Commercial Product

Tobramycin solution for inhalation has approval from the Food and Drug Administration (FDA) for maintenance therapy in patients with cystic fibrosis and who are colonized with Pseudomonas aeruginosa. The commercially available formulation is a 300 mg per 5 mL. It is a sterile, preservative-free product that is pH adjusted to 6.0. According to the labeling, this product should be used with a specific nebulizer, the Pari C Plus.

The evidence for maintenance therapy with inhaled tobramycin comes from well-controlled clinical trials that reported beneficial outcomes for this therapy. Recommendations are based on evidence suggesting clinical benefits including improved pulmonary function, reduced requirements for hospitaliz-ation, and less frequently required systemic therapy against Pseudomonas.

The dose of the inhaled tobramycin product is 300 mg by nebulization twice daily. It should be used as cyclic therapy as four weeks on alternating with four weeks off.

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