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 and the IUD, 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 NA - not available *Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition.

NY, NY: Ardent Media, Inc., 1998.

Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera® (injectable progestogen) 0.3 0.3 Oral contraceptives 5    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 14    (Female) without spermicide 5 21 Cervical cap    Nulliparous women 9 20    Parous women 26 40 Vaginal sponge    Nulliparous women 9 20    Parous women 20 40 Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, jellies, and vaginal suppositories) 6 26 Periodic abstinence (all methods) 1-9* 25 Withdrawal 4 19 No contraception (planned pregnancy) 85 85

Combination 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.

 Cerebral-vascular or coronary-artery disease.

 Thrombogenic valvulopathies.

 Thrombogenic rhythm disorders.

 Diabetes with vascular involvement.

 Uncontrolled hypertension.

 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, or active liver disease, as long as liver function has not returned to normal.

 Known or suspected pregnancy.

 Hypersensitivity to any of the components of Triphasil (levonorgestrel and ethinyl estradiol tablets—triphasic regimen).

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Thrombophlebitis -- Inflammation of a vein associated with a blood clot (THROMBUS).

Thromboembolism -- Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Deep thrombophlebitis --

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

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Diabetes --

Diabetes Mellitus -- A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

Diabetes Mellitus, Non-Insulin-Dependent -- subclass of diabetes mellitus that is not insulin responsive or dependent; characterized initially by insulin resistance and hyperinsulinemia and eventually by glucose intolerance, hyperglycemia, and overt diabetes; type II diabetes mellitus is no longer considered a disease exclusively found in adults; patients seldom develop ketosis but often exhibit obesity.

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)

Obstructive Jaundice -- JAUNDICE, the condition with yellowish staining of the skin and mucous membranes, that is due to impaired BILE flow in the BILIARY TRACT, such as INTRAHEPATIC CHOLESTASIS, or EXTRAHEPATIC CHOLESTASIS.

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.

Hepatic adenoma --

Liver diseases -- Pathological processes of the LIVER.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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.