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Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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 USE OF A CONTRACEPTIVE METHOD
|Method||Perfect Use||Typical Use|
|Norplant® System (6 capsules)||0.1||0.1|
|Copper T 380A||0.6||0.8|
|Condom (male) without spermicide||3||12|
|(female) without spermicide||5||21|
|Diaphragm with spermicidal|
|cream or jelly||6||18|
|Spermicides alone (foam, creams, jellies, and vaginalsuppositories)||6||21|
|Periodic abstinence (all methods)||1-9*||20|
|No contraception (planned pregnancy)||85||85|
|NA - not available |
*Depending on method (calendar, ovulation, symptothermal, post-ovulation)
Adapted from Hatcher RA et al., Contraceptive Technology, 16th Revised Edition. New York, NY: Irvington Publishers, 1994.
In a clinical trial with levonorgestrel and ethinyl estradiol 0.10 mg/0.02 mg tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see "WARNINGS" section):
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
- Mesenteric thrombosis
- Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related:
- Gastrointestinal symptoms (such as abdominal cramps and bloating)
- Breakthrough bleeding
- Change in menstrual flow
- Temporary infertility after discontinuation of treatment
- 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
- Rash (allergic)
- 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 the association has been neither confirmed nor refuted:
- Premenstrual syndrome
- Optic neuritis
- Changes in appetite
- Cystitis-like syndrome
- Loss of scalp hair
- Erythema multiforme
- Erythema nodosum
- Hemorrhagic eruption
- Impaired renal function
- Hemolytic uremic syndrome
- Budd-Chiari syndrome
- Changes in libido
Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your healthcare provider, pharmacist, or poison control at 1-800-222-1222.
Aviane FDA Warning
WARNING TO WOMEN WHO SMOKEDo not use this medication if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take Aviane (ethinyl estradiol and levonorgestrel) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aviane. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: October 4, 2017
What is ethinyl estradiol and levonorgestrel (alesse, altavera, amethyst, aviane, enpresse, lessina, levlen, levora, lutera, lybrel, nordette, orsythia, portia, sronyx, tri-levlen, triphasil-21, triphasil-28, trivora-28)?
Ethinyl estradiol and levonorgestrel is a combination drug that contains female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Ethinyl estradiol and levonorgestrel is used as contraception to prevent pregnancy.
Ethinyl estradiol and levonorgestrel may also be used for purposes not listed in this medication guide.
How should I take Aviane?
Take Aviane exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using Aviane. Follow your doctor's instructions.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.
Aviane packs contain seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
Use a back-up birth control if you are sick with severe vomiting or diarrhea.
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
If you need major surgery with long-term bed rest, you may need to stop using Aviane for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
While taking Aviane, you will need to visit your doctor regularly.
Store at room temperature away from moisture and heat.
What should I avoid while taking Aviane?
Do not smoke while taking Aviane, especially if you are older than 35 years of age.
Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
What other drugs will affect Aviane?
Other drugs may interact with birth control pills, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all your current medicines and any medicine you start or stop using.
Aviane Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Incidence not known
- Absent, missed, or irregular menstrual periods
- bloody stools
- blurred vision
- breast tenderness, enlargement, discharge
- changes in skin color, pain, tenderness, or swelling of the foot or leg
- chest pain or discomfort
- clay-colored stools
- dark or cloudy urine
- decrease in urine output or decrease in urine-concentrating ability
- difficult, burning, or painful urination
- difficulty in speaking
- dizziness or lightheadedness
- double vision
- dull ache or feeling of pressure or heaviness in the legs
- fast heartbeat
- fluid-filled skin blisters
- frequent urge to urinate
- headache, severe and throbbing
- inability to move the arms, legs, or facial muscles
- inability to speak
- itching of the vagina or outside the genitals
- itching skin near damaged veins
- light vaginal bleeding between regular menstrual periods
- loss of appetite
- pain during sexual intercourse
- pain or discomfort in the arms, jaw, back or neck
- pelvic pain
- pounding in the ears
- sensitivity to the sun
- skin thinness
- slow or fast heartbeat
- slow speech
- stomach bloating and cramping
- stomach pain and tenderness
- stopping of menstrual bleeding
- swelling, pain, or tenderness in the upper abdominal area
- swollen feet and ankles
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- thick, white curd-like vaginal discharge without odor or with mild odor
- troubled breathing
- twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Incidence not known
- changes in appetite
- changes in weight
- decreased interest in sexual intercourse
- decreased milk production
- loss in sexual ability, desire, drive, or performance
- mental depression
- patchy brown or dark brown discoloration of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.