Buy Zofran Online

Ondansetron (ondansetron)

OTHER BRAND NAMES

Zofran, Zofran ODT

THERAPEUTIC CLASS

5-HT3 receptor antagonist

DEA CLASS

RX

INDICATIONS

(Inj) Prevention of N/V associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin in patients ≥6 months of age. Prevention of postoperative nausea and/or vomiting (PONV) in patients ≥1 month of age. (PO) Prevention of N/V associated with: highly emetogenic cancer chemotherapy, including cisplatin ≥50mg/m2; 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. Prevention of PONV.

ADULT DOSAGE

Chemotherapy-Associated Nausea/Vomiting

Inj:
Prevention of N/V Associated w/ Initial and Repeat Courses of Emetogenic Chemotherapy (Including High-Dose Cisplatin):
Three 0.15mg/kg IV doses (diluted) up to a max of 16mg/dose; infuse over 15 min. Give 1st dose 30 min before the start of chemotherapy, then give subsequent doses 4 and 8 hrs after the 1st dose

Oral:
Prevention of N/V Associated w/ Highly Emetogenic Chemotherapy (Including Cisplatin ≥50mg/m2):
24mg (given as three 8mg tabs) 30 min before start of single-day chemotherapy

Prevention of N/V Associated w/ Moderately Emetogenic Chemotherapy:
8mg bid; give 1st dose 30 min before chemotherapy, then give subsequent dose 8 hrs after 1st dose, then administer 8mg q12h for 1-2 days after completion of chemotherapy

Postoperative Nausea/Vomiting

Prevention:
Inj:
4mg IM/IV undiluted immediately before induction of anesthesia or postoperatively if prophylactic antiemetic was not received and N/V occurs w/in 2 hrs after surgery; infuse IV in not less than 30 sec, preferably over 2-5 min

Oral:
16mg given 1 hr before induction of anesthesia

Radiotherapy Associated Nausea/Vomiting

Oral:
Prevention in Patients Receiving Either Total Body Irradiation, Single High-Dose Fraction to the Abdomen, or Daily Fractions to the Abdomen:
Usual: 8mg tid

Total Body Irradiation:
8mg should be administered 1-2 hrs before each fraction of radiotherapy administered each day

Single High-Dose Fraction Radiotherapy to the Abdomen:
8mg should be administered 1-2 hrs before radiotherapy, w/ subsequent doses q8h after 1st dose for 1-2 days after completion of radiotherapy

Daily Fractionated Radiotherapy to the Abdomen:
8mg should be administered 1-2 hrs before radiotherapy, w/ subsequent doses q8h after 1st dose for each day radiotherapy is given

PEDIATRIC DOSAGE

Chemotherapy-Associated Nausea/Vomiting

Inj:
Prevention of N/V Associated w/ Initial and Repeat Courses of Emetogenic Chemotherapy (Including High-Dose Cisplatin):
6 Months-18 Years:
Three 0.15mg/kg IV doses (diluted) up to a max of 16mg/dose; infuse over 15 min. Give 1st dose 30 min before the start of chemotherapy, then give subsequent doses 4 and 8 hrs after the 1st dose

Oral:
Prevention of N/V Associated w/ Moderately Emetogenic Cancer Chemotherapy:
4-11 Years:
4mg tid; give 1st dose 30 min before chemotherapy, then give subsequent doses 4 and 8 hrs after 1st dose, then administer 4mg q8h for 1-2 days after completion of chemotherapy

≥12 Years:
8mg bid; give 1st dose 30 min before chemotherapy, then give subsequent dose 8 hrs after 1st dose, then administer 8mg q12h for 1-2 days after completion of chemotherapy

Postoperative Nausea/Vomiting

Prevention:
1 Month-12 Years:
Inj:
≤40kg: 0.1mg/kg IV single dose
>40kg: 4mg IV single dose

Infuse in not less than 30 sec, preferably over 2-5 min immediately before or after induction of anesthesia or postoperatively if prophylactic antiemetic was not received and N/V occurs shortly after surgery

DOSING CONSIDERATIONS

Hepatic Impairment
Severe (Child-Pugh Score ≥10):
Oral:
Max: 8mg/day

Inj:
Max: 8mg/day infused over 15 min beginning 30 min prior to emetogenic chemotherapy

ADMINISTRATION

IV/IM/Oral routes

ODT
Do not attempt to push tabs through the foil backing
Peel back the foil backing of 1 blister and gently remove tab
Immediately place tab on top of the tongue where it will dissolve in seconds, then swallow w/ saliva

Inj
Should be diluted in 50mL of D5 or NaCl before administration
Do not mix w/ alkaline sol as a precipitate may form

HOW SUPPLIED

Tab: 24mg; (Zofran) Inj: 2mg/mL [20mL], Sol: 4mg base/5mL [50mL], Tab/Tab, Disintegrating (ODT): 4mg, 8mg

CONTRAINDICATIONS

Concomitant use w/ apomorphine.

WARNINGS/PRECAUTIONS

Hypersensitivity reactions reported in patients hypersensitive to other selective 5-HT3 receptor antagonists. ECG changes, including QT interval prolongation and torsades de pointes, reported; avoid in patients w/ congenital long QT syndrome. Monitor ECG in patients with electrolyte abnormalities (eg, hypokalemia, hypomagnesemia), CHF, bradyarrhythmias, and in patients taking other medications that lead to QT prolongation. Serotonin syndrome reported; d/c and initiate supportive treatment if symptoms occur. Use in patients following abdominal surgery or w/ chemotherapy-induced N/V may mask a progressive ileus and/or gastric distension. Does not stimulate gastric/intestinal peristalsis; do not use instead of NG suction. (ODT) Contains phenylalanine; caution in phenylketonuric patients.

ADVERSE REACTIONS

Headache, diarrhea, constipation, fever, pruritus, dizziness, bradycardia, drowsiness/sedation. (Inj) Inj-site reaction. (PO) Malaise/fatigue, anxiety/agitation, urinary retention.

DRUG INTERACTIONS

See Contraindications. Inducers or inhibitors of CYP3A4, CYP2D6, and CYP1A2 may change the clearance and T1/2. Potent CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin) may significantly increase clearance and decrease blood levels. May reduce analgesic activity of tramadol. May cause serotonin syndrome w/ other serotonergic drugs (eg, SSRIs, SNRIs, MAOIs, mirtazapine, fentanyl, lithium, tramadol, IV methylene blue); d/c and initiate supportive treatment if symptoms occur.

PREGNANCY AND LACTATION

Category B, caution in nursing.

MECHANISM OF ACTION

Selective 5-HT3 receptor antagonist; has not been established.

PHARMACOKINETICS

Absorption: Administration in various age groups resulted in different parameters. (PO) Well absorbed from GI tract; mean bioavailability (56%). Distribution: Plasma protein binding (70-76%). Metabolism: Extensive; via CYP3A4, 1A2, 2D6; hydroxylation (primary), glucuronide/sulfate conjugation. Elimination: Urine (5% unchanged). Refer to PI for additional pharmacokinetic information.

ASSESSMENT

Assess for previous hypersensitivity to the drug, congenital long QT syndrome, electrolyte abnormalities, CHF, bradyarrhythmias, hepatic impairment, pregnancy/nursing status, and possible drug interactions. (ODT) Assess for phenylketonuria.

MONITORING

Monitor for QT interval prolongation, torsades de pointes, hypersensitivity reactions, serotonin syndrome, and other adverse reactions. Monitor ECG in patients w/ electrolyte abnormalities, CHF, bradyarrhythmias, and in patients taking other medications that lead to QT prolongation. In patients who recently underwent abdominal surgery or in patients w/ chemotherapy-induced N/V, monitor for masking of a progressive ileus and/or gastric distension.

PATIENT COUNSELING

Inform about potential benefits/risks of therapy. Inform that drug may cause serious cardiac arrhythmias (eg, QT prolongation); instruct patients to contact physician if they perceive a change in their HR, if they feel lightheaded, or have a syncopal episode. Inform that chances of developing severe cardiac arrhythmias are higher in patients w/ a personal/family history of abnormal heart rhythms (eg, congenital long QT syndrome), patients taking medications (eg, diuretics) that may cause electrolyte abnormalities, and in patients w/ hypokalemia or hypomagnesemia. Advise of the possibility of serotonin syndrome; instruct to seek immediate medical attention if changes in mental status, autonomic instability, neuromuscular symptoms w/ or w/o GI symptoms occur. Inform that drug may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm; instruct to report any signs/symptoms of hypersensitivity reactions to physician. Advise to report the use of all medications to physician. Inform that drug may cause headache, drowsiness/sedation, constipation, fever, and diarrhea. Inform phenylketonuric patients that ODT contains phenylalanine.

STORAGE

20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Protect from light. Zofran: (Inj/ODT/Tab) 2-30°C (36-86°F). (Sol) 15-30°C (59-86°F); store bottles upright in cartons. (Inj/Sol/Tab) Protect from light. (Inj) Diluted Sol: Do not use beyond 24 hrs. Refer to PI for further information on stability and handling.

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