Label: ALBUTEROL SULFATE solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 2, 2024

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  • SPL UNCLASSIFIED SECTION
    Albuterol Sulfate Inhalation Solution 0.083% 1 - 1 - (Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate)
  • SPL UNCLASSIFIED SECTION
    PRESCRIBING INFORMATION - FOR INHALATION USE ONLY-NOT FOR INJECTION.
  • DESCRIPTION
    Albuterol sulfate inhalation solution is a relatively selective beta - 2-adrenergic bronchodilator (see - CLINICAL PHARMACOLOGYsection below). Albuterol sulfate, the racemic form of albuterol ...
  • CLINICAL PHARMACOLOGY
    The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate ...
  • INDICATIONS AND USAGE
    Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of ...
  • CONTRAINDICATIONS
    Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.
  • WARNINGS
    As with other inhaled beta-adrenergic agonists, albuterol sulfate inhalation solution can produce paradoxical bronchospasm, which can be life threatening. If it occurs, the preparation should be ...
  • PRECAUTIONS
    General - Albuterol, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and ...
  • ADVERSE REACTIONS
    Clinical Trial Experience - The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects which were considered probably or possibly ...
  • OVERDOSAGE
    Manifestations of overdosage may include seizures, anginal pain, hypertension, hypokalemia, tachycardia with rates up to 200 beats/min, and exaggeration of the pharmacological effects listed in ...
  • DOSAGE AND ADMINISTRATION
    Adults and Children 2 to 12 Years of Age - The usual dosage for adults and for children weighing at least 15 kg is 2.5 mg of albuterol (one vial) administered three to four times daily by ...
  • HOW SUPPLIED
    Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL - 2. Equivalent to 0.5 mL albuterol (as the sulfate) 0.5% (2.5 mg albuterol) diluted to 3 mL. Supplied ...
  • SPL UNCLASSIFIED SECTION
    Rx only. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 - Manufactured by: The Ritedose Corporation - Columbia, SC 29203 - TRC:ALSUIS:R3 - JAN 2013
  • PATIENT'S INSTRUCTIONS FOR USE
    Albuterol Sulfate Inhalation Solution 0.083%3 - Note: This is a unit-dose vial. No dilution is required. Read complete instructions carefully before using. Remove the vial from the foil ...
  • PRINCIPAL DISPLAY PANEL - 25 x 3 mL Vials Carton
    Mylan - ® NDC 0378-8270-52 - Albuterol Sulfate - Inhalation Solution, 0.083%* 2.5 mg / 3 mL* *Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate. FOR ORAL INHALATION ...
  • INGREDIENTS AND APPEARANCE
    Product Information