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INDICATIONS
AND USAGE
-Treatment of Gastroesophageal Reflux Disease
Associated With a History of Erosive Esophagitis:
PROTONIX I.V. for Injection is indicated for
short-term treatment (7 to 10 days) of patients
with gastroesophageal reflux disease (GERD) and a
history of erosive esophagitis.
Pathological Hypersecretion Associated with
Zollinger-Ellison Syndrome: PROTONIX I.V. for
Injection is indicated for the treatment of
pathological hypersecretory conditions associated
with Zollinger-Ellison Syndrome or other
neoplastic conditions.
| Prevention of rebleeding in peptic ulcer bleed (unlabeled
use): I.V.: 80 mg, followed by 8 mg/hour infusion for 72 hours. Note: A daily infusion of 40 mg does not raise gastric pH sufficiently to enhance coagulation in active GI bleeds. |
DOSAGE
AND ADMINISTRATION
PROTONIX I.V. for Injection may be administered
intravenously through a dedicated line or through
a Y-site. The intravenous line should be flushed
before and after administration of PROTONIX I.V.
for Injection with either 5% Dextrose Injection,
USP, 0.9% Sodium Chloride Injection, USP, or
Lactated Ringer's Injection, USP. When
administered through a Y-site, PROTONIX I.V. for
Injection is compatible with the following
solutions: 5% Dextrose Injection, USP, 0.9% Sodium
Chloride Injection, USP, or Lactated Ringer's
Injection, USP.
Midazolam HCl has
been shown to be incompatible with Y-site
administration of PROTONIX I.V. for Injection.
PROTONIX I.V. for Injection may not be compatible
with products containing zinc. When PROTONIX I.V.
for Injection is administered through a Y-site,
immediately stop use if precipitation or
discoloration occurs.
Parenteral drug
products should be inspected visually for
particulate matter and discoloration prior to and
during administration whenever solution and
container permit.
Treatment with
PROTONIX I.V. for Injection should be discontinued
as soon as the patient is able to be treated with
PROTONIX Delayed-Release Tablets. Also, data on
the safe and effective dosing for conditions other
than those described in INDICATIONS AND USAGE,
such as life-threatening upper gastrointestinal
bleeds, are not available. PROTONIX I.V. 40 mg
once daily does not raise gastric pH to levels
sufficient to contribute to the treatment of such
life-threatening conditions.
Parenteral routes of
administration other than intravenous are not
recommended.
No
dosage adjustment is necessary in patients with
renal impairment, hepatic impairment, or for
elderly patients. Doses higher than 40
mg/day have not been studied in hepatically-impaired
patients. No dosage adjustment is necessary in
patients undergoing hemodialysis.
Treatment of
Gastroesophageal Reflux Disease Associated With a
History of Erosive Esophagitis
The recommended adult dose is 40 mg
pantoprazole given once daily by intravenous
infusion for 7 to 10 days. Safety and efficacy of
PROTONIX I.V. for Injection as a treatment of
patients with GERD and a history of erosive
esophagitis for more than 10 days have not been
demonstrated (see INDICATIONS AND USAGE ).
Fifteen Minute Infusion
PROTONIX I.V. for Injection should be
reconstituted with 10 mL of 0.9% Sodium Chloride
Injection, USP, and further diluted (admixed) with
100 mL of 5% Dextrose Injection, USP, 0.9% Sodium
Chloride Injection, USP, or Lactated Ringer's
Injection, USP, to a final concentration of
approximately 0.4 mg/mL. The
reconstituted solution may be stored for up to 6
hours at room temperature prior to further
dilution. The admixed solution may be stored at
room temperature and must be used within 24 hours
from the time of initial reconstitution. Both the
reconstituted solution and the admixed solution do
not need to be protected from light.
PROTONIX I.V. for
Injection admixtures should be administered
intravenously over a period of approximately 15
minutes at a rate of approximately 7 mL/min.
Two Minute
Infusion
PROTONIX I.V. for Injection should be
reconstituted with 10 mL of 0.9% Sodium Chloride
Injection, USP, to a final concentration of
approximately 4 mg/mL. The reconstituted solution
may be stored for up to 24 hours at room
temperature prior to intravenous infusion and does
not need to be protected from light. PROTONIX I.V.
for Injection should be administered intravenously
over a period of at least 2 minutes.
Pathological
Hypersecretion Associated with Zollinger-Ellison
Syndrome The dosage of PROTONIX I.V. for
Injection in patients with pathological
hypersecretory conditions associated with
Zollinger-Ellison Syndrome or other neoplastic
conditions varies with individual patients. The
recommended adult dosage is 80 mg q12h. The
frequency of dosing can be adjusted to individual
patient needs based on acid output measurements.
In those patients who need a higher dosage, 80 mg
q8h is expected to maintain acid output below 10
mEq/h. Daily doses higher than 240 mg or
administered for more than 6 days have not been
studied. (See package insert Clinical Studies
section.) Transition from oral to I.V. and from
I.V. to oral formulations of gastric acid
inhibitors should be performed in such a manner to
ensure continuity of effect of suppression of acid
secretion. Patients with Zollinger-Ellison
Syndrome may be vulnerable to serious clinical
complications of increased acid production even
after a short period of loss of effective
inhibition.
Fifteen Minute Infusion
Each vial of PROTONIX I.V. for Injection should be
reconstituted with 10 mL of 0.9% Sodium Chloride
Injection, USP. The contents of the two vials
should be combined and further diluted (admixed)
with 80 mL of 5% Dextrose Injection, USP, 0.9%
Sodium Chloride Injection, USP, or Lactated
Ringer's Injection, USP, to a total volume of 100
mL with a final concentration of approximately 0.8
mg/mL. The
reconstituted solution may be stored for up to 6
hours at room temperature prior to further
dilution. The admixed solution may be stored at
room temperature and must be used within 24 hours
from the time of initial reconstitution. Both the
reconstituted solution and the admixed solution do
not need to be protected from light.
PROTONIX I.V. for
Injection should be administered intravenously
over a period of approximately 15 minutes at a
rate of approximately 7 mL/min.
Two minute
Infusion
PROTONIX I.V. for Injection should be
reconstituted with 10 mL of 0.9% Sodium Chloride
Injection, USP, per vial to a final concentration
of approximately 4 mg/mL. The reconstituted
solution may be stored for up to 24 hours at room
temperature prior to intravenous infusion and does
not need to be protected from light. The total
volume from both vials should be administered
intravenously over a period of at least 2 minutes.
HOW
SUPPLIED
PROTONIX® I.V. (pantoprazole sodium) for
Injection is supplied as a freeze-dried powder
containing 40 mg of pantoprazole per vial.
PROTONIX I.V. for
Injection is available as follows:
NDC 0008-0923-51 One carton containing 1 vial of
PROTONIX I.V. for Injection (each vial containing
40 mg pantoprazole).
Storage
Store PROTONIX I.V. for Injection vials at 20° -
25°C (68° - 77°F); excursions permitted to 15°
- 30°C (59° - 86°F). [See USP Controlled Room
Temperature.] Protect from light. Caution: the
reconstituted product should not be frozen. United
States Patent Numbers: 4,758,579; 6,780,881.
Wyeth® Marketed by
Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101
under license from Nycomed GmbH D78467 Konstanz,
Germany W10447C017 ET01 Rev 12/07
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