Rabeprazole

Registered South African indications:

• Active duodenal ulcer
• Active benign gastric ulcer
• Gastro-oesophageal reflux disease
• Zollinger-Ellison syndrome
• H. Pylori positive duodenal ulcers

Contraindications

• Known hypersensitivity to the active ingredient or any of the excipients
• Pregnancy
• Breastfeeding

Cautions

• Hypersensitivity to other proton pump inhibitors
• Hypersensitivity to substituted benzimidazoles
• Severe hepatic impairment
• Elderly
• High doses
• Prolonged treatment (>1 year)
• Children
• Risk of osteoporosis
• Risk factors for vitamin B12 deficiency
• Subacute cutaneous systemic lupus erythematosus with previous proton pump inhibitor use
• Hypomagnesaemia

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

Active duodenal ulcer 
Erosive or ulcerative gastro-oesophageal reflux disease

• Oral (tab): 10-20mg, dly in morning; Treatment duration: 4-8 weeks

Active benign gastric ulcer 

• Oral (tab): 10-20mg, dly in morning; Treatment duration: 6-12 weeks

Gastro-oesophageal reflux
- Maintenance

• Oral (tab): 10-20mg, dly; Treatment duration: 12 months

Gastro-oesophageal reflux disease
- Symptomatic treatment 

• Oral (tab): 10mg, dly; Treatment duration: 4 weeks

Zollinger-Ellison syndrome
Other pathological hypersecretory conditions

• Oral (tab): Initial: 60mg, dly; Max: 120mg/24hrs in divided doses

Eradication of H. Pylori (Additional agent required)

• Oral (tab): 20mg, 12hrly; Treatment duration: 7 days

Do not cut/crush/chew/dissolve

Not established for use in children

Pregnancy

• Contraindicated
• There are no data on the safety of rabeprazole in human pregnancy. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to rabeprazole sodium, although low foeto-placental transfer occurs in rats. Rabeprazole sodium is contraindicated during pregnancy

Breastfeeding

• Contraindicated
• It is not known whether rabeprazole sodium is excreted in human breast milk. No studies in breastfeeding women have been performed. Rabeprazole sodium is however excreted in rat mammary secretions. Therefore rabeprazole sodium should not be used during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Mild to moderate (Child-Pugh class A and B): No dose adjustment recommended
• Severe (Child-Pugh class C): Caution; no dose adjustment recommended
  Use is not recommended; Monitor for adverse effects

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Somnolence
• Insomnia
• Nervousness
• Depression
• Confusion
• Asthenia

Cardiovascular Disorders

• Peripheral oedema
• Chest pain

Respiratory Disorders

• Cough
• Pharyngitis
• Rhinitis
• Bronchitis
• Sinusitis

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Abdominal pain
• Constipation
• Flatulence
• Benign fundic gland polyps
• Dyspepsia
• Dry mouth
• Eructation
• Gastritis
• Stomatitis

Hepatobiliary Disorders

• Hepatitis
• Jaundice
• Hepatic encephalopathy

Genitourinary Disorders

• Urinary tract infection
• Interstitial nephritis
• Gynaecomastia

Endocrine and Metabolic Disorders

• Anorexia
• Hyponatremia
• Hypomagnesaemia

Musculoskeletal Disorders

• Non-specific pain
• Back pain
• Myalgia
• Leg cramps
• Arthralgia
• Fracture of the hip, wrist or spine 

Skin and Subcutaneous Tissue Disorders

• Rash
• Erythema
• Pruritus
• Sweating
• Bullous reactions
• Erythema multiforme
• Toxic epidermal necrolysis (TEN)
• Stevens-Johnson syndrome (SJS)
• Subacute cutaneous lupus erythematosus

Immune, Blood and Lymphatic System Disorders

• Infection
• Neutropenia
• Leucopenia
• Thrombocytopenia
• Leucocytosis
• Hypersensitivity
• Influenza-like illness
• Fever

Sensory Disorders

• Visual disturbance
• Taste disturbance

• Ketoconazole
• Itraconazole
• Methotrexate
• Proton pump inhibitors
• Atazanavir
• Other antacids

None routine. Specific cases may require

• Serum magnesium level

Interference with Laboratory Tests

• Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours
• To avoid this interference, Rabeprazole treatment should be stopped for at least 5 days before CgA measurements
• If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment

Rabeprazole is a proton pump inhibitor. It inhibits the H+/K+-ATPase enzyme, thereby suppressing gastric acid secretion at the surface of the gastric parietal cells.

Tablet 10mg

• Pariet (Janssen) originator
• Rabemed (Sandoz)

Tablet 20mg

• Pariet (Janssen) originator
• Rabemed (Sandoz)