PROTOCID

Pantoprazole

GASTROINTESTINAL » PROTON PUMP INHIBITOR

INDICATION

For the prevention and treatment of benign gastric ulcer, duodenal ulcer, NSAID associated complications, peptic ulcer associated with Helicobacter pylori, Erosive esophagitis, Zollinger-Ellison Syndrome, Prophylaxis for acid aspiration syndrome during induction of anesthesia or due to stress.

DOSAGE AND ADMINISTRATION

Delayed release tablet

The usual recommended adult oral dose is 40 mg given once daily, before breakfast. The duration of therapy is ranging from 2-8 weeks.Duodenal Ulcer: Protocid 40 mg tablet, once daily for 2-4 weeks.Benign Gastric Ulcer: Protocid 40mg tablet, once daily for 4-8 weeks. Erosive Esophagitis:Protocid 20-40mg tablet, once daily, for 4-8 weeks. NSAIDs induced ulcer: Protocid 20mg tablet once daily,in patient receiving continuous treatment with NSAIDs. Zollinger-Ellison Syndrome:80 mg tablet twice daily up to control of acid secretion. Prophylaxis for acid aspiration syndrome during induction of anaesthesia: 1 or 2 Protocid 40 mg tablet should be given the evening before surgery and repeated again the morning of surgery.

IV injection

Gastric ulcer, GERD Duodenal ulcer -40 mg Once daily until oral administration can be resumed

Zollinger–Ellison syndrome and other hypersecretory conditions-initially 80 mg then

160 mg if rapid acid control required -once daily adjusted according to response;

daily doses above 80 mg given in 2 divided doses- until oral administration can be resumed.

Mode of administration

Injection: The 4 mg / ml solution for IV injection is obtained by adding 10 ml of the provided solvent to the vial containing 40 mg Pantoprazole lyophilized powder. After reconstitution the injection should be given slowly over a period of at least 2.5 minutes at a maximum rate of 4 ml per minute.

Infusion: For IV infusion, reconstitute one lyophilized single dose vial of Protocid IV injection with 10 ml of provided solvent to make 10 ml solution containing 4 mg/ml of Pantoprazole approximately. Dilute the reconstituted solution to make final 100 ml solution of 0.4 mg/ml (approximately) of Pantoprazole with 0.9% Sodium Chloride Solution or 5% dextrose solution. The resultant infusion solution should be given intravenously over a period of 15 minutes. Do not dilute the Pantoprazole

solution to < 0.4 mg/ml. Both the reconstituted solution must be used within 24 hours from the time of initial reconstitution if stored at room temperature. Peptic ulcer associated with Helicobacter Pylori:

Pantoprazole (Protocid) 40 mg twice daily.

Amoxicillin (Moxilin) 1 g twice daily.

Clarithromycin (Claricin) 500 mg twice daily.       01-02 weeks

Pantoprazole (Protocid) 40 mg twice daily.

Clarithromycin (Claricin) 250 mg twice daily.

Metronidazole (Dirozyl) 400 mg twice daily.          01 week

Pantoprazole (Protocid) 40 mg twice daily.

Amoxicillin (Moxilin) 1 g twice daily.

Metronidazole (Dirozyl) 400 mg twice daily.          01-02 weeks

Pediatric Use

Safety and effectiveness of Pantoprazole in neonates and children have not been established.

Elderly

Dose adjustment is not required in the elderly.

Impaired Renal Function: The daily dose of 20 mg or 40 mg can be given.

Impaired Liver Function: In patients with severe liver disease dose should not be more than 20 mg Pantoprazole per day.

OR AS DIRECTED BY THE PHYSICIAN.

COMPOSITION

Protocid 20 mg Tablet (140’s): Each box contains 10X14 Tablets in alu-alu blister strips.

Protocid 20 mg Tablet (70’s): Each box contains 5X14 Tablets in alu-alu blister strips.

Protocid 40 mg Tablet: Each box contains 5X10 Tablets in alu-alu blister strips.

Protocid IV Injection : Each box contains 1 vial of lyophilized Pantoprazole 40 mg and 1

ampoule of 10 ml 0.9% Sodium chloride injection in blister strip for reconstitution with a 10 ml sterile disposable syringe.