Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3427
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ZOFRAN (Tablet)
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Instructions for Use/Handling ZOFRAN
ODT Orally Disintegrating Tablets: Do not attempt to push ZOFRAN ODT Tablets through
the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister
and GENTLY remove the tablet. IMMEDIATELY place
the ZOFRAN ODT Tablet on top of the tongue where it will dissolve
in seconds, then swallow with saliva. Administration with liquid is
not necessary.<br/>Prevention of Nausea and Vomiting
Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of ZOFRAN is 24 mg
given as three 8-mg tablets administered 30 minutes before the
start of single-day highly emetogenic chemotherapy, including cisplatin���50 mg/m. Multiday, single-dose administration
of a 24 mg dosage has not been studied.<br/>Pediatric Use: There is no experience with the use of a 24 mg
dosage in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the
general population.<br/>Prevention of Nausea and Vomiting
Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8-mg ZOFRAN
Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls
equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given
twice a day. 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 ZOFRAN Tablet or one 8-mg
ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg
of ondansetron) of ZOFRAN Oral Solution should be administered twice
a day (every 12 hours) for 1 to 2 days after completion
of chemotherapy. PediatricUse: 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 ZOFRAN Tablet or one 4-mg ZOFRAN ODT
Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of
ondansetron) of ZOFRAN Oral Solution 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. One 4-mg ZOFRAN Tablet or one 4-mg ZOFRAN ODT
Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of
ondansetron) of ZOFRAN Oral Solution should be administered 3 times
a day (every 8 hours) for 1 to 2 days after completion of
chemotherapy.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Prevention of Nausea and Vomiting
Associated With Radiotherapy, Either Total Body Irradiation, or Single
High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8-mg ZOFRAN Tablet
or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent
to 8 mg of ondansetron) of ZOFRAN Oral Solution given 3 times
a day. For total
body irradiation, one 8-mg ZOFRAN Tablet
or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent
to 8 mg of ondansetron) of ZOFRAN Oral Solution
should be administered 1 to 2 hours before each fraction of radiotherapy
administered each day. For single high-dose fraction radiotherapy to
the abdomen, one 8-mg ZOFRAN Tablet or
one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent
to 8 mg of ondansetron) of ZOFRAN Oral Solution
should be administered 1 to 2 hours before radiotherapy, with
subsequent doses every 8 hours after the first dose for 1to
2 days after completion of radiotherapy. For daily fractionated radiotherapy
to the abdomen, one 8-mg ZOFRAN Tablet
or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent
to 8 mg of ondansetron) of ZOFRAN Oral Solution
should be administered 1 to 2 hours before radiotherapy, with
subsequent doses every 8 hours after the first dose for each
day radiotherapy is given.<br/>Pediatric Use: There is no experience with the use of ZOFRAN Tablets,
ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the prevention of radiation-induced
nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the
general population.<br/>Postoperative Nausea and Vomiting: : The recommended
dosage is 16 mg given as two 8-mg ZOFRAN Tablets
or two 8-mg ZOFRAN ODT Tablets or 20 mL (4 teaspoonfuls
equivalent to 16 mg of ondansetron) of ZOFRAN Oral Solution 1 hour before induction of anesthesia.<br/>Pediatric Use: There is no experience with the use of
ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the
prevention of postoperative nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Dosage Adjustment for Patients With
Impaired Renal Function: The dosage recommendation is the same as for the
general population. There is no experience beyond first-day administration
of ondansetron.<br/>Dosage Adjustment for Patients With
Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pughscore of 10 or greater), clearance is reduced and apparent
volume of distribution is increased with a resultant increase in plasma
half-life. In such patients, a total daily dose of 8 mg should
not be exceeded.
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The active ingredient in ZOFRAN Tablets and ZOFRAN
Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate,
the racemic form of ondansetron and a selective blocking agent of
the serotonin 5-HTreceptor type. Chemically it is (��)
1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one,
monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is
CHNO���HCl���2HO, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is
soluble in water and normal saline. The active
ingredient in ZOFRAN ODT Orally Disintegrating Tablets is ondansetron
base, the racemic form of ondansetron, and a selective blocking agent
of the serotonin 5-HTreceptor type. Chemically it is
(��) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one.
It has the following structural formula: The empirical formula is CHNO representing a molecular weight of 293.4. Each 4-mg ZOFRAN Tablet for oral administration contains ondansetron
HCl dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ZOFRAN
Tablet for oral administration contains ondansetron HCl dihydrate
equivalent to 8 mg of ondansetron. Each tablet also contains
the inactive ingredients lactose, microcrystalline cellulose, pregelatinized
starch, hypromellose, magnesium stearate, titanium dioxide, triacetin,
and iron oxide yellow (8-mg tablet only). Each
4-mg ZOFRAN ODT Orally Disintegrating Tablet for oral administration
contains 4 mg ondansetron base. Each 8-mg ZOFRAN ODT Orally Disintegrating
Tablet for oral administration contains 8 mg ondansetron base.
Each ZOFRAN ODT Tablet also contains the inactive ingredients aspartame,
gelatin, mannitol, methylparaben sodium, propylparaben sodium, and
strawberry flavor. ZOFRAN ODT Tablets are a freeze-dried, orally administered
formulation of ondansetron which rapidly disintegrates on the tongue
and does not require water to aid dissolution or swallowing. Each 5 mL of ZOFRAN Oral Solution
contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg
of ondansetron. ZOFRAN Oral Solution contains the
inactive ingredients citric acid anhydrous, purified water, sodium
benzoate, sodium citrate, sorbitol, and strawberry flavor.
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Pharmacodynamics: Ondansetron is a selective 5-HTreceptor
antagonist. While its mechanism of action has not been fully characterized,
ondansetron is not a dopamine-receptor antagonist. Serotonin receptors
of the 5-HTtype are present both peripherally on vagal
nerve terminals and centrally in the chemoreceptor trigger zone of
the area postrema. It is not certain whether ondansetron's
antiemetic action is mediated centrally, peripherally, or in both
sites. However, cytotoxic chemotherapy appears to be associated with
release of serotonin from the enterochromaffin cells of the small
intestine. In humans, urinary 5-HIAA (5-hydroxyindoleacetic acid)
excretion increases after cisplatin administration in parallel with
the onset of emesis. The released serotonin may stimulate the vagal
afferents through the 5-HTreceptors and initiate the
vomiting reflex. In animals, the emetic response
to cisplatin can be prevented by pretreatment with an inhibitor of
serotonin synthesis, bilateral abdominal vagotomy and greater splanchnic
nerve section, or pretreatment with a serotonin 5-HTreceptor
antagonist. In normal volunteers, single intravenous
doses of 0.15 mg/kg of ondansetron had no effect on esophageal
motility, gastric motility, lower esophageal sphincter pressure, or
small intestinal transit time. Multiday administration of ondansetron
has been shown to slow colonic transit in normal volunteers. Ondansetron
has no effect on plasma prolactin concentrations. 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.<br/>Pharmacokinetics: Ondansetron is well absorbed from the
gastrointestinal tract and undergoes some first-pass metabolism. Mean
bioavailability in healthy subjects, following administration of a
single 8-mg tablet, is approximately 56%. Ondansetron systemic exposure does not increase proportionately
to dose. AUC from a 16-mg tablet was 24% greater than predicted from
an 8-mg tablet dose. This may reflect some reduction of first-pass
metabolism at higher oral doses. Bioavailability is also slightly
enhanced by the presence of food but unaffected by antacids. Ondansetron is extensively metabolized in humans, with
approximately 5% of a radiolabeled dose recovered as the parent compound
from the urine. The primary metabolic pathway is hydroxylation on
the indole ring followed by subsequent glucuronide or sulfate conjugation.
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. In vitro metabolism studies have shown that ondansetron is a substrate
for human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6,
and CYP3A4. In terms of overall ondansetron turnover, CYP3A4 played
the predominant role. Because of the multiplicity of metabolic enzymes
capable of metabolizing ondansetron, it is likely that inhibition
or loss of one enzyme (e.g., CYP2D6 genetic deficiency) will be compensated
by others and may result in little change in overall rates of ondansetron
elimination. Ondansetron elimination may be affected by cytochrome
P-450 inducers. In a pharmacokinetic study of 16 epileptic patients
maintained chronically on CYP3A4 inducers, carbamazepine, or phenytoin,
reduction in AUC, C, and Tof ondansetron
was observed.This resulted in a significant increase
in clearance. However, on the basis of available data, no dosage adjustment
for ondansetron is recommended (see PRECAUTIONS:
Drug Interactions). In humans, carmustine,
etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. Gender differences were shown in the disposition of ondansetron
given as a single dose. The extent and rate of ondansetron's absorption
is greater in women than men. Slower clearance in women, a smaller
apparent volume of distribution (adjusted for weight), and higher
absolute bioavailability resulted in higher plasma ondansetron levels.
These higher plasma levels may in part be explained by differences
in body weight between men and women. It is not known whether these
gender-related differences were clinically important. More detailed
pharmacokinetic information is contained in Tables 1 and 2 taken from
2 studies. Table 1. Pharmacokinetics in
Normal Volunteers: Single 8-mg ZOFRAN Tablet Dose Table 2. Pharmacokinetics in Normal Volunteers:
Single 24-mg ZOFRAN Tablet Dose A reduction in clearance and increase in elimination
half-life are seen in patients over 75 years of age. In clinical
trials with cancer patients, safety and efficacy was similar in patients
over 65 years of age and those under 65 years of age; there
was an insufficient number of patients over 75 years of age to
permit conclusions in that age-group. No dosage adjustment is recommended
in the elderly. In patients with mild-to-moderate
hepatic impairment, clearance is reduced 2-fold and mean half-life
is increased to 11.6 hours compared to 5.7 hours in normals.
In patients with severe hepatic impairment (Child-Pughscore of 10 or greater), clearance is reduced 2-fold to 3-fold and
apparent volume of distribution is increased with a resultant increase
in half-life to 20 hours. In patients with severe hepatic impairment,
a total daily dose of 8 mg should not be exceeded. Due to the very small contribution (5%) of renal clearance
to the overall clearance, renal impairment was not expected to significantly
influence the total clearance of ondansetron. However, ondansetron
oral mean plasma clearance was reduced by about 50% in patients with
severe renal impairment (creatinine clearance<30 mL/min).
This reduction in clearance is variable and was not consistent with
an increase in half-life. No reduction in dose or dosing frequency
in these patients is warranted. Plasma protein
binding of ondansetron as measured in vitro was 70% to 76% over the
concentration range of 10 to 500 ng/mL. Circulating drug also
distributes into erythrocytes. Four- and 8-mg
doses of either ZOFRAN Oral Solution or ZOFRAN ODT Orally Disintegrating
Tablets are bioequivalent to corresponding doses of ZOFRAN Tablets
and may be used interchangeably. One 24-mg ZOFRAN Tablet is bioequivalent
to and interchangeable with three 8-mg ZOFRAN Tablets.
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ZOFRAN Tablets, ZOFRAN ODT Orally Disintegrating
Tablets, and ZOFRAN Oral Solution are contraindicated for patients
known to have hypersensitivity to the drug.
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ZOFRAN Tablets, 4 mg (ondansetron HCl dihydrate
equivalent to 4 mg of ondansetron), are white, oval, film-coated
tablets engraved with "Zofran" on one side and "4" on the other in
daily unit dose packs of 3 tablets (NDC 0173-0446-04), bottles
of 30 tablets (NDC 0173-0446-00), and unit dose packs of 100 tablets
(NDC 0173-0446-02). Bottles:Store between 2��and 30��C (36��and
86��F). Protect from light.
Dispense in tight, light-resistant container as defined in the USP. Unit Dose Packs: Store between 2��and
30��C (36��and 86��F). Protect from light. Store blisters
in cartons. ZOFRAN Tablets, 8 mg (ondansetron
HCl dihydrate equivalent to 8 mg of ondansetron), are yellow,
oval, film-coated tablets engraved with "Zofran" on one side and "8"
on the other in daily unit dose packs of 3 tablets (NDC 0173-0447-04),
bottles of 30 tablets (NDC 0173-0447-00), and unit dose packs
of 100 tablets (NDC 0173-0447-02). Bottles:Store
between 2��and 30��C (36��and 86��F). Dispense in tight container as defined in the USP. Unit Dose Packs: Store between 2��and 30��C
(36��and 86��F). ZOFRAN ODT Orally
Disintegrating Tablets, 4 mg (as 4 mg ondansetron base)
are white, round and plano-convex tablets debossed with a���Z4���on one side in unit dose packs of 30 tablets (NDC 0173-0569-00). ZOFRAN ODT Orally Disintegrating Tablets, 8 mg (as
8 mg ondansetron base) are white, round and plano-convex tablets
debossed with a���Z8���on one side in unit dose packs
of 10 tablets (NDC 0173-0570-04) and 30 tablets (NDC 0173-0570-00). Store between 2��and 30��C (36��and 86��F). ZOFRAN Oral Solution, a clear, colorless
to light yellow liquid with a characteristic strawberry odor, contains
5 mg of ondansetron HCl dihydrate equivalent to 4 mg of
ondansetron per 5 mL in amber glass bottles of 50 mL with
child-resistant closures (NDC 0173-0489-00). Store upright between 15��and 30��C (59��and 86��F). Protect from light. Store bottles upright in
cartons.
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General: Ondansetron is not a drug that stimulates gastric
or intestinal peristalsis. It should not be used instead of nasogastric
suction. The use of ondansetron in patients following abdominal surgery
or in patients with chemotherapy-induced nausea and vomiting may mask
a progressive ileus and/or gastric distension. Rarely and predominantly with intravenous ondansetron, transient
ECG changes including QT interval prolongation have been reported.<br/>Information for Patients: Phenylketonurics: Phenylketonuric patients should be informed that ZOFRAN ODT Orally
Disintegrating Tablets contain phenylalanine (a component of aspartame).
Each 4-mg and 8-mg orally disintegrating tablet contains<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. With
dry hands, the blister backing should be peeled completely off the
blister. The tablet should be gently removed and immediately placed
on the tongue to dissolve and be swallowed with the saliva. Peelable
illustrated stickers are affixed to the product carton that can be
provided with the prescription to ensure proper use and handling of
the product.<br/>Drug Interactions: Ondansetron does not itself appear to induce or
inhibit the cytochrome P-450 drug-metabolizing enzyme system of the
liver (see CLINICAL PHARMACOLOGY, Pharmacokinetics). 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.<br/>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. However, on the basis of available data, no dosage
adjustment for ondansetron is recommended for patients on these drugs.<br/>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.<br/>Chemotherapy: Tumor response to chemotherapy in the P-388 mouse
leukemia model is not affected by ondansetron. In humans, carmustine,
etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover study in 76 pediatric patients, I.V.
ondansetron did not increase blood levels of high-dose methotrexate.<br/>Use in Surgical Patients: The coadministration of ondansetron had no effect
on the pharmacokinetics and pharmacodynamics of temazepam.<br/>Carcinogenesis, Mutagenesis, Impairment
of Fertility: Carcinogenic 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. Ondansetron was not mutagenic in standard tests for
mutagenicity. Oral administration of ondansetron up to 15 mg/kg/day
did not affect fertility or general reproductive performance of male
and female rats.<br/>Pregnancy:<br/>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. There
are, however, no adequate and well-controlled studies in pregnant
women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only
if clearly needed.<br/>Nursing Mothers: Ondansetron is excreted in the breast milk of rats.
It is not known whether ondansetron is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised
when ondansetron is administered to a nursing woman.<br/>Pediatric Use: Little information is available about dosage in
pediatric patients 4 years of age or younger (see CLINICAL PHARMACOLOGY
and DOSAGE AND ADMINISTRATION sections for use in pediatric patients
4 to 18 years of age).<br/>Geriatric Use: Of the total number of subjects enrolled in cancer
chemotherapy-induced and postoperative nausea and vomiting in US-
and foreign-controlled clinical trials, for which there were subgroup
analyses, 938 were 65 years of age and over. No overall differences
in safety or effectiveness were observed between these subjects and
younger subjects, and 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. Dosage adjustment is not needed in patients over the age of 65
(see CLINICAL PHARMACOLOGY).
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There is no specific antidote for ondansetron overdose.
Patients should be managed with appropriate supportive therapy. 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. These doses are more than 10 times
the recommended daily dose. In addition to
the adverse events listed above, the following events have been described
in the setting of ondansetron overdose:���Sudden blindness���(amaurosis) of 2 to 3 minutes' duration plus severe constipation
occurred in 1 patient that was administered 72 mg of ondansetron
intravenously as a single dose. Hypotension (and faintness) occurred
in a patient that took 48 mg of ZOFRAN 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 events resolved completely.
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ondansetron hydrochloride
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ZOFRAN (Tablet)
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The following have been reported as adverse events
in clinical trials of patients treated with ondansetron, the active
ingredient of ZOFRAN. A causal relationship to therapy with ZOFRAN
has been unclear in many cases.<br/>Chemotherapy-Induced Nausea and Vomiting: The adverse events in Table 5 have been reported
in���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���50 mg/m). Table 5. Principal Adverse Events
in US Trials: Single Day Therapy With 24-mg ZOFRAN Tablets (Highly
Emetogenic Chemotherapy) The adverse events in Table 6 have been reported
in���5% of adults receiving either 8 mg of ZOFRAN Tablets
2 or 3 times a day for 3 days or placebo in 4 trials.
These patients were receiving concurrent moderately emetogenic chemotherapy,
primarily cyclophosphamide-based regimens. Table
6. Principal Adverse Events in US Trials: 3 Days of Therapy With 8-mg
ZOFRAN Tablets (Moderately Emetogenic Chemotherapy)<br/>Central Nervous System: There have been rare reports consistent with, but
not diagnostic of, extrapyramidal reactions in patients receiving
ondansetron.<br/>Hepatic: In 723 patients receiving cyclophosphamide-based
chemotherapy in US clinical trials, AST and/or ALT values have been
reported to exceed twice the upper limit of normal in approximately
1% to 2% of patients receiving ZOFRAN Tablets. 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, but symptomatic hepatic disease did
not occur. The role of cancer chemotherapy in these biochemical changes
cannot be clearly determined. There have been
reports of liver failure and death in patients with cancer receiving
concurrent medications including potentially hepatotoxic cytotoxic
chemotherapy and antibiotics. The etiology of the liver failure is
unclear.<br/>Integumentary: Rash has occurred in approximately 1% of patients
receiving ondansetron.<br/>Other: Rare cases of anaphylaxis, bronchospasm, tachycardia,
angina (chest pain), hypokalemia, electrocardiographic alterations,
vascular occlusive events, and grand mal seizures have been reported.
Except for bronchospasm and anaphylaxis, the relationship to ZOFRAN
was unclear.<br/>Radiation-Induced Nausea and Vomiting: 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.
The most frequently reported adverse events were headache, constipation,
and diarrhea.<br/>Postoperative Nausea and Vomiting: The adverse events in Table 7 have been reported
in���5% of patients receiving ZOFRAN Tablets at a dosage of
16 mg orally in clinical trials. With the exception of headache,
rates of these events were not significantly different in the ondansetron
and placebo groups. These patients were receiving multiple concomitant
perioperative and postoperative medications. Table 7. Frequency of Adverse Events From Controlled Studies With
ZOFRAN Tablets (Postoperative Nausea and Vomiting)<br/>Observed During Clinical Practice: In addition to adverse events reported from clinical
trials, the following events have been identified during post-approval
use of oral formulations of ZOFRAN. Because they are reported voluntarily
from a population of unknown size, estimates of frequency cannot be
made. The events have been chosen for inclusion due to a combination
of theirseriousness, frequency of reporting, or potential causal
connection to ZOFRAN.<br/>Cardiovascular: Rarely and predominantly with intravenous ondansetron,
transient ECG changes including QT interval prolongation have been
reported.<br/>General: Flushing. Rare cases of hypersensitivity reactions,
sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema,
bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor)
have also been reported. 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 Special Senses: 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.
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Hypersensitivity reactions have been reported in
patients who have exhibited hypersensitivity to other selective 5-HTreceptor antagonists.
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1. Prevention of nausea and vomiting associated with
highly emetogenic cancer chemotherapy, including cisplatin���50 mg/m. 2. Prevention of nausea and vomiting
associated with initial and repeat courses of moderately emetogenic
cancer chemotherapy. 3. Prevention of nausea
and vomiting associated with radiotherapy in patients receiving either
total body irradiation, single high-dose fraction to the abdomen,
or daily fractions to the abdomen. 4. Prevention
of postoperative nausea and/or vomiting. As with other antiemetics,
routine prophylaxis is not recommended for patients in whom there
is little expectation that nausea and/or vomiting will occur postoperatively.
In patients where nausea and/or vomiting must be avoided postoperatively,
ZOFRAN Tablets, ZOFRAN ODT Orally Disintegrating Tablets, and ZOFRAN
Oral Solution are recommended even where the incidence of postoperative
nausea and/or vomiting is low.
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ZOFRAN
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