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Basic Drug Info
Drug Name:Lybrel
Manufacturer:Wyeth Pharmaceuticals Inc.
Other Info:

In addition to preventing pregnancy, some information suggests that the use of oral contraceptives provide certain other benefits.

The benefits are:Decreased blood loss, and less iron may be lost.

Therefore, anemia due to iron deficiency is less likely to occur.

Pain or other cycle-related symptoms may occur less frequently.

Ovarian cysts may occur less frequently.

Ectopic (tubal) pregnancy may occur less frequently.

Noncancerous cysts or lumps in the breast may occur less frequently.

Acute pelvic inflammatory disease may occur less frequently.

Oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus.

If you want more information about birth-control pills, ask your health care professional or pharmacist.

They have a more technical leaflet called the Professional Labeling which you may wish to read.

This product's label may have been updated.

For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.

United States Patent Numbers: 6,500,814; D497,803SWyeth®Wyeth Pharmaceuticals Inc.Philadelphia, PA 19101 W10522C007ET01Rev 09/08



Clinical Trials:


Indications and Usage

LYBREL 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 for pregnancy prevention.

Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception.

The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used.

Correct and consistent use of methods can result in lower failure rates.

Table 2: 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 an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4) 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 (RealityTM) 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 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.
Contraindications
Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disordersHistory 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 symptoms such as auraUncontrolled 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 LYBREL
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).

Neurological Signs and Symptoms --

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.

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. The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke, and transient ischemic attack), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.

The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis (see CONTRAINDICATIONS).

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher doses of estrogens and progestogens than those in common use today.

The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies.

Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers.

The relative risk does not provide information on the actual clinical occurrence of a disease.

Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers.

The attributable risk does provide information about the actual occurrence of a disease in the population.

For further information, the reader is referred to a text on epidemiological methods.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.