美国食品药品管理局(FDA)和诺华公司宣布，TOBI Podhaler(妥布霉素吸入干粉)已获准用于发生肺部铜绿假单胞菌(Pa)感染的囊性纤维化(CF)患者。TOBI Podhaler可通过袖珍干粉吸入器将抗生素妥布霉素送入肺内，因而比关联产品TOBI使用更便利，后者通过雾化器给药。
据诺华公司介绍，Pa感染是CF患者肺功能丧失的首要病因。尚不清楚对于年龄＜6岁的患者、肺功能超出特定范围的患者，以及肺部存在洋葱伯克霍尔德菌，TOBI Podhaler是否也安全、有效。
TOBI Podhaler在1个纳入674例年龄≥6岁、合并肺部Pa感染的CF患者的3期临床项目中得到了评估。其中425例患者接受了至少1剂TOBI Podhaler。2项试验对比评估了TOBI Podhaler与安慰剂的疗效，第3项试验则对比评估了TOBI Podhaler与安慰剂的安全性。各项研究均采用获准的剂量112 mg、2次/d(每剂包含4粒28 mg胶囊)，每个疗程包含28天治疗期和随后28 天停药期。疗效评估结果显示，TOBI Podhaler可比安慰剂更有效地改善肺功能。
在临床研究中接受TOBI Podhaler治疗的患者的常见不良反应包括咳嗽、咳血、肺紊乱(肺或CF急性加重)、气促、发热、咽痛、发声困难和头痛。
TOBI Podhaler不需要采用冰箱保存，而且与雾化Pa治疗不同的是，不需要动力源用于驱动给药装置。用于TOBI给药的雾化器必须每天用沸水消毒10分钟，而一次性Podhaler装置仅需在每次使用后用干布擦拭干净、并且每周更换即可。
TOBI PODHALER (tobramycin) capsule
[Novartis Pharmaceuticals Corporation]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TOBI Podhaler safely and effectively. See full prescribing information for TOBI Podhaler.
TOBI® PODHALER™ (tobramycin inhalation powder), for oral inhalation use
Initial U.S. Approval: 1975
 
INDICATIONS AND USAGE
TOBI Podhaler is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >80%, or patients colonized with Burkholderia cepacia (1).

DOSAGE AND ADMINISTRATION
DO NOT swallow TOBI Podhaler capsules (2)
For use with the Podhaler device only (2)
For oral inhalation only (2)
The recommended dosage is the inhalation of four 28 mg capsules twice-daily for 28 days (2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: 28 mg in a capsule (3)

CONTRAINDICATIONS
Known hypersensitivity to any aminoglycoside (4)

WARNINGS AND PRECAUTIONS
Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction (5.1, 5.2, 5.3)
Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported in clinical trials (5.1)
Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function (5.3)
Bronchospasm can occur with inhalation of TOBI Podhaler (5.4)
Audiograms, serum concentrations, and renal function should be monitored as appropriate (5.5)
Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus (5.6)
ADVERSE REACTIONS
The most common adverse reactions (≥10 % of TOBI Podhaler and TOBI patients in primary safety population) are cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided (7)

USE IN SPECIFIC POPULATIONS
Aminoglycosides can cause fetal harm when administered to a pregnant woman (8.1)
Nursing mother: discontinue drug or nursing, taking into cons