Norgestimate and ethinyl estradiol

Sprintec ® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )].

• Take one tablet daily by mouth at the same time every day
• Take tablets in the order directed on the blister pack
• Do not skip or delay tablet intake
• Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food
• Table 1 provides the recommended dosage and administration instructions for Sprintec
• Table 1: Instructions for Administration of Sprintec Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product
• Tablet Color: Sprintec active tablets are blue (Day 1 to Day 21)
• Sprintec has white inactive tablets (Day 22 to Day 28)
• Day 1 Start: Take first active tablet without regard to meals on the first day of menses
• Take subsequent active tablets once daily at the same time each day for a total of 21 days
• Take one white inactive tablet daily for 7 days and at the same time of day that active tablets were taken
• Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start: Take first active tablet without regard to meals on the first Sunday after the onset of menses
• Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Sprintec
• Take subsequent active tablets once daily at the same time each day for a total of 21 days. …

Sprintec (norgestimate and ethinyl estradiol tablets USP) is available in blister cards. Each blister card contains 28 tablets in the following order: 21 blue, round, flat-faced, beveled-edge, unscored tablet debossed with stylized b on one side and 987 on the other side contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 white, round, flat-faced, beveled-edge, unscored tablet (non-hor …

• Safety and efficacy of Sprintec tablets have been established in women of reproductive age
• Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated

Sprintec has not been studied in postmenopausal women and are not indicated in this population.

• See FDA-approved patient labeling (Patient Information and Instructions for Use)
• Counsel patients about the following information: Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning ]
• Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions ]
• Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted infections. …

• 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: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ] Have cerebrovascular disease [see …

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 Sprintec. Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. …

Thromboembolic Disorders and Other Vascular Problems : Stop 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. ( 5.1 ) Liver disease : Discontinue Sprintec if jaundice occurs. ( 5.2 ) High blood pressure : If used in women with well-controlled hypertension, monitor blood pressure and stop Sprintec if blood pressure rises significantly. ( 5.4 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Sprintec. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. …

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 ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] The most common adverse reactions reported during clinical trials (≥2%) were: Sprintec: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash. …

8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy, therefore, Sprintec should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. …

There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.