Esomeprazole
Indications
Registered South African indications:
- Gastro-oesophageal reflux disease (GORD)
- Treatment of erosive reflux oesophagitis
- Long-term management of patients with healed oesophagitis to prevent relapse
- Symptomatic treatment of gastro-oesophageal reflux disease (GORD) - Patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy (tab)
- Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk - In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori (tab)
- Healing of Helicobacter pylori associated duodenal ulcer
- Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcer disease
Esomeprazole has been used in pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion (tab)
Contraindications (ZA)
Registered South African contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- Hypersensitivity to substituted benzimidazoles
- Coadministration with atazanavir and nelfinavir
Warnings & precautions
South African recommendations
Caution in the following patient groups
- Pregnancy
- Breastfeeding
- Severe renal impairment
- Severe hepatic impairment
- Elderly
Granules for oral suspension
Mild gastrointestinal complaints
- Esomeprazole as is not indicated for mild gastrointestinal complaints such as nervous dyspepsia
Malignancy
- Prior to treatment or in the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, the possibility of malignancy of gastric ulcer or a malignant disease of the oesophagus should be excluded as the treatment with esomeprazole may alleviate the symptoms of malignant ulcers and can thus delay diagnosis
Long treatment
- Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance
Chromogranin A (CgA) increase
- During treatment with antisecretory medicines, serum gastrin increases in response to the decreased acid secretion. Also, chromogranin A (CgA) increase due to decreased gastric acidity
- The increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference, the esomeprazole treatment should be temporarily stopped 5 days before CgA measurements
- If CgA and gastrin levels have not returned to the reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment
Gastrointestinal infections
- Decreased gastric acidity increases gastric contents counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile
- Clostridium difficile is a bacterium that can cause severe debilitating diarrhoea that does not improve. Symptoms may include watery stools, abdominal pain, fever, and patients may develop more serious intestinal conditions
Subacute cutaneous lupus erythematosus (SCLE)
- Proton pump inhibitors are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE)
- If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care practitioner should consider stopping esomeprazole
- SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors
Risk of interstitial nephritis
- Interstitial nephritis has been reported on patience treated with esomeprazole. Interstitial nephritis may progress to acute kidney injury and/or chronic renal failure even after esomeprazole treatment discontinuation
Helicobacter pylori eradication
- When prescribing esomeprazole for eradication of Helicobacter pylori possible drug interactions for all components in the triple therapy should be considered
- Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when triple therapy is used in patients concurrently taking other medicines metabolised via CYP3A4, such as cisapride
Absorption of vitamin B12
- Esomeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy
Hypomagnesaemia
- Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like esomeprazole for at least three months, and in most cases for a year
- Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur, but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the esomeprazole
- For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment
Risk of fractures
- Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors
- Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of this increase may be due to other risk factors
- Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium
Serious cutaneous adverse reactions (SCARs)
- Serious cutaneous adverse reactions (SCARs) such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening, have been reported very rarely in association with esomeprazole treatment
- Patients should be advised of the signs and symptoms of the severe skin reaction EM/SJS/TEN/DRESS and should seek medical advice from their physician immediately when observing any indicative signs or symptoms
- Esomeprazole should be discontinued immediately upon signs and symptoms of severe skin reactions and additional medical care/close monitoring should be provided as needed. Re-challenge should not be undertaken in patients with EM/SJS/TEN/DRESS
Excipients with known effect
- Esomeprazole contains sucrose and dextrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take esomeprazole. Esomeprazole granules may be harmful to the teeth
Effects on ability to drive and use machines
- Esomeprazole may cause dizziness and blurred vision, thereby affecting the ability to drive or use machinery
Gastro-resistant tablets
Mild gastrointestinal complaints
- Esomeprazole as is not indicated for mild gastrointestinal complaints such as nervous dyspepsia
Malignancy
- In the presence of any alarm symptom (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis
Long treatment
- Regular monitoring of patients on long-term treatment (particularly those treated for more than a year) is recommended
Acute tubulointerstitial nephritis
- Acute interstitial nephritis (AIN)/acute tubulointerstitial nephritis has been observed in patients taking PPIs, such as esomeprazole, and may occur at any point during PPI therapy. Acute tubulointerstitial nephritis is characterised by an inflammatory reaction within the tubulointerstitial space of the kidney. Acute interstitial inflammatory reactions are associated with damage to the tubulointerstitium, leading to acute kidney injury (acute renal failure)
- Tubulointerstitial nephritis may be medicine-related, infectious, systemic, autoimmune, genetic, and idiopathic with the most common cause being related to a medication or medicine exposure. The risk of tubulointerstitial nephritis leading to chronic inflammation and reduced renal function associated with the use of protein pump inhibitors such as esomeprazole, is a class effect. Patients may present with non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). A delay in diagnosis and continued use of esomeprazole could lead to chronic kidney failure
- Healthcare professionals should frequently monitor renal function and check urine for haematuria and/or proteinuria. Patients should be advised to report any decrease in urine volumes or suspect that there is blood in their urine. Treatment with esomeprazole should be discontinued in patients with acute interstitial nephritis
Gastrointestinal infections
- Esomeprazole reduces gastric acidity which may increase gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with esomeprazole may lead to increased risk of gastrointestinal infections such as Salmonella and Campylobacter and also Clostridium difficile in hospitalised patients
- Clostridium difficile is a bacterium that can cause severe debilitating diarrhoea that does not improve. Symptoms may include watery stools, abdominal pain, fever, and patients may develop more serious intestinal conditions
Hypergastrinaemia
- Hypergastrinaemia may occur during treatment with esomeprazole
Vitamin absorption
- Esomeprazole may reduce the absorption of some vitamins such as vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy
Risk of fractures
- Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors
- Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of this increase may be due to other risk factors
- Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium
False-negative results
- Treatment with esomeprazole may cause false-negative results in the urea breath test for Helicobacter pylori infection
Coadministration with warfarin
- Prothrombin time and international normalised ratio (INR) should be monitored for increases in patients receiving esomeprazole and warfarin concurrently
On-demand therapy
- Patients on on-demand treatment should be instructed to contact their healthcare provider if their symptoms change in character
- When prescribing esomeprazole for on-demand therapy, the implications for interactions with other medicines, due to fluctuating plasma concentrations of esomeprazole, should be considered
Hypomagnesaemia
- Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like esomeprazole for at least three months, and in most cases for a year
- Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular dysrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI
- For patients expected to be on prolonged treatment or who take esomeprazole with digoxin or medicines that may cause hypomagnesaemia (e.g. diuretics), healthcare providers should consider measuring magnesium levels before starting esomeprazole treatment and periodically during treatment
CYP2C19 inhibition
- Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicines metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole
- Concomitant administration of clopidogrel and esomeprazole resulted in decreased exposure of the active metabolite of clopidogrel by an average of 40%. The maximum inhibition of (ADP induced) platelet aggregation decreased by an average of 14%. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged
Subacute cutaneous lupus erythematosus (SCLE)
- Proton pump inhibitors, such as esomeprazole, are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare provider should consider stopping esomeprazole
- SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors
Chromogranin A (CgA) increase
- During treatment with antisecretory medicines, serum gastrin increases in response to the decreased acid secretion. Also chromogranin A (CgA) increase due to decreased gastric acidity. Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours
- To avoid this interference, esomeprazole 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 esomeprazole treatment
Excipient warnings
- Esomeprazole contains sucrose and lactose. Patients with rare hereditary conditions such as fructose and/or galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take esomeprazole
Effects on ability to drive and use machines
- Esomeprazole can cause side effects, such as blurred vision and dizziness
- Caution is advised before driving a vehicle or operating machinery or performing any tasks that require concentration, until the effects of esomeprazole are known
Adult dosage (ZA)
Forms avail. in SA and covered in this monograph: gra, fct, tab
South African registered indications and dosages
Gastro-oesophageal reflux disease (GORD)
- Treatment of erosive reflux oesophagitis
- Oral (fct, tab): 40mg, once daily; Treatment duration: 4 weeks; An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed, or who have persistent symptoms
- Long-term management of patients with healed oesophagitis to prevent relapse
- Oral (fct, tab): 20mg, once daily
- Symptomatic treatment of gastro-oesophageal reflux disease (GORD)
- Oral (fct, tab): 20mg, once daily in patients without oesophagitis; If symptom control has not been achieved after 4 weeks, the patients should be further investigated; Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen: 20mg, once daily, when needed
Patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy
- Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk
- Oral (fct, tab): 20mg or 40mg, once daily
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori
- Healing of Helicobacter pylori associated duodenal ulcer
- Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcer disease
- Oral (fct, tab): 20mg, omeprazole with 1g amoxicillin and 500mg clarithromycin, twice daily; Treatment duration: 7 days
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion
- Oral (fct, tab): Initial: 40mg, twice daily; Then adjust dose individually and treatment should be continued as long as clinically indicated; Doses up to 120mg, twice daily have been administered
Method of administration (tablets):
Esomeprazole tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. The tablets can also be dispersed in half a glass of non-carbonated water. No other liquids may be used. Stir until the tablets disintegrate and drink the liquid with the with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed. For patients who cannot swallow the tablets, the tablets can be dispersed in non-carbonated water and administered through a gastric tube
Paediatric dosage (ZA)
Paed. forms avail. in SA and covered in this monograph: gra, fct, tab
South African registered indications and dosages
Gastro-oesophageal reflux disease (GORD)
- Treatment of erosive reflux oesophagitis
Children under 1 year
- Not established for use
Children between 1-11 years
- Oral (gra): <20kg: Recommended dose: 10mg, once daily; Treatment duration: 8 weeks
- Oral (gra): ≥20kg: Recommended dose: 10-20mg, once daily; Treatment duration: 8 weeks
Adolescents between 12-18 years
- See adult dosage (fct, tab)
- Symptomatic treatment of Gastro-oesophageal reflux disease (GORD)
Children under 1 year
- Not established for use
Children between 1-11 years
- Oral (gra): Recommended dose: 10mg, once daily; Treatment duration: 8 weeks
Adolescents between 12-18 years
- See adult dosage (fct, tab)
- Long-term management of patients with healed oesophagitis to prevent relapse
Children under 1 year
- Not established for use
Children between 1-11 years
- Oral (gra): Recommended dose: 10mg, once daily
Adolescents between 12-18 years
- See adult dosage (fct, tab)
Esomeprazole granules should not be used in children less than a year old since no data is available
The safety and efficacy of esomeprazole tablets in children younger than 12 years of age has not been established. No data is available
Doses over 1mg/kg have not been studied (gra)
Method of administration (granules):
For oral use. The contents of the 10mg sachet should be emptied into a container containing a tablespoon (15ml) of water. Stir the contents and leave for a few minutes to thicken. Stir again and drink within 30 minutes. If any material remains after drinking, add more water, stir, and drink immediately
For patients who have a nasogastric or gastric tube in place, the contents of the sachet can be added to a syringe containing 15ml of water. Immediately shake the syringe and leave for a few minutes to thicken. Shake the syringe and inject through the nasogastric or gastric tube within 30 minutes. Refill the syringe with an equal amount of water and shake and flush any remaining contents from the nasogastric or gastric tube into the stomach
Method of administration (tablets):
Esomeprazole tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. The tablets can also be dispersed in half a glass of non-carbonated water. No other liquids may be used. Stir until the tablets disintegrate and drink the liquid with the with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed. For patients who cannot swallow the tablets, the tablets can be dispersed in non-carbonated water and administered through a gastric tube
Pregnancy & lactation
Pregnancy
South African recommendations
Granules for oral suspension
- Caution
- Safety during pregnancy has not been established
Gastro-resistant tablets
- Caution
- Safety during pregnancy has not been established
- Clinical data on exposed pregnancies with esomeprazole are insufficient. With the racemic mixture omeprazole data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect
- Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/foetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development
- Caution should be exercised when prescribing to pregnant women. A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or foeto/neonatal toxicity of esomeprazole. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
Breastfeeding
South African recommendations
Granules for oral suspension
- Caution
- Safety during lactation has not been established
Gastro-resistant tablets
- Caution; not recommended
- It is not known whether esomeprazole is excreted in human breast milk. There is insufficient information on the effects of esomeprazole in newborns/infants
- Esomeprazole should not be used during breastfeeding
Fertility
South African recommendations
Granules for oral suspension
- No information available
Gastro-resistant tablets
- Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility
Renal impairment
South African recommendations
- Mild to moderate: No dose adjustment recommended
- Severe: Caution; no dose adjustment recommended
Use with caution in patients with severe renal insufficiency due to limited experience in these patients
Hepatic impairment
South African recommendations
- Mild to moderate: No dose adjustment recommended
- Severe: Caution; dose adjustment recommended
Max. daily dose: 20mg
Elderly
South African recommendations
- Caution; no dose adjustment recommended
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors
Adverse reactions
Blood and Lymphatic System Disorders
Less frequent
- Leukopenia
- Thrombocytopenia
- Agranulocytosis
- Pancytopenia
Immune System Disorders
Less frequent
- Hypersensitivity reactions e.g. angioedema, bronchospasm
- Anaphylactic reaction/shock
Metabolism and Nutrition Disorders
Less frequent
- Hyponatraemia
- Hypomagnesaemia
- Severe hypomagnesaemia may result in hypocalcaemia, hypomagnesaemia may also result in hypokalaemia
Psychiatric Disorders
Less frequent
- Insomnia
- Somnolence
- Agitation
- Confusion
- Depression
- Aggression
- Hallucinations
Nervous System Disorders
Frequent
- Headache
Less frequent
- Dizziness
- Paraesthesia
Eye Disorders
Less frequent
- Blurred vision
- Eye disorders
Ear and Labyrinth Disorders
Less frequent
- Vertigo
- Tinnitus
Cardiac Disorders
Less frequent
- Angina
- Tachycardia
- Bradycardia
Respiratory, Thoracic and Mediastinal Disorders
Less frequent
- Respiratory infection
- Sinusitis
- Cough
Gastrointestinal Disorders
Frequent
- Abdominal pain
- Diarrhoea
- Flatulence
- Nausea/vomiting
- Constipation
- Dyspepsia
Less frequent
- Dry mouth
- Taste disturbance
- Stomatitis
- Gastrointestinal candidiasis
- Pancreatitis
- Fundic gland polyps (benign)
- Gastrointestinal infections
- Microscopic colitis
Hepato-Biliary Disorders
Less frequent
- Increased liver enzymes
- Hepatitis
- Jaundice
- Hepatic encephalopathy
- Hepatic failure
Skin and Subcutaneous Tissue Disorders
Frequent
- Rash
Less frequent
- Dermatitis
- Pruritus
- Urticaria
- Alopecia
- Photosensitivity
- Bullous eruption
- Increased sweating
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Erythema multiforme
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis (TEN)
- Subacute cutaneous lupus erythematosus (SCLE)
Musculoskeletal, Connective Tissue and Bone Disorders
Less frequent
- Back pain
- Arthralgia
- Myalgia
- Musclar weakness
- Myopathy
- Fracture of the hip, wrist or spine
Renal and Urinary Disorders
Less frequent
- Acute interstitial nephritis/acute tubulointerstitial nephritis (which could lead to acute kidney injury and/or chronic renal failure)
- Urinary disorders
Reproductive System and Breast Disorders
Less frequent
- Gynaecomastia
- Impotence
General Disorders and Administration Site Conditions
Less frequent
- Fever
- Peripheral oedema
- Malaise
- Fatigue
Interactions
- Atazanavir
- Nelfinavir
- Clopidogrel
- Saquinavir
- Tipranavir
- Medicines with a gastric pH dependent absorption
- Ketoconazole
- Itraconazole
- Erlotinib
- Digoxin
- Diazepam
- Citalopram
- Imipramine
- Clomipramine
- Phenytoin
- Warfarin
- Cilostazol
- High dose methotrexate
- Tacrolimus
- CYP3A4 inhibitors
- Clarithromycin
- CYP2C19 inhibitors
- Voriconazole
- CYP2C19 inducers
- CYP3A4 inducers
- Rifampicin
Other interactions
- St. John's Wort
- Vitamin B12 (absorption affected)
- Interference with laboratory tests
- Investigations for neuroendocrine tumours, see Warnings and Precautions
Monitoring
None routine. Specific cases may require
- Renal function
- Check urine for haematuria and/or proteinuria - Serum magnesium levels
- Digoxin levels (when coadministered)
- Prothrombin time and international normalised ratio (when coadministered with warfarin)
- Plasma concentrations of phenytoin (when coadministered)
- Tacrolimus concentrations (when coadministered)
Additional observations
- Symptoms and signs of fracture
- Assess osteoporosis risk especially with long-term therapy - Signs and symptoms of severe skin reactions
Mechanism of action
Esomeprazole is the S-isomer of omeprazole. Omeprazole consists of both R- and S-isomers which have similar pharmacodynamic activities. Esomeprazole reduces gastric acid secretion through the specific inhibition of the enzyme H+,K+-ATPase, which is the acid pump in the parietal cells of the stomach. It accumulates in the acidic secretory canaliculi where it is concentrated, converted into the active form and inhibits both basal and stimulated acid secretion. The activated form irreversibly inactivates the pump molecule, and acid secretion only resumes after new pump molecules are synthesised, which provides prolonged suppression of acid secretion.
Dosage forms
- Tablet
- Granules
- Tablet, in blister pack
- Film-coated tablet
Formulation
Tablet 20mg
- Esotab 20mg (Forrester Pharma)
- Nectizole (Abex)
- Nesopram (Ranbaxy)
- Nexiflux (Abex)
- Nexipraz (Ranbaxy)
- Nexiam (AstraZeneca) originator
- Nexmezol (Sandoz)
- Nexomep (Sandoz)
- Trustan (Pharmacare Limited)
Tablet 40mg
- Esotab 40mg (Forrester Pharma)
- Mitogut 40 (Dr Reddy's)
- Nectizole (Abex)
- Nesopram (Ranbaxy Pharmaceuticals)
- Nexiflux (Abex)
- Nexipraz (Ranbaxy Pharmaceuticals)
- Nexiam (AstraZeneca) originator
- Nexmezol (Sandoz)
- Nexomep (Sandoz)
- Trustan (Pharmacare Limited)
Sachet 2.5mg
- Nexiam (AstraZeneca) originator
Sachet 5mg
- Nexiam (AstraZeneca) originator
Sachet 10mg
- Nexiam (AstraZeneca) originator
Injection (per vial) 40mg
- Aspepraz (Pharmacare)
- Nexiam (AstraZeneca) originator
- Nexipraz (Ranbaxy Pharmaceuticals)
- Truloc IV 40mg (Pharma Dynamics)
COMBINATION PREPARATIONS
Naproxen/ Esomeprazole
Tablet 500mg/20mg
- Vimovo (AstraZeneca) originator
References
1. PI - ESOMEPRAZOLE 10 GRANULES CIPLA 10 mg, granules for oral suspension, CIPLA MEDPRO (PTY) LTD - First Auth. 21 May 2024 [received from Business Solns 31 March 2026 ] 2. PI - PEPTIMEP 20 & PEPTIMEP 40 gastro-resistant tablets, Unimed Healthcare (Pty) Ltd - DATE OF REVISION OF THE TEXT 17 February 2026 Downloaded online 16 April 2026 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2026/03/m1-3-1-1-1-pi-approved.pdf] 3. SAIDS - Medication Check - Drug Free Sport - Esomeprazole Cipla Tablets, IV Injection, 10 Granules - Donwloaded online 20 April 2026 4. NAPOS - A02BC05 - Esomeprazole DRUGS FOR ACID RELATED DISORDERS - Downloaded online 21 April 2026 [https://www.drugs-porphyria.org/]
Brands & products
75 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days oldFctGeneric· 6 products
from R7.29/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Nextell Otc | 20 mg | 14 | S2 | R102.03 | R7.29 | R47.18 | 3010271001 |
| Nexilok 20 | 20 mg | 28 | S4 | R372.96 | R13.32 | R127.81 | 3005340001 |
| Nexgastro 20 | 20 mg | 14 | S2 | R192.14 | R13.72 | R78.36 | 3010272001 |
| Esomeprazole 20 Mg Cipla | 20 mg | 28 | S4 | R406.70 | R14.53 | R137.09 | 3005694001 |
| Nexilok 40 | 40 mg | 28 | S4 | R530.20 | R18.94 | R162.46 | 3005341001 |
| Esomeprazole 40 Mg Cipla | 40 mg | 28 | S4 | R553.83 | R19.78 | R165.94 | 3005695001 |
injectionGeneric· 10 products
from R7.36/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Hetenex 40 Injection | 40 mg | 5 | S4 | R367.93 | R7.36 | R126.43 | 3010500001 |
| Nexipraz iv powder for solution vial | 40 mg | 5 | S4 | R395.76 | R7.92 | R134.08 | 723472001 |
| Esomeprazole 40 Iv Cipla | 40 mg | 5 | S4 | R468.76 | R9.38 | R154.17 | 3006935002 |
| Mitogut 40 | 40 mg | 5 | S4 | R639.06 | R12.78 | R178.48 | 3000560001 |
| Esomeprazole 40 Iv Cipla | 40 mg | 5 | S4 | R66.27 | R13.25 | R34.81 | 3006935001 |
| Aspepraz powder for solution vial | 40 mg | 5 | S4 | R802.35 | R16.05 | R202.50 | 723621001 |
| Nexiam iv vial | 40 mg | 5 | S4 | R1321.58 | R26.43 | R278.89 | 704470002 |
| Nexiam 40Mg Iv | 40 mg | 5 | S4 | R980.64 | R39.23 | R228.73 | 704470001 |
| Truloc Iv 40 Mg | 40 mg | 10 | S4 | R461.34 | R46.13 | R152.12 | 3004946001 |
| Esomeprazole 40 Mg Cospharm | 40 mg | 1 | S4 | R75.57 | R75.57 | R38.03 | 3008042001 |
tabletGeneric· 53 products
from R8.94/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Vimovo 500/20mg | 20 mg | 60 | S4 | R536.27 | R8.94 | R163.36 | 718724002 |
| Vimovo 500/20mg | 20 mg | 30 | S4 | R292.01 | R9.73 | R105.54 | 718724001 |
| Trusfluks 20 | 20 mg | 28 | S4 | R284.27 | R10.15 | R103.41 | 3009659001 |
| Truloc 20 Mg | 20 mg | 30 | S4 | R361.76 | R12.06 | R124.73 | 3005139002 |
| Fluxtrin 20 | 20 mg | 30 | S4 | R376.32 | R12.54 | R128.74 | 3005257001 |
| Omiflynt | 20 mg | 28 | S2 | R351.92 | R12.57 | R122.02 | 718879002 |
| Jubigord 20 | 20 mg | 30 | S4 | R394.96 | R13.17 | R133.86 | 3006963001 |
| Esocid 20 | 20 mg | 14 | S2 | R185.46 | R13.25 | R76.05 | 3008574001 |
| Truloc 20 Mg | 20 mg | 14 | S4 | R187.29 | R13.38 | R76.68 | 3005139001 |
| Omiflynt | 20 mg | 14 | S2 | R193.93 | R13.85 | R78.98 | 718879001 |
| Trusfluks 40 | 40 mg | 28 | S4 | R388.91 | R13.89 | R132.20 | 3009660001 |
| Nectizole | 20 mg | 30 | S4 | R419.30 | R13.98 | R140.56 | 721061001 |
| Fluxtrin Otc | 20 mg | 14 | S2 | R196.51 | R14.04 | R79.87 | 3008323001 |
| Esomeprazole 20 Unicorn | 20 mg | 28 | S4 | R395.68 | R14.13 | R134.06 | 3006887002 |
| Jubigord 20 | 20 mg | 14 | S4 | R202.87 | R14.49 | R81.02 | 3006963002 |
| Nextell 20 Mg | 20 mg | 28 | S4 | R406.70 | R14.53 | R137.09 | 3004572002 |
| Nectizole Otc 20 | 20 mg | 14 | S2 | R204.44 | R14.60 | R81.45 | 3008881001 |
| Nesopram 20 | 20 mg | 30 | S4 | R441.88 | R14.73 | R146.77 | 721089001 |
| Nexes Otc | 20 mg | 14 | S2 | R212.66 | R15.19 | R83.71 | 3006955001 |
| Esomeprazole 20 Unicorn | 20 mg | 14 | S4 | R215.23 | R15.37 | R84.42 | 3006887001 |
| Nexipraz Otc | 20 mg | 14 | S2 | R215.26 | R15.38 | R84.43 | 3005630001 |
| Peptimep 20 | 20 mg | 30 | S4 | R463.57 | R15.45 | R152.74 | 3002447001 |
| Nexipraz | 20 mg | 30 | S4 | R469.41 | R15.65 | R153.52 | 720753001 |
| Nexiflux | 20 mg | 30 | S4 | R475.50 | R15.85 | R154.41 | 721056003 |
| Nexiflux | 20 mg | 28 | S4 | R448.12 | R16.00 | R148.49 | 721056001 |
| Nectizole Otc 20 | 20 mg | 7 | S2 | R112.20 | R16.03 | R50.70 | 3008881002 |
| Nexomep | 20 mg | 28 | S4 | R450.15 | R16.08 | R149.05 | 721578001 |
| Trustan | 20 mg | 28 | S4 | R457.88 | R16.35 | R151.17 | 720215002 |
| Nexipraz Otc | 20 mg | 7 | S2 | R118.19 | R16.88 | R52.77 | 3005630002 |
| Nexiflux | 20 mg | 14 | S4 | R241.44 | R17.25 | R91.63 | 721056002 |
| + 23 more tablet products (not shown) | |||||||
infusionGeneric· 2 products
from R9.64/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Nectizole Iv | 40 mg | 5 | S4 | R241.01 | R9.64 | R91.51 | 3005653002 |
| Nectizole Iv | 40 mg | 5 | S4 | R63.88 | R12.78 | R33.98 | 3005653001 |
sachetGeneric· 4 products
from R19.16/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Esomeprazole 10 Granules Cipla | 10 mg | 30 | S4 | R574.92 | R19.16 | R169.04 | 3010264001 |
| Nexiam | 10 mg | 28 | S4 | R704.38 | R25.16 | R188.09 | 715868001 |
| Nexiam | 5 mg | 28 | S4 | R704.38 | R25.16 | R188.09 | 720053001 |
| Nexiam | - mg | 28 | S4 | R704.38 | R25.16 | R188.09 | 720048001 |
- Aspepraz
- Esotab
- Mitogut 40
- Nectizole
- Nesopram
- Nexiam
- Nexiflux
- Nexmezol
- Nexipraz
- Nexomep
- Truloc
- Trustan
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.