Zofran description, usages, side effects, indications, overdosage, supplying and lots more!

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Zofran

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ZOFRAN DESCRIPTION


Zofran




Zofran






CLINICAL PHARMACOLOGY

Pharmacodynamics





Pharmacokinetics
















CLINICAL TRIALS

Chemotherapy-Induced Nausea and Vomiting

Highly Emetogenic Chemotherapy





Moderately Emetogenic Chemotherapy















Re-treatment


Pediatric Studies


Radiation-Induced Nausea and Vomiting

Total Body Irradiation


Single High-Dose Fraction Radiotherapy


Daily Fractionated Radiotherapy


Postoperative Nausea and Vomiting



INDICATIONS & USAGE








ZOFRAN CONTRAINDICATIONS




WARNINGS




PRECAUTIONS

General


INFORMATION FOR PATIENTS

Phenylketonurics



DRUG INTERACTIONS



Apomorphine


Phenytoin, Carbamazepine, and Rifampicin


Tramadol


Chemotherapy



Use in Surgical Patients


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Teratogenic Effects


NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE



ZOFRAN ADVERSE REACTIONS



Chemotherapy-Induced Nausea and Vomiting







Central Nervous System


Hepatic



Integumentary


Other


Radiation-Induced Nausea and Vomiting


Postoperative Nausea and Vomiting





Observed During Clinical Practice


Cardiovascular


General


Hepatobiliary


Lower Respiratory


Neurology:


Skin


Special Senses

Eye Disorders


DRUG ABUSE AND DEPENDENCE



OVERDOSAGE




DOSAGE & ADMINISTRATION

Instructions for Use/Handling ZOFRAN ODT Orally Disintegrating Tablets


Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy


Pediatric Use


Geriatric Use


Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy


Pediatric Use


Geriatric Use


Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen





Pediatric Use


Geriatric Use


Postoperative Nausea and Vomiting


Pediatric Use


Geriatric Use


Dosage Adjustment for Patients With Impaired Renal Function


Dosage Adjustment for Patients With Impaired Hepatic Function


HOW SUPPLIED













REFERENCES









PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Zofran

Zofran

Zofran

Ondansetron Hydrochloride TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-858(NDC:0173-0570)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE ONDANSETRON 8 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
GELATIN
mannitol
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM

Product Characteristics

Color Size Imprint Code Shape
white 14 mm Z8 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-858-08 10 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020781 2011-12-19


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