Label: IPRATROPIUM BROMIDE solution

  • 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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  • SPL UNCLASSIFIED SECTION
    Prescribing Information - Rx Only
  • DESCRIPTION
    The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane ...
  • CLINICAL PHARMACOLOGY
    Ipratropium bromide is an anticholinergic (parasympatholytic) agent that, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the ...
  • INDICATIONS AND USAGE
    Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of ...
  • CONTRAINDICATIONS
    Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.
  • WARNINGS
    The use of ipratropium bromide inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action ...
  • PRECAUTIONS
    General - Ipratropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Information for Patients - Patients should ...
  • ADVERSE REACTIONS
    Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign ...
  • OVERDOSAGE
    Acute systemic overdosage by inhalation solution is unlikely since ipratropium bromide is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration ...
  • DOSAGE AND ADMINISTRATION
    The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium ...
  • HOW SUPPLIED
    Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 68071-3769-2 - 25 vials per carton/25 vials per foil ...
  • SPL UNCLASSIFIED SECTION
    Rx Only - Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 - Manufactured by: The Ritedose Corporation - Columbia, SC 29203 - TRC:IPBRIS:R3 - MAY 2013
  • Patient's Instructions for Use
    Ipratropium Bromide - Inhalation Solution, 0.02% Read complete instructions carefully before using. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer ...
  • PRINCIPAL DISPLAY PANEL - 2.5 mL Pouch Carton
    pdp
  • INGREDIENTS AND APPEARANCE
    Product Information