Drug Interaction:
Monitor warfarin Phenytoin possibly CYP450 2CP metabolised drugs, sorvudine , brivudine Potentiated by leucovoricin
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
190. Capecitabine 150/500mg tablets 02-09-08
(Addl.Indication)
For the treatment of patients with metastatic
colorectal cancer
VISTOGARD® (uridine triacetate) oral granules
Initial U.S. Approval: 2015
Locally advanced , metastatic breast cancer
U.S FDA APPROVED DRUGS DURING 2007
110. Capecitatabin tablet 16-07-07
(150mg/500mg)
(for addl.indn)
(i) First line treatment of advanced cancer in
combination with platinum based regimen
(ii) Treatment of patients with locally advanced
or metastatic breast cancer in combination
with docetaxel following failure of cytotoxic
chemotherapy
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1Carbecitabine Anti-cancer 12-10-2000
2. Capicitabine Tablet 17-07-2007
Addl.Indication
i. First line treatment of advanced gastric cancer in combination
with platinum based regimen
ii. Treatment of patients with locally advanced or metastatic breast
cancer in combination with docetaxel following failure of cytotoxic
chemotherapy
3.Capecitabine 150/500mg tablets 02-09-2008
Addl.Indication
For the treatment of patient with metastatic colorectal cancer
Adverse Reaction:
GI upset, hand foot syndrome,
Somatitis, decreased appetite
Cardiac efects,
Haematological changes
Hyperbilirubinemia
Abdominal pain
Dermatitis
Headache Fever, Dizziness,
Taste disturbances
Myalgia
Nail disorder
Contra-Indications:
Hypersensitivity to flurouracil
Severe renal impairment
Dihydropyramidine dehydrogenase deficiency
Pregnancy
Lactation
Special precaution:
Coronary aterey disease
Hepatic, renal impairment
Elderly
Children
Dosages/ Overdosage Etc:
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.
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.
DOSAGE AND ADMINISTRATION
Recommended Dosage
Adults: 10 grams (1 packet) orally every 6 hours for 20 doses, without
regard to meals.
Pediatric: 6.2 grams/m2 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.
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.
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.
If a patient vomits within 2 hours of taking a dose of VISTOGARD,
initiate another complete dose as soon as possible after the vomiting
episode. Administer the next dose at the regularly scheduled time.
If a patient misses a dose at the scheduled time, administer that dose of
VISTOGARD as soon as possible.
Administer the next dose at the regularly scheduled time.
Administer VISTOGARD via a nasogastric tube (NG tube) or gastrostomy
tube (G-Tube) when necessary (e.g., severe mucositis or coma).
DOSAGE FORMS AND STRENGTHS
Oral granules: 10 gram packets
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information)
Dosing Instructions
Advise the patient or caregiver:
The importance of taking all 20 doses, even if they feel well.
That VISTOGARD can be taken mixed in food (applesauce, pudding or yogurt).
That the VISTOGARD granules should not be chewed.
That if the patient vomits within 2 hours of taking a dose of VISTOGARD to take
another complete dose as soon as possible after vomiting.
Take the next dose at the regularly scheduled time.
That if the patient misses a dose at the scheduled time, to take that dose of
VISTOGARD as soon as possible. Then take the next dose at the regularly
scheduled time.
Manufactured by:
Wellstat Therapeutics Corporation Gaithersburg, MD 20878
VISTOGARD® is a registered trademark of Wellstat Therapeutics Corporation.
Distributed by:
BTG International Inc.
West Conshohocken, PA 19428
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Uridine triacetate is an acetylated pro-drug of uridine. Following oral administration,
uridine triacetate is deacetylated by nonspecific esterases present throughout the body,
yielding uridine in the circulation. Uridine competitively inhibits cell damage and cell
death caused by fluorouracil
2. Pharmacokinetics
Absorption
VISTOGARD delivers 4- to 6-fold more uridine into the systemic circulation compared
to equimolar doses of uridine itself. Maximum concentrations of uridine in plasma
following oral VISTOGARD are generally achieved within 2 to 3 hours, and the
half-life ranges from approximately 2 to 2.5 hours.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
Limited case reports of uridine triacetate use during pregnancy are insufficient to inform
a drug-associated risk of birth defects and miscarriage.
2. Lactation
Risk Summary
There are no data on the presence of uridine triacetate in human milk, the effect on
the breastfed infant or the effect on milk production. The development and health
benefits of breastfeeding should be considered along with the mother’s clinical
need for VISTOGARD and any potential adverse effects on the breastfed infant
from VISTOGARD or from the underlying maternal condition.
3. Pediatric Use
The safety and effectiveness of VISTOGARD have been established in pediatric
patients. .
Manufacturer Details