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If you are sensitive to or have ever had an allergic reaction to ondansetron hydrochloride, you should not take this medication. If drugs similar to Zofran have given you a reaction, Zofran may cause one too. Any medication taken in excess can have serious consequences. Tramadol: Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol. There are, however, no adequate and well-controlled studies in pregnant women.
Possible Food And Drug Interactions When Taking ZofranThe dosage recommendation is the same as for the general population. Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. On the basis of available data, no dosage adjustment is recommended for patients on these drugs. Phenytoin, Carbamazepine, and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. OverdosageIf you suspect an overdose, seek medical attention immediately. Each 4-mg and 8-mg orally disintegrating tablet contains less than 0.03 mg phenylalanine. Patients should be instructed not to remove Zofran ODT Tablets from the blister until just prior to dosing. The tablet should not be pushed through the foil. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs. Chemotherapy: Tumor response to chemotherapy in the P-388 mouse leukemia model is not affected by ondansetron. It is not known whether ondansetron is excreted in human milk. Zofran PrecautionsCarcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 and 30 mg/kg/day, respectively. Teratogenic Effects : Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of Zofran. The adverse events in Table 7 have been reported in greater than 5% of patients receiving Zofran Tablets at a dosage of 16 mg orally in clinical trials. Zofran Adverse ReactionsThe adverse events in Table 5 have been reported in greater than 5% of adult patients receiving a single 24-mg Zofran Tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose greater than 50 mg/m). The adverse events reported in patients receiving Zofran Tablets and concurrent radiotherapy were similar to those reported in patients receiving Zofran Tablets and concurrent chemotherapy. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events. |
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