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

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Ondansetron Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ONDANSETRON HYDROCHLORIDE DESCRIPTION



Ondansetron Hydrochloride












CLINICAL PHARMACOLOGY

Pharmacodynamics








PHARMACOKINETICS




PRECAUTIONS: Drug Interactions











CLINICAL TRIALS

Chemotherapy-Induced Nausea and Vomiting



















Radiation-Induced Nausea and Vomiting








Postoperative Nausea and Vomiting



INDICATIONS & USAGE







ONDANSETRON HYDROCHLORIDE CONTRAINDICATIONS




WARNINGS




PRECAUTIONS

General



DRUG INTERACTIONS








Use in Surgical Patients


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE



ONDANSETRON HYDROCHLORIDE ADVERSE REACTIONS



Chemotherapy-Induced Nausea and Vomiting
















Radiation-Induced Nausea and Vomiting


Postoperative Nausea and Vomiting



Observed During Clinical Practice






















DRUG ABUSE AND DEPENDENCE



OVERDOSAGE




DOSAGE & ADMINISTRATION

Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy






Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy





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








Postoperative Nausea and Vomiting





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














Ondansetron Hydrochloride

Ondansetron Hydrochloride

Ondansetron Hydrochloride

Ondansetron Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-810(NDC:63304-459)
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
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
STARCH, CORN
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
yellow 12 mm 8;NO OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-810-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077851 2011-11-15


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