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OMEPRAZOLE is a brand name for Omeprazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Omeprazole 10mg gastro-resistant capsules are indicated for: Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Treatment of duodenal ulcers The recommended dose in patients with an active duodenal ulcer is omeprazole 20mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period.
In patients with poorly responsive duodenal ulcer omeprazole 40mg once daily is recommended and healing is usually achieved within four weeks. Prevention of relapse of duodenal ulcers For the prevention of relapse of duodenal ulcer in H.
pylori negative patients or when H. pylori eradication is not possible the recommended dose is omeprazole 20mg once daily. In some patients a daily dose of 10mg may be sufficient. In case of therapy failure, the dose can be increased to 40mg.
Treatment of gastric ulcers The recommended dose is omeprazole 20mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.
In patients with poorly responsive gastric ulcer omeprazole 40mg once daily is recommended and healing is usually achieved within eight weeks. Prevention of relapse of gastric ulcers For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is omeprazole 20mg once daily.
If needed, the dose can be increased to omeprazole 40mg once daily. H. pylori eradication in peptic ulcer disease For the eradication of H. pylori the selection of antibiotics should consider the individual patient’s drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.
• omeprazole 20mg + clarithromycin 500mg + amoxicillin 1,000mg, each twice daily for one week, or • omeprazole 20mg + clarithromycin 250mg (alternatively 500mg) + metronidazole 400mg (or 500mg or tinidazole 500mg), each twice daily for one week or • omeprazole 40mg once daily with amoxicillin 500mg and metronidazole 400mg (or 500mg or tinidazole 500mg), both three times a day for one week.
In each regimen, if the patient is still H. pylori positive, therapy may be repeated. Treatment of NSAID-associated gastric and duodenal ulcers For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is omeprazole 20mg once daily.
Summary of the safety profile The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting. 4). Tabulated list of adverse reactions The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing.
None was found to be dose- related. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Frequency categories are defined according to the following convention:
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data). g. fever, angioedema and anaphylactic reaction/shock Metabolism and nutrition disorders Rare: Hyponatraemia Not known: Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia.
Hypomagnesaemia may also be associated with hypokalaemia. 4) Musculoskeletal and connective tissue disorders Uncommon: Fracture of the hip, wrist or spine Rare: Arthralgia, myalgia Very rare: Muscular weakness Renal and urinary disorders Rare: Tubulointerstitial nephritis (with possible progression to renal failure) Reproductive system and breast disorders Very rare: Gynaecomastia General disorders and administration site conditions Uncommon: Malaise, peripheral oedema Rare: Increased sweating Paediatric population The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease.
There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive oesophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment.
g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.
5). g virus load) is recommended in combination with an increase in the dose of atazanavir to 400mg with 100mg of ritonavir; omeprazole 20mg should not be exceeded. Omeprazole, 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. Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered.
5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged. Severe hypomagnesaemia has been reported in patients treated with PPIs like omeprazole 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 PPI.
, diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported very rarely and rarely, respectively in association with omeprazole treatment.
1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period. Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in patients at risk (age > 60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is omeprazole 20mg once daily.
Treatment of reflux oesophagitis The recommended dose is omeprazole 20mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.
In patients with severe oesophagitis omeprazole 40mg once daily is recommended and healing is usually achieved within eight weeks. Long-term management of patients with healed reflux oesophagitis For the long-term management of patients with healed reflux oesophagitis the recommended dose is omeprazole 10mg once daily.
If needed, the dose can be increased to 20-40mg of omeprazole once daily. Treatment of symptomatic gastro-oesophageal reflux disease The recommended dose is omeprazole 20mg daily. Patients may respond adequately to 10mg daily, and therefore individual dose adjustment should be considered.
If symptom control has not been achieved after four weeks treatment with omeprazole 20mg daily, further investigation is recommended. Treatment of Zollinger-Ellison syndrome In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment continued as long as clinically indicated.
The recommended initial dose is omeprazole 60mg daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of omeprazole 20-120mg daily.
When dose exceed 80mg of omeprazole daily, the dose should be divided and given twice daily. Paediatric population Children over 1 year of age and ≥ 10 kg Treatment of reflux oesophagitis Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease The posology recommendations are as follows: Age Weight Posology ≥ 1 year of age 10-20 kg 10mg once daily.
The dose can be increased to 20mg once daily if needed ≥ 2 years of age > 20 kg 20mg once daily.
The dose can be increased to 40mg once daily if needed Reflux oesophagitis:
The treatment time is 4-8 weeks. Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease: The treatment time is 2–4 weeks. If symptom control has not been achieved after 2–4 weeks the patient should be investigated further.
Children and adolescents over 4 years of age Treatment of duodenal ulcer caused by H. pylori When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.
The treatment should be supervised by a specialist. 5mg/kg body weight are all administrated together two times daily for one week. 5mg/kg body weight […]
There are no long term data regarding the effects of omeprazole treatment on puberty and growth. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
8). Acute tubulointerstitial nephritis can progress to renal failure. Omeprazole should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated. Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of 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 professional should consider stopping Omeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. 1). If CgA gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Some children with chronic illnesses may require long-term treatment although it is not recommended. 1). As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Excipients Omeprazole contains sucrose and lactose anhydrous. Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.