Ondansetron/Zofran ODT Oral Tab Orally Dis: 4mg, 8mg Zuplenz Oral Film: 4mg, 8mg .
This website also contains material copyrighted by 3rd parties. IMMEDIATELY place the ZOFRAN ODT tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.Methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy. Oral administration of ondansetron up to 15 mg/kg per day (approximately 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area) did not affect fertility or general reproductive performance of male and female rats.In 2 randomized, double-blind, monotherapy trials, a single 24-mg oral dose of ZOFRAN was superior to a relevant historical placebo control in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/mThe first trial compared oral doses of ondansetron 24 mg as a single dose, 8 mg every 8 hours for 2 doses, and 32 mg as a single dose in 357 adult cancer patients receiving chemotherapy regimens containing cisplatin greater than or equal to 50 mg/mIn the same trial, 56% of patients receiving a single 24-mg oral dose of ondansetron experienced no nausea during the 24-hour trial period, compared with 36% of patients in the oral ondansetron 8-mg twice-a-day group (In a second trial, efficacy of a single 24-mg oral dose of ZOFRAN for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/mA randomized, placebo-controlled, double-blind trial was conducted in the US in 67 patients receiving a cyclophosphamide-based chemotherapy regimen containing doxorubicin.
A causal relationship to therapy with ZOFRAN was unclear in many cases.The most common adverse reactions reported in greater than or equal to 4% of 300 adults receiving a single 24-mg dose of ZOFRAN orally in 2 trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy (cisplatin greater than or equal to 50 mg/mThe 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. Adults. Contact the applicable plan Dosage Forms & Strengths ophthalmic solution (Rx) 0.1% (Alphagan P) 0.15% (Alphagan P, Qoliana) ophthalmic solution (OTC) 0.025% (Lumify) Elevated Intraocular Pressure. Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron.Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 mg/kg per day and 30 mg/kg per day, respectively (approximately 4 and 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area).Ondansetron was not mutagenic in standard tests for mutagenicity. Adult Pediatric. Table 1: Adult Recommended Dosage Regimen for Prevention of Nausea and VomitingFor single high-dose fraction radiotherapy to the abdomen:For daily fractionated radiotherapy to the abdomen:Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting[see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]We comply with the HONcode standard for trustworthy health information -
Antiemetic drugs are frequently used to treat vomiting in infants and children with gastroenteritis. In 2 trials, the response rates to ZOFRAN 4 mg three times a day in patients younger than 12 years was similar to ZOFRAN 8 mg three times daily in patients 12 to 18 years. IMMEDIATELY place the ZOFRAN ODT tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. This may reflect some reduction of first-pass metabolism at higher oral doses.Plasma protein binding of ondansetron as measured in vitro was 70% to 76% over the concentration range of 10 to 500 ng/mL. 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 6In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/day, respectively, during the period of organogenesis. <>
These highlights do not include all the information needed to use ZOFRAN TABLETS, ZOFRAN ODT, and ZOFRAN ORAL SOLUTION safely and effectively. 3 0 obj
Each ZOFRAN ODT tablet also contains the inactive ingredients aspartame, gelatin, mannitol, methylparaben sodium, propylparaben sodium, and strawberry flavor.
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