TRI-SPRINTEC

14.1 Contraception In four clinical trials with norgestimate and ethinyl estradiol, 4,756 women aged 15 to 41 years were studied for 24 cycles, providing a total of 45,244 cycles of exposure. The racial demographic was about 87 to 90% Caucasian, 6 to 10% African-American, with the remainder Asian (≤1%) or Other (2 to 5%). There were no exclusions on the basis of weight; the weight range for women treated was 80 to 310 lbs, with a mean weight of about 132 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years. 14.2 Acne Tri-Sprintec ® was evaluated for the treatment of acne v...

The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling:

• Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( )]
• Vascular events [see Warnings and Precautions ( )]
• Liver disease [see Warnings and Precautions ( )] The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastroint...

Tri-Sprintec ® is contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( )] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( )] o Have inherited...

• Thromboembolic Disorders and Other Vascular Problems: Stop Tri-Sprintec ® 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. ()
• Liver disease: Discontinue Tri-Sprintec ® if jaundice occurs. ()
• High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Tri-Sprintec ® if blood pressure rises significantly. ()
• Carboh...

7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. No drug-drug interaction studies were conducted with Tri-Sprintec ® . Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding...