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Protonix () is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Protonix () may be considered.
** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up
to 240 mg daily have been administered.
Directions for method of administration for each dosage form are presented in Table 2.
* Patients should be cautioned that Protonix () Delayed-Release Tablets and Protonix () for Delayed-Release Oral Suspension
should not be split, chewed, or crushed.
The active ingredient in Protonix () (pantoprazole sodium) For Delayed-Release Oral Suspension and Protonix () (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is CHFNNaOS x 1.5 HO, with a molecular weight of 432.4. The structural formula is:
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Antisecretory Activity
* Significantly different from placebo# Significantly different from 20 mg
Serum Gastrin Effects
Enterochromaffin-Like (ECL) Cell Effects
max
a Median values are reported for T
max
.
Absorption
max
max
max
Distribution
Metabolism
Elimination
14
Geriatric
max
Pediatric
a
Geometric mean values
b
Median values
Gender
max
Renal Impairment
Hepatic Impairment
Drug-Drug Interactions
Other Effects
Protonix () Delayed-Release Tablets were used in the following clinical trials.
* (p less than 0.05) versus 10 mg or 20 mg Protonix ()
# (p less than 0.05) versus 10 mg PROTOXIX
In this study, all Protonix () treatment groups had significantly greater healing rates than the placebo group. This was true regardless of status for the 40 mg and 20 mg Protonix () treatment groups. The 40 mg dose of Protonix () resulted in healing rates significantly greater than those found with either the 20 mg or 10 mg dose.
+
Once-daily treatment with Protonix () 40 mg or 20 mg resulted in significantly superior rates of healing at both 4 and 8 weeks compared with twice-daily treatment with 150 mg of nizatidine. For the 40 mg treatment group, significantly greater healing rates compared to nizatidine were achieved regardless of the status.
# (p less than 0.05 vs. Protonix () 20 mg)
Note: Protonix () 10 mg was superior (p less than 0.05) to ranitidine in Study 2, but not Study 1.
Protonix () 40 mg was superior to ranitidine in reducing the number of daytime and nighttime heartburn episodes from the first through the twelfth month of treatment. Protonix () 20 mg, administered once daily, was also effective in reducing episodes of daytime and nighttime heartburn in one trial, as presented in Table 10.
* (p less than 0.001 vs. rantidine, combined data from the two US studies)
