Ondansetron
Zofran ® |
| Usual
Diluents |
| D5W,
NS |
| Standard
Dilutions [Amount of drug]
[Infusion volume] [Infusion rate] |
| [All
doses] [50 ml] [15 min] |
|
| Stability
/ Miscellaneous |
EXP: 2
DAYS (RT/REF).
DOSAGE AND ADMINISTRATION
Prevention of Chemotherapy-Induced Nausea and
Vomiting:
Adult Dosing: The recommended I.V dosage of
ondansetron injection, USP for adults is a single
32 mg dose or three 0.15 mg/kg doses. A single 32
mg dose is infused over 15 minutes beginning 30
minutes before the start of emetogenic
chemotherapy. The recommended infusion rate should
not be exceeded.
With the three-dose (0.15 mg/kg) regimen, the
first dose is infused over 15 minutes beginning 30
minutes before the start of emetogenic
chemotherapy. Subsequent doses (0.15 mg/kg) are
administered 4 and 8 hours after the first dose of
ondansetron injection, USP.
Ondansetron injection, USP should not be mixed
with solutions for which physical and chemical
compatibility have not been established. In
particular, this applies to alkaline solutions as
precipitate may form.
Vial: DILUTE BEFORE USE FOR PREVENTION OF
CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.
Ondansetron injection, USP should be diluted in 50
mL of 5% dextrose injection or 0.9% sodium
chloride injection before administration.
Prevention of Postoperative Nausea and Vomiting:
Adult Dosing: The recommended I.V. dosage
of ondansetron injection, USP for adults is 4 mg
undiluted administered intravenously in not less
than 30 seconds, preferably over 2 to 5 minutes,
immediately before induction of anesthesia, or
postoperatively if the patient experiences nausea
and/or vomiting occurring shortly after surgery.
Alternatively 4 mg undiluted may be administered
intramuscularly as a single injection for adults.
While recommended as a fixed dose for patients
weighing more than 40 kg, few patients above 80 kg
have been studied. In patients who do not achieve
adequate control of postoperative nausea and
vomiting following a single, prophylactic,
pre-induction I.V. dose of ondansetron 4 mg,
administration of a second I.V. dose of 4 mg
ondansetron postoperatively does not provide
additional control of nausea and vomiting.
Vial: REQUIRES NO DILUTION FOR ADMINISTRATION FOR
POSTOPERATIVE NAUSEA AND VOMITING.
Dosage Adjustment for
Patients with Impaired Renal Function:
The dosage recommendation is the same as for the
general population. There is no experience beyond
the first-day administration of ondansetron.
Dosage Adjustment for
Patients with Impaired Hepatic Function:
In patients with severe hepatic impairment
(Child-Pugh2 score of 10 or greater), a single
maximal daily dose of 8 mg to be infused over 15
minutes beginning 30 minutes before the start of
the emetogenic chemotherapy is recommended. There
is no experience beyond first-day administration
of ondansetron.
Stability:
Ondansetron injection, USP is stable at room
temperature under normal lighting conditions for
48 hours after dilution with the following I.V.
fluids: 0.9% sodium chloride injection, 5 %
dextrose injection, 5% dextrose and 0.9% sodium
chloride injection, 5% dextrose and 0.45% sodium
chloride injection, and 3% sodium chloride
injection.
Although ondansetron injection, USP is chemically
and physically stable when diluted as recommended,
sterile precautions should be observed because
diluents generally do not contain preservative.
After dilution, do not use beyond 24 hours.
Note: Parenteral drug products should be inspected
visually for particulate matter and discoloration
before administration whenever solution and
container permit.
Precaution: Occasionally, ondansetron precipitates
at the stopper/vial interface in vials stored
upright. Potency and safety are not affected. If a
precipitate is observed, resolubilize by shaking
the vial vigorously.
HOW SUPPLIED
ONDANSETRON INJECTION. USP, 2 mg/mL, is supplied
as follows:
NDC 62778-027-01 2-mL single-dose vials (Carton of
5)
NDC 62778-028-01 20-mL multidose vial (Carton of
1)
Store between 20° and 25°C (68° and 77°F).
[See USP Controlled Room Temperature]. Protect
from light.
Manufactured by:
HIKMA FARMACêUTICA (PORTUGAL), S.A.
Estrada do Rio da MÒ, n0 8, 8A e 8B - Fervenca,
2705 - 906 Terrugem SNT
PORTUGAL
for:
WEST-WARD PHARMACEUTICAL Corp.
465 Industrial Way West
EATONTOWN NJ 07724
USA
Iss.: Sept.2006 |
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