Label: FORMOTEROL FUMARATE solution

  • NDC Code(s): 70748-261-30, 70748-261-60
  • Packager: Lupin Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 13, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Maintenance Treatment of COPD - Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of ...
  • 2 DOSAGE AND ADMINISTRATION
    The recommended dose of formoterol fumarate inhalation solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Formoterol fumarate inhalation solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each vial contains formoterol fumarate dihydrate, USP ...
  • 4 CONTRAINDICATIONS
    Use of a LABA, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS (5.1)]. Formoterol ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death - The safety and efficacy of formoterol fumarate inhalation solution in patients with asthma have not been established ...
  • 6 ADVERSE REACTIONS
    Long-acting beta2-adrenergic agonists, such as formoterol fumarate inhalation solution, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events ...
  • 7 DRUG INTERACTIONS
    7.1 Adrenergic Drugs - If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol may be potentiated [see ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental ...
  • 10 OVERDOSAGE
    The expected signs and symptoms with overdosage of formoterol fumarate inhalation solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs ...
  • 11 DESCRIPTION
    Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.1 mL single-use low-density polyethylene vial and overwrapped in a foil ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Formoterol fumarate is a long-acting, beta2-adrenergic receptor agonist (beta2-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. In ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - The carcinogenic potential of formoterol fumarate has been evaluated in 2-year drinking water and dietary studies in both rats and ...
  • 14 CLINICAL STUDIES
    14.1 Adult COPD Trial - Formoterol fumarate inhalation solution was evaluated in a 12-week, double-blind, placebo- and active-controlled, randomized, parallel-group, multicenter trial conducted ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Formoterol fumarate inhalation solution is supplied as a 2 mL sterile solution for nebulization in 2.1 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Serious Asthma-Related Events - Inform patients that long-acting beta agonist, such as ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION -  Formoterol Fumarate Inhalation Solution - (for moe' ter ol fue' ma rate ) What is formoterol fumarate inhalation solution? • Formoterol fumarate inhalation ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Formoterol Fumarate Inhalation Solution - 20 mcg/2 mL Vial - Rx Only - Sterile Unit Dose Vials - For Oral Inhalation Only. Each 2 mL Vial Contains:  ACTIVE: Formoterol fumarate, USP - INACTIVES ...
  • INGREDIENTS AND APPEARANCE
    Product Information