COMPOSITION
Each
enteric coated tablet contains
Pantoprazole 40mg
DESCRIPTION
PANTAGON contains Pantoprazole as an active ingredient.
Pantoprazole is a Proton Pump Inhibitor (PPI), a very potent inhibitor of
gastric acid output.
PHARMACOLOGY
Pharmacodynamics
Pantoprazole
is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid
production by forming a covalent bond to two sites of the H+ and K+
ATPase enzyme system at the secretory surface of the gastric parietal cell. The
binding to the H+ and K+ ATPase results in a duration of
antisecretory effect that persists longer than 24 hours for all doses tested.
Pharmacokinetics
PANTAGON is prepared as an enteric-coated tablet so that
absorption of pantoprazole begins only after the tablet leaves the
stomach. The drug is subject to low
first-pass hepatic extraction, displaying an estimated absolute oral
bioavailability of 77%. It is primarily excreted as urinary metabolites, the
remainder being excreted in the faeces and originates from biliary secretion.
INDICATIONS AND USAGE
Acid-related
disorders, e.g. peptic ulcer (duodenal and gastric ulcer), reflux oesophagitis
(gastro-oesophageal reflux disease) and Zollinger-Ellinson syndrome.
DOSAGE AND ADMINISTRATION
·
Treatment of Erosive
Esophagitis: Adult oral dose is 40
mg given once daily for up to 8 weeks. For those patients who have not healed
after 8 weeks of treatment, an additional 8 week course of PENTAGON may be considered.
·
Maintenance of
Healing of Erosive Oesophagitis: Adult
oral dose is one Tablet, taken daily.
·
Pathological
Hypersecretory Conditions Including Zollinger-Ellison Syndrome: Adult starting dose is 40 mg twice daily. Dosage
regimens should be adjusted to individual patient needs and should continue for
as long as clinically indicated.
No
dosage adjustment is necessary in patients with renal impairment, hepatic
impairment, or for elderly patients as well as in patients undergoing
hemodialysis.
CONTRAINDICATIONS
Hypersensitivity
to any of the components.
ADVERSE EFFECTS
Diarrhoea,
dizziness, pruritis and skin rash.
DRUG INTERACTION
·
Decreased
absorption of Ketoconazole and Itraconazole.
PATIENT’s INFORMATION
·
PANTAGON
tablets should be swallowed whole, with or without food in the stomach.
Concomitant administration of antacids does not affect
the absorption of PANTAGON.