Drug Class Description
Proton pump inhibitors (PPIs).
Generic Name
Omeprazole
Drug Description
Each capsule contains omeprazole 10, 20 or 40 mg.
Presentation
Hard gelatin capsules.Losec Capsules 10mg: hard gelatin capsules with an opaque pink body, marked 10 and an opaque pink cap marked A/OS in black ink. Each capsule contains omeprazole 10mg as enteric coated granules, with an aqueous based coating.Losec Capsules 20mg: hard gelatin capsules with an opaque pink body, marked 20 and an opaque reddish-brown cap marked A/OM in black ink. Each capsule contains omeprazole 20mg as enteric coated granules, with an aqueous based coating.Losec Capsules 40mg: hard gelatin capsules with an opaque reddish-brown body, marked 40 and an opaque reddish-brown cap marked A/OL in black ink. Each capsule contains omeprazole 40mg as enteric coated granules, with an aqueous based coating
Indications
Treatment of oesophageal reflux disease. In reflux oesophagitis the majority of patients are healed after 4 weeks. Symptom relief is rapid.Treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy.Relief of associated dyspeptic symptoms.Helicobacter pylori eradication: Omeprazole should be used in combination with antibiotics for eradication of Helicobacter pylori (Hp) in peptic ulcer disease.Prophylaxis of acid aspiration.Zollinger-Ellison syndrome.For 10 and 20mg Capsules only:Relief of reflux-like symptoms (e.g. heartburn) and/or ulcer-like symptoms (e.g. epigastric pain) associated with acid-related dyspepsia.Treatment and prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and gastroduodenal erosions in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment.Children over 1 year of age and 10 kg: Reflux oesophagitis. Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease.
Adult Dosage
AdultsOesophageal reflux disease including reflux oesophagitis The usual dosage is 20 mg Losec once daily. The majority of patients are healed after 4 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks treatment.Losec has also been used in a dose of 40 mg once daily in patients with reflux oesophagitis refractory to other therapy. Healing usually occurred within 8 weeks. Patients can be continued at a dosage of 20 mg once daily.Acid reflux diseaseFor long-term management Losec 10 mg once daily is recommended, increasing to 20 mg if symptoms return.Duodenal and benign gastric ulcersThe usual dose is 20 mg Losec once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. The majority of patients with benign gastric ulcer are healed after 8 weeks. In severe or recurrent cases the dose may be increased to 40 mg Losec daily. Long-term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dosage of 20 mg Losec once daily.For prevention of relapse in patients with duodenal ulcer the recommended dose is Losec 10 mg once daily, increasing to 20 mg once daily, if symptoms return.The following groups are at risk from recurrent ulcer relapse: those with Helicobacter pylori infection, younger patients (<60 years), those whose symptoms persist for more than one year and smokers. These patients will require initial long-term therapy with Losec 20 mg once daily, reducing to 10 mg once daily, if necessary.Helicobacter pylori (Hp) eradication regimens in peptic ulcer diseaseLosec is recommended at a dose of 40 mg once daily or 20 mg twice daily in association with antimicrobial agents as detailed below:Triple therapy regimens in duodenal ulcer disease:Losec and the following antimicrobial combinations:Amoxicillin 500 mg and metronidazole 400 mg both three times a day for one weekorClarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) both twice a day for one weekorAmoxicillin 1 g and clarithromycin 500 mg both twice a day for one week.Dual therapy regimens in duodenal ulcer disease:Losec and amoxicillin 750 mg to 1 g twice daily for two weeks. Alternatively, Losec and clarithromycin 500 mg three times a day for two weeks.Dual therapy regimens in gastric ulcer disease:Losec and amoxicillin 750 mg to 1 g twice daily for two weeks.In each regimen if symptoms return and the patient is Hp positive, therapy may be repeated or one of the alternative regimens can be used; if the patient is Hp negative then see dosage instructions for acid reflux disease.To ensure healing in patients with active peptic ulcer disease, see further dosage recommendations for duodenal and benign gastric ulcer.Prophylaxis of acid aspirationFor patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is Losec 40 mg on the evening before surgery followed by Losec 40 mg 2-6 hours prior to surgery.Zollinger-Ellison syndromeThe recommended initial dosage is 60 mg Losec once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given twice daily.For 10 and 20mg Capsules only:Acid-related dyspepsiaThe usual dosage is Losec 10 mg or 20 mg once daily for 2-4 weeks depending on the severity and persistence of symptoms.Patients who do not respond after 4 weeks or who relapse shortly afterwards, should be investigated.For the treatment of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosionsThe recommended dosage of Losec is 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment.For the prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms in patients with a previous history of gastroduodenal lesions who require continued NSAID treatmentThe recommended dosage of Losec is 20 mg once daily.ElderlyDose adjustment is not required in the elderly.ChildrenReflux oesophagitisThe treatment time is 4–8 weeks.Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux diseaseThe treatment time is 2-4 weeks. If symptom control has not been achieved after 2-4 weeks the patient should be investigated further.The dosage recommendations are as follows:Age Weight Dosage 1 year of age10-20 kg10 mg once daily. The dosage can be increased to 20 mg once daily if needed 2 years of age> 20 kg20 mg once daily. The dosage can be increased to 40 mg once daily if needed.Children over 4 years of ageIn combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori. When selecting appropriate combination therapy consideration should be given to official 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.WeightDosage15-30 kgCombination with two antibiotics: Losec 10 mg, amoxicillin 25mg/kg body weight and clarithromycin 7.5 mg/kg body weight are all administered together 2 times daily for 1 week30-40 kgCombination with two antibiotics: Losec 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administered 2 times daily for 1 week.>40 kgCombination with two antibiotics: Losec 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administered 2 times daily for 1 week.Impaired renal functionDose adjustment is not required in patients with impaired renal function.Impaired hepatic functionAs bioavailability and half-life can increase in patients with impaired hepatic function, the dose requires adjustment with a maximum daily dose of 20 mg.For patients (including children aged 1 year and above who can drink or swallow semisolid food) who are unable to swallow Losec Capsules The capsules may be opened and the contents swallowed directly with half a glass of water or suspended in 10 ml of noncarbonated water, any fruit juice with a pH less than 5 e.g. apple, orange, pineapple, or in applesauce or yoghurt and swallowed after gentle mixing. The dispersion should be taken immediately or within 30 minutes. Stir just before drinking and rinse it down with half a glass of water. Alternatively the actual capsules may be sucked and then swallowed with half a glass of water. There is no evidence to support the use of sodium bicarbonate buffer as a delivery form. It is important that the contents of the capsules should not be crushed or chewed.
Child Dosage
Over 2 years with severe ulcerating reflux oesophagitis only, 0 .7 -1 .4 mg/kg daily for 4 - 12 weeks; maximum 40 mg daily.
Contra Indications
Known hypersensitivity to omeprazole or to any of the other constituents of the formulation.When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with Losec is instituted, as treatment may alleviate symptoms and delay diagnosis.Omeprazole like other PPIs should not be administered with atazanavir
Special Precautions
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.Some children with chronic illnesses may require long-term treatment although it is not recommended.Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Interactions
Diazepam, phenytoin, warfarin, digoxin, ketoconazole, itraconazole.
Adverse Reactions
Losec is well tolerated and adverse reactions have generally been mild and reversible. The following have been reported as adverse events in clinical trials or reported from routine use, but in many cases a relationship to treatment with omeprazole has not been established.The following definitions of frequencies are used: Common> 1/100Uncommon> 1/1000 and < 1/100Rare< 1/1000CommonCentral and peripheral nervous systemHeadacheGastrointestinalDiarrhoea, constipation, abdominal pain, nausea/vomiting and flatulenceUncommonCentral and peripheral nervous systemDizziness, paraesthesia, light headedness, feeling faint, somnolence, insomnia and vertigoHepaticIncreased liver enzymesSkin Rash, dermatitis and/or pruritus. urticariaOtherMalaiseRareCentral and peripheral nervous systemReversible mental confusion, agitation, aggression, depression and hallucinations, predominantly in severely ill patientsEndocrineGynaecomastiaGastrointestinalDry mouth, stomatitis and gastrointestinal candidiasisHaematologicalLeukopenia, thrombocytopenia, agranulocytosis and pancytopeniaHepaticEncephalopathy in patients with preexisting severe liver disease; hepatitis with or without jaundice, hepatic failureMusculoskeletalArthritic and myalgic symptoms and muscular weaknessReproductive system and breast disordersImpotenceSkinPhotosensitivity, bullous eruption, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), alopeciaOtherHypersensitivity reactions e.g. angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Increased sweating, peripheral oedema, blurred vision, taste disturbance and hyponatraemiaThe 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. There are no long term data regarding the effects of omeprazole treatment on puberty and growth.
Manufacturer
AstraZeneca
Drug Availability
(POM)
Updated
22 November 2011
