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BETHKIS 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 six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.(See Clinical Studies)
DOSAGE AND ADMINISTRATION
The recommended dosage for patients six years of age and older is to administer one single- use ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. The doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart.
The 300 mg/4 mL dose of BETHKIS is the same for patients regardless of age or weight. BETHKIS has not been studied in patients less than six years old.
BETHKIS is administered by oral inhalation. Do not use by any other route.
BETHKIS is administered by inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios Air compressor over an approximately 15 minute period and until sputtering from the output of the nebulizer has occurred for at least one minute.
Further patient instructions on how to administer BETHKIS are provided in the PATIENT INFORMATION section.
Dosage Forms And Strengths
4 mL single-use ampules containing 300 mg of tobramycin.
Storage And Handling
BETHKIS 300 mg/4 mL is a clear, colorless to pale yellow solution and is available as follows:
4 mL single-use ampule (carton of 14 foil pouches each containing four ampules)
BETHKIS should be stored under refrigeration at 36-46 °F/2-8 °C. Upon removal from the refrigerator, or if refrigeration is unavailable, BETHKIS pouches (opened or unopened) may be stored at room temperature (up to 77 °F/25 °C) for up to 28 days. BETHKIS should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (36-46 °F/2-8 °C) or beyond 28 days when stored at room temperature (77 °F/25 °C).
BETHKIS ampules should not be exposed to intense light. BETHKIS is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.
4. CLSI Performance Standards for Antimicrobial Susceptibility Testing: 22ND Informational supplement CLSI document M100-S22. CLSI 2012.
6. PARI Vios Aerosol Delivery System with LC Plus Nebulizer: Instructions for Use. PARI Respiratory Equipment, Inc. 2010; 310D0028 Rev A 6-10.
Manufactured for Cornerstone Therapeutics Inc. by Catalent Pharma Solutions, LLC, Woodstock, Illinois 60098. Issued: 10/2012
Last reviewed on RxList: 10/26/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Bethkis Information
Report Problems to the Food and Drug Administration
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