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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 t.

Checked against the official label · Updated

Prescription medicine Safety alerts on record

Norgestimate and ethinyl estradiol: quick answers

Used for
Sprintec ® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
With food?
2.1 Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food.
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Apr 2025). Your prescription and pharmacist come first.

How to use Norgestimate and ethinyl estradiol

Ce que dit la notice officielle. Si un médecin vous l'a prescrit, suivez l'ordonnance. La notice de votre boîte prime si elle est différente.

Mise en garde grave : CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )]. …
Pour qui

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 )].

Comment le prendre et à quelle fréquence
  • 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. …
Strengths it comes in

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 …

Children
  • 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
Older adults

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

While you are taking it
  • 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. …
Talk to a doctor first if
  • 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 …
Medicines it may not mix with

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. …

Warnings

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. …

Effets secondaires possibles

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. …

Pregnancy and breastfeeding

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. …

If you take too much

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.

En cas d'oubli

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-04-08.

Registered products

United States (FDA)

Tri-lo-sprintecKit · Teva Pharmaceuticals USA, Inc.
NDC 0093-2140Label
Tri-lo-marziaKit · Lupin Pharmaceuticals, Inc.
NDC 68180-837Label
EstaryllaKit · Proficient Rx LP
NDC 82804-158Label
Norgestimate And Ethinyl EstradiolKit · A-S Medication Solutions
NDC 50090-2603Label
Norgestimate And Ethinyl EstradiolKit · Lupin Pharmaceuticals, Inc.
NDC 68180-838Label

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured fU.S. FDA Class II
2 Sep 2025 · AvKARE · OngoingFailed Content Uniformity Specifications
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals U.S. FDA Class II
7 Mar 2024 · Teva Pharmaceuticals USA, Inc · TerminatedFailed Dissolution Specifications
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, DistributeU.S. FDA Class III
10 Jan 2020 · Lupin Pharmaceuticals Inc. · TerminatedCGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. U.S. FDA Class II
21 Jun 2013 · Sandoz Incorporated · TerminatedContraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Norgestimate and ethinyl estradiol

Type the registration number on the pack, or scan it with your camera.

Ou prenez la boîte en photo
Encore 3 vérifications gratuites aujourd'hui Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Norgestimate and ethinyl estradiol

What is Norgestimate and ethinyl estradiol used for?

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 )]. (From the official U.S. FDA label.)

How do I take Norgestimate and ethinyl estradiol?

Follow your prescription or the leaflet in your pack. The official label says: 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. Tabl…

Should I take Norgestimate and ethinyl estradiol with food?

2.1 Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food.

Can I take Norgestimate and ethinyl estradiol while breastfeeding?

Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Ask your doctor or midwife first.

Do I need a prescription for Norgestimate and ethinyl estradiol?

Usually yes. Norgestimate and ethinyl estradiol is a prescription medicine in most countries. Rules differ by country.

What are the side effects of Norgestimate and ethinyl estradiol?

The official label lists: 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… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Norgestimate and ethinyl estradiol?

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. Always use the dose for the child's age or weight on the pack or prescription.

Can I take Norgestimate and ethinyl estradiol when pregnant or breastfeeding?

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… Ask your doctor or midwife first.

What medicines interact with Norgestimate and ethinyl estradiol?

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. Couns… Use the free interaction checker before combining medicines.

What happens if I take too much Norgestimate and ethinyl estradiol?

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. Get medical help right away.

How can I check that my Norgestimate and ethinyl estradiol is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.