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The active component of VENTOLIN Inhalation Solution is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). It has the chemical name a1-[(tert-butylamino)methyl] -4-hydroxy-m-xylene-a, a'-diol sulfate (2:1)(salt) and the following chemical structure:
Albuterol sulfate has a molecular weight of 576.7, and the empirical formula is (C13H21NO3)2·H2SO4.
Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is salbutamol.
VENTOLIN Inhalation Solution, 0.5% is in concentrated form. Dilute the appropriate volume of the solution (see DOSAGE AND ADMINISTRATION) with sterile normal saline solution to a total volume of 3 mL and administer by nebulization.
Each milliliter of VENTOLIN Inhalation Solution contains 5 mg of albuterol (as 6 mg of albuterol sulfate) in an aqueous solution containing benzalkonium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. VENTOLIN Inhalation Solution contains no sulfiting agents. It is supplied in a 20-mL amber glass bottle.
VENTOLIN Inhalation Solution is a clear, colorless to light yellow solution.
VENTOLIN 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 bronchospasm.
To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used.
Children 2 to 12 Years of Age: For children 2 to 12 years of age, initial dosing should be based upon body weight (0.1 to 0.15 mg/kg per dose), with subsequent dosing titrated to achieve the desired clinical response. Dosing should not exceed 2.5 mg three to four times daily by nebulization. The following table outlines approximate dosing according to body weight.
| Approximate Weight | Approximate Weight | Dose | Volume of |
| (kg) | (lb) | (mg) | Inhalation Solution |
| 10-15 | 22-33 | 1.25 | 0.25 mL |
| >15 | >33 | 2.5 | 0.5 mL |
The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total volume of 3 mL prior to administration via nebulization.
Adults and Children Over 12 Years of Age: The usual dosage for adults and children over 12 years of age is 2.5 mg of albuterol administered three to four times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% inhalation solution with 2.5 mL of sterile normal saline solution. The flow rate is regulated to suit the particular nebulizer so that VENTOLIN Inhalation Solution will be delivered over approximately 5 to 15 minutes.
The use of VENTOLIN Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Drug compatibility (physical and chemical), efficacy, and safety of VENTOLIN Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
VENTOLIN Inhalation Solution, 0.5% is supplied in amber glass bottles of 20 mL (NDC 0173-0385-58) with accompanying calibrated dropper in boxes of one.
Store between 2° and 25°C (36° and 77°F).
Glaxo Wellcome Inc, Research Triangle Park, NC 27709, September 1998 RL-634
The results of clinical trials with VENTOLIN Inhalation Solution in 135 patients showed the following side effects that were considered probably or possibly drug related:
| Percent Incidence of Adverse Reactions | |
| Percent Incidence | |
| Reaction | n = 135 |
| Central nervous system | |
| Tremors | 20% |
| Dizziness | 7% |
| Nervousness | 4% |
| Headache | 3% |
| Sleeplessness | 1% |
| Gastrointestinal | |
| Nausea | 4% |
| Dyspepsia | 1% |
| Ear, nose, and throat | |
| Nasal congestion | 1% |
| Pharyngitis |
|
