Drug: Aviane

21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate and titanium dioxide.
7 Light-green, inert tablets each contain: 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 starch.

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An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see "WARNINGS" section):
  • Thrombophlebitis
  • Arterial thromboembolism
  • Pulmonary embolism
  • Myocardial infarction
  • Cerebral hemorrhage
  • Cerebral thrombosis
  • Hypertension
  • 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:
  • Nausea
  • Vomiting
  • Gastrointestinal symptoms (such as abdominal cramps and bloating)
  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Temporary infertility after discontinuation of treatment
  • Edema
  • 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
  • Migraine
  • 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
  • Cataracts
  • Optic neuritis
  • Changes in appetite
  • Cystitis-like syndrome
  • Headache
  • Nervousness
  • Dizziness
  • Hirsutism
  • Loss of scalp hair
  • Erythema multiforme
  • Erythema nodosum
  • Hemorrhagic eruption
  • Vaginitis
  • Porphyria
  • Impaired renal function
  • Hemolytic uremic syndrome
  • Budd-Chiari syndrome
  • Acne
  • Changes in libido
  • Colitis
Read the Aviane (levonorgestrel and ethinyl estradiol tablets) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

To achieve maximum contraceptive effectiveness, Aviane (levonorgestrel and ethinyl estradiol tablets) ™ (levonorgestrel and ethinyl estradiol tablets, USP 0.10 mg/0.02) must be taken exactly as directed and at intervals not exceeding 24 hours. 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. The dosage of Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 is one orange tablet daily for 21 consecutive days, followed by one light-green inert tablet for 7 consecutive days, according to the prescribed schedule. It is recommended that Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 tablets be taken at the same time each day. Sunday start During the first cycle of medication, the patient is instructed to begin taking Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 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 seven consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of orange tablets. During the first cycle, contraceptive reliance should not be placed on Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 until an orange tablet has been taken daily for 7 consecutive days. The possibility of ovulation and conception prior to initiation of medication should be considered. The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on orange tablets—7 days on light-green inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using another method of birth control until she has taken an orange tablet daily for 7 consecutive days. Day 1 start During the first cycle of medication, the patient is instructed to begin taking Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 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. Withdrawal bleeding should usually occur within three days following discontinuation of orange tablets. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Aviane (levonorgestrel and ethinyl estradiol tablets) ™ – 28 tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered. 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 (levonorgestrel and ethinyl estradiol tablets) ™. 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 (levonorgestrel and ethinyl estradiol tablets) ™ on the day after her last tablet. She should not wait any days between packs. 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. 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 (levonorgestrel and ethinyl estradiol tablets) ™ 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 before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. 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. In the nonlactating mother, Aviane (levonorgestrel and ethinyl estradiol tablets) ™ may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (See "CONTRAINDICATIONS", "WARNINGS", and "PRECAUTIONS" concerning thromboembolic disease).

Source: http://www.rxlist.com

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin, and possibly with griseofulvin, ampicillin, and tetracyclines. Interactions with laboratory tests Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:
  1. Increased prothrombin and factors Vll, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine induced platelet aggregability.
  2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
  3. Other binding proteins may be elevated in serum.
  4. Sex-hormone binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels remain unchanged.
  5. Triglycerides may be increased.
  6. Glucose tolerance may be decreased.
  7. Serum folate levels may be depressed by oral-contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
Last reviewed on RxList: 12/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 Male sterilization 0.1 0.15 Female sterilization 0.4 0.4 Depo-Provera®(injectable progestogen) 0.3 0.3 Oral contraceptives   3   Combined 0.1 NA   Progestin only 0.5 NA IUD     Progesterone 1.5 2.0   Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 12   (female) without spermicide 5 21 Cervical cap     Nulliparous women 9 18   Parous women 26 36 Diaphragm with spermicidal     cream or jelly 6 18 Spermicides alone (foam, creams, jellies, and vaginalsuppositories) 6 21 Periodic abstinence (all methods) 1-9* 20 Withdrawal 4 19 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.

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Oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep-vein thrombophlebitis or thromboembolic disorders Cerebrovascular or coronary artery disease Known or suspected carcinoma of the breast Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas Known or suspected pregnancy Last reviewed on RxList: 12/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. Noncontraceptive Health Benefits The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol. Effects on menses:
  • Increased menstrual cycle regularity
  • Decreased blood loss and decreased incidence of iron-deficiency anemia
  • Decreased incidence of dysmenorrhea
  • Effects related to inhibition of ovulation:
  • Decreased incidence of functional ovarian cysts
  • Decreased incidence of ectopic pregnancies
Effects from long-term use:
  • Decreased incidence of fibroadenomas and fibrocystic disease of the breast
  • Decreased incidence of acute pelvic inflammatory disease
  • Decreased incidence of endometrial cancer
  • Decreased incidence of ovarian cancer

Source: http://www.rxlist.com

Aviane (levonorgestrel and ethinyl estradiol tablets) ™ –28 tablets (0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets, USP) are available in cartons of six dispenser cards of 28 tablets each, NDC 0555-9045-58, as follows: 21 active tablets, orange, round coated tablet marked "dp" and "016", 7 inert tablets, light-green, round tablet marked "dp" and "519". Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. REFERENCES AVAILABLE UPON REQUEST. MANUFACTURED BY BARR LABORATORIES, INC. POMONA, NY 10970. Revised Oct 2003. FDA Rev date: 10/31/2001 Last reviewed on RxList: 12/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Physical examination and follow-up A periodic history and physical examination is 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. 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".) 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. 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. 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. Contact lenses: Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Carcinogenesis See "WARNINGS" section. Pregnancy Pregnancy Category X. See "CONTRAINDICATIONS" and "WARNINGS" sections. Nursing mothers Small amounts of oral-contraceptive steroids have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child. Information For The Patient See Patient Labeling.Last reviewed on RxList: 12/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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