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If you are a consumer or patient please visit this version. Ondansetron tablets are a 5-HT 3 receptor antagonist indicated for the prevention of:. Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:. The recommended dosage regimens for Oblong shaped tablet and pediatric patients are described in Table 1 and Table 2, respectively. Corresponding doses of ondansetron tablets, ondansetron orally disintegrating tablets and ondansetron oral solution may be used interchangeably. In patients with severe hepatic impairment Child-Pugh score of 10 or greaterdo not exceed a total daily dose of 8 mg [see Use in Specific Populations 8.
Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. If hypersensitivity reactions occur, discontinue use of ondansetron; treat promptly per standard of care and monitor until s and symptoms resolve [see Contraindications 4 ].
Electrocardiogram ECG changes, including QT interval prolongation have been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT Oblong shaped tablet. ECG monitoring is recommended in patients with electrolyte abnormalities e. The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists alone. Most reports have been associated with concomitant use of serotonergic drugs e. 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-HT 3 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 s and symptoms: mental status changes e. 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 Drug Interactions 7. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.
Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The following clinically ificant adverse reactions are described elsewhere in the labeling:.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions have been reported in Oblong shaped tablet trials of patients treated with ondansetron, the active ingredient of ondansetron tablets.
A causal relationship to therapy with ondansetron was unclear in many cases. The most common adverse reactions reported in 4 trials in adults for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy primarily cyclophosphamide-based regimens are shown in Table 3. The increases were transient and did not appear to be related to dose or duration of therapy.
On repeat exposure, similar transient elevations in transaminase values occurred in some courses, Oblong shaped tablet symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes is unclear.
Liver failure and death has been reported in cancer patients receiving concurrent medications, including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. Except for bronchospasm and anaphylaxis, the relationship to ondansetron is unclear. Prevention of Postoperative Nausea and Vomiting The most common adverse reactions reported in adults in trial s of prevention of postoperative nausea and vomiting are shown in Table 4.
In these trial spatients were receiving multiple concomitant perioperative and postoperative medications in both treatment groups. The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Rarely and predominantly with intravenous ondansetron, transient ECG changes, including QT interval prolongation have been reported. General Flushing : Rare cases of hypersensitivity reactions, sometimes severe e. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron. Hepatobiliary Liver enzyme abnormalities.
Lower Respiratory Hiccups. Neurology Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Skin Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Eye Disorders Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.
Serotonin syndrome including altered mental status, autonomic instability, and neuromuscular symptoms has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including SSRIs and SNRIs. Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue ondansetron and initiate supportive treatment [see Warnings and Precautions 5.
Ondansetron does not itself Oblong shaped tablet to induce or inhibit the cytochrome P drug-metabolizing enzyme system of the liver [see Clinical Pharmacology In patients treated with potent inducers of CYP3A4 i. However, on the basis of Oblong shaped tablet data, no dosage adjustment for ondansetron is recommended for patients on these drugs [see Clinical Pharmacology Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small trials indicate that when used together, ondansetron may increase patient-controlled administration of tramadol.
Monitor patients to ensure adequate pain Oblong shaped tablet when ondansetron is administered with tramadol. Carmustine, etoposide, and cisplatin do not affect the Oblong shaped tablet of ondansetron. In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase systemic concentrations of high-dose methotrexate.
Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied. Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy see Data.
Available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes.
In the U. Available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. Ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. One large retrospective cohort study examined women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, Oblong shaped tablet, preterm delivery, infants of low birth weight, or infants small for gestational age.
Two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. Relative risks RR ranged from 0. A subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects RR 2.
Several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. A retrospective cohort study of 1. Medicaid Database showed an increased risk of oral clefts among 88, pregnancies in which oral ondansetron was prescribed in the first trimester RR 1.
In the subgroup of women who received both forms of administration, the Oblong shaped tablet was 1. Two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate OR 1. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation the palate is formed between the 6th and 9th weeks of pregnancy.
With the exception of a slight decrease in maternal body weight gain in the rabbits, there were no ificant effects of ondansetron on the maternal animals or the development of the offspring. With the exception of a slight reduction in maternal body weight gain, there were no effects upon the Oblong shaped tablet rats and the pre- and postnatal development of their offspring, including reproductive Oblong shaped tablet of the mated F1 generation.
It is not known whether ondansetron is present in human milk. There are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. However, it has been demonstrated that ondansetron is present in the milk of rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The safety and effectiveness of orally administered ondansetron have been established in pediatric patients 4 years and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Use of ondansetron in these age-groups is supported by evidence from adequate and well- controlled studies of ondansetron in adults with additional data from 3 open-label, uncontrolled, non-US trials in pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens [see Dosage and Administration 2. Additional information on the use of ondansetron in pediatric patients may be found in Ondansetron Injection prescribing information. The safety and effectiveness of orally administered ondansetron have not been established in pediatric patients for:.
Of the total of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in U. No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects. A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology There were an insufficient of patients older than 75 years of age and older in the clinical trials to Oblong shaped tablet safety or efficacy conclusions in this age group.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is needed in elderly patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment.
In patients with severe hepatic impairment, clearance is reduced and the apparent volume of distribution is increased, resulting in a ificant increase in the half-life of ondansetron. Therefore, do not exceed a total daily dose of 8 mg in patients with severe hepatic impairment Child-Pugh score of 10 or greater [see Dosage and Administration 2. No dosage adjustment is recommended for patients with any degree of renal impairment mild, moderate, or severe.
Oblong shaped tablet is no experience beyond first-day administration of ondansetron [see Clinical Pharmacology Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.
There is no specific antidote for ondansetron overdose.
Patients should be managed with appropriate supportive therapy. Hypotension and faintness occurred in a patient that took 48 mg of ondansetron tablets. Following infusion of 32 Oblong shaped tablet over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed.
In all instances, the adverse reactions resolved completely. Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron exceeding estimated ingestion of 5 mg per kg in young children. Reported symptoms included somnolence, agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure.
Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days. The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type.
Ondansetron hydrochloride USP dihydrate is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP dihydrate equivalent to 4 mg or 8 mg or 24 mg Oblong shaped tablet ondansetron.
Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch maizemagnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Ondansetron is a selective 5-HT 3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist.
Serotonin receptors of the 5-HT 3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine.Oblong shaped tablet
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