BETHKIS- tobramycin solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Chiesi USA, Inc.

INN (Alþjóðlegt nafn):

TOBRAMYCIN

Samsetning:

TOBRAMYCIN 300 mg in 4 mL

Stjórnsýsluleið:

RESPIRATORY (INHALATION)

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Risk Summary Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [Warnings and Precautions ( 5.6 )] . Although there are no available data on use of BETHKIS in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology ( 12.3 )] . There are risks

Vörulýsing:

BETHKIS 300 mg/4 mL is supplied as a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution and is available as follows: BETHKIS should be stored under refrigeration at 2°C ‑ 8°C (36°F ‑ 46°F). Upon removal from the refrigerator, or if refrigeration is unavailable, BETHKIS pouches (opened or unopened) may be stored at room temperature [up to 25°C (77°F)] for up to 28 days. BETHKIS should not be used beyond the expiration date stamped on the ampule when stored under refrigeration 2°C ‑ 8°C (36°F ‑ 46°F) or beyond 28 days when stored at room temperature [up to 25°C (77°F)]. BETHKIS ampules should not be exposed to intense light. BETHKIS is light sensitive; unopened ampules should be returned to the foil pouch.  The solution in the ampule is colorless to pale 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.

Leyfisstaða:

New Drug Application

Vara einkenni

BETHKIS- TOBRAMYCIN SOLUTION
CHIESI USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETHKIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETHKIS.
BETHKIS® (TOBRAMYCIN INHALATION SOLUTION), FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1980
RECENT MAJOR CHANGES
Warnings and Precautions, Ototoxicity (5.1) 2/2023
INDICATIONS AND USAGE
BETHKIS is an inhaled aminoglycoside antibacterial indicated for the
management of cystic fibrosis
patients with _Pseudomonas aeruginosa_. (1) Safety and efficacy have
not been demonstrated in patients
under the age of six years, patients with a forced expiratory volume
in one second (FEV ) less than 40% or
greater than 80% predicted, or patients colonized with _Burkholderia
cepacia_. (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only (2.1)
Administer the entire contents of one ampule twice daily by oral
inhalation in repeated cycles of 28
days on drug, followed by 28 days off drug. (2.1)
DOSAGE FORMS AND STRENGTHS
Inhalation solution: 300 mg tobramycin per 4-mL solution in a
single-use ampoule. (16)
CONTRAINDICATIONS
BETHKIS is contraindicated in patients with a known hypersensitivity
to any aminoglycoside. (4)
WARNINGS AND PRECAUTIONS
Caution should be exercised when prescribing BETHKIS to patients with
known or suspected auditory,
vestibular, renal, or neuromuscular dysfunction. (5.1, 5.2, 5.3 and
5.5)
Aminoglycoside may aggravate muscle weakness because of a potential
curare-like effect on
neuromuscular function. (5.3)
Bronchospasm can occur with inhalation of BETHKIS. (5.4)
Audiograms, serum concentration, and renal function should be
monitored as appropriate. (5.2 and
5.5)
Fetal harm can occur when aminoglycosides are administered to a
pregnant woman. Apprise women of
the potential hazard to the fetus. (5.6)
ADVERSE REACTIONS
Common adverse reactions (more than 5%) occurring more frequently in
BETHKIS patients are forced
expiratory volume decreased, rales, red blood cell sedimentati