"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.
TOBI Podhaler is 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% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies].
DOSAGE AND ADMINISTRATION
DO NOT SWALLOW TOBI PODHALER CAPSULES
FOR USE WITH THE PODHALER DEVICE ONLY
FOR ORAL INHALATION ONLY
TOBI Podhaler capsules must not be swallowed as the intended effects in the lungs will not be obtained. The contents of
TOBI Podhaler capsules are only for oral inhalation and should only be used with the Podhaler device.
The recommended dosage of TOBI Podhaler for both adults and pediatric patients 6 years of age and older is the inhalation of the contents of four 28 mg TOBI Podhaler capsules twice-daily for 28 days using the Podhaler device.
Refer to the Instructions For Use (IFU) for full administration information.
Dosage is not adjusted by weight. Each dose of four capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart.
TOBI Podhaler is administered twice-daily in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.
TOBI Podhaler capsules should always be stored in the blister and each capsule should only be removed IMMEDIATELY BEFORE USE.
For patients taking several different inhaled medications and/or performing chest physiotherapy, the order of therapies should follow the physician's recommendation. It is recommended that TOBI Podhaler is taken last.
Dosage Forms And Strengths
28 mg: clear, colorless hypromellose capsule with “NVR AVCI” in blue radial imprint on one part of the capsule and the Novartis logo in blue radial imprint on the other part of the capsule.
TOBI Podhaler contains aluminum blister-packaged 28 mg TOBI Podhaler (tobramycin inhalation powder) clear, colorless hypromellose capsules with “NVR AVCI” in blue radial imprint on one part of the capsule and the Novartis logo in blue radial imprint on the other part of the capsule, and Podhaler devices.
Each Podhaler device consists of the inhaler body, mouthpiece, capsule chamber and blue push button. The Podhaler device is provided in a case that protects the device during shipment, storage and its one week in-use period.
Unit Dose (blister pack), Box of 224 capsules contains: NDC 0078-0630-35
4 weekly packs, each containing: 56 capsules (7 blister cards of 8 capsules) 1 Podhaler device
1 reserve Podhaler device
Unit dose (blister pack), Box of 56 capsules (7-day pack) contains: NDC 0078-0630-20 56 capsules (7 blister cards of 8 capsules) 1 Podhaler device
Unit dose (blister pack), Box of 8 capsules (1-day pack) contains: NDC 0078-0630-19 8 capsules (1 blister card of 8 capsules) 1 Podhaler device
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Protect TOBI Podhaler from moisture.
- TOBI Podhaler capsules should be used with the Podhaler device only. The Podhaler device should not be used with any other capsules.
- Capsules should always be stored in the blister and each capsule should only be removed immediately before use.
- Always use the new Podhaler device provided with each weekly pack.
Keep this and all drugs out of the reach of children.
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936. Revised: Oct 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/14/2015
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.
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