Pantoprazole

Registered South African indications:

Pantoprazole IV is indicated for intravenous administration to patients who cannot be treated orally

• Short-term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis
• Duodenal ulcer that has been demonstrated to be associated with Helicobacter pylori infection, used in combination with appropriate antibiotics may be useful
• Zollinger-Ellison syndrome

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Severe hepatic impairment
• Children, safety has not been established
• Coadministration with atazanavir and nelfinavir

• Mild to moderate hepatic impairment
• Elderly
• Risk factors for Vitamin B12 deficiency
• Prolonged treatment (>1 year)
• Subacute cutaneous systemic lupus erythematosus with previous proton pump inhibitor use
• Risk factors for osteoporosis 

Forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

Pantoprazole IV is indicated for intravenous administration to patients who cannot be treated orally. As soon as oral therapy is possible, treatment should be replaced with the same oral dose, in compliance with the approved dosage regimen

Duodenal ulcer

• IV: 40mg, once daily; May be used up to 7 days; Total treatment duration with IV and oral pantoprazole: 2-4 weeks

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If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection, use in combination with appropriate antibiotics may be useful

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Gastric ulcer

• IV: 40mg, once daily; May be used up to 7 days; Total treatment duration with IV and oral pantoprazole: 4-8 weeks

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In the case of a suspected gastric ulcer, malignancy of the gastric ulcer should be excluded, as treatment could conceal the symptoms and may delay diagnosis

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Reflux oesophagitis

• IV: 40mg, once daily; May be used up to 7 days; Total treatment duration with IV and oral pantoprazole: 4-8 weeks

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If gastroesophageal reflux disease (GERD) symptom control has not been achieved after four weeks of treatment with the prescribed daily dose, especially where differentiation of diagnosis of GERD with angina and congestive heart failure is present, further investigation is recommended

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Zollinger-Ellison Syndrome

• IV: Initial: 80mg, daily; Thereafter: Titrate up or down as needed using measurements of gastric acid secretion as a guide; For doses >80mg daily: The dose should be divided and given twice daily

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In case rapid acid control is required, a starting dose of 80mg pantoprazole (2 vials of pantoprazole IV) is sufficient to manage a decrease of acid output into the target range (<10mEq/hr) within one hour in the majority of patients. Transition from pantoprazole IV to the oral formulation should be performed as soon as it is clinically justified

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Long-term treatment with pantoprazole IV is currently not indicated as there are insufficient clinical data.

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Method of administration
The ready-to-use solution may be administered directly after reconstitution with sodium chloride 9mg/ml (0.9%) solution for injection, or it may be further diluted with sodium chloride 9mg/ml (0.9%) solution for injection or glucose (5%) solution for injection before parenteral administration. For instructions for preparation and storage of solution before parenteral administration. The medicine should be administered intravenously over 2 - 15 minutes

Contraindicated

Pregnancy

South African recommendations

• Contraindicated
• Safety in pregnancy has not been established

Breastfeeding

South African recommendations

• Contraindicated
• Excretion of pantoprazole into human milk has been reported. Safety during lactation has not been established

Fertility

South African recommendations

• It has been reported that there was no evidence of impaired fertility following the administration of pantoprazole in animal studies

South African recommendations

• No dose adjustment recommended

South African recommendations

• Mild to moderate: Caution; dose adjustment recommended
  A daily dose of 20mg should not be exceeded in patients with mild to moderate liver impairment
• Severe: Contraindicated

South African recommendations

• No dose adjustment recommended

Central Nervous System Disorders

• Sleep disorders
• Depression 
• Disorientation 
• Hallucinations
• Fatigue 
• Increased body temperature
• Confusion 
• Headache
• Dizziness
• Paraesthesia

Cardiovascular Disorders

• Peripheral oedema

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Abdominal distension
• Bloating
• Constipation
• Dry mouth
• Abdominal pain
• Abdominal discomfort

Hepatobiliary disorders

• Increased liver enzymes
• Increased bilirubin
• Hepatocellular injury
• Jaundice
• Hepatocellular failure

Genitourinary Disorders

• Interstitial nephritis 
• Gynaecomastia

Endocrine and Metabolic Disorders

• Hyperlipidaemias 
• Weight changes
• Hyponatraemia
• Hypomagnesaemia 
• Hypocalcaemia
• Hypokalaemia

Musculoskeletal Disorders

• Fracture of the hip, wrist or spine 
• Arthralgia
• Myalgia
• Muscle spasm

Skin and Subcutaneous Tissue Disorders

• Rash
• Exanthema
• Eruption
• Pruritus
• Urticaria
• Angioedema
• Stevens-Johnson syndrome
• Lyell syndrome
• Erythema multiforme
• Photosensitivity
• Subacute cutaneous lupus erythematosus 
• Injection site thrombophlebitis

Immune, Blood and Lymphatic System Disorders

• Agranulocytosis
• Thrombocytopenia
• Leukopenia
• Pancytopenia
• Hypersensitivity 

Sensory Disorders

• Blurred vision
• Taste disorders

• Agents whose absorption are pH-dependant
• Protease inhibitors 
• Warfarin
• Methotrexate

None routine. Specific cases may require

• Serum magnesium 
• Hepatic function

Pantoprazole is a proton pump inhibitor. It inhibits the H+/K+-ATPase enzyme, thereby decreasing the secretion of hydrochloric acid in the parietal cells of the stomach.