Label: SPRINTEC- norgestimate and ethinyl estradiol kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 11, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC - ®(norgestimate/ethinyl estradiol ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: 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)].

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  • 1 INDICATIONS AND USAGE
    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  ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 How to Start Sprintec - Sprintec is dispensed in a blister pack tablet dispenser - [see How Supplied/Storage and Handling ( 16)]. Sprintec may be started using either a Day 1 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    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 ...
  • 4 CONTRAINDICATIONS
    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 ...
  • 5 WARNINGS AND PRECAUTIONS
    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 ...
  • 6 ADVERSE REACTIONS
    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 ...
  • 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an ...
  • 10 OVERDOSAGE
    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.
  • 11 DESCRIPTION
    Sprintec - ®(norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Oral Contraception - COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - [See Warnings and Precautions ( 5.2, 5.11) and Use in Specific Populations ( 8.1).]
  • 14 CLINICAL STUDIES
    14.1 Contraception - In three US clinical trials with norgestimate and ethinyl estradiol, 1,651 women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24,272 cycles of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Sprintec - ®(norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of six blister cards. Each card contains 21 blue tablets and 7 white tablets containing ...
  • 17 PATIENT COUNSELING INFORMATION
    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 ...
  • Patient Information
    Sprintec - ®[sprin-tek] (norgestimate and ethinyl estradiol tablets) What is the most important information I should know about Sprintec? Do not use Sprintec if you smoke ...
  • Package/Label Display Panel, Part 1 of 2
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  • Package/Label Display Panel, Part 2 of 2
    NDC 0555- 9016-58 - 6 Blister Cards, 28 Tablets Each - 28 DAY REGIMEN - Sprintec® (norgestimate and ethinyl estradiol tablets USP) 0.250 mg/0.035 mg - Usual Dosage: One tablet daily for 28 ...
  • INGREDIENTS AND APPEARANCE
    Product Information