HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ORTHO-CYCLEN or ORTHO TRI-CYCLEN safely and effectively. See full prescribing information for ORTHO-CYCLEN and ORTHO TRI-CYCLEN.

ORTHO-CYCLEN ® and ORTHO TRI-CYCLEN ® (norgestimate/ethinyl estradiol) tablets, for oral use
Initial U.S. Approval: 1989
WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning.
ORTHO-CYCLEN or ORTHO TRI-CYCLEN is contraindicated in women over 35 years old who smoke. (4)
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4)
INDICATIONS AND USAGE
ORTHO-CYCLEN and ORTHO TRI-CYCLEN are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1)

ORTHO TRI-CYCLEN is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.

ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2)

DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.2)
Take tablets in the order directed on the blister pack. (2.2)
Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
ORTHO-CYCLEN consists of 28 round, biconvex, coated tablets in the following order (3):

21 blue tablets each containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
7 dark green tablets (inert)
ORTHO TRI-CYCLEN consists of 28 round, biconvex, coated tablets in the following order (3):

7 white tablets each containing 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
7 light blue tablets each containing 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
7 blue tablets each containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
7 dark green tablets (inert)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems: Stop ORTHO-CYCLEN or ORTHO TRI-CYCLEN if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1)
Liver disease: Discontinue ORTHO-CYCLEN or ORTHO TRI-CYCLEN if jaundice occurs. (5.2)
High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop ORTHO-CYCLEN or ORTHO TRI-CYCLEN if blood pressure rises significantly. (5.3)
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking ORTHO-CYCLEN or ORTHO TRI-CYCLEN. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. (5.5)
Headache: eva luate significant change in headaches and discontinue ORTHO-CYCLEN or ORTHO TRI-CYCLEN if indicated. (5.6)
Bleeding Irregularities and Amenorrhea: eva luate irregular bleeding or amenorrhea. (5.7)
ADVERSE REACTIONS
The most common adverse reactions reported during clinical trials (≥2%) were:

ORTHO-CYCLEN: headache/migra