Label: ARFORMOTEROL TARTRATE solution

  • NDC Code(s): 62756-277-02, 62756-277-03
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 27, 2022

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ARFORMOTEROL TARTRATE INHALATION SOLUTION safely and effectively. See full prescribing information for ARFORMOTEROL TARTRATE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Maintenance Treatment of COPD - Arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in ...
  • 2 DOSAGE AND ADMINISTRATION
    The recommended dose of arformoterol tartrate inhalation solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose of greater than 30 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Arformoterol tartrate inhalation solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each 2 mL vial contains 15 mcg of arformoterol equivalent ...
  • 4 CONTRAINDICATIONS
    Arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. Use of a ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Asthma-Related Events - Hospitalizations, Intubations Deaths - The safety and efficacy of arformoterol tartrate inhalation solution in patients with asthma have not been established ...
  • 6 ADVERSE REACTIONS
    Long-acting beta2-adrenergic agonists, such as arformoterol tartrate, as monotherapy (without inhaled corticosteroids) for asthma increase the risk of asthma-related events.  Arformoterol tartrate ...
  • 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 arformoterol may be potentiated [see ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies in pregnant women.  Arformoterol tartrate should only be used during pregnancy if the expected benefit to the ...
  • 9 DRUG ABUSE AND DEPENDENCE
    There were no reported cases of abuse or evidence of drug dependence with the use of arformoterol tartrate inhalation solution in the clinical trials.
  • 10 OVERDOSAGE
    The expected signs and symptoms associated with overdosage of arformoterol tartrate inhalation solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any ...
  • 11 DESCRIPTION
    Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Arformoterol, the (R,R)-enantiomer of formoterol, is a selective  long-acting beta2-adrenergic  receptor agonist (beta2-agonist) that has two-fold greater  potency ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies were conducted in mice using oral administration and rats using inhalation administration to evaluate the ...
  • 14 CLINICAL STUDIES
    14.1 Adult COPD Trials - Arformoterol tartrate inhalation solution was studied in two identical, 12-week, double-blind, placebo-and active-controlled, randomized, multi-center, parallel group ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Arformoterol tartrate inhalation solution is supplied in a single strength (15 mcg of arformoterol, equivalent to 22 mcg of arformoterol tartrate) as 2 mL of a sterile, clear, colorless aqueous ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use) with each new prescription and refill. The complete text of the Patient Information ...
  • Patient Information
    Dispense with Patient Information available at: https://www.sunpharma.com/usa/products - PATIENT INFORMATION -   Arformoterol Tartrate (ar for MOE ter ol  TAR-trate) Inhalation ...
  • INSTRUCTIONS FOR USE
    Instructions for Using Arformoterol Tartrate Inhalation Solution - Arformoterol tartrate inhalation solution is used only in a standard jet nebulizer machine connected to an air compressor. Make ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Pouch Label
    NDC 62756-277-01 - Arformoterol Tartrate Inhalation Solution - 15 mcg*/2 mL - *Potency expressed as arformoterol - For Oral Inhalation Only - After opening the foil pouch, the unused vials should be ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton Label
    NDC 62756-277-02 - Arformoterol Tartrate Inhalation Solution - 15 mcg*/2 mL - *Potency expressed as arformoterol - For Oral Inhalation Only - KEEP REFRIGERATED OR STORE AT ROOM TEMPERATURE FOR UP TO 6 ...
  • INGREDIENTS AND APPEARANCE
    Product Information