Drug Catalog - Product Detail
ONDANSETRON HYDROCHLORDE 4MG/5ML SOL 50ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 54838-0555-50 | SILARX | 50 | 4MG/5ML | SOLUTION |
PACKAGE FILES
Generic Name
ONDANSETRON HYDROCHLORIDE
Substance Name
ONDANSETRON HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA091342
Description
11 DESCRIPTION The active ingredient in ondansetron oral solution, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 5 mL of ondansetron oral solution, USP contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Ondansetron oral solution, USP contains the inactive ingredients citric acid anhydrous, glycerin, purified water, sodium benzoate, strawberry flavor, and sucrose. Sodium citrate maybe added for pH adjustment. ondansetron-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ondansetron oral solution, USP a clear, colorless liquid with a characteristic strawberry odor, contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron per 5 mL in brown bottles of 50 mL (NDC 54838-555-50) with child-resistant closures. 17856-0555-01 ONDANSETRON 2MG/2.5ML - 2.5 ML SYRINGE 120 ct UD 17856-0555-02 ONDANSETRON 2MG/2.5ML - 2.5 ML ENFIT SYRINGE 120 ct UD 17856-0555-03 "ONDANSETRON 2MG/2.5ML - 2.5 ML SYRINGE 60 ct UD OVERWRAP" 17856-0555-04 ONDANSETRON 4MG/5ML - 1.25 ML SYRINGE 120 ct UD 17856-0555-05 ONDANSETRON 4MG/5ML - 5 ML CUP 72 ct UD 17856-0555-06 ONDANSETRON 4MG/5ML-1.5MG/1.9ML 48SYRINGE UD 17856-0555-07 ONDANSETRON ORAL SOLUTION 0.8mg/1mL ENFIT SYR UD Store at 20° to 25°C (68° to 77°F), [See USP Controlled Room Temperature]. Protect from light. Store bottles upright in cartons.
Indications & Usage
1 INDICATIONS AND USAGE Ondansetron oral solution, USP is indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 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 oral solution, USP is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 ( 1 ) 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 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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 ) 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, USP 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/m 2 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 administered 1 to 2 hours before radiotherapy, with subsequent 8-mg doses every 8 hours after the first dose for each day radiotherapy is given. Postoperative 16 mg administered 1 hour before induction of anesthesia. Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting Indication Dosage Regimen Moderately Emetogenic Cancer Chemotherapy 12 to 17 years of age: 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. 4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent 4-mg dose 4 and 8 hours after the first dose. Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy. 2.2 Dosage in Hepatic Impairment In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] .