Brand Information

Strength	Rate	Packing Style
500mg	1609.50	10s tablets

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. .

XABINE

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation