The major side-ef ects are constipation, headache and diarrhoea
but they are mild to moderate in nature. In chemotherapy-induced
nausea and vomiting, rash has occurred in approximately 1% of
Seton (ondansetron) is a potent, highly selective 5-HT3
patients receiving ondansetron. Sensation of warmth or flushing,
(serotonin) receptor antagonist. Due to antagonism of 5-HT3
hiccup, occasional alterations of in liver enzymes, hypersensitivity
(serotonin) receptor on neurons located both in the central and
reactions, involuntary movements, seizures, chest pain,
peripheral nervous system, it inhibits the triggering of vomiting
arrythmias, hypotension and bradycardia are also reported.
reflex. It has proven to be highly ef icacious in the treatment of
chemotherapy and radiotherapy induced nausea and vomiting. COTRAINDICATION
Ondansetron is contraindicated in patients with a history of
hypersensitivity to ondansetron and other selective 5-HT
Seton is indicated in
l Prevention and treatment of nausea and vomiting induced by
l Prevention of nausea and vomiting associated with radiotherapy.
It should be used cautiously in case of moderate or severe
l Prevention of postoperative nausea and vomiting.
hepatic impairment. It is not a drug that stimulates gastric or
intestinal peristalsis. It should not be used instead of nasogastric
DOSAGE AND ADMINISTRATION
Prevention of nausea and vomiting associated with highly
USE IN PREGNANCY AND LACTATION Adult use: The recommended adult oral dose is 24 mg to be
Pregnancy category B. There are no adequate and wel -control ed
administered 30 minutes before the start of single-day highly
studies in pregnant women. This drug should be used during
emetogenic chemotherapy, then fol owed by 8 mg oral y every 12
pregnancy only if clearly needed. It is not known whether
ondansetron is excreted in human milk. Caution should be
Prevention of nausea and vomiting associated with moderately
exercised when ondansetron is administered to nursing women. Adult dose: 8 mg oral y 30 minutes before treatment; then DRUG INTERACTION
fol owed by 8 mg every 12 hours for up to 5 days or up to 1 to 2
Ondansetron is metabolized by hepatic cytochrome P-450
days after completion of the chemotherapy.
metabolizing enzymes. So, inducers or inhibitors of these
Pediatric use: For pediatric patients (4 to 11 years), the dose is 4
enzymes may change the clearance and hence, the half-life of
Prevention of nausea and vomiting associated with radiotherapy:
Adult dose: The recommended oral dose is 8 mg given three PACKAGING Seton 8 Tablet: Box containing 3 x 10 tablets in blister pack.
For total body irradiation, 8 mg should be administered 1 to 2
Each film-coated tablet contains ondansetron hydrochloride
hours before each fraction of radiotherapy administered each day.
dihydrate USP which is equivalent to ondansetron 8 mg.
For single high-dose fraction radiotherapy to the abdomen, 8 mg
should be administered 1 to 2 hours before radiotherapy, with
subsequent doses every 8 hours after the first dose up to 1 to 2
Keep in a dry place away from light and heat.
days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen, 8 mg should
be administered 1 to 2 hours before radiotherapy, with
subsequent doses every 8 hours after the first dose for each day
Adult use: The recommended dose is 16 mg given 1 hour before
induction of anesthesia or 8 mg 1 hour before anesthesia fol owed
by 8 mg at intervals of 8 hours for 2 further doses. In patient with
severe hepatic impairment, a total daily dose of 8 mg should not
INSTITUTO DE INVES TIGACIONES LEGISLATIVAS UNIDAD DE INFORMATICA LEGISLATIVA LEY DEL REGIS TRO PUBLICO DE LA PROPIEDAD DEL ESTADO DE SAN LUIS Fecha de Aprobación: Fecha de Promulgación: Fecha de Publicación: Estimado Usuario: La edición de las disposiciones jurídicas del ámbito Federal o Estatal, en medios electrónicos no representa una versión o
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