Lansoprazole

Registered South African indications: 

• Gastric ulcers
• Duodenal ulcers
• Reflux oesophagitis
• Heartburn and hyperacidity (otc)

Contraindications

South African recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Lactation
• Liver impairment (otc)
• Severe liver impairment (S4 formulations)
• Coadministration with atazanavir or nelfinavir

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Coadministration with atazanavir (30mg)

Cautions 

• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Mild to moderate liver impairment (S4 formulations) (South African recommendations)
• Moderate to severe hepatic impairment (Recommendations in other jurisdictions)
• Elderly
• Previous gastrointestinal bleeding
• Malignant gastric tumour 
• Risk factors for osteoperosis
• Prolonged use
• High doses
• Fructose intolerance
• Glucose-galactose malabsorption 
• Sucrase-isomaltase insufficiency

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

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Gastric ulcer

• Oral (cap): 30mg, dly; Treatment duration: Up to 8 weeks

Duodenal ulcer
- Helicobacter pylori positive ulcers, as part of an eradication program with appropriate antibiotics (Additional agents required)

• Oral (cap): 30mg, dly; Treatment duration: Up to 4 weeks

Oesophagitis due to gastro-oesophageal reflux

• Oral (cap): 30mg, dly; Treatment duration: 4 weeks, a repeat course of 4 weeks may be necessary depending on endoscopic results

Prevention of gastro-oesophageal reflux
- As maintenance treatment

• Oral (cap): 15mg, dly; Treatment duration: Up to a max. period of 1 year

Functional dyspepsia

• Oral (cap): 15-30mg, dly; Treatment duration: 2-4 weeks

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Lansoprazole capsules should preferably be taken before a meal

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Heartburn and hyperacidity
- As short-term symptomatic relief

• Oral (cap): 15mg, dly in the morning; Treatment duration: Max. period of 14 days; Max: 15mg/24hrs

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Lansoprazole capsules should preferably be taken before a meal and should be swallowed whole. Do not crush or chew

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Indications and dosages registered in other jurisdictions

Duodenal ulcer

• Oral (cap): 30mg, dly in the morning; Treatment duration: 2 weeks, continued for another 2 weeks in those not fully healed within the initial treatment period

Gastric ulcer
Reflux oesophagitis
Non-steroidal anti-inflammatory drug (NSAID) associated benign gastric and duodenal ulcers in patients requiring continued NSAID therapy

• Oral (cap): 30mg, dly in the morning; Treatment duration: 4 weeks, continued for another 4 weeks in those not fully healed within the initial treatment period

- Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age >65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment

• Oral (cap): 15mg, dly in the morning; Increased to 30mg, dly in the morning for treatment failure

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For the indication of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID therapy, patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used

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Reflux oesophagitis prophylaxis

• Oral (cap): 15-30mg, dly in the morning

Eradication of Helicobacter pylori (Additional agents required)

• Oral (cap): 30mg, 12hrly; Treatment duration: 7 days

Symptomatic gastro-oesophageal reflux disease

• Oral (cap): 15-30mg, dly in the morning; Treatment duration: Up to 4 weeks, further examinations recommended if symptoms are not relieved within 4 weeks

Zollinger-Ellison syndrome

• Oral (cap): Initial: 60mg, dly; Maintenance: 60-180mg, dly, adjusted on an individual patient basis, with doses above 120mg given 12hrly

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Lansoprazole capsules should be taken at least 30min before food. Capsules should be swallowed whole with liquid. For patients with difficulty swallowing; the capsules may be emptied, but the contents may not be chewed or ground

Not established for use in children

Pregnancy 

South African recommendations

• Contraindicated
• Lansoprazole capsules should not be used in pregnancy
• Safety in pregnancy has not been established
• Adequate and well-controlled studies in humans have not been done

Recommendations in other jurisdictions

• Caution; not recommended
• There is limited amount of data from the use of lansoprazole in pregnant women
• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid, the use of lansoprazole during pregnancy

Breastfeeding 

South African recommendations

• Contraindicated
• Lansoprazole capsules should not be used in lactation
• Safety in lactation has not been established
• Adequate and well-controlled studies in humans have not been done
• It is not known whether lansoprazole is distributed into breast milk. However, lansoprazole or its metabolites are distributed into the milk of rats. Lansoprazole has been shown to cause tumourigenic effects in animals
• Mothers on lansoprazole otc should not breastfeed their infants

Recommendations in other jurisdictions

• Caution; not recommended
• It is not known whether lansoprazole is excreted in human breast milk. Animal studies have shown excretion of lansoprazole in milk. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with lansoprazole should be made taking into account the benefit of breastfeeding to the child and the benefit of lansoprazole therapy to the woman

Renal Impairment 

• No dose adjustment recommended 

Hepatic Impairment

South African recommendations

• Contraindicated (otc)
• Mild to moderate: Caution; no dose adjustment recommended (S4 formulations)
• Severe: Contraindicated (S4 formulations)

Recommendations in other jurisdictions

• Moderate to severe: Caution; dose adjustment recommended

Hepatic Impairment	Dose
Mild	No adjustment necessary
Moderate to severe	Reduce dose by 50%

Elderly 

• Caution; dose adjustment recommended
  Max: 30mg/24hrs; unless there are compelling clinical indications

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Depression 
• Insomnia
• Hallucinations
• Confusion
• Headache
• Dizziness
• Restlessness
• Vertigo
• Paresthesia
• Somnolence
• Tremor
• Fatigue

Gastrointestinal Disorders

• Nausea and vomiting 
• Diarrhoea
• Stomach cramps
• Constipation
• Flatulence
• Dry mouth
• Dry throat
• Glossitis
• Oesophageal candida
• Pancreatitits
• Colitis
• Stomatitis

Hepatobiliary Disorders

• Increased hepatic enzyme levels 
• Hepatitis
• Jaundice

Genitourinary Disorders

• Interstitial nephritis
• Impotence

Endocrine and Metabolic Disorders

• Hypomagnesaemia
• Gynaecomastia
• Increase in cholesterol and triglyceride levels 
• Hyponatremia
• Anorexia

Musculoskeletal Disorders

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

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Pruritis
• Rash
• Petechiae
• Purpura
• Hair loss
• Erythema multiforme
• Photosensitivity
• Steven-Johnson syndrome
• Toxic epidermal necrolysis
• Subacute cutaneous lupus erythematosus
• Hyperhidrosis
• Oedema

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Eosinophilia
• Leucopenia
• Anaemia 
• Agranulocytosis 
• Pancytopenia
• Anaphylactic shock
• Angioedema
• Fever

Sensory Disorders

• Visual disturbances
• Taste disturbances

• Atazanavir
• Nelfinavir
• Ketoconazole  
• Itraconazole
• Digoxin  
• Theophylline
• Tacrolimus
• Rifampicin 
• St. Johns wort
• Fluvoxamine
• Sucralfate
• Antacids
• CYP3A4 inducers
• CYP2C19 inducers

None routine. Specific cases may require

• Magnesium levels
• Hepatic function  

Lansoprazole is a gastric proton pump inhibitor. It decreases acid secretion in gastric parietal cells through inhibition of the H⁺/K⁺ ATPase enzyme system, which blocks the final step in gastric acid production. The inhibition is dose-dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.

Capsule 15mg

• Aspen Lansoprazole (Pharmacare)
• Burnloc (Adcock)
• Lancap (Pharma Dynamics) 
• Lancap OTC (Pharma Dynamics)
• Lanzor (Sanofi) originator
• Lanzor HB (Winthrop) originator (Discontinued: 13/07/2018)
• Lansoloc OTC (Cipla Medpro)
• Lansoprazole Unicorn (Unicorn)
• Lansoprazole-Winthrop (Winthrop)
• Ran-Lansoprazole (Ranbaxy)
• Roznal OTC (Adcock)
• Simayla Lansoprazole (Ranbaxy)

Capsule 30mg

• Adco-Roznal (Adcock)
• Aspen Lansoprazole (Pharmacare)
• Lancap (Pharma Dynamics) 
• Lanzor (Sanofi) originator
• Lansoloc  (Cipla Medpro)
• Lansoprazole Unicorn (Unicorn)
• Lansoprazole-Winthrop (Winthrop)
• Ran-Lansoprazole (Ranbaxy)
• Simayla Lansoprazole (Ranbaxy)