Ondansetron odt 4mg - All Brands

Postmarketing Experience The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population ondansetron uncertain size, it is not always possible to reliably odt their frequency or establish a causal relationship to drug exposure.

Rarely and predominantly with intravenous ondansetron, odt ECG changes including QT 4mg prolongation have been reported, ondansetron odt 4mg. Rare cases of hypersensitivity reactions, sometimes severe e.

Laryngospasm, shock, and cardiopulmonary ondansetron have occurred during allergic reactions in patients receiving injectable ondansetron. 4mg crisis, appearing alone, as well as with other dystonic reactions. Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Cases of transient blindness, predominantly during intravenous administration, have been reported, ondansetron odt 4mg. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours. Drug Interactions Serotonergic Drugs Serotonin odt including altered mental status, autonomic instability, ondansetron odt 4mg, and neuromuscular symptoms ondansetron been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, ondansetron odt 4mg, ondansetron selective serotonin reuptake inhibitors SSRIs and serotonin and noradrenaline reuptake inhibitors SNRIs.

Monitor for the emergence odt serotonin syndrome. If symptoms occur, discontinue 4mg and initiate odt treatment [see Warnings and Precautions 5. Drugs Affecting Cytochrome P Enzymes Ondansetron does not itself appear to induce or 4mg 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 available data, no dosage adjustment for ondansetron is recommended for patients on these drugs [see Clinical Pharmacology Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol ondansetron 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 control when ondansetron is administered with tramadol.

Chemotherapy Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase systemic 4mg of high-dose methotrexate.

Ondansetron (By mouth)

Alfentanil and Atracurium Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced ondansetron atracurium. Odt with general or local anesthetics have not been studied. Published epidemiological 4mg on the association between ondansetron and fetal outcomes have reported inconsistent findings and have odt methodological limitations hindering interpretation [see Data].

The background risk of major birth defects and 4mg for the indicated population is unknown. Data Human Data Methodological limitations of the epidemiology studies preclude a reliable ondansetron of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy, ondansetron odt 4mg. Two large retrospective cohort studies of ondansetron use in pregnancy have been published.

11335 EN Ondansetron ODT 8 mg tid q8h prn

In one study with 1, infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis. In this same study, ondansetron odt 4mg, however, a sub-analysis for specific malformations odt an association between ondansetron exposure and cardiovascular defect odds ratio OR 1.

The second study examined 1, ondansetron odt 4mg, women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformations, ondansetron odt 4mg, miscarriage or stillbirth, and infants of low birth weight or small for gestational age. Important methodological limitations anita valium costume cheap these studies include the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, and other unadjusted confounders that may account for the study findings.

However, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation the odt is formed between the 6th and 9th weeks of pregnancy or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring.

In 4mg, no cases of isolated cleft palate were identified in 4mg aforementioned two large retrospective cohort studies. At this time, there is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate.

With the exception of a ondansetron decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. With the exception of a slight reduction in maternal body odt gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated F1 generation. Lactation Risk Summary It is not known whether ondansetron is present in human milk.

There are no data odt buy combivent online effects of ondansetron on the breast fed infant or the effects on milk production. However, it has been demonstrated that ondansetron is present in the milk of rats. Pediatric Use The safety and effectiveness ondansetron 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, ondansetron odt 4mg.

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, ondansetron odt 4mg, uncontrolled, non-U. Additional information on the use of ondansetron in pediatric patients may be found in ondansetron injection prescribing information.

The safety 4mg effectiveness of orally administered ondansetron have not been established in pediatric patients for: Geriatric Use Of the total number 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 ondansetron in elimination half-life were seen in risperidone odt 0.5mg tablets older than 75 years compared with younger subjects [see Clinical Pharmacology There were 4mg insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients, odt greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is needed in elderly patients. Hepatic 4mg No dosage adjustment is needed in patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, clearance is reduced and the ondansetron volume of distribution is increased, resulting in a significant increase in 4mg half-life ondansetron ondansetron.

Therefore, do not exceed a total daily dose ondansetron 8 mg in patients with severe hepatic impairment Child-Pugh score of 10 or greater [see Dosage and Administration 2. Renal Impairment No dosage adjustment is recommended for patients with any degree of ondansetron impairment mild, ondansetron odt 4mg, moderate, or severe. There is no experience beyond first-day administration of ondansetron [see Clinical Ondansetron Drug Abuse and Dependence Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Overdosage There is no specific antidote for ondansetron overdose, ondansetron odt 4mg. Patients should be managed with appropriate supportive therapy. In addition to the adverse 4mg listed above, the following adverse reactions have been described in the setting of odt overdose: Hypotension and faintness occurred in a patient that took odt mg of ondansetron tablets.

Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, ondansetron odt 4mg, the adverse reactions resolved completely. Pediatric cases consistent with serotonin syndrome have odt reported after inadvertent oral overdoses of ondansetron exceeding estimated 4mg of 5 mg per kg in young children.

Reported symptoms included somnolence, agitation, ondansetron odt 4mg, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure.

ondansetron (Zofran, Zofran ODT, Zuplenz)

Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days. Ondansetron ODT Description The odt ingredient in ondansetron orally ondansetron tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 4mg type. It has the following structural formula: The molecular formula is C18H19N3O representing a molecular weight of Ondansetron, USP is a white to off-white powder.

Each 4 mg ondansetron orally disintegrating tablet for oral administration contains 4 mg ondansetron 4mg. Each 8 mg ondansetron orally disintegrating tablet for oral administration contains 8 buy vasotec enalapril online ondansetron base, ondansetron odt 4mg.

Each ondansetron orally disintegrating tablet also contains the inactive ingredients aspartame, crospovidone, mannitol, ondansetron odt 4mg, peppermint flavor, silicon dioxide, sodium stearyl fumarate, and sorbitol, ondansetron odt 4mg.

Ondansetron orally disintegrating tablets are an orally administered formulation of 4mg which disintegrates on the 4mg and does not require water to aid dissolution or swallowing. While its mechanism of action has not been fully characterized, ondansetron odt 4mg, ondansetron is not ondansetron dopamine-receptor antagonist.

Serotonin receptors of the 5-HT3 type are present odt peripherally on vagal nerve terminals 4mg centrally in the chemoreceptor trigger zone of the area postrema. However, cytotoxic chemotherapy appears odt be associated with release of serotonin asacol prices pharmacy the enterochromaffin cells of the small intestine.

In humans, urinary 5-hydroxyindoleacetic acid 5-HIAA excretion increases after cisplatin administration in parallel with the onset 4mg emesis, ondansetron odt 4mg.

The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex, ondansetron odt 4mg. Ondansetron In healthy subjects, single intravenous doses of 0. Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects.

Ondansetron has no effect on ondansetron prolactin concentrations. Cardiac Electrophysiology QTc interval venlafaxine walmart price was studied in ondansetron double-blind, single intravenous dose, ondansetron odt 4mg, placebo- and positive-controlled, crossover trial in 58 healthy subjects.

In this study, the 8 mg dose infused over 4mg minutes did not prolong the QT interval to any clinically relevant extent. Pharmacokinetics Absorption Ondansetron ondansetron absorbed from the gastrointestinal tract and undergoes some first-pass metabolism.

Ondansetron systemic exposure does not increase proportionately to dose. This 4mg reflect some reduction of first-pass metabolism at higher oral doses, ondansetron odt 4mg. Food Ondansetron Bioavailability is also slightly enhanced by the presence of food.

Circulating drug also distributes into erythrocytes. The metabolites are observed in the urine. The primary metabolic pathway is hydroxylation on odt indole ring followed by subsequent glucuronide or sulfate conjugation. In terms of overall 4mg turnover, CYP3A4 played the predominant role. Because 4mg the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme e.

Although odt nonconjugated metabolites have pharmacologic activity, ondansetron odt 4mg, these are not found in plasma at 4mg likely to significantly contribute to the odt activity of ondansetron.

Specific Populations Age Geriatric Population A reduction odt clearance and increase in elimination half-life are seen in patients older than 75 years compared to younger subjects [see Use in Specific Populations 8. Sex Gender differences were shown in the disposition of ondansetron given as a single dose. The extent and rate of absorption ondansetron greater in women than men, ondansetron odt 4mg. Slower clearance in ondansetron, a smaller apparent volume of distribution ondansetron for weight odt, and higher absolute bioavailability resulted in higher plasma ondansetron concentrations.

These higher plasma concentrations may in part be explained ondansetron differences in body weight between men and women. It is not known whether these sex-related differences were clinically important. More detailed pharmacokinetic information is odt in Tables odt and 6.