VORICONAZOLE- voriconazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals (USA) Inc.

INN (International Name):

VORICONAZOLE

Composition:

VORICONAZOLE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. Voricon

Product summary:

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: NDC 68382-735-06 in bottles of 30 tablets NDC 68382-735-16 in bottles of 90 tablets NDC 68382-735-01 in bottles of 100 tablets NDC 68382-735-05 in bottles of 500 tablets NDC 68382-735-10 in bottles of 1000 tablets NDC 68382-735-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Voriconazole Tablets, 200 mg are white to off-white, oval, biconvex, film-coated tablet debossed with "736" on one side and plain on the other side and are supplied as follows: NDC 68382-736-06 in bottles of 30 tablets NDC 68382-736-16 in bottles of 90 tablets NDC 68382-736-01 in bottles of 100 tablets NDC 68382-736-05 in bottles of 500 tablets NDC 68382-736-10 in bottles of 1000 tablets NDC 68382-736-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VORICONAZOLE- VORICONAZOLE TABLET
Zydus Pharmaceuticals (USA) Inc.
----------
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. Voricon

Summary of Product characteristics

VORICONAZOLE- VORICONAZOLE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
----------
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:
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 AND ADMINISTRATION
DOSAGE IN ADULTS (2.3)
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
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 mild to moderate hepatic impairment (Child-
Pugh Class A and B) (2.5)
Renal Impairment: Avoid intravenous administration in adult patients
with moderate to severe renal impairment
(creatinine clearance <50 mL/min) (2.6)
DOSAGE IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER (2.4)
For pediatric patients 2 to less than 12 years of age and 12 to 14
years of age weighing less than 50 kg see