TOBRAMYCIN solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Amneal Pharmaceuticals LLC

ІПН (Міжнародна Ім'я):

TOBRAMYCIN

Склад:

TOBRAMYCIN 300 mg in 5 mL

Адміністрація маршрут:

RESPIRATORY (INHALATION)

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas 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 (14)]. Tobramycin inhalation solution 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 [see Warnings and Precautions (5.5)]. Although there are no available data on tobramycin use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inha

Огляд продуктів:

Tobramycin inhalation solution USP is supplied as a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution packaged in a 5 mL single-dose ampule (300 mg tobramycin) for nebulization. It is available as follows: 5 mL single-dose ampule packaged in cartons containing 56 ampules (14 pouches, each containing 4 ampules)                       NDC 65162-914-46 Tobramycin inhalation solution should be stored under refrigeration at 2º to 8ºC or 36º to 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 (2º to 8ºC or 36º to 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.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

TOBRAMYCIN- TOBRAMYCIN SOLUTION
AMNEAL PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOBRAMYCIN INHALATION
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TOBRAMYCIN
INHALATION SOLUTION.
TOBRAMYCIN INHALATION SOLUTION, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1975
RECENT MAJOR CHANGES
Warnings and Precautions, Ototoxicity (5.2) 2/2023
INDICATIONS AND USAGE
Tobramycin is an aminoglycoside antibacterial indicated for the
management of cystic fibrosis in adults
and pediatric patients 6 years of age and older with _Pseudomonas
aeruginosa_. (1)
Safety and efficacy have not been demonstrated in patients under the
age of 6 years, patients with
forced expiratory volume in 1 second (FEV ) < 25% or > 75% predicted,
or patients colonized with
_Burkholderia cepacia. _(1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
The recommended dosage for adults and pediatric patients 6 years of
age and older is one single-dose
ampule (300 mg) twice daily by oral inhalation in alternating periods
of 28 days on drug, followed by 28
days off drug. (2.1)
Dosage is not adjusted by weight. (2.1)
Take doses as close to 12 hours apart as possible; but not less than 6
hours apart. (2.1)
Administer each 300 mg dose by inhalation using a hand-held PARI LC
PLUS Reusable Nebulizer with a
DeVilbiss Pulmo-Aide compressor. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution: 300 mg per 5 mL solution in a single-dose ampule.
(3)
CONTRAINDICATIONS
Known hypersensitivity to any aminoglycoside. (4)
WARNINGS AND PRECAUTIONS
Bronchospasm: Can occur with inhalation of tobramycin. Treat as
medically appropriate, if it occurs.
(5.1)
Ototoxicity: Tinnitus and hearing loss have been reported in patients
receiving tobramycin. If noted,
manage as medically appropriate, including potentially discontinuing
tobramycin. (5.2)
Nephrotoxicity: Has been associated with aminoglycosides as a class.
If nephrotoxicity develops,
manage the patient a