Pantomak

Pantomak® 20 mg tablet: Each enteric-coated tablet contains Pantoprazole Sodium Sesquihydrate USP equivalent to Pantoprazole 20 mg.

Pantomak® 40 mg tablet: Each enteric-coated tablet contains Pantoprazole Sodium Sesquihydrate USP equivalent to Pantoprazole 40 mg.

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific action on the proton pumps of the parietal cells.

1. For the symptomatic improvement and healing of gastrointestinal  diseases which require a reduction in acid secretion:

                • Duodenal ulcer

                • Gastric ulcer

                • Gastro esophageal reflux disease (GERD)

                • For the treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing)

                • Reflux esophagitis

                • Zollinger-Ellison Syndrome

2. Eradication of Helicobacter pylori (hereinafter referred to as H. pylori) in combination with-

                • Clarithromycin and Amoxycillin or

                • Clarithromycin and Metronidazole or

                • Amoxycillin and Metronidazole

Tablet-

Duodenal Ulcer

The recommended oral dosage is one gastro-resistant 40 mg pantoprazole tablet per day. A duodenal ulcer generally heals within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.

Gastric Ulcer

The recommended oral dosage is one gastro-resistant 40 mg pantoprazole tablet per day. A 4-week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

GERD

For mild reflux disease and the associated symptoms, the recommended dosage is one Pantoprazole 20 mg tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If symptom control has not been achieved after four weeks treatment with pantoprazole 20 mg tablets daily, further investigation is recommended. For treatment of reflux esophagitis, the recommended oral dosage is one Pantoprazole 40 mg tablet per day. A 4-week period is usually required for treatment of reflux esophagitis, however if this is not sufficient, healing will usually be achieved within a further 4 weeks.

Zollinger-Ellison Syndrome

Initially 80 mg once daily adjusted according to response daily doses above 80 mg given in 2 divided doses.

H. pylori Eradication

In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. One of the following combinations of pantoprazole tablets with antibiotics is effective-

1. Twice daily one gastro-resistant 40 mg pantoprazole tablet

                • Twice daily 1000 mg amoxycillin

                • Twice daily 500 mg clarithromycin

2. Twice daily one gastro-resistant 40 mg pantoprazole tablet

                • Twice daily 500 mg metronidazole

                • Twice daily 500 mg clarithromycin

3. Twice daily one gastro-resistant 40 mg pantoprazole tablet

                • Twice daily 1000 mg amoxycillin

                • Twice daily 500 mg metronidazole

Gastrointestinal complaints such as upper abdominal pain, diarrhoea, constipation or flatulence,headache, dizziness, disturbances in vision (blurred vision).

In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on longterm use. In the case of a rise of the liver enzymes pantoprazole tablets should be discontinued.

Pantoprazole tablets may reduce or increase the absorption of drugs whose bioavailability is pH-dependent (e.g. ketoconazole). Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of Pantoprazole with other drugs or compounds which are metabolized using the same enzyme system cannot be excluded. However, no clinically significant interactions were observed in specific tests with a number of such drugs or compounds, namely carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, antipyrine, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, and an oral contraceptive.

There are no known symptoms of overdosage in human. Doses up to 240 mg i.v. were administered over two minutes and were well tolerated. In the case of overdosage with clinical signs of intoxication, the usual rules of intoxication therapy apply.

Store at temperature not exceeding 30° C in a dry place. Protect from light.

Pantomak® 20 mg Tablet: Each box contains 5x10's tablets in blister strips.

Pantomak® 40 mg Tablet: Each box contains 3x10's tablets in blister strips.