pantoprazole sodium for iijection
Indications
Pantoprazole is indicated for use in adults for:
• reflux oesophagitis.
• gastric and duodenal ulcer.
• Zollinger-Ellison syndrome and other pathological hypersecretory conditions.
Dosage and Administration
Usage:Intravenous
1.Gastric and duodenal ulcer, reflux oesophagitis:the recommended dose is 40 mg pantoprazole daily.
2.Zollinger-Ellison syndrome and other pathological hypersecretory conditions: the recommended initial dose is 80 mg pantoprazole daily.
3.this medicine is not recommended in children under 18 years of age.
Precautions & Warning:
1.Patients with hepatic impairment
A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment
2.Gastric malignancy
Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis.
3.Co-administration with HIV protease inhibitors is not recommended due to its significantly reduced bioavailability .
4.Gastrointestinal infections caused by bacteria
Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter or C. difficile.
5.Hypomagnesaemia
6.Bone fractures
Proton pump inhibitors, especially when used in high doses and for a long time (over 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly.
7.Subacute cutaneous lupus erythematosus (SCLE)
8.Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
9.Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Contraindications:
Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients.
Adverse Reactions:
1.Gastrointestinal disorders:Fundic gland polyps (benign);Diarrhoea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort
2.Psychiatric disorders:Sleep disorders
3.Nervous system disorders:Headache; Dizziness
4.Hepatobiliary disorders:Liver enzymes level increased (transaminases, γ -GT);Bilirubin level increased
5.Skin and subcutaneous tissue disorders:Rash / exanthema / eruption; Pruritus
6.Musculoskeletal and connective tissue disorders:Fracture of the hip, wrist or spine;Arthralgia; Myalgia
Drug interactions:
1. Medicinal products with pH-dependent absorption pharmacokinetics
2. HIV protease inhibitors
3. Coumarin anticoagulants (phenprocoumon or warfarin)
Storage instructions:
This medicinal product does not require any special temperature storage conditions.