Label: LEVONORGESTREL AND ETHINYL ESTRADIOL kit

  • NDC Code(s): 0378-7281-53, 0378-7281-85
  • Packager: Mylan Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 15, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for LEVONORGESTREL AND ETHINYL ...
  • 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, including levonorgestrel and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)].

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  • 1 INDICATIONS AND USAGE
    Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 How to Start and Take Levonorgestrel and Ethinyl Estradiol Tablets - Levonorgestrel and ethinyl estradiol tablets are dispensed in an Extended-Cycle Blister Pack [see How Supplied/Storage ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Levonorgestrel and Ethinyl Estradiol Tablets, USP are available as round, biconvex, unscored tablets, packaged in carton of 3 pouches, each pouch contains Extended-Cycle Tablet Blister Pack of 91 ...
  • 4 CONTRAINDICATIONS
    Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Thromboembolic Disorders and Other Vascular Conditions • Stop levonorgestrel and ethinyl estradiol tablets if an arterial or venous thrombotic/thromboembolic event occurs. • Stop ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic ...
  • 10 OVERDOSAGE
    There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
  • 11 DESCRIPTION
    Levonorgestrel and ethinyl estradiol tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 white to off-white active tablets each containing 0.15 mg of levonorgestrel ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - COCs prevent pregnancy primarily by suppressing ovulation. 12.2 Pharmacodynamics - No specific pharmacodynamic studies were conducted with levonorgestrel and ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - See Warnings and Precautions (5.2, 5.11).
  • 14 CLINICAL STUDIES
    In a 12-month, multicenter, randomized, open-label clinical trial, 456 women aged 18-40 were studied to assess the safety and efficacy of levonorgestrel and ethinyl estradiol tablets, completing ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg are available as round, biconvex, unscored tablets, packaged in carton of 3 pouches, each pouch contains ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Cigarette Smoking - Cigarette smoking increases the risk of serious cardiovascular ...
  • FDA-approved Patient Labeling
    Patient Information - Levonorgestrel and Ethinyl Estradiol Tablets, USP - WARNING TO WOMEN WHO SMOKE - Do not use levonorgestrel and ethinyl estradiol tablets if you smoke cigarettes ...
  • Instructions For Use
    Levonorgestrel and Ethinyl Estradiol Tablets, USP - Important information about taking levonorgestrel and ethinyl estradiol tablets - • Take 1 pill every day at the same time. Take the pills in ...
  • PRINCIPAL DISPLAY PANEL - 0.15 mg /0.03 mg
    NDC 0378-7281-53    Rx only - Levonorgestrel and Ethinyl - Estradiol Tablets, USP - 0.15 mg /0.03 mg - Each extended-cycle tablet blister pack each containing 91 tablets: 84 white to off-white ...
  • INGREDIENTS AND APPEARANCE
    Product Information