Ondansetron Hydrochloride And Dextrose
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Questions & Answers
Side Effects & Adverse Reactions
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Efficacy of the 32-mg single dose beyond 24 hours in these patients has not been established.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Ondansetron in 5 % Dextrose Injection is ondansetron hydrochloride (HCl), the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 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 C18H19N3O·HCl·2H2O, representing a molecular weight of 365.9.
Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline.
Sterile, Premixed Solution for Intravenous Administration in Single-Dose, Flexible Plastic Containers: Each 50 mL contains ondansetron 32 mg (as the hydrochloride dihydrate); dextrose 2500 mg; and citric acid 26 mg and sodium citrate 11.5 mg as buffers in Water for Injection, USP.
It contains no preservatives. The osmolarity of this solution is 270 mOsm/L (approx.), and the pH is 3 to 4.
The flexible plastic container is fabricated from a specially formulated, plastic film. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
Sources
Ondansetron Hydrochloride And Dextrose Manufacturers
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West-ward Pharmaceutical Corp
![Ondansetron Hydrochloride And Dextrose Injection, Solution [West-ward Pharmaceutical Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ondansetron Hydrochloride And Dextrose | West-ward Pharmaceutical Corp
Prevention of Chemotherapy-Induced Nausea and Vomiting: Adult Dosing:The recommended I.V. dosage of ondansetron injection for adults is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE). With the three-dose (0.15-mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron injection.
Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility has not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Flexible Plastic Container: REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
Pediatric Dosing:On the basis of the available information (see CLINICAL TRIALS: Pediatric Studies and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric cancer patients 4 to 18 years of age should be three 0.15-mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron in 5 % Dextrose Injection. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.
Dosing information for pediatric cancer patients 6 months to 48 months of age is approved for GlaxoSmithKline Corporation’s ondansetron injection. However, due to GlaxoSmithKline’s marketing exclusivity rights, this drug product is not labeled for use in this subpopulation of pediatric patients.
Flexible Plastic Container: REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
Geriatric Dosing:The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal Function:The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Dosage Adjustment for Patients With Impaired Hepatic Function:In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron.
Ondansetron in 5 % Dextrose Injection in Flexible Plastic Containers: Instructions for Use:
To Open: Tear outer wrap at notch and remove solution container. Check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
Preparation for Administration: Use aseptic technique.
1. Close flow control clamp of administration set.
2. Remove cover from outlet port at bottom of container.
3. Insert piercing pin of administration set into port with a twisting motion until the pin
is firmly seated. NOTE: See full directions on administration set carton.
4. Suspend container from hanger.
5. Squeeze and release drip chamber to establish proper fluid level in chamber during
infusion of Ondansetron in 5 % Dextrose Injection.
6. Open flow control clamp to expel air from set. Close clamp.
7. Attach set to venipuncture device. If device is not indwelling, prime and make
venipuncture.
8. Perform venipuncture.
9. Regulate rate of administration with flow control clamp.
Caution: Ondansetron in 5 % Dextrose Injection in flexible plastic containers is to be administered by I.V. drip infusion only. Ondansetron in 5 % Dextrose Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form. If used with a primary I.V. fluid system, the primary solution should be discontinued during ondansetron in 5 % Dextrose Injection. Do not administer unless solution is clear and container is undamaged.
Warning: Do not use flexible plastic container in series connections.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
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Pfizer Labs, Division Of Pfizer Inc.
Ondansetron Hydrochloride And Dextrose | Pfizer Labs, Division Of Pfizer Inc.
Prevention of Chemotherapy-Induced Nausea and Vomiting: Adult Dosing:The recommended I.V. dosage of ondansetron injection for adults is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE). With the three-dose (0.15-mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of ondansetron injection.
Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility has not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Flexible Plastic Container:REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
Pediatric Dosing:On the basis of the available information (see CLINICAL TRIALS: Pediatric Studies and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric cancer patients 4 to 18 years of age should be three 0.15-mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron in 5 % Dextrose Injection. The drug should be infused intravenously over 15 minutes. Little information is available about dosage in pediatric cancer patients younger than 6 months of age.
Dosing information for pediatric cancer patients 6 months to 48 months of age is approved for GlaxoSmithKline Corporation's ondansetron injection. However, due to GlaxoSmithKline's marketing exclusivity rights, this drug product is not labeled for use in this subpopulation of pediatric patients.
Flexible Plastic Container:REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
Geriatric Dosing:The dosage recommendation is the same as for the general population.
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Claris Lifesciences, Inc
Ondansetron Hydrochloride And Dextrose | Claris Lifesciences, Inc
Prevention of Chemotherapy-Induced Nausea and Vomiting: Adult Dosing:The recommended I.V. dosage of Ondansetron in 5% dextrose injection for adults is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded (see OVERDOSAGE). With the three-dose (0.15-mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron in 5% dextrose injection.
Ondansetron in 5% dextrose injectionshould not be mixed with solutions for which physical and chemical compatibility has not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Flexible PVC free single use Container:REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
Pediatric Dosing:On the basis of the available information (see CLINICAL TRIALS: Pediatric Studies and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric cancer patients 6 months to 18 years of age should be three 0.15-mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy, subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron in 5 % Dextrose Injection. The drug should be infused intravenously over 15 minutes.
Little information is available about dosage in pediatric cancer patients younger than 6 months of age.
Flexible PVC free single use Container:REQUIRES NO DILUTION. Ondansetron in 5 % Dextrose Injection, 32 mg in 50 mL.
Geriatric Dosing:The dosage recommendation is the same as for the general population.
![Ondansetron Hydrochloride And Dextrose Injection, Solution [Pfizer Labs, Division Of Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2a09af01-3983-466f-8ed8-c849af848b56&name=container.jpg)
![Ondansetron Hydrochloride And Dextrose Injection, Solution [Claris Lifesciences, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d931b294-8834-4c7f-ac05-9aeb078cd86e&name=8eef2a1d-20ea-45d2-84ef-f9e64ec84796-02.jpg)
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