PENTA 40 (ENTERIC COATED TABLETS)
GASTRIC PROTON PUMP INHIBITOR
PROPERTIES AND PHARMACOLOGY:
PENTA 40 (Pantoprazole) is a specific proton Pump ( H+,
K+,-ATPase ) inhibitor of the gastric parietal cell. Due
to its mechanism of action, PENTA 40 reduces gastric
acid secretion whatever the nature of the stimulation.
PENTA 40 causes rapid, effective and lasting inhibition
of gastric acid secretion. Gastric secretory functions
recover after the end of the treatment.
Pantoprazole is orally administered as enteric coated
tablet because the drug is destroyed by the gastric
The clinical studies showed that ingestion of a 40
mg/day dose leads to an absolute bioavailability of
approximately 77 % and this proportion lasts during all
the treatment period.
Maximum serum concentration is reached after 1 to 6
hours of oral administration of a 40 mg dose.
The plasma half-life elimination is of one hour and
Pantoprazole is 98 % bound to plasma proteins. Following
oral administration of drug about the total quantity of
the administered drug was excreted by hepatic
biotransformation, mean while its metabolites were 80 %
excreted by kidneys and the remaining quantities via the
Concomitant food intake do not delay the drug absorption
or reduces Cmax And bioavailability. The administration
of an antacid with Pantoprazole does not affect its
- Gastric ulcer.
- Duodenal ulcer.
- Peptic ulcers or reflux esophagitis.
- Zollinger-Ellison syndrome.
Hypersensitivity to any of the drug components.
WARNING AND SPECIAL PRECAUTIONS FOR USE:
Children: The use of Pantoprazole in children has
not been studied.
Liver impairment: It is advisable to take one
dose of PENTA 40 mg Every two days.
Carcinoid tumors or malignancy should be excluded
prior to prescribing PENTA 40.
Periodic liver function tests should be done
PREGNANCY AND LACTATION:
Pregnancy Category B, this drug should be used during
pregnancy only if clearly needed.
Pantoprazole excretion in human milk has been detected
in a study of a single nursing mother after a single 40
mg oral dose. The clinical relevance of this finding is
not known, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking
into account the benefit of the drug to the mother.
PENTA 40 is well tolerated, only few cases of headache,
diarrhoea, dizziness, skin rashes and pruritus have been
The clinical studies showed that the concomitant
administration of PENTA 40 with antipyrine, diazepam,
digoxin, nifedipine, warfarin, phenytoin, theophylline,
diclofenac, caffeine, oral contraceptives and antacids (
aluminium or magnesium hydroxides ) do not reduces the
bioavailability of Pantoprazole .
DOSAGE AND ADMINISTRATION:
PENTA 40 once a day, preferably administered before or
during the morning meal.
Duodenal ulcer: One tablet of PENTA 40/day, for 4
Gastric ulcer: One tablet of PENTA 40/day, for 4
weeks and may be prolonged to 8 weeks.
Esophagitis due to gastroesophageal reflux: One tablet
of PENTA 40/day, for 4 weeks with a second 4 weeks
treatment period, at the same dosage depending on
Hepatic insufficiency: One tablet of PENTA 40
every two days .
Elderly patients and in renal insufficiency: The daily
dose should not exceed 40 mg.
The tablets should not be chewed or broken and should be
taken with sufficient quantity of water .
The drug will not be prescribed nor retaken without
A dosage of 240 mg. of Pantoprazole has been well
A part from symptomatic treatment, no specific
therapeutic recommendation can be made in cases of
Pantoprazole is slightly removed from the circulation by
PACKAGE AND COMPOSITION:
PENTA 40: 2x10 enteric coated tablets. Each tablet
contains: Pantoprazole base 40 mg .
Store at room temperature.
Keep away of the reach of children.