Zofran


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ondansetron

(on-dan-se-tron) ,

Ondissolve ODF

(trade name),

Zofran

(trade name),

Zofran ODT

(trade name),

Zuplenz

(trade name)

Classification

Therapeutic: antiemetics
Pharmacologic: five ht3 antagonists
Pregnancy Category: B

Indications

Prevention of nausea and vomiting associated with highly or moderately emetogenic chemotherapy. Oral: Prevention of nausea and vomiting associated with radiation therapy.Prevention and treatment of postoperative nausea and vomiting.

Action

Blocks the effects of serotonin at 5-HT3–receptor sites (selective antagonist) located in vagal nerve terminals and the chemoreceptor trigger zone in the CNS.

Therapeutic effects

Decreased incidence and severity of nausea and vomiting following chemotherapy or surgery.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability; 100% absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Extensively metabolized by the liver (primarily by CYP3A4); 5% excreted unchanged by the kidneys.
Half-life: Adults—3.5–5.5 hr; Children 5 mo–12 yr—2.9 hr.

Time/action profile (antiemetic effect)

ROUTEONSETPEAKDURATION
PO, IVrapid15–30 min4–8 hr
IMrapid40 minunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Orally disintegrating tablets contain aspartame and should not be used in patients with phenylketonuria;Congenital long QT syndrome;Concurrent use of apomorphine.
Use Cautiously in: Hepatic impairment (daily dose not to exceed 8 mg);Abdominal surgery (may mask ileus); Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children ≤3 yr (PO) or <1 mo (parenteral) (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • dizziness
  • drowsiness
  • fatigue
  • weakness

Cardiovascular

  • torsade de pointes (life-threatening)
  • QT interval prolongation

Gastrointestinal

  • constipation (most frequent)
  • diarrhea (most frequent)
  • abdominal pain
  • dry mouth
  • ↑ liver enzymes

Neurologic

  • extrapyramidal reactions

Interactions

Drug-Drug interaction

Use with apomorphine ↑ risk of severe hypotension and loss of consciousness; concurrent use contraindicated.Carbamazepine, phenytoin, and rifampin may ↓ levels.

Route/Dosage

Oral (Adults) Prevention of nausea/vomiting associated with highly-emetogenic chemotherapy—24 mg 30 min prior to chemotherapy.
Oral (Adults and Children >11 yr) Prevention of nausea/vomiting associated with moderately emetogenic chemotherapy—8 mg 30 min prior to chemotherapy and repeated 8 hr later; 8 mg q 12 hr may be given for 1–2 days following chemotherapy. Prevention of radiation-induced nausea/vomiting—8 mg 1–2 hr prior to radiation; may be repeated q 8 hr, depending on type, location, and extent of radiation. Prevention of postoperative nausea/vomiting—16 mg 1 hr before induction of anesthesia.
Oral (Children 4–11 yr) Prevention of nausea/vomiting associated with moderately emetogenic chemotherapy—4 mg 30 min prior to chemotherapy and repeated 4 and 8 hr later; 4 mg q 8 hr may be given for 1–2 days following chemotherapy.
Intravenous (Adults) Prevention of chemotherapy-induced nausea/vomiting—0.15 mg/kg (max dose = 16 mg) 30 min prior to chemotherapy, repeated 4 and 8 hr later.
Intramuscular Intravenous (Adults) Prevention of postoperative nausea/vomiting—4 mg before induction of anesthesia or postoperatively.
Intravenous (Children 6 mo–18 yr) Prevention of chemotherapy-induced nausea/vomiting—0.15 mg/kg (max dose = 16 mg) 30 min prior to chemotherapy, repeated 4 and 8 hr later.
Intravenous (Children 1 mo–12 yr and >40 k g) Prevention of postoperative nausea/vomiting—4 mg.
Intravenous (Children 1 mo–12 yr and ≤40 kg) Prevention of postoperative nausea/vomiting—0.1 mg/kg.

Hepatic Impairment

Oral Intramuscular Intravenous (Adults) Severe hepatic impairment—Not to exceed 8 mg/day.

Availability (generic available)

Orally disintegrating tablets (contain aspartame)strawberry flavor: 4 mg, 8 mg Cost: Generic — 4 mg $668.78 / 30, 8 mg $1,113.95 / 30
Oral soluble film (Zuplenz): 4 mg, 8 mg Cost: All strengths $16.50 / 1
Tablets: 4 mg, 8 mg, 24 mg Cost: Generic — 4 mg $735.05 / 30, 8 mg $1,217.42 / 30, 24 mg $105.50 / 1
Oral solutionstrawberry flavor: 4 mg/5 mL Cost: $269.74 / 50 mL
Solution for injection: 2 mg/mL

Nursing implications

Nursing assessment

  • Assess patient for nausea, vomiting, abdominal distention, and bowel sounds prior to and following administration.
  • Assess patient for extrapyramidal effects (involuntary movements, facial grimacing, rigidity, shuffling walk, trembling of hands) periodically during therapy.
  • Monitor ECG in patients with hypokalemia, hypomagnesemia, HF, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval.
  • Lab Test Considerations: May cause transient ↑ in serum bilirubin, AST, and ALT levels.

Potential Nursing Diagnoses

Imbalanced nutrition: less than body requirements (Indications)
Diarrhea (Side Effects)
Constipation (Side Effects)

Implementation

  • First dose is administered prior to emetogenic event.
  • Oral: For orally disintegrating tablets, do not attempt to push through foil backing; with dry hands, peel back backing and remove tablet. Immediately place tablet on tongue; tablet will dissolve in seconds, then swallow with saliva. Administration of liquid is not necessary.
  • Intravenous Administration
  • Administer undiluted (2 mg/mL) immediately before induction of anesthesia or postoperatively if nausea and vomiting occur shortly after surgery.
  • Rate: Administer over at least 30 sec and preferably over 2–5 min.
  • Intermittent Infusion: Diluent: Dilute doses for prevention of nausea and vomiting associated with chemotherapy in 50 mL of D5W, 0.9% NaCl, D5/0.9% NaCl, D5/0.45% NaCl. Solution is clear and colorless. Stable for 7 days at room temperature following dilution.Concentration: 1 mg/mL.
  • Rate: Administer each dose over 15 min.
  • Y-Site Compatibility: acetaminophen, aldesleukin, alemtuzumab, alfentanil, amifostine, amikacin, aminocaproic acid, anakinra, anidulafungin, argatroban, ascorbic acid, atropine, azithromycin, aztreonam, benztropine, bivalirudin, bleomycin, bumetanide, buprenorphine, busulfan, butorphanol, calcium chloride, calcium gulconate, carboplatin, carmustine, caspofungin, cefazolin, cefotaxime, cefoxitin, ceftaroline, ceftazidime, cefuroxime, chlorpromazine, ciprofloxacin, cisatracurium, cisplatin, cladribine, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dacarbazine, dactinomycin, daunorubicin, dexamethasone sodium phosphate, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doripenem, doxorubicin, doxorubicin liposome, doxycycline, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, epoetin alfa, eptifibatide, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, floxuridine, fluconazole, fludarabine, folic acid, fosaprepritant, gemcitabine, gentamicin, glycopyrrolate, heparin, hetastarch, hydrocortisone sodium succinate, hydrocortisone sodium phosphate, hydromorphone, idarubicin, ifosfamide, imipenem/cilastatin, irinotecan, isoproterenol, ketorolac, labetalol, levofloxacin, lidocaine, linezolid, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, mesna, methotrexate, methoxamine, methyldopate, metoclopramide, metoprolol, metronidazole, midazolam, mitomycin, mitoxantrone, morphine, moxifloxacin, multivitamins, mycophenolate, nafcillin, nalbuphine, naloxone, nesiritide, nitroglycerin, nitroprusside, norepinephrine, octreotide, oxacillin, oxaliplatin, oxytocin, paclitaxel, pamidronate, pancuronium, papaverine, penicillin G, pentamidine, pentazocine, pentostatin, phentolamine, phenylephrine, phytonadione, piperacillin/tazobactam, potassium acetate, potassium chloride, potassium phosphates, procainamide, prochlorperazine, promethazine, propranolol, protamine, pyridoxine, ranitidine, remifentanil, rocuronium, sodium acetate, sodium phosphates, streptokinase, streptozocin, succinylcholine, sufentanil, tacrolimus, telavancin, teniposide, theophylline, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, tolazoline, topotecan, vancomycin, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: acyclovir, allopurinol, aminophylline, amphotericin B cholesteryl, amphotericin B colloidal, amphotericin B lipid complex, amphotericin B liposome, ampicillin, ampicillin/sulbactam, azathioprine, cefepime, cefoperazone, chloramphenicol, dantrolene, diazoxide, ertapenem, furosemide, ganciclovir, indomethacin, lorazepam, micafungin, milrinone, pantoprazole, pemetrexed, pentobarbital, phenobarbital, phenytoin, rituximab, sargramostim, sodium bicarbonate, thiopental, trastuzumab, trimethoprin/sulfamethoxazole

Patient/Family Teaching

  • Instruct patient to take ondansetron as directed.
  • Advise patient to notify health care professional immediately if symptoms of irregular heart beat or involuntary movement of eyes, face, or limbs occur.

Evaluation/Desired Outcomes

  • Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.
  • Prevention of postoperative nausea and vomiting.
  • Prevention of nausea and vomiting due to radiation therapy.

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 ?
Even though the only FDA approval for this drug was only for seriously ill patients, GSK began marketing Zofran "off label" as an established safe and effective treatment for "morning sickness" without undertaking a single study establishing that this powerful drug was safe or effective for pregnant mothers and their growing children.
Women across the country who have become pregnant while taking the medication accuse GlaxoSmithKline of allegedly failing to provide the public with adequate warnings about the risk of Zofran birth defects.
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.
There is also greater competition from generic counterparts in important markets, especially against anti-nausea drug Zofran and antidepressant Wellbutrin.
In Europe, vaccine sales helped drive growth, offsetting the impact of increased competition for many of its products including Zofran, used to treat nausea and vomiting associated with chemotherapy.
The FDA has approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy.
According to Ayotte, Glaxo engaged in a scheme to inflate the price of the anti-nausea drugs Zofran and Kytril for the Medicare and Medicaid programs, which reimburse health-care providers based on the manufacturers' prices.
Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.
South San Francisco, CA) has licensed exclusive United States and Canadian rights to a proprietary lingual spray formulation of the anti-emetic compound ondansetron hydrochloride, the active ingredient of GlaxoSmithkline's Zofran .
Among the stash reportedly found in his hotel room after he left were Vicodin, Compazine, an anti- anxiety drug, Neurotin, an anti-seizure drug, Vioxx, an anti-inflammatory drug, Zofran, an anti- nausea drug, and melatonin, a sleeping aid.
Its cancer drug Zofran saw sales rise 19 per cent to pounds 601 million, while Coreg for heart failure was up 56 per cent at pounds 251 million.