TOBRAMYCIN solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK)

Disponible desde:

Sandoz Inc

Designación común internacional (DCI):

TOBRAMYCIN

Composición:

TOBRAMYCIN 300 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with P. aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia (see CLINICAL STUDIES). Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Resumen del producto:

Tobramycin Inhalation Solution, USP 300 mg is available as follows: NDC 0781-7171-56 5 mL single-dose ampule (carton of 56) Tobramycin inhalation solution should be stored under refrigeration at 2ºC-8ºC/36ºF-46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, tobramycin inhalation solution pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. Tobramycin inhalation solution should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2ºC-8ºC/36ºF-46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF). Tobramycin inhalation solution ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.

Estado de Autorización:

New Drug Application Authorized Generic

Ficha técnica

TOBRAMYCIN- TOBRAMYCIN SOLUTION
SANDOZ INC
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TOBRAMYCIN INHALATION SOLUTION, USP
NEBULIZER SOLUTION – FOR INHALATION USE ONLY
DESCRIPTION
Tobramycin Inhalation Solution, USP is a solution for inhalation. It
is a sterile, clear, slightly yellow,
non-pyrogenic, aqueous solution with the pH and salinity adjusted
specifically for administration by a
compressed air driven reusable nebulizer. The chemical formula for
tobramycin is C
H N O 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 5 mL ampule contains 300 mg tobramycin and 11.25 mg
sodium chloride in sterile water
for injection. Sulfuric acid and sodium hydroxide are added to adjust
the pH to 6.0. Nitrogen is used for
sparging. All ingredients meet USP requirements. The formulation
contains no preservatives.
CLINICAL PHARMACOLOGY
Tobramycin inhalation solution is specifically formulated for
administration by inhalation. When
inhaled, tobramycin is concentrated in the airways.
PHARMACOKINETICS
Tobramycin inhalation solution contains tobramycin, a cationic polar
molecule that does not readily
cross epithelial membranes.
The bioavailability of tobramycin inhalation solution may vary because
of individual differences in nebulizer performance and airway
pathology.
Following administration of
tobramycin inhalation solution, tobramycin remains concentrated
primarily in the airways.
_Sputum Concentrations: _Ten minutes after inhalation of the first
300-mg dose of tobramycin inhalation
solution, the average concentration of tobramycin was 1237 mcg/g
(ranging from 35 to 7417 mcg/g) in
sputum. Tobramycin does not accumulate in sputum; after 20 weeks of
therapy with the tobramycin
inhalation solution regimen, the average concentration of tobramycin
at ten minutes after inhalation was
1154 mcg/g (ranging from 39 to 8085 mcg/g) in sputum. High variability
of tobramycin co