children and adolescents taking dolasetron. No efficacy information has been collected in the pediatric postoperative nausea/vomiting studies. There is no experience in neonates, infants, or children under 2 years of age.
Geriatric
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Because dolasetron can cause QT interval prolongation, geriatric patients taking dolasetron may be at increased risk for serious abnormal cardiac rhythms. Therefore, cautious administration and careful monitoring, including electrocardiogram (ECG) monitoring, is recommended. Also, in controlled clinical trials in the prevention of chemotherapy-induced nausea and vomiting, 723 (32%) of 2264 patients were 65 years of age or older. Of the 723 elderly patients in the trial, 563 received oral dolasetron. No differences in safety or effectiveness have been observed between elderly and younger patients. Controlled clinical studies in the prevention and treatment of post-operative nausea and vomiting (PONV) did not include sufficient numbers of patients aged 65 years or older. Only 57 (2%) geriatric patients out of 3289 total patients participated in the controlled PONV trials eva luating differences between the elderly and younger patients. Other reported clinical experiences have not identified differences in responses between geriatric and younger patients.
Pregnancy
Dolasetron has been classified as FDA pregnancy risk category B. Animal studies have not revealed any teratogenic effects associated with dolasetron. There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Other alternatives exist. The American College of Obstetricians and Gynecologists recommends the use of ondansetron for the treatment of nausea and vomiting of pregnancy in patients who are dehydrated, requiring IV fluid replacement, and have failed other therapies.
Breast-feeding
According to the manufacturer, it is not known whether dolasetron is excreted in human milk. However, because of its low molecular weight, transfer into breast milk should be expected. Caution should be exercised when administering dolasetron to a breast-feeding woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
ADVERSE REACTIONS
Severe
oliguria / Early / 2.6-2.6
bradycardia / Rapid / 0-2.0
atrial fibrillation / Early / 0-2.0
atrial flutter / Early / 0-2.0
pancreatitis / Delayed / 0-2.0
renal failure (unspecified) / Delayed / 0-2.0
angioedema / Rapid / 0-2.0
anaphylactoid reactions / Rapid / 0-2.0
bronchospasm / Rapid / 0-2.0
torsade de pointes / Rapid / Incidence not known
ventricular fibrillation / Early / Incidence not known
AV block / Early / Incidence not known
cardiac arrest / Early / Incidence not known
ventricular tachycardia / Early / Incidence not known
serotonin syndrome / Delayed / Incidence not know
Moderate
hypotension / Rapid / 0-5.3
sinus tachyc |
