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Drug overview for ONDANSETRON ODT (ondansetron):
Generic name: ONDANSETRON (on-DANCE-eh-tron)
Drug class: Antiemetic
Therapeutic class: Gastrointestinal Therapy Agents
Ondansetron hydrochloride, a selective, first-generation inhibitor of type 3 serotonin (5-HT3) receptors, is an antiemetic.
No enhanced Uses information available for this drug.
Generic name: ONDANSETRON (on-DANCE-eh-tron)
Drug class: Antiemetic
Therapeutic class: Gastrointestinal Therapy Agents
Ondansetron hydrochloride, a selective, first-generation inhibitor of type 3 serotonin (5-HT3) receptors, is an antiemetic.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ONDANSETRON ODT (ondansetron) have been approved by the FDA:
Indications:
Prevention of cancer chemotherapy-induced nausea and vomiting
Prevention of post-operative nausea and vomiting
Prevention of radiation-induced nausea and vomiting
Professional Synonyms:
Cancer chemotherapy-induced n & v prophylaxis
Postop nausea and vomiting prophylaxis
Postoperative nausea and vomiting prophylaxis
Radiation-induced nausea and vomiting prophylaxis
Indications:
Prevention of cancer chemotherapy-induced nausea and vomiting
Prevention of post-operative nausea and vomiting
Prevention of radiation-induced nausea and vomiting
Professional Synonyms:
Cancer chemotherapy-induced n & v prophylaxis
Postop nausea and vomiting prophylaxis
Postoperative nausea and vomiting prophylaxis
Radiation-induced nausea and vomiting prophylaxis
The following dosing information is available for ONDANSETRON ODT (ondansetron):
Dosage of ondansetron, which is available for oral or IV use as the hydrochloride dihydrate and also for oral use as ondansetron base (orally disintegrating tablets), is expressed in terms of ondansetron.
For the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults and children 12 years of age and older, an initial ondansetron dose of 8 mg is given 30 minutes before administration of an emetogenic drug and the dose is repeated 8 hours after the initial dose. An 8-mg dose should be administered at 12-hour intervals for 1-2 days following completion of the emetogenic chemotherapy.
For children 4-11 years of age, an initial ondansetron dose of 4 mg is given 30 minutes before administration of a moderately emetogenic cancer chemotherapy drug, with subsequent doses 4 and 8 hours after the initial dose. A 4-mg dose should then be administered at 8-hour intervals for 1-2 days following completion of emetogenic cancer chemotherapy. Little information currently is available regarding dosages for children younger than 4 years of age.
For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy in adults, a single oral 24-mg dose of ondansetron is given 30 minutes before administration of single-day chemotherapy. The manufacturer states that multiple-day, single-daily-dose oral administration of ondansetron 24 mg has not been studied to date. In addition, safety and efficacy of single-daily-dose oral administration of the 24-mg dose have not been established in pediatric patients.
The manufacturer states that dosage modification is not necessary in geriatric patients.
For the prevention of cancer chemotherapy-induced nausea and vomiting in adults and pediatric patients 6 months of age and older, an initial IV ondansetron dose of 0.15 mg/kg (up to a maximum of 16 mg per dose) is given as a 15-minute infusion beginning 30 minutes before administration of an emetogenic drug and is repeated twice at 4-hour intervals following the initial dose. Because of the risk of QT interval prolongation (see Cautions: Cardiovascular Effects), an antiemetic regimen consisting of a single IV ondansetron dose of 32 mg no longer is recommended for prevention of cancer chemotherapy-induced nausea and vomiting.
Efficacy and safety of alternative single-dose IV ondansetron regimens for prevention of cancer chemotherapy-induced nausea and vomiting have not been established.
The manufacturer states that dosage modification is not necessary in geriatric patients. Little information currently is available regarding dosages for pediatric patients younger than 6 months of age.
The manufacturer states that patients with renal impairment do not require ondansetron dosage adjustment, but there is no experience with continuing ondansetron beyond the first day of therapy in such patients. Although only about 5% of the drug is eliminated by the kidneys and renal impairment was not expected to substantially alter elimination of ondansetron, mean plasma clearance has been decreased by about 41-50% in patients with severe renal impairment (creatinine clearances less than 30 mL/minute). However, the decrease in clearance was variable and not consistent with an increase in plasma half-life of the drug. In patients with severe hepatic impairment (Child-Pugh score of 10 or greater) clearance is decreased and apparent volume of distribution of ondansetron is increased with a resultant increase in plasma half-life; therefore, the manufacturer recommends that the total daily dose not exceed 8 mg in such patients.
For the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults and children 12 years of age and older, an initial ondansetron dose of 8 mg is given 30 minutes before administration of an emetogenic drug and the dose is repeated 8 hours after the initial dose. An 8-mg dose should be administered at 12-hour intervals for 1-2 days following completion of the emetogenic chemotherapy.
For children 4-11 years of age, an initial ondansetron dose of 4 mg is given 30 minutes before administration of a moderately emetogenic cancer chemotherapy drug, with subsequent doses 4 and 8 hours after the initial dose. A 4-mg dose should then be administered at 8-hour intervals for 1-2 days following completion of emetogenic cancer chemotherapy. Little information currently is available regarding dosages for children younger than 4 years of age.
For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy in adults, a single oral 24-mg dose of ondansetron is given 30 minutes before administration of single-day chemotherapy. The manufacturer states that multiple-day, single-daily-dose oral administration of ondansetron 24 mg has not been studied to date. In addition, safety and efficacy of single-daily-dose oral administration of the 24-mg dose have not been established in pediatric patients.
The manufacturer states that dosage modification is not necessary in geriatric patients.
For the prevention of cancer chemotherapy-induced nausea and vomiting in adults and pediatric patients 6 months of age and older, an initial IV ondansetron dose of 0.15 mg/kg (up to a maximum of 16 mg per dose) is given as a 15-minute infusion beginning 30 minutes before administration of an emetogenic drug and is repeated twice at 4-hour intervals following the initial dose. Because of the risk of QT interval prolongation (see Cautions: Cardiovascular Effects), an antiemetic regimen consisting of a single IV ondansetron dose of 32 mg no longer is recommended for prevention of cancer chemotherapy-induced nausea and vomiting.
Efficacy and safety of alternative single-dose IV ondansetron regimens for prevention of cancer chemotherapy-induced nausea and vomiting have not been established.
The manufacturer states that dosage modification is not necessary in geriatric patients. Little information currently is available regarding dosages for pediatric patients younger than 6 months of age.
The manufacturer states that patients with renal impairment do not require ondansetron dosage adjustment, but there is no experience with continuing ondansetron beyond the first day of therapy in such patients. Although only about 5% of the drug is eliminated by the kidneys and renal impairment was not expected to substantially alter elimination of ondansetron, mean plasma clearance has been decreased by about 41-50% in patients with severe renal impairment (creatinine clearances less than 30 mL/minute). However, the decrease in clearance was variable and not consistent with an increase in plasma half-life of the drug. In patients with severe hepatic impairment (Child-Pugh score of 10 or greater) clearance is decreased and apparent volume of distribution of ondansetron is increased with a resultant increase in plasma half-life; therefore, the manufacturer recommends that the total daily dose not exceed 8 mg in such patients.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ONDANSETRON ODT 4 MG TABLET | Maintenance | Adults place 2 tablets (8 mg) on top of the tongue where they will dissolve, then swallow by translingual route 2 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ONDANSETRON ODT 4 MG TABLET | Maintenance | Adults place 2 tablets (8 mg) on top of the tongue where they will dissolve,then swallow by translingual route 2 times per day |
The following drug interaction information is available for ONDANSETRON ODT (ondansetron):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Apomorphine/Selected 5-HT3 Antagonists SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The mechanism for risk of profound hypotension or loss of consciousness is not known. CLINICAL EFFECTS: Concurrent use of apomorphine with a 5-HT3 antagonist may result in profound hypotension and loss of consciousness.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of apomorphine states that concurrent use with 5-HT3 antagonists is contraindicated. Alternative agents, such as trimethobenzamide, are recommended for prevention of nausea and vomiting caused by apomorphine.(3) DISCUSSION: Profound hypotension and loss of consciousness have been reported with the concurrent use of apomorphine and ondansetron.(1,2) Selected 5-HT3 Antagonists linked to this monograph include: alosetron, azasetron, and ramosetron. |
APOKYN, APOMORPHINE HCL, ONAPGO |
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Tramadol/5-HT3 Antagonists SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The interaction may involve a reduction in the binding involving 5-HT3 receptors.(1) CLINICAL EFFECTS: Concurrent use of 5-HT3 antagonists may decrease the effectiveness of tramadol, resulting in increased use of tramadol.(1-3) 5-HT3 antagonists may not be effective in reducing tramadol-induced nausea.(4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Consider the use of alternative anti-emetics in patients receiving tramadol, or the use of other opioids in patients receiving 5-HT3 antagonists. DISCUSSION: In a randomized study in 59 post-surgical patients in recovery, compared to tramadol alone, patients receiving concurrent ondansetron required significantly larger doses of tramadol at four hours (223 mg versus 71 mg), at 8 hours (285 mg versus 128 mg), and at 12 hours (406 mg versus 190 mg). Vomiting rates at 4 hours and 8 hours were significantly higher with tramadol and concurrent ondansetron compared to tramadol alone.(1) In a randomized, double-blind study in 40 surgical patients undergoing lumbar laminectomy, compared to tramadol alone, cumulative tramadol consumption with concurrent ondansetron during the first 24 hours was significantly increased (between 26% and 35%) as well as thereafter (22% to 25%).(2) In another randomized study in 120 post-surgical patients, it was discovered that tramadol consumption was increased in those patients receiving concurrent ondansetron compared to tramadol alone.(3) In a prospective, randomized, double-blinded study in dental patients, patients received one of four treatments: fentanyl and metoclopramide, tramadol and metoclopramide, fentanyl and ondansetron, or tramadol and ondansetron. The patients who received tramadol and ondansetron had the highest nausea scores among the treatment groups. There were no significant differences in the incidences of pain or nausea in the 24 hours following the procedure.(4) In a randomized, controlled trial in 40 surgical patients undergoing hernioplasty or thyroidectomy, compared to tramadol alone, cumulative tramadol consumption was higher at the 2-hour time point with concurrent ondansetron (0.24 +/- 0.1 vs. 0.17 +/- 0.16; p = 0.01).(5) A systematic review and meta-analysis of randomized controlled trials in the postoperative setting comparing tramadol alone and in combination with ondansetron were included. At 4-hours, 8-hours, 12-hours, and 24-hours post-procedure, patients had increased tramadol requirements when administered with concurrent ondansetron compared to tramadol alone.(6) 5-HT3 antagonists linked to this monograph include: alosetron, azasetron, dolasetron, granisetron, ondansetron, palonosetron, ramosetron, and tropisetron. |
CONZIP, QDOLO, TRAMADOL HCL, TRAMADOL HCL ER, TRAMADOL HCL-ACETAMINOPHEN |
The following contraindication information is available for ONDANSETRON ODT (ondansetron):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Congenital long QT syndrome |
| Prolonged QT interval |
| Torsades de pointes |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bradycardia |
| Chronic heart failure |
| Hypokalemia |
| Hypomagnesemia |
| Neuroleptic malignant syndrome |
| Serotonin syndrome |
| Severe hepatic disease |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Extrapyramidal disease |
| Myocardial ischemia |
The following adverse reaction information is available for ONDANSETRON ODT (ondansetron):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 25 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal ECG Abnormal hepatic function tests Acute hepatic failure Anaphylaxis Angioedema Atrial fibrillation Bradycardia Bronchospastic pulmonary disease Dyspnea Extrapyramidal disease Heart block Hypotension Hypoxia Laryngeal edema Myocardial ischemia Oculogyric crisis Prolonged QT interval Shock Stevens-johnson syndrome Supraventricular tachycardia Tachycardia Torsades de pointes Toxic epidermal necrolysis Transient blindness Ventricular premature beats |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Constipation Diarrhea Drowsy Fever Headache disorder Malaise |
Dizziness Fatigue General weakness Pruritus of skin Skin rash Symptoms of anxiety Urinary retention |
| Rare/Very Rare |
|---|
|
Agitation Angina Blurred vision Hiccups Palpitations Paresthesia Urticaria Ventricular tachycardia Xerostomia |
The following precautions are available for ONDANSETRON ODT (ondansetron):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in rats and rabbits receiving oral ondansetron dosages up to 15 and 30 mg/kg daily, respectively, and IV ondansetron dosages up to 4 mg/kg daily (approximately 1.4 and 2.9 times, respectively, the recommended human IV dosage of 0.15 mg/kg given 3 times daily (calculated on the basis of body surface area)) have not revealed evidence of harm to the fetus. There are no adequate and controlled studies to date using ondansetron in pregnant women, and the drug should be used during pregnancy only when clearly needed.
It is not known whether ondansetron is distributed into human milk; however, the drug is distributed into the milk of lactating rats. Because many drugs are distributed in human milk, ondansetron should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ONDANSETRON ODT (ondansetron):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ONDANSETRON ODT (ondansetron)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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