ONDANSETRON- ondansetron hydrochloride injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ondansetron hydrochloride (UNII: NMH84OZK2B) (ondansetron - UNII:4AF302ESOS)

থেকে পাওয়া:

Sagent Pharmaceuticals

INN (আন্তর্জাতিক নাম):

ondansetron hydrochloride

রচনা:

ondansetron 2 mg in 1 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 patients know

পণ্য সারাংশ:

Ondansetron Injection, USP, 2 mg per mL, is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ONDANSETRON- ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Myocardial Ischemia (5.4)
10/2021
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
Ondansetron Injection (2 mg per mL): 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
Hypersensitivi