Pantoprazole (as Sodium) 40 mg.

20 E.C.Tablets.

Proton pump inhibitors.

 

Gastrointestinal Agents

PENTA 40 (ENTERIC COATED TABLETS)
(PANTOPRAZOLE)
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 acid.
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 digestive tube.
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 bioavailability.
 

INDICATIONS:
- Gastric ulcer.
- Duodenal ulcer.
- Peptic ulcers or reflux esophagitis.
- Zollinger-Ellison syndrome.
 

CONTRAINDICATIONS:
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 during treatment.
 

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.
 

SIDE EFFECTS:
PENTA 40 is well tolerated, only few cases of headache, diarrhoea, dizziness, skin rashes and pruritus have been reported.
 

DRUG INTERACTIONS:
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 weeks.
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 endoscopic results.
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 physician supervision.

OVERDOSAGE:
A dosage of 240 mg. of Pantoprazole has been well tolerated.
A part from symptomatic treatment, no specific therapeutic recommendation can be made in cases of overdosage.
Pantoprazole is slightly removed from the circulation by hemodialysis.
 

PACKAGE AND COMPOSITION:
PENTA 40: 2x10 enteric coated tablets. Each tablet contains: Pantoprazole base 40 mg .
 

STORAGE:
Store at room temperature.
Keep away of the reach of children.

 

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