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Albuterol Sulfate

"Jan 3, 2011 -- The Ritedose Corporation has recalled some single-dose vials of Albuterol Sulfate Inhalation Solution because an incorrect label could lead to a possible overdose.

The recall includes 0.083% Albuterol Sulfate Inhalation S"...

Albuterol Sulfate

Albuterol Sulfate
Inhalation Solution 0.042% (1.25 mg*/3 mL) and 0.021% (0.63 mg*/3 mL)
(*Potency expressed as albuterol, equivalent to 1.5 mg and 0.75 mg albuterol sulfate)

DRUG DESCRIPTION

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate (albuterol sulfate inhalation solution) . Albuterol sulfate (albuterol sulfate inhalation solution) is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate (albuterol sulfate inhalation solution) is α1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows:

Albuterol Sulfate Structural Formula Illustration

The molecular weight of albuterol sulfate (albuterol sulfate inhalation solution) is 576.7 and the empirical formula is (C13 H21 NO3)2 •H2 SO4. Albuterol sulfate (albuterol sulfate inhalation solution) is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.75 mg of albuterol sulfate (albuterol sulfate inhalation solution) (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (albuterol sulfate inhalation solution) (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 4.0 (see HOW SUPPLIED).

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).

What are the possible side effects of albuterol inhalation?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • tremor, nervousness;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp...

Read All Potential Side Effects and See Pictures of Albuterol Sulfate »

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

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