ZOFRAN- ondansetron 4mg tablet, orally disintegrating

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ONDANSETRON (UNII: 4AF302ESOS) (ONDANSETRON - UNII:4AF302ESOS)
Available from:
Advanced Rx Pharmacy of Tennessee, LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
1 INDICATIONS AND USAGE Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.
Authorization status:
Abbreviated New Drug Application
Authorization number:
80425-0113-2

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ZOFRAN- ondansetron 4mg tablet, orally disintegrating

Advanced Rx Pharmacy of Tennessee, LLC

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Ondansetron ODT 4mg # 60

Dosage and Administration Section

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table

2, respectively.

Corresponding doses of ondansetron tablets, ondansetron orally disintegrating tablets and ondansetron

oral solution may be used interchangeably.

Table 1: Adult Recommended Dosage Regimen for Prevention of Nausea and Vomiting

Indication

Dosage Regimen

Highly Emetogenic Cancer Chemotherapy

A single 24 mg dose administered 30 minutes before the start of single-day highly emetogenic

chemotherapy, including cisplatin greater than or equal to 50 mg/m2

Moderately Emetogenic Cancer Chemotherapy

8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 8 hours

after the first dose.

Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

Radiotherapy

For total body irradiation: 8 mg administered 1 to 2 hours before each fraction of radiotherapy each

day.

For single high-dose fraction radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before

radiotherapy, with subsequent 8 mg doses every 8 hours after the first dose for 1 to 2 days after

completion of radiotherapy.

For daily fractionated radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before radiotherapy,

with subsequent 8 mg doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative

16 mg administered 1 hour before induction of anesthesia.

Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting

Indication

Dosage Regimen

Moderately Emetogenic Cancer Chemotherapy

12 to 17 years of age: 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent

8 mg dose 8 hours after the first dose.

Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent

4 mg dose 4 and 8 hours after the first dose.

Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy.

2.2 Dosage in Hepatic Impairment

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total

daily dose of 8 mg [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY

(12.3)].

2.3 Administration Instructions for Ondansetron Orally Disintegrating Tablets

Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands,

remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the

tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it

will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

Indications and Usage Section

1 INDICATIONS AND USAGE

Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting

associated with:

highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2

initial and repeat courses of moderately emetogenic cancer chemotherapy

radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the

abdomen, or daily fractions to the abdomen

Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea

and/or vomiting.

Principal Display Panel

ZOFRAN

ondansetron 4 mg tablet, orally disintegrating

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:8 0 425-0 113(NDC:6 58 6 2-39 0 )

Route of Administration

ORAL

Advanced Rx Pharmacy of Tennessee, LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O NDANSETRO N (UNII: 4AF30 2ESOS) (ONDANSETRON - UNII:4AF30 2ESOS)

ONDANSETRON

4 mg

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

Flavor

GUARANA, STRAWBERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 425-0 113-2

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/12/20 10

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 46 9

0 4/12/20 10

Labeler -

Advanced Rx Pharmacy of T ennessee, LLC (117023142)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Advanced Rx Pharmacy o f Tennessee, LLC

1170 23142

re pa c k(8 0 425-0 113)

Revised: 12/2020

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