VISTOGARD- uridine triacetate granule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

uridine triacetate (UNII: 2WP61F175M) (uridine - UNII:WHI7HQ7H85)

Available from:

Wellstat Therapeutics Corporation

INN (International Name):

uridine triacetate

Composition:

uridine triacetate 951 mg in 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VISTOGARD® is indicated for the emergency treatment of adult and pediatric patients: - following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or - who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. Limitations of Use - VISTOGARD is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs. - The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established. None. Risk Summary Limited case reports of uridine triacetate use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. When adminis

Product summary:

VISTOGARD orange-flavored oral granules (95% w/w) are available in single-dose packets containing 10 grams of uridine triacetate. Store at USP controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30 °C (59° to 86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

VISTOGARD- URIDINE TRIACETATE GRANULE
WELLSTAT THERAPEUTICS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VISTOGARD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VISTOGARD.
VISTOGARD (URIDINE TRIACETATE) ORAL GRANULES
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
VISTOGARD is a pyrimidine analog indicated for the emergency treatment
of adult and pediatric patients:
following a fluorouracil or capecitabine overdose regardless of the
presence of symptoms, or
who exhibit early-onset, severe or life-threatening toxicity affecting
the cardiac or central nervous system, and/or early-
onset, unusually severe adverse reactions (e.g., gastrointestinal
toxicity and/or neutropenia) within 96 hours following
the end of fluorouracil or capecitabine administration. (1)
Limitations of use:
VISTOGARD is not recommended for the non-emergent treatment of adverse
reactions associated with fluorouracil or
capecitabine because it may diminish the efficacy of these drugs. (1)
The safety and efficacy of VISTOGARD initiated more than 96 hours
following the end of fluorouracil or capecitabine
administration have not been established. (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage
Adults: 10 grams (1 packet) orally every 6 hours for 20 doses, without
regard to meals. (2.1)
Pediatric: 6.2 grams/m of body surface area (not to exceed 10 grams
per dose) orally every 6 hours for 20 doses,
without regard to meals. See the full prescribing information for body
surface area-based dosing. (2.1)
Preparation and Administration
Pediatric: Measure the dose using either a scale accurate to at least
0.1 gram, or a graduated teaspoon accurate to ¼
teaspoon. (2.1)
Mix each VISTOGARD dose with 3 to 4 ounces of soft foods such as
applesauce, pudding or yogurt and ingest within
30 minutes of mixing. Do not chew the VISTOGARD granules. Drink at
least 4 ounces of water. (2.2)
If a patient vomits within 2 hours of taking a dose of VISTOGARD,
initiate another c