Zofran


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ondansetron hydrochloride

Apo-Ondansetron (CA), Dom-Ondansetron (CA), Gen-Ondansetron (CA), Novo-Ondansetron (CA), Ondemet (UK), PHL-Ondansetron (CA), PMS-Ondansetron (CA), Ratio-Ondansetron (CA) Sandoz Ondansetron (CA), Zofran, Zofran ODT, Zofran Preservative Free

Pharmacologic class: Serotonin type 3 (5-HT3) antagonist

Therapeutic class: Antiemetic

Pregnancy risk category B

Action

Blocks serotonin at 5-HT3 receptor sites in vagal nerve terminals by disrupting CNS chemoreceptor trigger zone

Availability

Injection: 2 mg/ml in 2- and 20-ml vials

Injection (premixed): 32 mg/50 ml single-dose containers

Injection USP (preservative-free): 2 mg/ml in 2-ml single-dose vials

Oral solution: 4 mg/5 ml

Tablets: 4 mg, 8 mg, 24 mg

Tablets (orally disintegrating): 4 mg, 8 mg

Indications and dosages

To prevent nausea and vomiting caused by moderately emetogenic chemotherapy

Adults and children older than age 12: 8 mg (tablet) or 10 ml (oral solution) P.O. b.i.d.; give first dose 30 minutes before chemotherapy and repeat dose 8 hours later. Give 8 mg (tablet) or 10 ml (oral solution) P.O. q 12 hours for 1 to 2 days after chemotherapy ends.

Children ages 4 to 11: 4 mg (tablet) or 5 ml (oral solution) P.O. q 8 hours; give first dose 30 minutes before chemotherapy and repeat dose 4 and 8 hours later. Give 4 mg (tablet) or 5 ml (oral solution) P.O. q 8 hours for 1 to 2 days after chemotherapy ends.

To prevent nausea and vomiting caused by highly emetogenic chemotherapy

Adults and children older than age 12: 32 mg I.V. as a single dose infused over 15 minutes, starting 30 minutes before chemotherapy; or three 0.15-mg/kg doses I.V., with first dose infused over 15 minutes, starting 30 minutes before chemotherapy and repeated 4 hours and 8 hours later.

To prevent nausea and vomiting caused by radiation

Adults and children older than age 12: 8 mg (tablet) or 10 ml (oral solution) P.O. 1 to 2 hours before radiation and repeated q 8 hours, depending on radiation type, location, and extent

Prevention and treatment of postoperative nausea and vomiting

Adults and children older than age 12: 16 mg (tablet) or 20 ml (oral solution) P.O. 1 hour before anesthesia induction, or 4 mg I.V. or I.M. before anesthesia or postoperatively

Children ages 2 to 12 weighing more than 40 kg (88 lb): 4 mg I.V. before anesthesia or postoperatively

Children ages 2 to 12 weighing less than 40 kg (88 lb): 0.1 mg/kg I.V. before anesthesia or postoperatively

Dosage adjustment

• Hepatic impairment

Contraindications

• Hypersensitivity to drug

• Concurrent use of apomorphine

Precautions

Use cautiously in:

• hepatic disease

• congenital long QT syndrome (avoid use)

• hypersensitivity to other selective 5-HT3 receptor antagonists

• phenylketonuria (with orally disintegrating tablets)

• pregnant or breastfeeding patients

• children younger than age 12.

Administration

• Give first dose before emetogenic event.

• Remove orally disintegrating tablet by peeling back foil with dry hands; don't push tablet through foil backing. After removing, place tablet on patient's tongue, where it will dissolve within seconds. Tell patient to swallow saliva.

• Give undiluted when administering I.M. before anesthesia induction.

• Give undiluted by direct I.V. immediately before anesthesia induction, or postoperatively if nausea and vomiting occur. Administer slowly, over at least 30 seconds (preferably over 2 to 5 minutes).

• For intermittent I.V. infusion, dilute in 50 ml of dextrose 5% in water (D5W) and normal saline solution or D5W and half-normal saline solution. Infuse over 15 minutes.

• When giving I.V., don't use flexible plastic container in series connection.

Adverse reactions

CNS: headache, dizziness, malaise, drowsiness, fatigue, weakness, extra-pyramidal reactions

CV: chest pain, hypotension, ECG changes including QT-interval prolongation (rare and mostly with I.V. use), torsades de pointes (postmarketing reports)

GI: constipation, diarrhea, abdominal pain, dry mouth

GU: urinary retention

Respiratory: bronchospasm

Skin: rash

Other: pain at injection site, shivering, anaphylaxis

Interactions

Drug-drug. Drugs that alter hepatic enzyme activity: altered pharmacokinetics of ondansetron

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, bilirubin: transient elevations

Patient monitoring

• Monitor GI status.

• Assess for extrapyramidal reactions.

• Check vital signs. Watch for hypotension and bronchospasm.

• Monitor fluid intake and output. Stay alert for urinary retention.

Be aware that cases of torsades de pointes have been reported. Monitor ECG in patients with electrolyte abnormalities (such as hypokalemia or hypomagnesemia), congestive heart failure, or bradyarrhythmias, and in patients taking other drugs that lead to prolonged QT interval.

Be aware that using ondansetron after abdominal surgery or with chemotherapy-induced nausea and vomiting may mask a progressive ileus or gastric distention.

Patient teaching

• Tell patient to remove orally disintegrating tablet by peeling back foil with dry hands-not by pushing tablet through foil backing. Instruct him to place tablet on tongue, where it will dissolve within seconds, and then to swallow saliva.

Instruct patient to immediately report extrapyramidal symptoms, irregular heartbeats, abdominal distention after abdominal surgery, or allergic reaction.

• Inform patient with phenylketonuria (or caregiver) that powder contains phenylalanine.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

Zofran

(zō′frăn′)
n.
A trademark for the drug ondansetron hydrochloride.

Zofran®

Ondansetron Therapeutics An orally disintegrating tablet–ODT indicated for preventing RT and chemoherapy-induced and postoperative N&V. See Ondansetron.

Zofran

A brand name for ONDANSETRON.
References in periodicals archive ?
3] receptor antagonists, including Zofran, has been identified as a tential safety issue" in the FDA's adverse event reporting database during the first quarter of 2013, and that the agency was investigating this possible association further.
In addition to the dosage change, caution is recommended in administration of Zofran to patients with congenital long QT intervals, patients with congestive heart failure, those with bradyarrhythmias, or those taking other medications which prolong QT intervals.
Meyer said she was prescribed Zofran (ondansetron), which she has to take immediately when she wakes up.
043 billion to resolve civil liability under the False Claims Act related to off-label promotion of Advair, Lamictal and Zofran, and kickbacks paid to health care professionals to promote and prescribe those drugs as well as Imitrex, Lotronex, Flovent and Valtrex.
Philadelphia PA) received approval for a generic version of GlaxoSmithKline Plc's Zofran.
Ondansetron Injection USP, 2 mg/mL is the generic equivalent of GlaxoSmithKline's Zofran Injection, 2 mg/mL.
The physician orders a liter bolus of Normal Saline to run wide open, Zofran or Phenergan for the nausea and abdominal pain, and oral Potassium for the hypokalemia, thus preparing the patient for discharge.
President Private Schools Association (PSA) Zofran Elahi said that schools in rural areas started their study activities a week earlier while the institutes in the suburbs of the capital including City School, Beacon House and Frobels International resumed their activities today.
The following year, GSK donated thousands of units of Zofran to HPIC for use by over 1,000 Cuban cancer patients.
In addition, GSK continued to face notable exposure to generic competition in the key US market with the Wellbutrin XL, Zofran and Coreg IR brands all cited as generic sales casualties.
There is also greater competition from generic counterparts in important markets, especially against anti-nausea drug Zofran and antidepressant Wellbutrin.
Glaxo has also been under pressure from generic competition for its anti-nausea drug Zofran and antidepressant Wellbutrin, and is trading against a strong period last year when lower legal charges boosted profits.