Bethkis Inhalation Solution

Generic name:tobramycin
Dosage form: respiratory solution
Drug classes:Aminoglycosides, Inhaled anti-infectives

Medically reviewed by Drugs.com. Last updated on May 1, 2021.

Indications and Usage for Bethkis Inhalation Solution

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)].

Bethkis Inhalation Solution Dosage and Administration

Dosage

Bethkis is for oral inhalation only [see Dosage and Administration (2.2)]. The recommended dosage of BETHKIS 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.

If patients miss a dose, they should take it as soon as possible anytime up to 6 hours prior to their next scheduled dose. If less than 6 hours remain before the next dose, wait until their next scheduled dose.

Administration Instructions

BETHKIS is administered by oral inhalation using a hand-held PAR...