Aminoglycosides
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Bethkis Inhalation Solution Dosage

Drug Detail:Bethkis (inhalation) (Tobramycin (inhalation) [ toe-bra-my-sin ])

Generic Name: TOBRAMYCIN 300mg in 4mL

Dosage Form: respiratory solution

Drug Class: Aminoglycosides Inhaled anti-infectives

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

2.1 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.

2.2 Administration Instructions

BETHKIS is administered by oral 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. BETHKIS should not be diluted or mixed with dornase alfa or other medications in the nebulizer. BETHKIS is not for subcutaneous, intravenous, or intrathecal administration.

Further patient instructions on how to administer BETHKIS are provided in the Patient’s Instructions for Use [see Patient Counseling Information (17)].

BETHKIS should not be used 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.

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