Pantoprazole is a 'proton pump inhibitor', and chemically a benzimidazole derivative. It is available as pantoprazole sodium sesquihydrate 20mg & 40mg tablet & capsule for oral administration and also as 40mg injection vial for i.v. administration.
Indication: Pantoprazole is indicated where suppression of acid secretion is of therapeutic benefit, such as-peptic ulcer diseases (PUD); gastrooesophageal reflux diseases (GERO); treatment of ulcer resistant to H2 receptor antagonists (H2RAs); treatment of ulcers induced by nonsteroidal anti- inflammatory drugs (NSAIDs); gastrointestinal bleeding from stress or acid peptic diseases; eradication of helicobacter pylori (in combination with antibiotics); Zollinger Ellison syndrome; prophylaxis for acid aspiration syndrome during induction of anaesthesia.
Contra Indication: Known hypersensitivity to any of the product. .
Side Effect: No serious adverse reactions have been reported yet. There are two commonest symptomatic adverse effects are reported, headache (1.3%) and diarrhoea (1.S%).
Other side-effects may include abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus etc, Peripheral oedema has occasionally been reported in female patients.
Precautions & warnings:
Cautions: Exclude gastric malignancy & severe liver disease before treatment is started, No dosage adjustment of pantoprazole is required in patients with mild, moderate or severe renal insufficiency or in elderly patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment, but in hepatic cirrhosis, the dosing is reduced to every other day.
Pregnancy & lactation: There are no data are available on administration of pantoprazole to pregnant women & lactating mother, therefore, it is better to avoid in pregnancy and breast feeding. This drug could only be used during pregnancy & lactation if it is clearly needed to safe the mother; in the case of lactating mother nursing may be discontinued.
Dosage & Administration: By mouth: The usual recommended adult oral dose is 40mg once daily, preferably in the morning with or without food. The duration of therapy is ranging from 2-8 weeks. In duodenal ulcers, pantoprazole 40mg once daily given for 2-4 weeks; it generally heals within 2 weeks. In gastric ulcers, pantoprazole 40mg once daily given for 4-8 weeks; it usually heals within 4 weeks.
In reflux oesophagitis, pantoprazole 40mg once daily given for 4-8 weeks; it also heals within 4 weeks of treatment. In resistant ulcers, 40mg once daily given for 8 weeks. In ulcers induced by NSAIDs, 40mg once daily, in patients receiving continuous treatment with NSAIDs. In gastrointestinal bleeding from stress or acid peptic diseases, usual adult dosage; if required the dosage may be increased. Eradication of Helicobacter pylori pantoprazole 40mg twice daily in 'triple therapy' in combination with appropriate antibiotic for one week achieved eradication rates of 90-100%.
Zollinger-Ellison syndrome-pantoprazole 160mg (40mg x 4 tablets) per day; once control of acid secretion has been achieved, the dose should be gradually reduced to the lowest effective dose that maintains acid control. Prophylaxis for acid aspiration syndrome during induction of anaesthesia-pantoprazole 40-80mg should be given the evening before surgery and repeated again the morning of surgery.
Maintenance therapy: Maintenance treatment should be the lowest effective dose of the drug. Pantoprazole 20mg or 40mg, both are safe and effective in maintaining patients with healed reflux oesophagitis and peptic ulcer disease (PUD) in remission.
By i.v injection: Usual recommended adult dose: Duodenal ulcer-40mg once daily for 2-4 weeks; Gastric ulcer-40mg once daily for 4-8 weeks; Gastro-esophageal reflux disease-40mg once daily for 4 weeks. I.V injection should be given slowly by diluting in 10 ml of sterile water for injection to make 10 ml solution containing 4mg/ml of pantoprazole approximately. Subsequently add 10 ml of reconstituted solution to 90 ml of normal saline or 5 % dextrose solution to make 100 ml solution of 0.4 mg/ml of pantoprazole approximately. The resultant infusion should be given i.v over a period of 2-15 minutes.
Drug interaction: No significant interactions with concomitantly administered other drugs have been noted.