VORICONAZOLE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)

제공처:

Major Pharmaceuticals

INN (국제 이름):

VORICONAZOLE

구성:

VORICONAZOLE 50 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive apergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus . There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1, 14.5) and Microbiology (12.4)].   Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and Microbiology (12.4)]. Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3, 14.5) and Microbiology (12.4)]. Voricona

제품 요약:

Voriconazole Tablets, 50 mg are white to off-white, round, biconvex, film-coated tablet debossed with "735" on one side and plain on the other side and are supplied as follows: Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6596-04 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP).

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

VORICONAZOLE- voriconazole tablet
Major Pharmaceuticals
----------
FDA-Approved Patient Labeling
Voriconazole (vor i KON a zole) Tablets
Read the Patient Information that comes with Voriconazole Tablets
before you start taking it and each time
you get a refill. There may be new information. This information does
not take the place of talking with your
healthcare provider about your condition or treatment.
What are Voriconazole Tablets?
Voriconazole Tablets are a prescription medicine used to treat certain
serious fungal infections in your blood
and body. These infections are called "aspergillosis," "esophageal
candidiasis," "Scedosporium," "Fusarium,"
and "candidemia".
It is not known if voriconazole tablets are safe and effective in
children younger than 2 years old.
Do not take Voriconazole Tablets if you:
•
are allergic to voriconazole or any of the ingredients in Voriconazole
Tablets . See the end of this
leaflet for a complete list of ingredients in Voriconazole Tablets.
•
are taking any of the following medicines:
•
cisapride
•
pimozide
•
quinidine
•
sirolimus
•
rifampin
•
carbamazepine
•
long-acting barbiturates like phenobarbital
•
efavirenz
•
ritonavir
•
rifabutin
•
ergotamine, dihydroergotamine (ergot alkaloids)
•
St. John's Wort (herbal supplement)
Ask your healthcare provider or pharmacist if you are not sure if you
are taking any of the medicines listed
above.
Do not start taking a new medicine without talking to your healthcare
provider or pharmacist.
Before you take voriconazole , tell your healthcare provider about all
of your medical conditions, including if
you:
•
have or ever had heart disease, or an abnormal heart rate or rhythm.
Your healthcare provider may
order a test to check your heart (EKG) before starting Voriconazole
Tablets.
•
have liver or kidney problems. Your healthcare provider may do blood
tests to make sure you can take
Voriconazole Tablets.
•
have trouble digesting dairy products, lactose (milk sugar), or
regular table sugar. Voriconazole Table

제품 특성 요약

VORICONAZOLE- VORICONAZOLE TABLET
MAJOR PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VORICONAZOLE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VORICONAZOLE TABLETS.
VORICONAZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage (1) 1/2019
Dosage and Administration (2) 1/2019
Contraindications (4) 1/2019
Warnings and Precautions (5) 1/2019
INDICATIONS AND USAGE
Voriconazole is an azole antifungal indicated for the treatment of
adults and pediatric patients 2 years of
age and older with:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
INFECTION
LOADING DOSE
MAINTENANCE DOSE
INTRAVENOUS
INFUSION
INTRAVENOUS
INFUSION
ORAL
INVASIVE ASPERGILLOSIS
6 mg/kg every 12
hours for the first 24
hours
4 mg/kg every 12
hours
200 mg every 12
hours
CANDIDEMIA IN NONNEUTROPENICS
AND OTHER DEEP TISSUE _CANDIDA_
INFECTIONS
3 to 4 mg/kg every 12
hours
200 mg every 12
hours
SCEDOSPORIOSIS AND FUSARIOSIS
4 mg/kg every 12
hours
200 mg every 12
hours
ESOPHAGEAL CANDIDIASIS
Not Evaluated
Not evaluated
200 mg every 12
hours
•
•
•
•
•
INFECTION
LOADING DOSE
MAINTENANCE DOSE
INTRAVENOUS
INFUSION
INTRAVENOUS
INFUSION
ORAL
INVASIVE ASPERGILLOSIS
9 mg/kg
every12 hours
for the first
24 hours
8 mg/kg every
12 hours after
the first
24 hours
9 mg/kg every
12 hours
(maximum dose
of 350 mg every
12 hours)
CANDIDEMIA IN
NONNEUTROPENICS AND OTHER
DEEP TISSUE _CANDIDA_
INFECTIONS
SCEDOSPORIOSIS AND
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue _Candida_
infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by _Scedosporium apiospermum _and
_Fusarium _species including
_Fusarium solani_ , in patients intolerant of, or refractory to, other
therapy (1.4)
DOSAGE IN ADULTS (2.3)
Adult patients weighing less than 40 kg: oral maintenance dose 100 or
150 mg every 12 hours
Hepatic Impairment: Use half the maintenance dose in adult patients
with m