国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK)
Chiesi USA, Inc.
TOBRAMYCIN
TOBRAMYCIN 300 mg in 4 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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
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.
New Drug Application
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 阅读完整的文件