Label: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

  • NDC Code(s): 69097-840-34, 69097-840-53, 69097-840-64, 69097-840-87
  • Packager: Cipla USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 11, 2024

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  • DESCRIPTION
    The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a ...
  • CLINICAL PHARMACOLOGY
    Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a combination of the β2-adrenergic bronchodilator, albuterol sulfate, and the anticholinergic bronchodilator, ipratropium ...
  • INDICATIONS AND USAGE
    Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
  • CONTRAINDICATIONS
    Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.
  • WARNINGS
    Paradoxical Bronchospasm - In the clinical study of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm ...
  • PRECAUTIONS
    General - 1. Effects Seen with Sympathomimetic Drugs - As with all products containing sympathomimetic amines, Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be used with ...
  • ADVERSE REACTIONS
    Adverse reaction information concerning Ipratropium Bromide and Albuterol Sulfate Inhalation Solution was derived from the 12-week controlled clinical trial. ADVERSE EVENTS OCCURRING IN ≥ 1 ...
  • OVERDOSAGE
    The effects of overdosage with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not ...
  • DOSAGE AND ADMINISTRATION
    The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per ...
  • HOW SUPPLIED
    Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store in pouch until ...
  • PATIENT INSTRUCTIONS FOR USE
    Ipratropium Bromide and Albuterol Sulfate - Inhalation Solution - 0.5 mg / 3 mg per 3 mL - Patient's Instructions for Use - Read this patient information completely every time your prescription ...
  • PATIENT INFORMATION
    Ipratropium Bromide and Albuterol Sulfate Inhalation Solution - 0.5 mg / 3 mg per 3 mL - Prescription Only. Read the patient information that comes with Ipratropium Bromide 0.5 mg and ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 69097-840-53 - Ipratropium Bromide and Albuterol Sulfate - Inhalation Solution - 0.5 mg / 3 mg per 3 mL - FOR ORAL INHALATION ONLY - STORAGE CONDITIONS: PROTECT FROM LIGHT. Unit-dose vials ...
  • INGREDIENTS AND APPEARANCE
    Product Information