ONDANSETRON ODT- ondansetron tablet, orally disintegrating

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ONDANSETRON (UNII: 4AF302ESOS) (ONDANSETRON - UNII:4AF302ESOS)

Verfügbar ab:

Advanced Rx Pharmacy of Tennessee, LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. Ondansetron orally disintegrating tablets are contraindicated in patients: known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see ADVERSE REACTIONS (6.2)] receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness 8.1 Pregnancy Risk Summary Published epidemiological studies on the association between ondansetron use and major birth defects hav

Produktbesonderheiten:

Ondansetron Orally Disintegrating Tablets USP, 4 mg are white to off-white, round tablets debossed with ‘5’ on one side and ‘E’ on the other side with an embossed circular edge. Bottles of 60 Tablets NDC: 80425-0113-02 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ONDANSETRON ODT- ONDANSETRON TABLET, ORALLY DISINTEGRATING
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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ONDANSETRON ODT 4MG TABLETS
1. 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.
2. 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 administer