Label: LOJAIMIESS- levonorgestrel and ethinyl estradiol and ethinyl estradiol tablets kit

  • NDC Code(s): 70700-207-87, 70700-207-93
  • Packager: Xiromed LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 16, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LOJAIMIESS safely and effectively. See full prescribing information for LOJAIMIESS. LOJAIMIESS® (levonorgestrel and ethinyl ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and ...

    WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

    Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 LoJaimiess, 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
    LoJaimiess is indicated for use by females of reproductive potential to prevent pregnancy.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 How to Start and Take LoJaimiess - Begin LoJaimiess on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first white to off-white tablet that ...
  • 3 DOSAGE FORMS AND STRENGTHS
    LoJaimiess (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is available in Extended-Cycle Tablet Blister Pack, each containing a 13-week supply of ...
  • 4 CONTRAINDICATIONS
    LoJaimiess 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 females who are ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Thromboembolic Disorders and Other Vascular Conditions - Stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if an arterial or deep venous ...
  • 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 and ethinyl estradiol tablets should be discontinued during ...
  • 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
    LoJaimiess (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is an extended-cycle oral contraceptive regimen of 84 white to off-white tablets each containing ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - COCs prevent pregnancy primarily by suppressing ovulation. 12.2 Pharmacodynamics - No pharmacodynamic studies were conducted with LoJaimiess. 12.3 ...
  • 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 open-label clinical trial, 2,185 women aged 18-41 were studied to assess the safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    LoJaimiess (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is available in an Extended-Cycle Tablet Blister Pack that contains 84 round, white to off-white ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information: Cigarette Smoking - Cigarette ...
  • PATIENT INFORMATION LoJaimiess®
    WARNING TO WOMEN WHO SMOKE - Do not use LoJaimiess if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 70700-207-93 - RX Only - LoJaimiess® Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg and 0.01 mg
  • INGREDIENTS AND APPEARANCE
    Product Information