established.
Neonates
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Hepatic Impairment
No dosage adjustments are needed.
Renal Impairment
No dosage adjustments are needed.
ADMINISTRATION
Oral Administration
May be administered without regard to meals.
For pediatric patients, dolasetron injection may be mixed in apple or apple-grape juice for oral dosing. The diluted product may be kept for up to 2 hours at room temperature. If the IV injection is used for oral administration in children, the dose is the same as for the tablets.
Injectable Administration
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
Dolasetron may be administered by direct IV injection or as an intravenous infusion.
Direct IV injection
Administer IV at a rate not to exceed 100 mg over 30 seconds.
Intravenous infusion
Dilute dose in a compatible IV solution (0.9% Sodium Chloride , 5% Dextrose, 5% Dextrose and 0.45% Sodium Chloride, 5% Dextrose and Lactated Ringer's, Lactated Ringer's, and mannitol 10% injection) to 50 mL.
Infuse over a period of 15 minutes.
Diluted dolasetron is stable for up to 24 hours when stored under normal lighting conditions at room temperature, and for up to 48 hours under refrigeration.
STORAGE
Anzemet:
- Protect from light
- Store at controlled room temperature (between 68 and 77 degrees F)
CONTRAINDICATIONS / PRECAUTIONS
Dolasetron hypersensitivity, granisetron hypersensitivity, ondansetron hypersensitivity, palonosetron hypersensitivity
Do not use dolasetron in patients with a known dolasetron hypersensitivity. Although cross-sensitivity reactions have been reported in patients who have received other 5-HT3 receptor antagonists, these reactions have not been seen with dolasetron. Nevertheless, use dolasetron with caution in patients with a known hypersensitivity to related drugs (e.g., granisetron hypersensitivity, palonosetron hypersensitivity, or ondansetron hypersensitivity). Furthermore, it has been hypothesized that antagonism at serotonin (5HT) receptors, and the subsequent increased concentrations of serotonin, increase the risk of developing bronchospasm and/or vasoconstriction. There have been several reports of anaphylactic/anaphylactoid reactions associated with the use of drugs in this class. It is not clear at this time if these reactions are due to the use of the serotonin antagonist alone or due to a drug interaction between the serotonin antagonist and a chemotherapeutic agent. Nevertheless, clinicians should not overlook this possibility.
Alcoholism, atrial fibrillation, bradycardia, cardiac arrhythmias, cardiac disease, coronary artery disease, diabetes mellitus, females, heart failure, hepatic disease, hypertension, hypocalcemia, hypokalemia, hypomagnesemia, long QT syndrome, malnutrition, myocardial infarction, nausea/vomiting, QT prolongation, renal impairment, sick sinus syndrome, thyroid disease
Dolasetron can cause dose-dependent ECG interval changes (PR and QTc prolongation and QRS widening), second or third degree atrioventricular block (AV block), cardiac arrest and serious ventricular arrhythmias. In December 2010, the FDA announced that because of the risk of QT prolongation from increased drug exposure, dolasetron injection is contraindicated for use for the prevention |
