GIVPEP-40 Injection

GIVPEP-40 Injection
Pantoprazole 40 mg

Pantoprazole is a proton pump inhibitor, i.e., it inhibits specifically and dose proportionally H+,K+ – ATPase,
the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach. Pantoprazole is
a substituted benzimidazole which accumulates in the acidic compartment of the parietal cells after
absorption. In the parietal cell it is protonated and chemically re-arranged to the active inhibitor, a cyclic
sulphenamide, which binds to the H+,K+-ATPase, thus inhibiting the proton pump and causing suppression
of stimulated and basal gastric acid secretion after single and multiple intravenous and oral pantoprazole
dosing. Because pantoprazole acts distal to the receptor level, it can influence gastric acid secretion
irrespective of the nature of the stimulus.

Pantoprazole exerts its full effect in a strongly acidic environment (pH<3) and remains mostly inactive at higher pH values, which explains its selectivity for the acid secreting parietal cells of the stomach. Therefore, the complete pharmacological and therapeutic effect for pantoprazole can only be achieved in the acid- secreting parietal cells. By means of a feedback mechanism this effect is diminished at the same rate as acid secretion is inhibited. Effect on gastric acid secretion

The mean inhibition of pentagastrin stimulated acid output after 40 mg/day is 85% after seven days, 21/2 to
31/2 hours after dosing. After stopping the intake of pantoprazole, there is no evidence of rebound
hypersecretion and 7 days after taking the last dose, the acid output is normal. Pantoprazole maintains the
physiological pH-rhythm. The values, however, are shifted to higher levels. During the night, periods with pH
values approximating placebo have been found. Although pantoprazole has a half-life of approximately 1
hour, the antisecretory effect increases during repeated once daily administration, demonstrating that the
duration of action markedly exceeds the serum elimination half-life.

INDICATIONS

Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis
GIVPEP-40 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
GIVPEP-40 for Injection is indicated for the treatment of pathological hypersecretory conditions associated
with Zollinger-Ellison Syndrome or other neoplastic conditions.

DOSAGE AND ADMINISTRATION

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.
Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome
The dosage of GIVPEP-40 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