"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.
(tobramycin) Inhalation Powder
TOBI Podhaler consists of a dry powder formulation of tobramycin for oral inhalation only with the Podhaler device. The inhalation powder is filled into clear, colorless hypromellose capsules.
Each clear, colorless hypromellose capsule contains a spray dried powder of 28 mg of tobramycin active ingredient with 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment).
The active component of TOBI Podhaler is tobramycin. Tobramycin is an aminoglycoside antibiotic. Its chemical name is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2deoxy-L-streptamine; its structural formula is:
Tobramycin has a molecular weight of 467.52, and its empirical formula is C18H37N5O9. Tobramycin is a white to almost white powder; visually free from any foreign contaminants. Tobramycin is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in chloroform and ether.
The Podhaler device is a plastic device used to inhale the dry powder contained in the TOBI Podhaler capsule. Under standardized in vitro testing at a fixed flow rate of 60 L/min and volume of 2 L for 2 seconds, the Podhaler device has a target delivered dose of 102 mg of tobramycin from the mouthpiece (4 capsules per dose). Peak inspiratory flow rate and inhaled volumes were explored in 96 cystic fibrosis patients aged 6 years and older. Older patients with significant disease progression and associated decreases in forced expiratory volume (FEV1) and younger patients with inhaled volumes < 1 L were able to generate inspiratory flow rates and volumes required to receive their medication when following the instructions for use. However, no pediatric patients aged 6 to 10 years with FEV1 less than 40% predicted were evaluated.
Last reviewed on RxList: 10/14/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional TOBI Podhaler Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.