REMS
Pseudomonas aeruginosa
.Spectrum:
Absorption: Well absorbed after IM administration. IV administration results in complete bioavailability. Low absorption follows administration by inhalation.
Distribution: Widely distributed throughout extracellular fluid; crosses the placenta; small amounts enter breast milk. Poor penetration into CSF.
Half-Life: Neonates: 211 hr; Infants: 35 hr; Children: 13 hr; Adolescents: 0.52.5 hr; Adults: 24 hr (↑ in renal impairment to 570 hr).
ROUTE | ONSET | PEAK | DURATION |
IM | rapid | 3090 min | 624 hr |
IV | rapid | end of infusion‡ | 624 hr |
‡All parenterally administered aminoglycosides.
‡Postdistribution peak occurs 30 min after the end of a 30-min infusion and 15 min after the end of a 1-hr infusion.
Contraindicated in:
Use Cautiously in:
EENT: ototoxicity (vestibular and cochlear),
Inhalation only
tinnitus, voice alterationGI: CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
GU: nephrotoxicity
F and E: hypomagnesemia
MS: muscle paralysis (high parenteral doses)
Resp:
Inhalation only
bronchospasm, wheezingMisc: hypersensitivity reactions
Drug-drug:
Inhaln
(Adults and Children ≥6 yr): Nebulizer solution300 mg twice daily for 28 days, then off for 28 days, then repeat cycle; Powder for inhalationInhale contents of four 28mg capsules twice daily for 28 days, then off for 28 days, then repeat cycle.Renal Impairment
Lab Test Considerations:
Toxicity and Overdose:
IV Administration:
NDC Code