Zofran 40mg/20ml(Ondansetron) (Ondansetron Hydrochloride Hydrate)

Reference priceBRL R$3,412.50Original source price: INR 52,500.00. Converted estimates are available by currency selection.

Brand	Zofran
Manufacturer	GlaxoSmithKline GmbH & Co.KG
Prescription required	Yes

Description

Zofran 40mg/20ml(Ondansetron) (Ondansetron Hydrochloride Hydrate) is a medicine catalog record in the MediPriceHub database. Active ingredient: Ondansetron Hydrochloride Hydrate. Clinical use summary: See the Benefits field on this page for the product-specific indication or intended use. That field is kept separate from catalog metadata so users can distinguish clinical information from packaging information. Manufacturer or supplier: GlaxoSmithKline GmbH & Co.KG. Therapeutic category: Medicine Library > Oncology Medicines > Radiotherapy. Pack information: 40 / 20. Origin country or market: United States. This page is for medicine catalog reference only and should be read together with the approved prescribing information in the patient or buyer's country.

Benefits

Ondansetron tablets are 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.

How to Use

Use Ondansetron Hydrochloride Hydrate under the supervision of a qualified healthcare professional. Use it only according to the approved label and the instructions of a qualified healthcare professional. Do not start, stop, change the dose, split or crush a dosage form, mix with other medicines, or repeat a course unless the approved product information or a clinician confirms that it is appropriate. Check the local prescribing information for age limits, dose adjustments, missed-dose instructions, storage after opening or reconstitution, and monitoring requirements.

Specification

Active ingredient: Ondansetron Hydrochloride Hydrate. Pack size: 40 / 20. Pack unit: bottle. Manufacturer: GlaxoSmithKline GmbH & Co.KG. Origin country: United States. Source category: Medicine Library > Oncology Medicines > Radiotherapy. Availability, prescription status, storage, and exact approved use may vary by country. Check the local product information before clinical or procurement decisions.

Side Effects

ondansetron hydrochloride ZOFRAN - ondansetron hydrochloride injection GlaxoSmithKline LLC DESCRIPTION Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Sterile Injection for Intravenous (I.V.) or Intramuscular (I.M.) Administration Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9.0 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Each 1 mL of aqueous solution in the 20-mL multidose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP. ZOFRAN Injection is a clear, colorless, nonpyrogenic, sterile solution. The pH of the injection solution is 3.3 to 4.0. CLINICAL PHARMACOLOGY Pharmacodynamics In animals, the emetic response to cisplatin can be prevented by pretreatment with an inhibitor of serotonin synthesis, bilateral abdominal vagotomy and greater splanchnic nerve section, or pretreatment with a serotonin 5-HT3 receptor antagonist. In normal volunteers, single I.V. doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time. In another study in six normal male volunteers, a 16-mg dose infused over 5 minutes showed no effect of the drug on cardiac output, heart rate, stroke volume, blood pressure, or electrocardiogram (ECG). Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers. Ondansetron has no effect on plasma prolactin concentrations. In a gender-balanced pharmacodynamic study (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis. Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied. Pharmacokinetics Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by glucuronide or sulfate conjugation. Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In normal adult volunteers, the following mean pharmacokinetic data have been determined following a single 0.15-mg/kg I.V. dose. Table 1. Pharmacokinetics in Normal Adult Volunteers the mean elimination half-life was 4.0 hours, and there was no difference in the multidose pharmacokinetics over a 4-day period. In a study of 21 pediatric cancer patients (4 to 18 years of age) who received three I.V. doses of 0.15 mg/kg of ondansetron at 4-hour intervals, patients older than 15 years of age exhibited ondansetron pharmacokinetic parameters similar to those of adults. Patients 4 to 12 years of a

Esta informação é apenas para referência. Consulte um profissional de saúde antes de usar qualquer medicamento.