Dymista
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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.
ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. In addition, post-marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation.
The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ondansetron alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.
Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ondansetron and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ondansetron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron is used concomitantly with other serotonergic drugs (see PRECAUTIONS and OVERDOSAGE).
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
- 1.
- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m 2.
- 2.
- Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
- 3.
- Prevention of 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.
- 4.
- 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 where nausea and/or vomiting must be avoided postoperatively, Ondansetron Oral Solution, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Ondansetron Oral Solution, USP is ondansetron hydrochloride (HCl) as the dihydrate, 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 molecular formula is C18H19N3O•HCl•2H2O, representing a molecular weight of 365.9.
Ondansetron HCl 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 HCl dihydrate equivalent to 4 mg of ondansetron. Ondansetron Oral Solution, USP contains the inactive ingredients citric acid anhydrous, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, and strawberry flavor.
Sources
Dymista Manufacturers
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Meda Pharmaceuticals Inc.
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Dymista | Roxane Laboratories, Inc
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer ChemotherapyThe recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatric UseThere is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric UseThe dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer ChemotherapyThe recommended adult oral dosage is one 8 mg ondansetron tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric UseFor pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric UseThe dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the AbdomenThe recommended oral dosage is one 8 mg ondansetron tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP given 3 times a day.
For total body irradiation, one 8 mg ondansetron tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric UseThere is no experience with the use of Ondansetron Oral Solution, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric UseThe dosage recommendation is the same as for the general population.
Postoperative Nausea and VomitingThe recommended dosage is 16 mg given as two 8 mg ondansetron tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of Ondansetron Oral Solution, USP 1 hour before induction of anesthesia.
Pediatric UseThere is no experience with the use of Ondansetron Oral Solution, USP in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric UseThe dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal FunctionThe 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 FunctionIn patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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