BETHKIS- tobramycin solution
Chiesi USA, Inc.
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 (14))
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.
4 mL single-use ampules containing 300 mg of tobramycin.
BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer.
Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used to adjust the pH, as needed, to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives.
BETHKIS 300 mg/4 mL is a clear, colorless to pale yellow solution and is available as follows:
NDC 10122-820-56: 4 mL single-use ampule (carton of 14 foil pouches each containing four ampules)
NDC 10122-820-28: 4 mL single-use ampule (carton of 7 foil pouches each containing four ampules)
You should store BETHKIS ampules in a refrigerator (36-46 �F or 2-8 �C). However, when you don't have a refrigerator available (e.g., transporting your BETHKIS), you may store the foil pouches (opened or unopened) at room temperature (up to 77 �F/25 �C) for up to 28 days.
BETHKIS is light sensitive; unopened ampules should be returned to the foil pouch. Avoid exposing BETHKIS ampules to intense light. Unrefrigerated BETHKIS, which is normally colorless to pale yellow, may darken with age; however, the color change does not indicate any change in the quality of the product.
You should not use BETHKIS if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days. You should not use BETHKIS beyond the expiration date stamped on the ampule.
