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Informe sobre ondansetron. Hiperemesis gravídica
From: Jorge Renzi (jrenzi@satlink.com)
Sun Sep 22 16:29:55 2002
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Queridos amigos: les envío información sobre el ondansetron y su empleo durante la gestación. Como verán es una droga Categoria B que con limitaciones y en caso de no responder a la terapéutica corriente se puede utilizar durante la gestación.Siempre en estos casos tenemos que balancear riesgos y beneficios. Pero en el caso com hace referencia el colega sería una droga de elección.
Saludos
Dr. Jorge Renzi
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
PRECAUTIONS
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 distention.
Drug Interactions
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, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of ondansetron. On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs. 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.
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 per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of ondansetron up to 15 mg/kg per day did not affect fertility or general reproductive performance of male and female rats.
Pregnancy
Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day 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.
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.
Pediatric Use
Little information is available about dosage in pediatric patients under 2 years of age (see DOSAGE AND ADMINISTRATION section for use in pediatric patients 4 to 18 years of age receiving cancer chemotherapy or for use in pediatric patients 2 to 12 years of age receiving general anesthesia).
Use in Elderly Patients
Dosage adjustment is not needed in patients over the age of 65 (see CLINICAL PHARMACOLOGY). Prevention of nausea and vomiting in elderly patients was no different than in younger age-groups.
TABLETS
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.
Use in Surgical Patients
The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.
Pediatric Use
Little information is available about dosage in children 4 years of age or younger (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION sections for use in children 4 to 18 years of age).
Use in Elderly Patients
Dosage adjustment is not needed in patients over the age of 65 (see CLINICAL PHARMACOLOGY). Prevention of nausea and vomiting in elderly patients was no different than in younger age-groups.
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