Norgestimate

Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

• 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 )].ICD-10: Z30.9

• Sprintec is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases.contraindicated

Take one tablet daily by mouth at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) Do not skip or delay tablet intake. ( 2.1 ) 2.1 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.

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. ( 5.6 ) Headache : Evaluate significant change in headaches and discontinue Sprintec if indicated. ( 5.7 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea. ( 5.8 ) 5.1 Thromboembolic Disorders and Other Vascular Problems Stop Sprintec if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop Sprintec if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions ( 6.2 )]. If feasible, stop Sprintec at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. Start Sprintec no earlier than 4 weeks after delivery, in women who are not breastfeeding.

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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of norgestimate and ethinyl estradiol was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of norgestimate and ethinyl estradiol for contraception. Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. In all 3 trials, subjects were followed for up to 24 cycles.

Lactating women: Not recommended; can decrease milk production. ( 8.2 ) 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. 8.2 Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other forms of contraception until she discontinues breast-feeding. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Sprintec and any potential adverse effects on the breast-fed child from Sprintec or from the underlying maternal condition. 8.4 Pediatric Use Safety and efficacy of Sprintec tablets have been established in women of reproductive age.

Metabolism

Absorption Norgestimate (NGM) and EE are rapidly absorbed following oral administration. NGM is rapidly and completely metabolized by first pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate.

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.

• Sep 25, 2002ANDAANDA075804Barr
• Dec 29, 2003ANDAANDA075808Barr
• Jun 29, 2009ANDAANDA076784Barr Labs Inc
• Jun 17, 2011ANDAANDA200494Glenmark Pharms Ltd
• Apr 5, 2012ANDAANDA200538Glenmark Pharms Ltd
• May 23, 2012ANDAANDA090523Novast Labs Ltd
• May 30, 2012ANDAANDA090524Novast Labs Ltd
• Jun 25, 2012ANDAANDA200541Lupin Pharms

1. 1Nausea4099.1%
2. 2Headache2806.2%
3. 3Drug Ineffective2525.6%
4. 4Fatigue2415.4%
5. 5Vomiting2255.0%
6. 6Anxiety2084.6%
7. 7Pain2054.6%
8. 8Depression1763.9%
9. 9Dizziness1593.5%
10. 10Rash1533.4%
11. 11Pruritus1393.1%
12. 12Off Label Use1353.0%
13. 13Diarrhoea1302.9%
14. 14Product Substitution Issue1162.6%
15. 15Product Dose Omission Issue1152.6%

The 10 most recently updated of 46 ClinicalTrials.gov registrations naming Norgestimate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
  Recruiting · Phase 1 · Interventional · 45 enrolled · Amgen
  NCT07523711updated 2026-04-27
• Premature Discontinuation of Contraceptive Implants
  Completed · Phase 4 · Interventional · 600 enrolled · University of Colorado, Denver
  NCT04828824updated 2026-04-23
• Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
  Completed · Phase 1 · Interventional · 74 enrolled · Vertex Pharmaceuticals Incorporated
  NCT07074327updated 2026-03-30
• International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
  Recruiting · Observational · 68,100 enrolled · Center for Epidemiology and Health Research, Germany
  NCT06186271updated 2025-08-20
• Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants
  Completed · Phase 1 · Interventional · 50 enrolled · Vertex Pharmaceuticals Incorporated
  NCT06820307updated 2025-05-29
• A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
  Completed · Observational · 20 enrolled · University of Colorado, Denver
  NCT05061472updated 2024-12-11
• To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
  Completed · Phase 3 · Interventional · 409 enrolled · Bayer
  NCT00754065updated 2024-11-20
• A Multicentre, Prospective, Open-label, Non-comparative Study
  Unknown · Phase 4 · Interventional · 228 enrolled · Italfarmaco
  NCT06067256updated 2023-10-04
• Inpatient Adolescent Contraception
  Completed · Early phase 1 · Interventional · 25 enrolled · Children's Mercy Hospital Kansas City
  NCT04423068updated 2023-04-05
• A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants
  Completed · Phase 1 · Interventional · 40 enrolled · Eli Lilly and Company
  NCT04172987updated 2023-03-27

Frequently asked questions

How does Norgestimate work?

Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

What is Norgestimate used for?

According to FDA labeling, Norgestimate carries indications including: 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 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Norgestimate?

Norgestimate is classified as Progestin, Progestational Hormone Receptor Agonists, Decreased Embryonic Implantation, Decreased Uterine Smooth Muscle Contraction or Tone, Increased Blood Pressure, Increased Coagulation Activity, Inhibit Ovarian Follicular Phase, Inhibit Ovulation.

What are the contraindications for Norgestimate?

Norgestimate labeling lists contraindications including: Sprintec is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases.. Always consult the full prescribing information and a clinician.