CASPOFUNGIN ACETATE injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

CASPOFUNGIN ACETATE (UNII: VUW370O5QE) (CASPOFUNGIN - UNII:F0XDI6ZL63)

Доступна с:

Fresenius Kabi USA, LLC

ИНН (Международная Имя):

CASPOFUNGIN ACETATE

состав:

CASPOFUNGIN ACETATE 5 mg in 1 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Caspofungin acetate for Injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.1,14.5)] . Caspofungin acetate for Injection is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.2, 14.5)] . Limitations of Use: Caspofungin acetate for Injection has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida . Caspofungin acetate for Injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.3, 14.5)]. Limitations of Use: Caspofungin acetate for Injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the

Обзор продуктов:

How Supplied Caspofungin acetate for Injection is a lyophilized white to off-white cake or powder for intravenous infusion, supplied in single-dose vials with a rubber stopper and an aluminum seal as follows: Storage and Handling The lyophilized vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Reconstituted Concentrate Reconstituted Caspofungin acetate for Injection in the vial may be stored at ≤ 25°C (≤ 77°F) for one hour prior to the preparation of the patient infusion solution. Diluted Product The final patient infusion solution in the intravenous bag or bottle can be stored at ≤ 25°C (≤ 77°F) for 24 hours or at 2° to 8°C (36° to 46°F) for 48 hours. The container closure is not made with natural rubber latex.

Статус Авторизация:

New Drug Application

Характеристики продукта

CASPOFUNGIN ACETATE - CASPOFUNGIN ACETATE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CASPOFUNGIN ACETATE
FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CASPOFUNGIN
ACETATE FOR INJECTION.
CASPOFUNGIN ACETATE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Caspofungin acetate for Injection is an echinocandin antifungal
indicated in adults and pediatric patients (3
months of age and older) for:
Empirical therapy for presumed fungal infections in febrile,
neutropenic patients. (1)
Treatment of candidemia and the following Candida infections:
intra-abdominal abscesses, peritonitis
and pleural space infections. (1)
Treatment of esophageal candidiasis. (1)
Treatment of invasive aspergillosis in patients who are refractory to
or intolerant of other therapies. (1)
DOSAGE AND ADMINISTRATION
_Important Administration Instructions for All Patients (2.1):_
Administer by slow intravenous (IV) infusion over approximately 1
hour. Do not administer by
intravenous (IV) bolus administration.
Do not mix or co-infuse Caspofungin acetate for Injection with other
medications. Do not use diluents
containing dextrose (α- D-glucose).
_Dosage in Adults [18 years of age and older] (2.2):_
Administer a single 70 mg loading dose on Day 1, followed by 50 mg
once daily for all indications except
esophageal candidiasis.
For esophageal candidiasis, use 50 mg once daily with no loading dose.
_Dosage in Pediatric Patients [3 months to 17 years of age] (2.3)_:
Dosing should be based on the patient's body surface area.
For all indications, administer a single 70 mg/m2 loading dose on Day
1, followed by 50 mg/m2 once
daily thereafter.
Maximum loading dose and daily maintenance dose should not exceed 70
mg, regardless of the
patient's calculated dose.
_Dosage Adjustments in Patients with Hepatic Impairment (2.4):_
Reduce dosage for adult patients wi