Ondansetron odt 8mg tablets pregnancy

Talk to your doctor or pharmacist before taking ondansetron. Children and adolescents Children receiving ondansetron with drugs that are harmful to liver should undergo regular check up for liver problems. Other medicines and Ondansetron Ondansetron may have an effect on other drugs or other drugs may have an effect on Ondansetron. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, natural supplements or vitamins or minerals.

It may be necessary to adjust the dose. Researchers examined 84 trials, with 11, people receiving ondansetron, published between and September The number needed to treat NNT to prevent vomiting within 24 hours was 9.

In the three duplicated reports, the NNT was significantly lower at 3. When all 25 reports were combined, the apparent NNT improved to 4.

The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day every 12 hours for 1 to 2 days after completion of chemotherapy. Pediatric Use For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day.

The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. Remove the tablet gently and immediately place it on the top of the tongue. The tablet will then dissolve in a few seconds. It can be swallowed with saliva. The two drugs are from the same therapeutic class, and would not be expected to be prescribed together. Serotonergic actions of the two drugs might also increase the risk for additive serotonergic side effects.

Major If ondansetron and haloperidol must be coadministered, ECG monitoring is recommended. QT prolongation and TdP have been observed during haloperidol treatment. Excessive doses particularly in the overdose setting or IV administration of haloperidol may be associated with a higher risk of QT prolongation.

Major Consider periodic monitoring of EGCs for QT prolongation and monitor electrolytes if coadministration of histrelin and ondansetron is necessary; correct any electrolyte abnormalities. Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine: Major Avoid coadministration of hydroxychloroquine and ondansetron.

Hydroxychloroquine increases the QT interval and should not be administered with other drugs known to prolong the QT interval.

Ventricular arrhythmias and torsade de pointes TdP have been reported with the use of hydroxychloroquine. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include ondansetron. Ibutilide administration can cause QT prolongation and torsades de pointes TdP ; proarrhythmic events should be anticipated. The potential for proarrhythmic events with ibutilide increases with the coadministration of other drugs that prolong the QT interval.

If ondansetron and ibutilide must be coadministered, ECG monitoring is recommended. Major If ondansetron and idarubicin must be coadministered, ECG monitoring is recommended. Acute cardiotoxicity can occur during the administration of idarubicin; although, the incidence is rare. Major Iloperidone has been associated with QT prolongation; however, torsade de pointes TdP has not been reported. According to the manufacturer, since iloperidone may prolong the QT interval, it should be avoided in combination with other agents also known to have this effect, such as ondansetron.

Major Avoid coadministration of inotuzumab ozogamicin with ondansetron due to the potential for additive QT prolongation and risk of torsade de pointes TdP. If coadministration is unavoidable, obtain an ECG and serum electrolytes prior to the start of treatment, after treatment initiation, and periodically during treatment. Inotuzumab has been associated with QT interval prolongation. Major Ipecac has been shown to be effective in producing emesis in patients who have ingested antiemetics, provided ipecac is given promptly usually within 1 hour of antiemetic consumption.

If ipecac is administered after the antiemetic therapy has begun to exert therapeutic effects, ipecac may be less effective. The duration of the antiemetics action may need to be taken into account when selecting the appropriate clinical path for treating patients for overdosage. Patients on chronic or longer-acting antiemetic therapy, such as the 5HT-3 receptor antagonists, may be unresponsive to ipecac or other methods which induce vomiting.

Moderate Concomitant use of isavuconazonium with ondansetron may result in increased serum concentrations of ondansetron.

Caution and close monitoring are advised if these drugs are used together. Major Because of the potential risk and severity of serotonin syndrome, use caution when administering ondansetron with other drugs that have serotonergic properties such as Monoamine oxidase inhibitors. Minor Rifampin may reduce the efficacy of ondansetron by decreasing its systemic exposure; however, based on available data, no ondansetron dosage adjustment is recommended.

The proposed mechanism is rifampin-related induction of ondansetron metabolism through cytochrome P 3A4. These changes in ondansetron exposure with CYP3A4 inducers are not thought to be clinically relevant. Major Caution is advised when administering itraconazole with drugs that are known to prolong that QT interval and are metabolized by CYP3A4, such as ondansetron.

Both ondansetron and itraconazole are associated with QT prolongation; coadministration may increase this risk. In addition, coadministration of itraconazole a potent CYP3A4 inhibitor with ondansetron a CYP3A4 substrate may result in elevated ondansetron plasma concentrations and an increased risk for adverse events, including QT prolongation.

If itraconazole therapy is stopped, it may be prudent to continue close monitoring for up to 2 weeks after discontinuing itraconazole. Once discontinued, the plasma concentration of itraconazole decreases to almost undetectable concentrations within 7 to 14 days. The decline in plasma concentrations may be even more gradual in patients with hepatic cirrhosis or who are receiving concurrent CYP3A4 inhibitors.

Minor Use caution when administering ivacaftor and ondansetron concurrently. Co-administration of ivacaftor with CYP3A and P-gp substrates, such as ondansetron, can increase ondansetron exposure leading to increased or prolonged therapeutic effects and adverse events; however, the clinical impact of this has not yet been determined. Major Avoid coadministration of ivosidenib with ondansetron due to an increased risk of QT prolongation.

If concomitant use is unavoidable, monitor ECGs for QTc prolongation and monitor electrolytes; correct any electrolyte abnormalities as clinically appropriate.

An interruption of therapy and dose reduction of ivosidenib may be necessary if QT prolongation occurs. Prolongation of the QTc interval and ventricular arrhythmias have been reported in patients treated with ivosidenib.

Minor Ixabepilone is a weak inhibitor of P-glycoprotein Pgp. Ondansetron is a Pgp substrate, and concomitant use of ixabepilone with a Pgp substrate may cause an increase in ondansetron concentrations. Use caution if ixabepilone is coadministered with a Pgp substrate.

Major Caution is advised when administering ketoconazole with drugs that are known to prolong that QT interval and are metabolized by CYP3A4, such as ondansetron. Both ondansetron and ketoconazole are associated with QT prolongation; coadministration may increase this risk.

In addition, coadministration of ketoconazole a potent CYP3A4 inhibitor with ondansetron a CYP3A4 substrate may result in elevated ondansetron plasma concentrations and an increased risk for adverse events, including QT prolongation.

Major Monitor serum electrolytes and ECG for evidence of QT prolongation if coadministration of ondansetron and lapatinib is necessary. Lapatinib has been associated with concentration-dependent QT prolongation; ventricular arrhythmias and TdP have been reported in postmarketing experience.

Correct hypokalemia or hypomagnesemia prior to lapatinib administration. Moderate Caution and close monitoring of ondansetron-associated adverse reactions is advised with concomitant administration of ledipasvir. Ondansetron is a substrate of the drug transporter P-glycoprotein P-gp ; ledipasvir is a P-gp inhibitor. Taking these drugs together may increase ondansetron plasma concentrations. Major If ondansetron and lenvatinib must be coadministered, ECG monitoring is recommended.

QT prolongation was reported during clinical trials of lenvatinib. Major Androgen deprivation therapy e. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with leuprolide include ondansetron. Major If ondansetron and levofloxacin must be coadministered, ECG monitoring is recommended. Levofloxacin has been associated with a risk of QT prolongation and TdP.

Although extremely rare, TdP has been reported during postmarketing surveillance of levofloxacin. Severe Rarely and predominantly reported with intravenous ondansetron, transient ECG changes including QT prolongation have occurred.

Drugs which have been established to have a causal association with QT prolongation and TdP torsade de pointe and are contraindicated for use with ondansetron include levomethadyl. Major Because of the potential risk and severity of serotonin syndrome, use caution when administering ondansetron with other drugs that have serotonergic properties such as levomilnacipran. Major Because of the potential risk and severity of serotonin syndrome, use caution when administering ondansetron with other drugs that have serotonergic properties such as linezolid.

Major Ondansetron and lithium are associated with QT prolongation. Coadministration may increase the risk of QT prolongation; therefore, ondansetron and lithium should be coadministered with caution and close monitoring. Because of the potential risk and severity of serotonin syndrome, use caution when administering ondansetron with other drugs that have serotonergic properties such as lithium.

Moderate Moderate to significant dietary sodium changes, or changes in sodium and fluid intake, may affect lithium excretion. Systemic sodium chloride administration may result in increased lithium excretion and therefore, decreased serum lithium concentrations. In addition, high fluid intake may increase lithium excretion. For patients receiving sodium-containing intravenous fluids, symptom control and lithium concentrations should be carefully monitored.

It is recommended that patients taking lithium maintain consistent dietary sodium consumption and adequate fluid intake during the initial stabilization period and throughout lithium treatment. Supplemental oral sodium and fluid should be only be administered under careful medical supervision.

Lofexidine prolongs the QT interval. In addition, there are postmarketing reports of TdP. Moderate The coadministration of ondansetron with diuretics associated with hypokalemia could increase the risk of QT prolongation. Potassium levels should be within the normal range prior to and during therapy with ondansetron. Major Coadminister loperamide and ondansetron together with caution and monitor the ECG.

At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes TdP , and cardiac arrest. Ondansetron has also been associated with an increased risk of QT prolongation and TdP.

Risk for QT prolongation increases with increased dosage, and a 32 mg IV dose of ondansetron must no longer be used for the prevention of chemotherapy-induced nausea and vomiting. Major Due to the potential for QT prolongation and torsade de pointes TdP , caution is advised when administering lopinavir; ritonavir with ondansetron.

Lopinavir; ritonavir is associated with QT prolongation. Minor Lumacaftor; ivacaftor may reduce the efficacy of ondansetron by decreasing its systemic exposure; however, based on available data, no ondansetron dosage adjustment is recommended. Lumacaftor is a strong CYP3A inducer. Major Avoid concurrent administration of macimorelin with drugs that prolong the QT interval, such as ondansetron.

Use of these drugs together may increase the risk of developing torsade de pointes-type ventricular tachycardia. Sufficient washout time of drugs that are known to prolong the QT interval prior to administration of macimorelin is recommended.

Treatment with macimorelin has been associated with an increase in the corrected QT QTc interval. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , ondansetron and maprotiline should be used together cautiously.

Maprotiline has been reported to prolong the QT interval, particularly in overdose or with higher-dose prescription therapy elevated serum concentrations. Cases of long QT syndrome and torsade de pointes TdP tachycardia have been described with maprotiline use, but rarely occur when the drug is used alone in normal prescribed doses and in the absence of other known risk factors for QT prolongation.

Limited data are available regarding the safety of maprotiline in combination with other QT-prolonging drugs. There is evidence that the use of halofantrine after mefloquine causes a significant lengthening of the QTc interval. Mefloquine alone has not been reported to cause QT prolongation. However, due to the lack of clinical data, mefloquine should be used with caution in patients receiving drugs that prolong the QT interval.

Drugs which have been established to have a causal association with QT prolongation and TdP torsade de pointe and are contraindicated for use with ondansetron include mesoridazine. No dosage adjustment is needed in elderly patients. Hepatic Impairment 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 significant 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. Renal Impairment No dosage adjustment is recommended for patients with any degree of renal impairment mild, moderate, or severe. There is no experience beyond first-day administration of ondansetron [see Clinical Pharmacology 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. Patients should be managed with appropriate supportive therapy. In addition to the adverse reactions listed above, the following adverse reactions have been described in the setting of ondansetron overdose: Hypotension and faintness occurred in a patient that took 48 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, 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.

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