Anzemet Tablets Drug Information
dolasetron mesylate
Drug Summary
CLASSES
Serotonin/5HT3 Antagonist Antiemetics/antinauseants
DEA CLASS
Rx
DESCRIPTION
Oral/intravenous antiemetic; 5-HT3 receptor antagonist
Oral tablet used for prevention of chemotherapy-induced nausea/vomiting; injection used for prevention and treatment of PONV
Risk of dose-dependent QT prolongation and torsades de pointes
COMMON BRAND NAMES
Anzemet
HOW SUPPLIED
Anzemet Oral Tab: 50mg, 100mg
DOSAGE & INDICATIONS
For chemotherapy-induced nausea/vomiting prophylaxis (CINV prophylaxis).
NOTE: In December 2010, the FDA announced that because of the risk of QT prolongation, dolasetron injection is longer indicated for chemotherapy-induced nausea/vomiting (CINV) prophylaxis.
Oral dosage
Adults
100 mg PO administered within 1 hour before chemotherapy.
Children 2-11 and Adolescents
1.8 mg/kg PO (not to exceed 100 mg) administered within 1 hour before chemotherapy.
For the treatment of post-operative nausea/vomiting (PONV).
Intravenous dosage
Adults
12.5 mg IV as a single dose. Administer when PONV presents.
Children >= 2 years and Adolescents
0.35 mg/kg IV (not to exceed 12.5 mg) as a single dose when PONV presents.
For post-operative nausea/vomiting (PONV) prophylaxis.
Intravenous dosage
Adults
12.5 mg IV, administered 15 minutes before the cessation of anesthesia. Routine prophylaxis is not recommended for all patients; however, in patients where nausea and/or vomiting must be avoided postoperatively, dolasetron is recommended even where the incidence of postoperative nausea and/or vomiting is low. Do not rechallenge a patient who has failed a previous trial of a 5-HT3 receptor antagonist with a repeat dose of dolasetron.
Children >= 2 years and Adolescents
0.35 mg/kg IV (not to exceed 12.5 mg), administered 15 minutes before the cessation of anesthesia. Routine prophylaxis is not recommended for all patients; however, in patients where nausea and/or vomiting must be avoided postoperatively, dolasetron is recommended even where the incidence of postoperative nausea and/or vomiting is low. Do not rechallenge a patient who has failed a previous trial of a 5-HT3 receptor antagonist with a repeat dose of dolasetron.
MAXIMUM DOSAGE
Adults
100 mg/dose PO; 12.5 mg/dose IV (for prevention/treatment of post-operative nausea/vomiting). Information on maximum total daily dose is unavailable.
Geriatric
100 mg/dose PO; 12.5 mg/dose IV (for prevention/treatment of post-operative nausea/vomiting). Information on maximum total daily dose is unavailable.
Adolescents
17 years: 100 mg/dose PO; 12.5 mg/dose IV (for prevention/treatment of post-operative nausea/vomiting). Information on maximum total daily dose is unavailable.
<= 16 years: For prevention/treatment of post-op nausea/vomiting, 0.35 mg/kg IV, not to exceed 12.5 mg/dose IV; for prevention of chemotherapy-induced nausea/vomiting, 1.8 mg/kg PO, not to exceed 100 mg/dose PO. Information on maximum total daily dose is unavailable.
Children
>= 2 years: For prevention/treatment of post-op nausea/vomiting, 0.35 mg/kg IV, not to exceed 12.5 mg/dose IV; for prevention of chemotherapy-induced nausea/vomiting, 1.8 mg/kg PO, not to exceed 100 mg/dose PO. Information on maximum total daily dose is unavailable.
< 2 years: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been |
