ONDANSETRON- ondansetron hydrochloride injection, solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

AuroMedics Pharma LLC

INN (Международно Name):

ONDANSETRON HYDROCHLORIDE

Композиция:

ONDANSETRON 2 mg in 1 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Ondansetron Injection is approved for patients aged 6 months and older. Ondansetron Injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes. Ondansetron Injection is approved for patients aged 1 month and older. Ondansetron Injection is contraindicated for pat

Каталог на резюме:

Ondansetron Injection USP, 4 mg per 2 mL (2 mg / mL), is supplied as follows: Ondansetron Injection USP, 4 mg per 2 mL (2 mg / mL) 2 mL Single-dose Vials in a Carton of 25.                                   NDC 55150-125-02 The vial stopper is not made with natural rubber latex. Store between 2° and 30°C (36° and 86°F). Protect from light. Protect from freezing. Retain in carton until time of use.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ONDANSETRON - ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION
AUROMEDICS PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON
INJECTION.
ONDANSETRON INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Ondansetron Injection is a 5-HT receptor antagonist indicated for the
prevention of:
nausea and vomiting associated with initial and repeat courses of
emetogenic cancer chemotherapy. (1.1)
postoperative nausea and/or vomiting. (1.2)
DOSAGE AND ADMINISTRATION
Prevention of nausea and vomiting associated with initial and repeat
courses of emetogenic cancer chemotherapy (2.1):
Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or
0.9% Sodium Chloride Injection is required
before administration to adult and pediatric patients.
Adults and pediatric patients 6 months of age and older: The
recommended dosage is 0.15 mg/kg per dose for 3 doses
(maximum of 16 mg per dose), infused intravenously over 15 minutes.
Administer the first dose 30 minutes before the start of chemotherapy
and subsequent doses 4 and 8 hours after the
first dose.
Prevention of postoperative nausea and/or vomiting (2.2):
Dilution of Ondansetron Injection is not required before
administration to adult and pediatric patients.
See full prescribing information for the recommended dosage and
administration instructions for adult and pediatric
patients 1 month of age and older.
Patients with severe hepatic impairment (2.3):
Do not exceed a total daily dose of 8 mg.
DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/2 mL single-dose vial. (3)
CONTRAINDICATIONS
Patients known to have hypersensitivity (e.g., anaphylaxis) to this
product or any of its components. (4)
Concomitant use of apomorphine. (4, 7.2)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions including anaphylaxis and bronchospasm,
have been reported in patients who have exhibited