Pantoprazole

Registered South African indications:

• Short-term temporary relief of heartburn and hyperacidity (20mg)
• Short-term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis (40mg)
• Duodenal ulcer that has been demonstrated to be associated with Helicobacter pylori infection, used in combination with appropriate antibiotics may be useful (40mg)
• Zollinger-Ellison Syndrome (40mg)

Registered South African contraindications

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

• Pregnancy
• Breastfeeding
• Mild to moderate hepatic impairment
• 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: ect, tab

South African registered indications and dosages

20mg gastro-resistant tablets

Short-term temporary relief of heartburn and hyperacidity

• Oral (ect): 20mg, dly; Max. treatment duration: 14 days; Max: 20mg/24hrs

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Pantoprazole 20mg should be taken in the morning. It should be swallowed whole with a little water either before or during breakfast

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40mg gastro-resistant tablets

Duodenal ulcer

• Oral (ect): 40mg, once daily; Total treatment duration: 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

• Oral (ect): 40mg, once daily; Treatment duration: 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

• Oral (ect): 40mg, once daily; Treatment duration: 4-8 weeks

Zollinger-Ellison Syndrome

• Oral (ect): 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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Long-term management and prevention of relapse in gastro-oesophageal reflux disease

• Oral (ect): Maintenance dose: 20mg, daily; Increasing to 40mg, daily if a relapse occurs; After healing of the relapse: The dose can be reduced to 20mg; Experience with long-term administration is limited

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For oral administration, pantoprazole should be swallowed whole with a little water either before or during breakfast

Contraindicated

Pregnancy

South African recommendations

• Caution; positive evidence of risk in animal studies
• The safety in pregnant women has not been established
• Animal studies have shown reproductive toxicity
• As a precautionary measure, it is preferable to avoid the use of pantoprazole during pregnancy

Breastfeeding

South African recommendations

• Caution
• Safety during lactation has not been established
• Animal studies have shown the excretion of pantoprazole in breast milk
• There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported
• A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breastfeeding or to discontinue/abstain from pantoprazole therapy takes into account the benefit of breastfeeding for the child and the benefit of pantoprazole therapy for the woman

Fertility

South African recommendations

• 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 moderately severe 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.

Tablet otc 20mg

• Pentoz otc (Dr Reddy)
• Peploc otc (Pharma Dynamics)
• Prazoloc otc (Cipla Medpro)
• Topzole (Takeda) originator

Tablet 20mg

• Aspen Pantoprazole (Pharmacare)
• Conoran (Ranbaxy)
• Gastriwin (Takeda)
• Mylan Pantoprazole (Xixia)
• Pantocid ect (Ranbaxy)
• Pantoloc (Takeda) originator
• Pantoprazole unicorn (Sandoz)
• Pantor (Trinity Pharma)
• Pentoz (Dr Reddy)
• Peptazol 20 (Pharmacorp)
• Peploc (Pharma Dynamics)
• Prazoloc (Cipla)
• Topraflux (Sandoz)
• Topzole (Takeda)

Tablet 40mg

• Aspen Pantoprazole (Pharmacare)
• Conoran (Ranbaxy)
• Gastriwin (Takeda)
• Mylan Pantoprazole (Xixia)
• Pantocid ect (Ranbaxy)
• Pantoloc (Takeda)
• Pantoprazole unicorn (Sandoz)
• Pantor (Trinity Pharma)
• Pentoz (Dr Reddy)
• Peptazol (Pharmacorp)
• Peploc (Pharma Dynamics)
• Prazoloc (Cipla)
• Topraflux (Sandoz)
• Topzole (Takeda)

Injection (per vial) 40mg

• Gastriwin (Takeda)
• Pantocid (Ranbaxy)
• Pantoloc (Takeda)
• Peploc (Pharma Dynamics)
• Prazoloc IV (Cipla)
• Viapan (Safeline)

Injection (per 10ml) 40mg

• Aspen Pantoprazole (Pharmacare)
• Ivacid IV (Ranbaxy)
• Pantocid (Pharmaplan) Discontinued: 01/04/2018
• Pantoprazole Specpharm (Specpharm)
• Topraflux (Sandoz)

Injection (per 15ml) 40mg

• Adco Pantoprazole (Adcock)