Generic

Pantoprazole

Therapeutic Class

Antiulcerant

Pack Size

Pantium 20 mg Tablet: Each box contains 60 tablets (6 x 10’s) in Alu-Alu blister pack within aluminium pouch with desiccant.

Indications

Benign gastric ulcer, duodenal ulcer, Gastroesophageal reflux disease (GERD), NSAID induced peptic ulcer, acid hypersecretory conditions including Zollinger-Ellison syndrome, eradication of Helicobacter pylori (in combination with Antibiotics), ulcer resistant to H2-receptor antagonists.

Therapeutic Class

Antiulcerant

Dosage & Administration

Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks if not fully healed. Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed. GERD: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks if not fully healed. NSAIDs induced peptic ulcer: 20 mg daily. Acid hypersecretory conditions including Zollinger-Ellison syndrome: Initially 80 mg once daily adjusted according to response (Elderly - max. 40 mg daily), daily doses above 80 mg given in two divided doses. Eradication of Helicobacter pylori: 40 mg twice daily by triple therapy with antibiotics. Ulcer resistant to H2-receptor antagonists: 40 mg once daily for 8 weeks. Maintenance therapy: 20 mg daily, increased to 40 mg daily if symptoms return. Safety and effectiveness in case of children have not been established.

Contraindications

Pantoprazole is contraindicated in patients with known hypersensitivity to the active drug or any other components of the formulation.

Side Effects

Pantoprazole is well tolerated in both short term and long term treatment. Headache and diarrhoea are the most common side effects and rarely included abdominal pain, flatulence, rash, insomnia, hyperglycemia.

Pregnancy & Lactation

Teratology studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

Precautions

Patients should be cautioned that this tablet should not be split, crushed or chewed. The tablet should be swallowed whole, with or without food in the stomach. Concomitant administration of antacids does not affect the absorption of Pantoprazole.

Storage Conditions

Store in a cool and dry place, protected from light. Keep out of the reach of the children.