A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tobi Indications, Dosage, Storage, Stability - Tobramycin
Tobi Indications, Dosage, Storage, Stability - Tobramycin
INDICATIONS
AND USES
TOBI 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 FEV 1 <25% or >75% predicted, or patients
colonized with Burkholderia cepacia (see CLINICAL STUDIES).
DOSAGE AND ADMINISTRATION
The recommended dosage for both adults and pediatric patients 6 years of age
and older is one single-use ampule (300 mg) administered BID for 28 days. Dosage
is not adjusted by weight. All patients should be administered 300 mg BID. The
doses should be taken as close to 12 hours apart as possible; they should not
be taken less than six hours apart.
TOBI is inhaled while the patient is sitting or standing upright and breathing
normally through the mouthpiece of the nebulizer. Nose clips may help the patient
breathe through the mouth.
TOBI is administered BID in alternating periods of 28 days. After 28 days of
therapy, patients should stop TOBI therapy for the next 28 days, and then resume
therapy for the next 28 day on/28 day off cycle.
TOBI is supplied as a single-use ampule and is administered by inhalation,
using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide
compressor. TOBI is not for subcutaneous, intravenous or intrathecal administration.
Usage
TOBI is administered by inhalation over an approximately 15 minute period,
using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide
compressor. TOBI should not be diluted or mixed with dornase alfa (PULMOZYME®,
Genentech) in the nebulizer.
During clinical studies, patients on multiple therapies were instructed to
take them first, followed by TOBI.
HOW SUPPLIED
TOBI is supplied in single-use, low-density polyethylene plastic 5 mL ampules.
TOBI is packaged in boxes of 56 ampules (14 flexible, laminated foil over-pouches,
each containing 4 ampules).
NDC 63430-065-01
Storage
TOBI should be stored under refrigeration at 2-8°C/36-46°F. Upon removal from
the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or
unopened) may be stored at room temperature (up to 25°C/77°F) for up to 28 days.
TOBI should not be used beyond the expiration date stamped on the ampule when
stored under refrigeration (2-8°C/36-46°F) or beyond 28 days when stored at
room temperature (25°C/77°F).
TOBI 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.
REFERENCES
- Neu HC. Tobramycin: an overview. [Review]. J Infect Dis 1976; Suppl 134:S3-19.
- Weber A, Smith A, Williams-Warren J et al. Nebulizer delivery of tobramycin
to the lower respiratory tract. Pediatr Pulmonol 1994; 17 (5):331-9.
- Bryan LE. Aminoglycoside resistance. Bryan LE, Ed. Antimicrobial drug resistance.
Orlando, FL: Academic Press, 1984: 241-77.
Rx Only
Manufactured for
PathoGenesis Corporation
201 Elliott Avenue West, Seattle, WA 98119
by Automatic Liquid Packaging, Inc.,
Woodstock, IL 60098
Packaged by Packaging Coordinators Inc.,
Philadelphia, PA 19114-1123
©PathoGenesis Corporation, 1999
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