgestrel and ethinyl estradiol. Manufactured by Teva Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- Aviane
- Generic Name
- Levonorgestrel and Ethinyl Estradiol
- NDC Code (Product)
0555-9045- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA075796
- Marketing Start
- 04/02/2001
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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…
Dosage & 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, f…
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.
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…
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 …
Frequently Asked Questions
What is Aviane used for?
Aviane contains Levonorgestrel and Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is Aviane a controlled substance?
Aviane is not classified as a controlled substance by the DEA.
What is the generic name for Aviane?
The generic name for Aviane is Levonorgestrel and Ethinyl Estradiol. There are 11 other brand versions of Levonorgestrel and Ethinyl Estradiol.
What is the NDC code for Aviane ?
The NDC (National Drug Code) for Aviane is 0555-9045, listed by Teva Pharmaceuticals USA, Inc..