Bethkis
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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))
History
There is currently no drug history available for this drug.
Other Information
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. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin 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)]-2-deoxy-L‑streptamine.
The structural formula for tobramycin is:
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.
Sources
Bethkis Manufacturers
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Cornerstone Therapeutics Inc.
![Bethkis (Tobramycin) Solution [Cornerstone Therapeutics Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bethkis | Chiesi Usa, Inc.
2.1 Dosing InformationThe 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.
2.2 AdministrationBETHKIS 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 COUNSELING INFORMATION (17) and the PATIENT’S INSTRUCTIONS FOR USE.
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