ZOFRAN- ondansetron hydrochloride solution ZOFRAN ODT- ondansetron hydrochloride tablet, orally disintegrating ZOFRAN- ondan

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)

זמין מ:

GlaxoSmithKline LLC

INN (שם בינלאומי):

ONDANSETRON HYDROCHLORIDE

הרכב:

ONDANSETRON 4 mg in 5 mL

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

ZOFRAN® is indicated for the prevention of nausea and vomiting associated with: ZOFRAN is also indicated for the prevention of postoperative nausea and/or vomiting. ZOFRAN is contraindicated in patients: Risk Summary Available data do not reliably inform the association of ZOFRAN and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see Data ]. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognize

leaflet_short:

ZOFRAN Tablets ZOFRAN ODT Orally Disintegrating Tablets ZOFRAN Oral Solution Store upright between 15°C and 30°C (59°F and 86°F). Protect from light. Store bottles upright in cartons.

מצב אישור:

New Drug Application

מאפייני מוצר

ZOFRAN- ONDANSETRON HYDROCHLORIDE SOLUTION
ZOFRAN ODT- ONDANSETRON HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING
ZOFRAN- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOFRAN TABLETS, ZOFRAN ODT, AND
ZOFRAN ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ZOFRAN TABLETS,
ZOFRAN ODT, AND ZOFRAN ORAL SOLUTION.
ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLETS, FOR ORAL USE
ZOFRAN ODT (ONDANSETRON) ORALLY DISINTEGRATING TABLETS
ZOFRAN (ONDANSETRON HYDROCHLORIDE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
ZOFRAN is a 5-HT receptor antagonist indicated for the prevention of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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3
nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin greater than or
equal to 50 mg/m . (1)
2
nausea and vomiting associated with initial and repeat courses of
moderately emetogenic cancer chemotherapy. (1)
nausea and vomiting associated with radiotherapy in patients receiving
either total body irradiation, single high-dose
fraction to the abdomen, or daily fractions to the abdomen. (1)
postoperative nausea and/or vomiting. (1)
See full prescribing information for the recommended dosage in adults
and pediatrics. (2)
Patients with severe hepatic impairment: do not exceed a total daily
dose of 8 mg. (2.2, 8.6)
Tablets: 4 mg and 8 mg (3)
Orally Disintegrating Tablets: 4 mg and 8 mg (3)
Oral Solution: 4 mg/5 mL (3)
Patients known to have hypersensitivity (e.g., anaphylaxis) to
ondansetron or any components of the formulation. (4)
Concomitant use of apomorphine. (4)
Hypersensitivity reactions including anaphylaxis and bronchospasm:
Discontinue ZOFRAN if suspected. Monitor and
treat promptly per standard of care until signs and symptoms resolve.
(5.1)
QT interval prolongation and Tors