COMPOSITION :

Each capsule contains : Pantoprazole Sodium Sesquihydrate equivalent to Pantoprazole 40 mg.

(as enteric coated pellets).

DESCRIPTION :

Pentrax (Pantoprazole) is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid produ

by covalently binding to (H+ / K+) - ATPase enzyme system at the secretory surface of the gastric parieta

Pentrax is prepared as an enteric-coated pellets so that absorption of Pantoprazole begins only after the ca

leaves the stomach. The absorption of Pantoprazole is rapid, with a Cmax of 2.5 µg/ml that occurs approxim

2.5 hours after oral dose. Following initial oral dose of 40 mg Pantoprazole, a 51% mean inhibition of acid sec

was achieved by 2.5 hours. With once a day dosing for 7 days the mean inhibition was increased to 85%

secretion had returned to normal within a week after the last dose of Pantoprazole. There was no eviden

rebound hypersecretion. Pantoprazole is extensively metabolized in the liver and excreted in urine.

INDICATIONS :

Pentrax is indicated in the following cases:

- Short-term treatment of Erosive Esophagitis associated with Gastroesophageal reflux disease (GERD).

- Maintenance of healing of Erosive Esophagitis.

- Pathological Hypersecretory conditions including Zollinger - Ellison Syndrome.

DOSAGE & ADMINISTRATION :

- Treatment of Erosive Esophagitis : The recommended adult oral dose is 40 mg given once daily for up to

8 weeks and for those patients who have not healed after 8 weeks of treatment, an additional 8 weeks cou

of Pentrax may be considered.

- Maintenance of healing of Erosive Esophagitis : The recommended adult oral dose is one Pentrax capsul

40 mg taken daily.

- Pathological Hypersecretory conditions including Zollinger - Ellison Syndrome : The recommended adult st

dose is 40 mg twice daily. The dose should be adjusted to individual patients needs and should continue f

long as clinically indicated.

RESTRICTIONS ON USE :

Contraindications

Hypersensitivity reaction to Pantoprazole.

Use in Pregnancy & Lactation

There are no adequate and well controlled studies on its use.

Precautions

Treatment with Pantoprazole may mask symptoms of malignancy and therefore delay diagnosis.

DRUG INTERACTIONS :

Pantoprazole may interfere with absorption of drugs where gastric pH is an important determinate of their

bioavailability e.g : Ketoconazole, Ampicillin esters and iron salts.

SIDE EFFECTS :

Pantoprazole is well tolerated in both short term and long term trials. Reported adverse effects includes :

headache, diarrhea, flatulence, abdominal pain, rash and eructation. Nausea, vomiting and abnormal liver

function test may appear in long term treatment.

STORAGE INSTRUCTIONS :

- Store below 30°C in a dry place , protect from light.

- Close the bottle tightly after each use.

- Discard three months from the date of opening.

PRESENTATIONS :

Pentrax capsules : Pack of 14 capsules.

Pentrax capsules : Strip pack of 10 x10 capsules.