Basic Drug Info
Drug Name:ALESSE 28
Manufacturer:Wyeth Pharmaceuticals, Inc.
Other Info:

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Wyeth®Wyeth Pharmaceuticals Inc.Philadelphia, PA 19101 W10491C003ET01Rev 02/08

Clinical Trials:

Indications and Usage

ALESSE 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.

% of Women Experiencing anUnintended Pregnancy within theFirst Year of Use % of Women ContinuingUse at One Year 3 Method(1)Typical Use 1(2)Perfect Use 2(3)(4) Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: 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.

Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.

The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant.

Among such populations, about 89% become pregnant within one year.

This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.

Foams, creams, gels, vaginal suppositories, and vaginal film.

Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.

With spermicidal cream or jelly.

Without spermicides.The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose.

The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

Chance 485 85 Spermicides 526 6 40 Periodic abstinence 25 63    Calendar 9    Ovulation Method 3    Sympto-Thermal 62    Post-Ovulation 1 Cap 7    Parous Women 40 26 42    Nulliparous Women 20 9 56 Sponge    Parous Women 40 20 42    Nulliparous Women 20 9 56 Diaphragm 720 6 56 Withdrawal 19 4 Condom 8    Female (Reality) 21 5 56    Male 14 3 61 Pill 5 71    Progestin only 0.5    Combined 0.1 IUD    Progesterone T 2.0 1.5 81    Copper T380A 0.8 0.6 78    LNg 20 0.1 0.1 81 Depo-Provera®0.3 0.3 70 LevonorgestrelImplants (Norplant®)0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 In a clinical trial with ALESSE (levonorgestrel and ethinyl estradiol 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.
Combination oral contraceptives should not be used in women with any of the following conditions:Thrombophlebitis or thromboembolic disordersA history of deep-vein thrombophlebitis or thromboembolic disordersCerebrovascular or coronary artery disease (current or past history)Valvular heart disease with thrombogenic complicationsThrombogenic rhythm disordersHereditary or acquired thrombophiliasMajor surgery with prolonged immobilizationDiabetes with vascular involvementHeadaches with focal neurological symptomsUncontrolled hypertensionKnown or suspected carcinoma of the breast or personal history of breast cancerCarcinoma of the endometrium or other known or suspected estrogen-dependent neoplasiaUndiagnosed abnormal genital bleedingCholestatic jaundice of pregnancy or jaundice with prior pill useHepatic adenomas or carcinomas, or active liver diseaseKnown or suspected pregnancyHypersensitivity to any of the components of ALESSE
Thrombophlebitis -- Inflammation of a vein associated with a blood clot (THROMBUS).

Deep thrombophlebitis --

Coronary Artery Disease -- Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Heart valve disease -- Pathological conditions involving any of the various HEART VALVES and the associated structures (PAPILLARY MUSCLES and CHORDAE TENDINEAE).

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Icterus -- A clinical manifestation of HYPERBILIRUBINEMIA, characterized by the yellowish staining of the SKIN; MUCOUS MEMBRANE; and SCLERA. Clinical jaundice usually is a sign of LIVER dysfunction.

adenoma -- A benign epithelial tumor with a glandular organization.


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.

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